Teveten 600mg Film-coated Tablets

1. Name Of The Medicinal Product

Teveten 600mg film-coated tablets.

2. Qualitative And Quantitative Composition

Eprosartan mesilate equivalent to 600mg eprosartan free base.

For excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablets.

Capsule-shaped, biconvex, white film-coated tablet with the inscription '5046'.

4. Clinical Particulars

4.1 Therapeutic Indications

Eprosartan is indicated for the treatment of essential hypertension.

4.2 Posology And Method Of Administration

The recommended dose is 600 mg eprosartan once daily.

The dose may be increased to 800 mg eprosartan once daily if further response is required. Achievement of maximal blood pressure reduction in most patients may take 2 to 3 weeks of treatment.

Eprosartan may be used alone or in combination with other anti-hypertensives, e.g. thiazide-type diuretics, calcium channel blockers, if a greater blood pressure lowering effect is required.

Eprosartan should be taken with food.

Elderly (>75 years): As clinical experience is limited in patients over 75 years, a starting dose of 300 mg once daily is recommended.

Dosage in hepatically impaired patients: There is limited experience in patients with hepatic impairment (see section 4.3 and section 5.2). In patients with mild to moderate hepatic impairment, a starting dose of 300 mg once daily is recommended.

Dosage in renally impaired patients: No dose adjustment is required in patients with creatinine clearance 60-80 ml/min. As clinical experience is limited in patients with creatinine clearance <60 ml/min, a starting dose of 300mg once daily is recommended (see section 4.4).

Children: As safety and efficacy in children have not been established, treatment of children is not recommended.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Second and third trimester of pregnancy (see sections 4.4 and 4.6).

Severe hepatic impairment.

Haemodynamically significant bilateral renovascular disease or severe stenosis of a solitary functioning kidney

4.4 Special Warnings And Precautions For Use

Hepatic impairment

When Eprosartan is used in patients with mild to moderate hepatic impairment, special care should be exercised due to the fact that there is limited experience in this patient population

Renal impairment

No dose adjustment is required in patients with mild to moderate renal insufficiency (creatinine clearance ≥ 30 ml/min). Caution is recommended for use in patients with creatinine clearance < 30 ml/min or in patients undergoing dialysis

Patients at risk of renal impairment

Patients whose renal function is dependent predominantly on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe cardiac insufficiency [NYHA-classification: class IV], bilateral renal artery stenosis, or renal artery stenosis of a solitary kidney) are at increased risk of developing oliguria and/or progressive azotaemia and rarely acute renal failure during therapy with an angiotensin converting enzyme (ACE) inhibitor. These events are more likely to occur in patients treated concomitantly with a diuretic. The possibility of similar effects cannot be excluded with angiotensin II receptor antagonists. When eprosartan is to be used in patients with renal impairment, renal function should be assessed before starting treatment with eprosartan and at intervals during the course of therapy. If worsening of renal function is observed during therapy, treatment with eprosartan should be reassessed.

Hypotension

Symptomatic hypotension may occur in patients with severe sodium depletion and/or volume depletion (e.g. high dose diuretic therapy). These conditions should be corrected before commencing therapy. There is an increased risk of severe hypotension when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medical products that affect the renin-angiotensin-aldosterone system.

Aortic and mitral valve stenosis or obstructive hypertrophic cardiomyopathy.

As with other vasodilators, special caution is indicated in patients suffering from haemodynamically relevant aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.

Primary hyperaldosteronism

Patients with primary hyperaldosteronism will not generally respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin-aldosterone system. Therefore, the use of Teveten is not recommended.

Hyperkalaemia

Although eprosartan has no significant effect on serum potassium there is no experience of concomitant administration with K-sparing diuretics or K-supplements. Consequently, as with other angiotensin II antagonists, the risk of hyperkalaemia when taken with K-sparing diuretics or K-supplements cannot be excluded. Regular monitoring for serum potassium levels is recommended when drugs that may increase potassium are administered with eprosartan in patients with renal impairment.

Pregnancy

Eprosartan should not be initiated during pregnancy. Unless continued Eprosartan therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with Eprosartan should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

Other conditions

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions have been observed. No effect on the pharmacokinetics of digoxin and the pharmacodynamics of warfarin or glyburide (glibenclamide) has been shown with eprosartan. Similarly no effect on eprosartan pharmacokinetics has been shown with ranitidine, ketoconazole or fluconazole.

Eprosartan has been safely used concomitantly with thiazide diuretics (e.g. hydrochlorothiazide) and calcium channel blockers (e.g. sustained-release nifedipine) without evidence of clinically significant adverse interactions. It has been safely co-administered with hypolipidaemic agents (e.g. lovastatin, simvastatin, pravastatin, fenofibrate, gemfibrozil, niacin).

Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. The possibility of a similar effect can not be excluded and careful monitoring of serum lithium levels is recommended during concomitant use.

Eprosartan has been shown not to inhibit human cytochrome P450 enzymes CYP1A, 2A6, 2C9/8, 2C19, 2D6, 2E and 3A in vitro.

Combination with NSAIDs: When Angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.

As with ACE inhibitors, concomitant use of Angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.

4.6 Pregnancy And Lactation

Pregnancy

The use of Eprosartan is not recommended during the first trimester of pregnancy (see section 4.4). The use of Eprosartan is contraindicated during second and third trimester of pregnancy (see sections 4.3 and 4.4).

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor blockers, similar risks may exist for this class of drugs. Unless continued Eprosartan therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with Eprosartan should be stopped immediately and, if appropriate, alternative therapy should be started.

Exposure to Eprosartan therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).

Should exposure to Eprosartan have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken Eprosartan should be closely observed for hypotension (see sections 4.3 and 4.4).

Lactation

Because no information is available regarding the use of Eprosartan during breast-feeding, Eprosartan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

4.7 Effects On Ability To Drive And Use Machines

The effect of eprosartan on the ability to drive and use machines has not been studied, but based on its pharmacodynamic properties, eprosartan is unlikely to affect this ability. When driving vehicles or operating machines, it should be taken into account, that occasionally dizziness or weariness may occur during treatment of hypertension.

4.8 Undesirable Effects

Clinical Trials

The most commonly reported adverse drug reactions of patients treated with eprosartan are headache and unspecific gastrointestinal complaints, occurring in approximately 11% and 8%, respectively, of patients.

ADVERSE EVENTS REPORTED DURING CLINICAL TRIALS IN PATIENTS TREATED WITH EPROSARTAN (n = 2316)

MedDRA system organ class	Very common	Common	Uncommon
Immune system disorders			Hypersensitivity
Nervous system disorders	Headache	Dizziness
Vascular disorders			Hypotension
Respiratory, thoracic and mediastinal disorders		Rhinitis
Gastrointestinal disorders		Flatulence and unspecific gastrointestinal complaints (e.g., nausea, diarrhoea, vomiting)
Skin and subcutaneous tissue disorders		Allergic skin reactions (e.g. rash, pruritus)	Angioedema
Musculoskeletal and connective tissue disorders		Arthralgia
General disorders and administration site reactions		Asthenia

Postmarketing experience

In addition to those adverse events reported during clinical trials, the following side effects have been reported spontaneously during postmarketing use of eprosartan. A frequency cannot be estimated from the available data (not known).

Renal and urinary disorders

Impaired renal function including renal failure in patients at risk.

Laboratory Findings

In placebo-controlled clinical studies, significantly elevated serum potassium concentrations were observed in 0.9% of patients treated with eprosartan and 0.3% of patients who received placebo.

Significantly low values of haemoglobin were observed in 0.1% and 0% patients treated with eprosartan and placebo respectively.

In rare cases elevations of BUN values were reported in patients treated with eprosartan. In rare cases increases in liver function values were also observed but were not considered to be causally related to eprosartan treatment.

4.9 Overdose

Limited data are available with regard to overdosage in humans. Eprosartan was well tolerated after oral dosing (maximum unit dose taken to date in humans 1200 mg) with no mortality in rats and mice up to 3000 mg/kg and in dogs up to 1000 mg/kg. The most likely manifestation of overdosage would be hypotension. If symptomatic hypotension occurs, supportive treatment should be instituted.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Eprosartan is a potent, synthetic, orally active non-biphenyl non-tetrazole angiotensin II receptor antagonist, which binds selectively to the AT₁ receptor. Angiotensin II is a potent vasoconstrictor and the primary active hormone of the renin-angiotensin-aldosterone system, playing a major part in the pathophysiology of hypertension. Angiotensin II binds to the AT₁ receptor in many tissues (e.g. smooth vascular musculature, suprarenals, kidney, heart) and produces important biological effects such as vasoconstriction, sodium retention and release of aldosterone. More recently, angiotensin II has been implicated in the genesis of cardiac and vascular hypertrophy through its effect on cardiac and smooth muscle cell growth.

Eprosartan antagonised the effect of angiotensin II on blood pressure, renal blood flow and aldosterone secretion in normal volunteers. In hypertensive patients, comparable blood pressure control is achieved when eprosartan is administered as a single dose or in two divided doses. In placebo-controlled studies, in 299 patients treated receiving 600-800 mg once daily, there was no evidence of first dose postural hypotension. Discontinuation of treatment with eprosartan does not lead to a rapid rebound increase in blood pressure.

Eprosartan was evaluated in mild to moderate hypertensive patients (sitting DBP

A dose of 1200 mg once daily, for 8 weeks, has been shown in 72 patients in clinical trials to be effective. In placebo-controlled studies using doses up to 1200 mg once daily, there is no apparent dose relationship in the incidence of adverse experiences reported.

In patients with hypertension, blood pressure reduction did not produce a change in heart rate.

In hypertensive patients eprosartan does not affect fasting triglycerides, total cholesterol, or LDL (low density lipoprotein) cholesterol levels. In addition, eprosartan has no effect on fasting blood sugar levels.

Eprosartan does not compromise renal autoregulatory mechanisms. In normal adult males eprosartan has been shown to increase mean effective renal plasma flow. Effective renal plasma flow is not altered in patients with essential hypertension and patients with renal insufficiency treated with eprosartan. Eprosartan does not reduce glomerular filtration rate in normal males, in patients with hypertension or in patients with varying degrees of renal insufficiency. Eprosartan has a natriuretic effect in normal subjects on a salt restricted diet.

Eprosartan does not significantly affect the excretion of urinary uric acid.

Eprosartan does not potentiate effects relating to bradykinin (ACE-mediated), e.g. cough. In a study specifically designed to compare the incidence of cough in patients treated with eprosartan and an angiotensin converting enzyme inhibitor, the incidence of dry persistent cough in patients treated with eprosartan (1.5%) was significantly lower (p<0.05) than that observed in patients treated with an angiotensin converting enzyme inhibitor (5.4%). In a further study investigating the incidence of cough in patients who had previously coughed while taking an angiotensin converting enzyme inhibitor, the incidence of dry, persistent cough was 2.6% on eprosartan, 2.7% on placebo, and 25.0% on an angiotensin converting enzyme inhibitor (p<0.01, eprosartan versus angiotensin converting enzyme inhibitor).

5.2 Pharmacokinetic Properties

Absolute bioavailability following a single 300 mg oral dose of eprosartan is about 13%, due to limited oral absorption. Eprosartan plasma concentrations peak at one to two hours after an oral dose in the fasted state. Plasma concentrations are dose proportional from 100 to 200 mg, but less than proportional for 400 and 800 mg doses. The terminal elimination half-life of eprosartan following oral administration is typically five to nine hours. A slight accumulation (14%) is seen with chronic use of eprosartan. Administration of eprosartan with food delays absorption with minor increases (<25%) observed in C_max and AUC.

Plasma protein binding of eprosartan is high (approximately 98%) and constant over the concentration range achieved with therapeutic doses. The extent of plasma protein binding is not influenced by gender, age, hepatic dysfunction or mild-moderate renal impairment but has shown to be decreased in a small number of patients with severe renal impairment.

Following oral and intravenous dosing with [¹⁴C] eprosartan in human subjects, eprosartan was the only drug-related compound found in the plasma and faeces. In the urine, approximately 20% of the radioactivity excreted was an acyl glucuronide of eprosartan with the remaining 80% being unchanged eprosartan.

The volume of distribution of eprosartan is about 13 litres. Total plasma clearance is about 130 ml/min. Biliary and renal excretion contribute to the elimination of eprosartan. Following intravenous [¹⁴C] eprosartan, about 61% of radioactivity is recovered in the faeces and about 37% in the urine. Following an oral dose of [¹⁴C] eprosartan, about 90% of radioactivity is recovered in the faeces and about 7% in the urine.

Both AUC and C_max values of eprosartan are increased in the elderly (on average, approximately two-fold).

Following administration of a single 100 mg dose of eprosartan, AUC values of eprosartan (but not C_max) are increased, on average, by approximately 40% in patients with hepatic impairment. Since an intravenous dose of eprosartan was not administered to patients with hepatic impairment, the plasma clearance of eprosartan could not be measured.

Compared to subjects with normal renal function (n=7), mean AUC and C_max values were approximately 30% higher in patients with creatinine clearance 30-59 ml/min (n=11) and approximately 50% higher in patients with creatinine clearance 5-29 ml/min (n=3).

In a separate investigation, mean AUC was approximately 60% higher in patients undergoing dialysis (n=9) compared to subjects with normal renal function (n=10).

There is no difference in the pharmacokinetics of eprosartan between males and females.

5.3 Preclinical Safety Data

General toxicology

Eprosartan given orally at dosages up to 1000 mg/kg per day for up to six months in rats and up to one year in dogs did not result in any significant drug-related toxicity.

Reprotoxicity

In pregnant rabbits, eprosartan has been shown to produce maternal and foetal mortality at 10 mg/kg per day during late pregnancy only. This is most likely due to effects on the renin angiotensin aldosterone system. Maternal toxicity but no foetal effects were observed at 3 mg/kg per day.

Genotoxicity

Genotoxicity was not observed in a battery of in vitro and in vivo tests.

Carcinogenicity

Carcinogenicity was not observed in rats and mice given up to 600 or 2000 mg/kg per day respectively for two years.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet cores

Lactose

Microcrystalline cellulose

Pregelatinised starch

Magnesium stearate

Crospovidone

Film-coat

Hypromellose

Titanium dioxide (E171)

Macrogol 400

Polysorbate 80

6.2 Incompatibilities

None known.

6.3 Shelf Life

PVC/Aclar blister packs:	36 months
HDPE bottles:	36 months

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep container in the outer carton.

6.5 Nature And Contents Of Container

Opaque PVC/Aclar blister packs containing 28 tablets or 56 tablets.

HDPE bottles containing 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Abbott Healthcare Products Limited

Mansbridge Road

West End

Southampton

SO18 3JD

8. Marketing Authorisation Number(S)

PL 00512/0165

9. Date Of First Authorisation/Renewal Of The Authorisation

29 November 1999/17 April 2003

10. Date Of Revision Of The Text

09/09/2011

LEGAL CATEGORY

POM

norfloxacin ophthalmic

Generic Name: norfloxacin ophthalmic (nor FLOX a sin off THAL mik)

Brand Names: Chibroxin

What is norfloxacin ophthalmic?

Norfloxacin ophthalmic is an antibiotic.

Norfloxacin ophthalmic is used to treat bacterial infections of the eyes.

Norfloxacin ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about norfloxacin ophthalmic?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.

If you wear contact lenses, ask your doctor if you should wear them during treatment. Norfloxacin ophthalmic can cause the development of crystals on contact lenses. After applying this medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Who should not use norfloxacin ophthalmic?

Do not use norfloxacin ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only. It is not known whether norfloxacin ophthalmic will harm an unborn baby. Do not use norfloxacin ophthalmic without first talking to your doctor if you are pregnant. It is also not known whether norfloxacin ophthalmic passes into breast milk. Do not use norfloxacin ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use norfloxacin ophthalmic?

Use norfloxacin ophthalmic eye drops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using the eye drops.

To apply the eye drops:

• 
  

  Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

  
  

If you are using norfloxacin ophthalmic to treat a corneal ulcer, you may notice a whitish buildup on the ulcer. This means that the medication is working; it is not a harmful development.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eye drop that is discolored or has particles in it. Store norfloxacin ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using norfloxacin ophthalmic?

Use caution when driving, operating machinery, or performing other hazardous activities. Norfloxacin ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment. Norfloxacin ophthalmic can cause the development of crystals on contact lenses. After applying this medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with norfloxacin ophthalmic unless otherwise directed by your doctor.

Norfloxacin ophthalmic side effects

Serious side effects are not expected with this medication.

If you are using norfloxacin ophthalmic to treat a corneal ulcer, you may notice a whitish buildup on the ulcer. This means that the medication is working; it is not a harmful development.

Commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling or crusting, a bad taste in your mouth, tearing, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Norfloxacin ophthalmic Dosing Information

Usual Adult Dose for Conjunctivitis:

Instill 1 or 2 drops to the affected eye(s) 4 times daily for up to 7 days. For severe infections, instill 1 or 2 drops to the affected eye(s) every 2 hours while awake on the first day.

Usual Pediatric Dose for Conjunctivitis:

1 year to 18 years: Instill 1 or 2 drops to the affected eye(s) 4 times daily for up to 7 days. For severe infections, instill 1 or 2 drops to the affected eye(s) every 2 hours while awake on the first day.

What other drugs will affect norfloxacin ophthalmic?

Do not use other eye drops or medications during treatment with norfloxacin ophthalmic unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with norfloxacin ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More norfloxacin ophthalmic resources

• Norfloxacin ophthalmic Dosage
• Norfloxacin ophthalmic Use in Pregnancy & Breastfeeding
• Norfloxacin ophthalmic Support Group
• 0 Reviews for Norfloxacin - Add your own review/rating

Compare norfloxacin ophthalmic with other medications

• Conjunctivitis
• Ophthalmic Surgery

Where can I get more information?

• Your pharmacist has additional information about norfloxacin ophthalmic written for health professionals that you may read.

Coversyl Arginine Plus

1. Name Of The Medicinal Product

COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablets

2. Qualitative And Quantitative Composition

One film-coated tablet contains 3.395 mg perindopril corresponding to 5 mg perindopril arginine and 1.25 mg indapamide.

Excipient : 71.33 mg lactose monohydrate

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

White, rod-shaped film-coated tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of essential hypertension, COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet is indicated in patients whose blood pressure is not adequately controlled on perindopril alone.

4.2 Posology And Method Of Administration

Oral route

One COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet per day as a single dose, preferably to be taken in the morning, and before a meal.

When possible individual dose titration with the components is recommended. COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet should be used when blood pressure is not adequately controlled on COVERSYL ARGININE PLUS 2.5mg/0.625mg film-coated tablet (where available). When clinically appropriate, direct change from monotherapy to COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet may be considered.

Elderly (see section 4.4)

Treatment should be initiated after considering blood pressure response and renal function.

Patients with renal impairment (see section 4.4)

In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contra-indicated.

In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), it is recommended to start treatment with the adequate dosage of the free combination.

In patients with creatinine clearance greater than or equal to 60 ml/min, no dose modification is required. Usual medical follow-up will include frequent monitoring of creatinine and potassium.

Patients with hepatic impairment (see sections 4.3, 4.4 and 5.2)

In severe hepatic impairment, treatment is contra-indicated.

In patients with moderate hepatic impairment, no dose modification is required.

Children and adolescents

COVERSYL ARGININE PLUS 5mg/1.25mg should not be used in children and adolescents as the efficacy and tolerability of perindopril in children and adolescents, alone or in combination, have not been established.

4.3 Contraindications

Linked to perindopril:

-	Hypersensitivity to perindopril or any other ACE inhibitor
-	History of angioedema (Quincke's oedema) associated with previous ACE inhibitor therapy
-	Hereditary/idiopathic angioedema
-	Second and third trimesters of pregnancy (see sections 4.4 and 4.6)

Linked to indapamide:

-	Hypersensitivity to indapamide or to any other sulphonamides
-	Severe renal impairment (creatinine clearance below 30 ml/min)
-	Hepatic encephalopathy
-	Severe hepatic impairment
-	Hypokalaemia
-	As a general rule, this medicine is inadvisable in combination with non antiarrhythmic agents causing torsades de pointes (see section 4.5)
-	Lactation (see section 4.6).

Linked to COVERSYL ARGININE PLUS 5mg/1.25mg:

-	Hypersensitivity to any of the excipients

Due to the lack of sufficient therapeutic experience, COVERSYL ARGININE PLUS 5mg/1.25mg should not be used in:

-	Dialysis patients
-	Patients with untreated decompensated heart failure.

4.4 Special Warnings And Precautions For Use

Special warnings

Common to perindopril and indapamide:

Lithium:

The combination of lithium and the combination of perindopril and indapamide is usually not recommended (see section 4.5).

Linked to perindopril:

Neutropenia/agranulocytosis:

Neutropenia/agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely. Perindopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function. Some of these patients developed serious infections which in a few instances did not respond to intensive antibiotic therapy. If perindopril is used in such patients, periodical monitoring of white blood cell counts is advised and patients should be instructed to report any sign of infection (e.g. sore throat, fever).

Hypersensitivity/angioedema:

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with angiotensin converting enzyme inhibitors, including perindopril. This may occur at any time during treatment. In such cases perindopril should be discontinued promptly and appropriate monitoring should be instituted to ensure complete resolution of symptoms prior to dismissing the patient. In those instances where swelling has been confined to the face and lips the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms.

Angioedema associated with laryngeal oedema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, which may include subcutaneous epinephrine solution 1:1000 (0.3 ml to 0.5 ml) and/or measures to ensure a patent airway, should be administered promptly.

Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks.

Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see section 4.3).

Intestinal angioedema has been reported rarely in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan, or ultrasound or at surgery and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

Anaphylactoid reactions during desensitisation:

There have been isolated reports of patients experiencing sustained, life-threatening anaphylactoid reactions while receiving ACE inhibitors during desensitisation treatment with hymenoptera (bees, wasps) venom. ACE inhibitors should be used with caution in allergic patients treated with desensitisation, and avoided in those undergoing venom immunotherapy. However these reactions could be prevented by temporary withdrawal of ACE inhibitor for at least 24 hours before treatment in patients who require both ACE inhibitors and desensitisation.

Anaphylactoid reactions during LDL apheresis:

Rarely, patients receiving ACE inhibitors during low density lipoprotein (LDL)-apheresis with dextran sulphate have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE-inhibitor therapy prior to each apheresis.

Haemodialysis patients:

Anaphylactoid reactions have been reported in patients dialysed with high-flux membranes (e.g., AN 69®) and treated concomitantly with an ACE inhibitor. In these patients consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.

Potassium-sparing diuretics, potassium salts:

The combination of perindopril and potassium-sparing diuretics, potassium salts is usually not recommended (see section 4.5).

Pregnancy and lactation:

ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

Use of perindopril is not recommended during breast-feeding.

Linked to indapamide:

When liver function is impaired, thiazide diuretics and thiazide-related diuretics may cause hepatic encephalopathy. Administration of the diuretic should be stopped immediately if this occurs.

Photosensitivity:

Cases of photosensitivity reactions have been reported with thiazides and related thiazides diuretics (see section 4.8). If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.

Precautions for use

Common to perindopril and indapamide:

Renal impairment:

In cases of severe renal impairment (creatinine clearance < 30 ml/min), treatment is contra-indicated.

In certain hypertensive patients without pre-existing apparent renal lesions and for whom renal blood tests show functional renal insufficiency, treatment should be stopped and possibly restarted either at a low dose or with one constituent only.

In these patients usual medical follow-up will include frequent monitoring of potassium and creatinine, after two weeks of treatment and then every two months during therapeutic stability period. Renal failure has been reported mainly in patients with severe heart failure or underlying renal failure including renal artery stenosis.

The drug is usually not recommended in case of bilateral renal artery stenosis or a single functioning kidney.

Hypotension and water and electrolyte depletion:

There is a risk of sudden hypotension in the presence of pre-existing sodium depletion (in particular in individuals with renal artery stenosis). Therefore systematic testing should be carried out for clinical signs of water and electrolyte depletion, which may occur with an inter-current episode of diarrhoea or vomiting. Regular monitoring of plasma electrolytes should be carried out in such patients.

Marked hypotension may require the implementation of an intravenous infusion of isotonic saline.

Transient hypotension is not a contra-indication to continuation of treatment. After re-establishment of a satisfactory blood volume and blood pressure, treatment can be started again either at a reduced dose or with only one of the constituents.

Potassium levels:

The combination of perindopril and indapamide does not prevent the onset of hypokalaemia particularly in diabetic patients or in patients with renal failure. As with any antihypertensive agent containing a diuretic, regular monitoring of plasma potassium levels should be carried out.

Excipients:

COVERSYL ARGININE PLUS 5mg/1.25mg should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Linked to perindopril:

Cough:

A dry cough has been reported with the use of angiotensin converting enzyme inhibitors. It is characterised by its persistence and by its disappearance when treatment is withdrawn. An iatrogenic aetiology should be considered in the event of this symptom. If the prescription of an angiotensin converting enzyme inhibitor is still preferred, continuation of treatment may be considered.

Children and adolescents:

The efficacy and tolerability of perindopril in children and adolescents, alone or in combination, have not been established.

Risk of arterial hypotension and/or renal insufficiency (in cases of cardiac insufficiency, water and electrolyte depletion, etc...):

Marked stimulation of the renin-angiotensin-aldosterone system has been observed particularly during marked water and electrolyte depletions (strict sodium-free diet or prolonged diuretic treatment), in patients whose blood pressure was initially low, in cases of renal artery stenosis, congestive heart failure or cirrhosis with oedema and ascites.

The blocking of this system with an angiotensin converting enzyme inhibitor may therefore cause, particularly at the time of the first administration and during the first two weeks of treatment, a sudden drop in blood pressure and/or an increase in plasma levels of creatinine, showing a functional renal insufficiency. Occasionally this can be acute in onset, although rare, and with a variable time to onset.

In such cases, the treatment should then be initiated at a lower dose and increased progressively.

Elderly:

Renal function and potassium levels should be tested before the start of treatment. The initial dose is subsequently adjusted according to blood pressure response, especially in cases of water and electrolyte depletion, in order to avoid sudden onset of hypotension.

Patients with known atherosclerosis:

The risk of hypotension exists in all patients but particular care should be taken in patients with ischaemic heart disease or cerebral circulatory insufficiency, with treatment being started at a low dose.

Renovascular hypertension:

The treatment for renovascular hypertension is revascularisation. Nonetheless, angiotensin converting enzyme inhibitors can be beneficial in patients presenting with renovascular hypertension who are awaiting corrective surgery or when such a surgery is not possible.

If COVERSYL ARGININE PLUS 5mg/1.25mg is prescribed to patients with known or suspected renal artery stenosis, treatment should be started in a hospital setting at a low dose and renal function and potassium levels should be monitored, since some patients have developed a functional renal insufficiency which was reversed when treatment was stopped.

Other populations at risk:

In patients with severe cardiac insufficiency (grade IV) or in patients with insulin dependent diabetes mellitus (spontaneous tendency to increased levels of potassium), treatment should be started under medical supervision with a reduced initial dose. Treatment with beta-blockers in hypertensive patients with coronary insufficiency should not be stopped: the ACE inhibitor should be added to the beta-blocker.

Diabetic patients:

The glycaemia levels should be closely monitored in diabetic patients previously treated with oral antidiabetic drugs or insulin, namely during the first month of treatment with an ACE inhibitor.

Ethnic differences:

As with other angiotensin converting enzyme inhibitors, perindopril is apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of a higher prevalence of low-renin states in the black hypertensive population.

Surgery / anaesthesia:

Angiotensin converting enzyme inhibitors can cause hypotension in cases of anaesthesia, especially when the anaesthetic administered is an agent with hypotensive potential.

It is therefore recommended that treatment with long-acting angiotensin converting enzyme inhibitors such as perindopril should be discontinued where possible one day before surgery.

Aortic or mitral valve stenosis / hypertrophic cardiomyopathy:

ACE inhibitors should be used with caution in patients with an obstruction in the outflow tract of the left ventricle.

Hepatic failure:

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up (see section 4.8).

Hyperkalaemia:

Elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including perindopril. Risk factors for the development of hyperkalaemia include those with renal insufficiency, worsening of renal function, age (> 70 years), diabetes mellitus, inter-current events, in particular dehydration, acute cardiac decompensation, metabolic acidosis and concomitant use of potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene, or amiloride), potassium supplements or potassium-containing salt substitutes; or those patients taking other drugs associated with increases in serum potassium (e.g. heparin). The use of potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes particularly in patients with impaired renal function may lead to a significant increase in serum potassium. Hyperkalaemia can cause serious, sometimes fatal arrhythmias. If concomitant use of the above-mentioned agents is deemed appropriate, they should be used with caution and with frequent monitoring of serum potassium (see section 4.5).

Linked to indapamide:

Water and electrolyte balance:

Sodium levels:

These should be tested before treatment is started, then at regular intervals. All diuretic treatment can cause a reduction in sodium levels, which may have serious consequences. Reduction in sodium levels can be initially asymptomatic and regular testing is therefore essential. Testing should be more frequent in elderly and cirrhotic patients (see sections 4.8 and 4.9).

Potassium levels:

Potassium depletion with hypokalaemia is a major risk with thiazide diuretics and thiazide-related diuretics. The risk of onset of lowered potassium levels (< 3.4 mmol/l) should be prevented in some high risk populations such as elderly and/or malnourished subjects, whether or not they are taking multiple medications, cirrhotic patients with oedema and ascites, coronary patients and patients with heart failure.

In such cases hypokalaemia increases the cardiac toxicity of cardiac glycosides and the risk of rhythm disorders.

Subjects presenting with a long QT interval are also at risk, whether the origin is congenital or iatrogenic. Hypokalaemia, as with bradycardia, acts as a factor which favours the onset of severe rhythm disorders, in particular torsades de pointes, which may be fatal.

In all cases more frequent testing of potassium levels is necessary. The first measurement of plasma potassium levels should be carried out during the first week following the start of treatment.

If low potassium levels are detected, correction is required.

Calcium levels:

Thiazide diuretics and thiazide-related diuretics may reduce urinary excretion of calcium and cause a mild and transient increase in plasma calcium levels. Markedly raised levels of calcium may be related to undiagnosed hyperparathyroidism. In such cases the treatment should be stopped before investigating the parathyroid function.

Blood glucose:

Monitoring of blood glucose is important in diabetic patients, particularly when potassium levels are low.

Uric acid:

Tendency to gout attacks may be increased in hyperuricaemic patients.

Renal function and diuretics:

Thiazide diuretics and thiazide-related diuretics are only fully effective when renal function is normal or only slightly impaired (creatinine levels lower than approximately 25 mg/l, i.e. 220 µmol/l for an adult).

In the elderly the value of plasma creatinine levels should be adjusted to take account of the age, weight and sex of the patient, according to the Cockroft formula:

clcr = (140 - age) x body weight / 0.814 x plasma creatinine level
with:	age expressed in years body weight in kg plasma creatinine level in micromol/l

This formula is suitable for an elderly male and should be adapted for women by multiplying the result by 0.85.

Hypovolaemia, resulting from the loss of water and sodium caused by the diuretic at the start of treatment, causes a reduction in glomerular filtration. It may result in an increase in blood urea and creatinine levels. This transitory functional renal insufficiency is of no adverse consequence in patients with normal renal function but may however worsen a pre-existing renal impairment.

Athletes:

Athletes should note that this product contains an active substance which may cause a positive reaction in doping tests.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Common to perindopril and indapamide:

Concomitant use not recommended:

Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. Concomitant use of thiazide diuretics may further increase lithium levels and enhance the risk of lithium toxicity with ACE inhibitors. Use of perindopril combined with indapamide with lithium is not recommended, but if the combination proves necessary, careful monitoring of serum lithium levels should be performed (see section 4.4).

Concomitant use which requires special care:

- Baclofen: Potentiation of antihypertensive effect. Monitoring of blood pressure and renal function, and dose adaptation of the antihypertensive if necessary.

- Non-steroidal anti-inflammatory medicinal products (included acetylsalicylic acid at high doses): when ACE-inhibitors are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Concomitant use of ACE-inhibitors and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.

Concomitant use which requires some care:

- Imipramine-like antidepressants (tricyclics), neuroleptics: Increased antihypertensive effect and increased risk of orthostatic hypotension (additive effect).

- Corticosteroids, tetracosactide: Reduction in antihypertensive effect (salt and water retention due to corticosteroids).

- other antihypertensive agents: use of other antihypertensive medicinal products with perindopril/indapamide could result in additional blood pressure lowering effect.

Linked to perindopril:

Concomitant use not recommended:

- Potassium-sparing diuretics (spironolactone, triamterene, alone or in combination), potassium (salts): ACE inhibitors attenuate diuretic induced potassium loss. Potassium sparing diuretics e.g. spironolactone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium (potentially lethal). If concomitant use is indicated because of documented hypokalaemia they should be used with caution and with frequent monitoring of serum potassium and by ECG.

Concomitant use which requires special care:

- Antidiabetic agents (insulin, hypoglycaemic sulphonamides): Reported with captopril and enalapril.

The use of angiotensin converting enzyme inhibitors may increase the hypoglycaemic effect in diabetics receiving treatment with insulin or with hypoglycaemic sulphonamides. The onset of hypoglycaemic episodes is very rare (improvement in glucose tolerance with a resulting reduction in insulin requirements).

Concomitant use which requires some care:

- Allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide: Concomitant administration with ACE inhibitors may lead to an increased risk for leucopenia.

- Anaesthetic drugs: ACE inhibitors may enhance the hypotensive effects of certain anaesthetic drugs.

- Diuretics (thiazide or loop diuretics): Prior treatment with high dose diuretics may result in volume depletion and in a risk of hypotension when initiating therapy with perindopril.

- Gold: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including perindopril.

Linked to indapamide:

Concomitant use which requires special care:

- Torsades de pointes inducing drugs: Due to the risk of hypokalaemia, indapamide should be administered with caution when associated with medicinal products that induced torsades de pointes such as class IA antiarrhythmic agents (quinidine, hydroquinidine, disopyramide); class III antiarrhythmic agents (amiodarone, dofetilide, ibutilide, bretylium, sotalol); some neuroleptics (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, sultopride, tiapride), butyrophenones (droperidol, haloperidol), other neuroleptics (pimozide); other substances such as bepridil, cisapride, diphemanil, IV erythromycin, halofantrine, mizolastine, moxifloxacin, pentamidine, sparfloxacin, IV vincamine, methadone, astemizole, terfenadine. Prevention of low potassium levels and correction if necessary: monitoring of the QT interval.

- Potassium-lowering drugs: amphotericin B (IV route), glucocorticoids and mineralocorticoids (systemic route), tetracosactide, stimulant laxatives: Increased risk of low potassium levels (additive effect). Monitoring of potassium levels, and correction if necessary; particular consideration required in cases of treatment with cardiac glycosides. Non stimulant laxatives should be used.

- Cardiac glycosides: Low potassium levels favour the toxic effects of cardiac glycosides. Potassium levels and ECG should be monitored and treatment reconsidered if necessary.

Concomitant use which requires some care:

- Metformin: Lactic acidosis due to metformin caused by possible functional renal insufficiency linked to diuretics and in particular to loop diuretics. Do not use metformin when plasma creatinine levels exceed 15 mg/l (135 micromol/l) in men and 12 mg/l (110 micromol/l) in women.

- Iodinated contrast media: In cases of dehydration caused by diuretics, there is an increased risk of acute renal insufficiency, particularly when high doses of iodinated contrast media are used. Rehydration should be carried out before the iodinated compound is administered.

- Calcium (salts): Risk of increased levels of calcium due to reduced elimination of calcium in the urine.

- Ciclosporin: Risk of increased creatinine levels with no change in circulating levels of ciclosporin, even when there is no salt and water depletion.

4.6 Pregnancy And Lactation

Pregnancy:

Linked to perindopril:

The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors is contra-indicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.

Exposure to ACE inhibitor therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).

Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see sections 4.3 and 4.4).

Linked to indapamide:

Prolonged exposure to thiazide during the third trimester of pregnancy can reduce maternal plasma volume as well as uteroplacental blood flow, which may cause a foeto-placental ischaemia and growth retardation. Moreover, rare cases of hypoglycaemia and thrombocytopenia in neonates have been reported following exposure near term.

Lactation:

COVERSYL ARGININE PLUS 5mg/1.25mg is contra-indicated during lactation.

Use of perindopril is not recommended during breast-feeding.

Indapamide is excreted in human milk. Indapamide is closely related to thiazide diuretics which have been associated, during breast-feeding, with decrease or even suppression of milk lactation. Hypersensitivity to suphonamide-derived drugs, hypokalaemia and nuclear icterus might occur.

As, with both drugs, serious adverse reactions might occur in nursing infants, a decision should be made whether to discontinue nursing or to discontinue therapy taking account the importance of this therapy for the mother.

4.7 Effects On Ability To Drive And Use Machines

Linked to perindopril, indapamide and COVERSYL ARGININE PLUS 5mg/1.25mg:

Neither the two active substances nor COVERSYL ARGININE PLUS 5mg/1.25mg affect alertness but individual reactions related to low blood pressure may occur in some patients, particularly at the start of treatment or in combination with another antihypertensive medication.

As a result the ability to drive or operate machinery may be impaired.

4.8 Undesirable Effects

The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide. Four percent of the patients on treatment with COVERSYL ARGININE PLUS 5mg/1.25mg experience hypokalaemia (potassium level < 3.4 mmol/l).

The following undesirable effects could be observed during treatment and ranked under the following frequency:

Very common (

Blood and the lymphatic system disorders:

Very rare:

- Thrombocytopenia, leucopenia/neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia.

- Anaemia (see section 4.4) has been reported with angiotensin converting enzyme inhibitors in specific circumstances (patients who have had kidney transplants, patients undergoing haemodialysis).

Psychiatric disorders:

Uncommon: mood or sleep disturbances.

Nervous system disorders:

Common: Paraesthesia, headache, asthenia, feelings of dizziness, vertigo.

Very rare: Confusion.

Eye disorders:

Common: Vision disturbance.

Ear and labyrinth disorders:

Common: Tinnitus.

Vascular disorders:

Common: Hypotension whether orthostatic or not (see section 4.4).

Cardiac disorders:

Very rare: Arrhythmia including bradycardia, ventricular tachycardia, atrial fibrillation, angina pectoris and myocardial infarction possibly secondary to excessive hypotension in high-risk patients (see section 4.4).

Respiratory, thoracic and mediastinal disorders:

Common:

- A dry cough has been reported with the use of angiotensin converting enzyme inhibitors. It is characterised by its persistence and by its disappearance when treatment is withdrawn. An iatrogenic aetiology should be considered in the presence of this symptom. Dyspnoea.

Uncommon: Bronchospasm.

Very rare: Eosinophilic pneumonia, rhinitis.

Gastrointestinal disorders:

Common: Constipation, dry mouth, nausea, epigastric pain, anorexia, vomiting, abdominal pain, taste disturbance, dyspepsia, diarrhoea.

Very rare: Pancreatitis.

Hepato-biliary disorders:

Very rare: Hepatitis either cytolytic or cholestatic (see section 4.4).

Not known: In case of hepatic insufficiency, there is a possibility of onset of hepatic encephalopathy (see sections 4.3 and 4.4).

Skin and subcutaneous tissue disorders:

Common: Rash, pruritus, maculopapular eruptions.

Uncommon:

- Angioedema of face, extremities, lips, mucous membranes, tongue, glottis and/or larynx, urticaria (see section 4.4).

- Hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions.

- Purpura.

Possible aggravation of pre-existing acute disseminated lupus erythematosus.

Very rare: erythema multiforme, toxic epidermal necrolysis, Stevens Johnson syndrome.

Cases of photosensitivity reactions have been reported (see section 4.4).

Musculoskeletal, connective tissue and bone disorders:

Common: Cramps.

Renal and urinary disorders:

Uncommon: Renal insufficiency.

Very rare: Acute renal failure.

Reproductive system and breast disorders:

Uncommon: Impotence.

General disorders and administration site conditions:

Common: Asthenia.

Uncommon: Sweating.

Investigations:

- Potassium depletion with particularly serious reduction in levels of potassium in some at risk populations (see section 4.4).

- Reduced sodium levels with hypovolaemia causing dehydration and orthostatic hypotension.

- Increase in uric acid levels and in blood glucose levels during treatment.

- Slight increase in urea and in plasma creatinine levels, reversible when treatment is stopped. This increase is more frequent in cases of renal artery stenosis, arterial hypertension treated with diuretics, renal insufficiency.

- Increased levels of potassium, usually transitory.

Rare: Raised plasma calcium levels.

4.9 Overdose

The most likely adverse reaction in cases of overdose is hypotension, sometimes associated with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion, oliguria which may progress to anuria (due to hypovolaemia). Salt and water disturbances (low sodium levels, low potassium levels) may occur.

The first measures to be taken consist of rapidly eliminating the product(s) ingested by gastric lavage and/or administration of activated charcoal, then restoring fluid and electrolyte balance in a specialised centre until they return to normal.

If marked hypotension occurs, this can be treated by placing the patient in a supine position with the head lowered. If necessary an intravenous infusion of isotonic saline may be given, or any other method of volaemic expansion may be used.

Perindoprilat, the active form of perindopril, can be dialysed (see section 5.2).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: perindopril and diuretics, ATC code: C09BA04

COVERSYL ARGININE PLUS 5mg/1.25mg is a combination of perindopril arginine salt, an angiotensin converting enzyme inhibitor, and indapamide, a chlorosulphamoyl diuretic. Its pharmacological properties are derived from those of each of the components taken separately, in addition to those due to the additive synergic action of the two products when combined.

Pharmacological mechanism of action

Linked to COVERSYL ARGININE PLUS 5mg/1.25mg:

COVERSYL ARGININE PLUS 5mg/1.25mg produces an additive synergy of the antihypertensive effects of the two components.

Linked to perindopril:

Perindopril is an inhibitor of the angiotensin converting enzyme (ACE inhibitor) which converts angiotensin I to angiotensin II, a vasoconstricting substance; in addition the enzyme stimulates the secretion of aldosterone by the adrenal cortex and stimulates the degradation of bradykinin, a vasodilatory substance, into inactive heptapeptides.

This results in:

- a reduction in aldosterone secretion,

- an increase in plasma renin activity, since aldosterone no longer exercises negative feedback,

- a reduction in total peripheral resistance with a preferential action on the vascular bed in muscle and the kidney, with no accompanying salt and water retention or reflex tachycardia, with chronic treatment.

The antihypertensive action of perindopril also occurs in patients with low or normal renin concentrations.

Perindopril acts through its active metabolite, perindoprilat. The other metabolites are inactive.

Perindopril reduces the work of the heart:

- by a vasodilatory effect on veins, probably caused by changes in the metabolism of prostaglandins : reduction in pre-load,

- by reduction of the total peripheral resistance: reduction in afterload.

Studies carried out on patients with cardiac insufficiency have shown:

- a reduction in left and right ventricular filling pressures,

- a reduction in total peripheral vascular resistance,

- an increase in cardiac output and an improvement in the cardiac index,

- an increase in regional blood flow in muscle.

Exercise test results also showed improvement.

Linked to indapamide:

Indapamide is a sulphonamide derivative with an indole ring, pharmacologically related to the thiazide group of diuretics. Indapamide inhibits the reabsorption of sodium in the cortical dilution segment. It increases the urinary excretion of sodium and chlorides and, to a lesser extent, the excretion of potassium and magnesium, thereby increasing urine output and having an antihypertensive action.

Characteristics of antihypertensive action

Linked to COVERSYL ARGININE PLUS 5mg/1.25mg:

In hypertensive patients regardless of age, COVERSYL ARGININE PLUS 5mg/1.25mg exerts a dose-dependent antihypertensive effect on diastolic and systolic arterial pressure whilst supine or standing. This antihypertensive effect lasts for 24 hours. The reduction in blood pressure is obtained in less than one month without tachyphylaxis; stopping treatment has no rebound effect. During clinical trials, the concomitant administration of perindopril and indapamide produced antihypertensive effects of a synergic nature in relation to each of the products administered alone.

PICXEL, a multicentre, randomised, double blind active controlled study has assessed on echocardiography the effect of perindopril/indapamide combination on LVH versus enalapril monotherapy.

In PICXEL, hypertensive patients with LVH (defined as left ventricular mass index (LVMI) > 120 g/m² in male and > 100 g/m² in female) were randomised either to perindopril tert-butylamine 2 mg (equivalent to 2.5 mg perindopril arginine)/indapamide 0.625 mg or to enalapril 10 mg once a day for a one-year treatment. The dose was adapted according to blood pressure control, up to perindopril tert-butylamine 8 mg (equivalent to 10 mg perindopril arginine) and indapamide 2.5 mg or enalapril 40 mg once a day. Only 34% of the subjects remained treated with perindopril tert-butylamine 2 mg (equivalent to 2.5 mg perindopril arginine)/indapamide 0.625mg (versus 20% with Enalapril 10mg).

At the end of treatment, LVMI had decreased significantly more in the perindopril/indapamide group (-10.1 g/m²) than in the enalapril group (-1.1 g/m²) in the all randomised patients population. The between group difference in LVMI change was -8.3 (95% CI (-11.5,-5.0), p < 0.0001).

A better effect on LVMI was reached with higher perindopril/indapamide doses than those licensed for COVERSYL ARGININE PLUS 2.5mg/0.625mg and COVERSYL ARGININE PLUS 5mg/1.25mg.

Regarding blood pressure, the estimated mean between-group differences in the randomised population were -5.8 mmHg (95% CI (-7.9, -3.7), p < 0.0001) for systolic blood pressure and -2.3 mmHg (95% CI (-3.6,-0.9), p = 0.0004) for diastolic blood pressure respectively, in favour of the perindopril/indapamide group.

Linked to perindopri

Sensi-Care

Generic Name: topical emollients (TOP i kal ee MOL i ents)

Brand Names: Aloe Vesta Cream, AlphaSoft, AmeriPhor, Aqua Glycolic, Aqua Lube, Aquaphor, Aveeno, Baby Lotion, Baby Oil, Bag Balm, Baza-Pro, Beta Care, Blistex Lip Balm, Carmex, CarraKlenz, CeraVe, CeraVe AM, Cetaphil Lotion, Chap Stick, Citraderm, CoolBottoms, Corn Huskers Lotion, Curel Moisture Lotion, Derma Soothe, Dr Scholl's Essentials Cracked Skin Repair, Eucerin, Herpecin-L, K-Y Jelly, Keri Lotion, Lamisilk Heel Balm, Lubri-Soft, Lubriderm, Mederma, Moisturel, Natural Ice, NeutrapHor, NeutrapHorus Rex, Neutrogena Cleansing, Neutrogena Lotion, Nivea, Nutraderm, Pacquin, Phisoderm, Pretty Feet & Hands, Proshield Skincare Kit, Remedy 4-in-1 Cleansing Lotion, Replens, Secura, Sensi-Care, Soft Sense, St. Ives, Theraplex Lotion, Vaseline Intensive Care

What are Sensi-Care (topical emollients)?

Emollients are substances that moisten and soften your skin.

Topical (for the skin) emollients are used to treat or prevent dry skin. Topical emollients are sometimes contained in products that also treat acne, chapped lips, diaper rash, cold sores, or other minor skin irritation.

There are many brands and forms of topical emollients available and not all are listed on this leaflet.

Topical emollients may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Sensi-Care (topical emollients)?

You should not use a topical emollient if you are allergic to it. Topical emollients will not treat or prevent a skin infection.

Ask a doctor or pharmacist before using this medication if you have deep wounds or open sores, swelling, warmth, redness, oozing, bleeding, large areas of skin irritation, or any type of allergy.

What should I discuss with my healthcare provider before using Sensi-Care (topical emollients)?

You should not use a topical emollient if you are allergic to it. Topical emollients will not treat or prevent a skin infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• 
  

  deep wounds or open sores;

  
  


• 
  

  swelling, warmth, redness, oozing, or bleeding;

  
  


• 
  

  large areas of skin irritation;

  
  


• 
  

  any type of allergy; or

  
  


• if you are pregnant or breast-feeding.

How should I use Sensi-Care (topical emollients)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Clean the skin where you will apply the topical emollient. It may help to apply this product when your skin is wet or damp. Follow directions on the product label.

Shake the product container if recommended on the label.

Apply a small amount of topical emollient to the affected area and rub in gently.

If you are using a stick, pad, or soap form of topical emollient, follow directions for use on the product label.

Do not use this product over large area of skin. Do not apply a topical emollient to a deep puncture wound or severe burn without medical advice.

If your skin appears white or gray and feels soggy, you may be applying too much topical emollient or using it too often.

Some forms of topical emollient may be flammable and should not be used near high heat or open flame, or applied while you are smoking.

Store as directed away from moisture, heat, and light. Keep the bottle, tube, or other container tightly closed when not in use.

What happens if I miss a dose?

Since this product is used as needed, it does not have a daily dosing schedule. Seek medical advice if your condition does not improve after using a topical emollient.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Sensi-Care (topical emollients)?

Avoid getting topical emollients in your eyes, nose, or mouth. If this does happen, rinse with water. Avoid exposure to sunlight or tanning beds. Some topical emollients can make your skin more sensitive to sunlight or UV rays.

Sensi-Care (topical emollients) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using the topical emollient and call your doctor if you have severe burning, stinging, redness, or irritation where the product was applied.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sensi-Care (topical emollients)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied products. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Sensi-Care resources

• Sensi-Care Use in Pregnancy & Breastfeeding
• Sensi-Care Support Group
• 0 Reviews for Sensi-Care - Add your own review/rating

• Biafine Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)


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• Dry Skin

Where can I get more information?

• Your pharmacist can provide more information about topical emollients.

Baxan Capsules & Suspension

The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

Baxan^TM Capsules & Suspension

Cefadroxil Monohydrate

Your doctor has prescribed Baxan Capsules or Suspension for you or your child. Please read this leaflet before you use this medicine. It gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.
REMEMBER:
This medicine is for you or your child. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

What Is In Baxan?

The active ingredient in Baxan Suspension is cefadroxil monohydrate. Each capsule contains 500mg and 5ml teaspoonful of Suspension contains either 125, 250 or 500mg cefadroxil.

The other ingredients are:

Capsules:

colloidal silicon dioxide, lactose, magnesium stearate, gelatin capsules containing titanium dioxide

Suspension:

flavourings, polysorbate 40, sodium benzoate, sucrose, titanium dioxide, xanthan gum

Cefadroxil monohydrate is an antibiotic agent and a member of the family of medicines called cephalosporins.

The suspension is packed in blister strips of 20s and the suspension in bottles which contain 60ml liquid.

• 
  U.K. Product Licence Holder
  
  
  

  Bristol-Myers Squibb Holdings Ltd

  
  

  Uxbridge

  
  

  Middlesex

  
  

  UB8 1DH

  
  
  
  


• 
  Manufacturer:
  
  
  

  Bristol-Myers Squibb Srl.

  
  

  Via del Murillo

  
  

  Sermoneta

  
  

  Latina

  
  

  Italy

  
  
  
  

What is this medicine for?

Baxan is used to treat bacterial infections of the respiratory tract (nose, throat and lungs) such as tonsillitis, pneumonia, bronchitis, sinusitis and laryngitis; and an infection of the tubes of the ear called otitis media. It is also used to treat infections of the skin such as boils and bedsores, infections of the reproductive and urinary systems such as kidney infection and cystitis, and infections of the bones and joints.

Before Taking Your Medicine:

Should I be taking Baxan?

DO NOT take Baxan if you have had an allergic reaction to similar medicines or any of the ingredients in Baxan Suspension. Tell your doctor if you are allergic to penicillin or cephalosporin antibiotics before you start Baxan. If you are giving Baxan to a child, tell the doctor of any previous allergic reactions that this child has shown.

What if I am pregnant,

planning to become pregnant or breast-feeding?


If you are pregnant or may become pregnant or are breast-feeding you should speak to your doctor before taking Baxan.

Have you ever been told your kidneys don't work properly?

If yes, remind your doctor because this may affect the dose he prescribes.

What if I am diabetic?

If you use chemical tests to check for sugar in the urine, Baxan may cause a false positive reaction. This does not occur with dipstick type tests.

Can I use other medicines?

It is usually all right to take Baxan with other medicines. Always tell your doctor about all other medicines you are using even those you have bought at a pharmacy or other places, e.g. a supermarket.

Is it all right to drink alcohol?

There is no interaction between Baxan and moderate amounts of alcohol. However, you should check with your doctor whether it is advisable for you to drink alcohol.

Is it all right to drive?

Baxan preparations do not usually affect your ability to drive.

Using Your Medicine:

How should I take Baxan Capsules or Suspension?

You should follow your doctor's instructions. Check the label for how much Baxan to take and how often to take it. The capsules should be swallowed whole with a glass of water. A 5ml spoon should be used to measure the dose. The average teaspoon does not measure the correct amount of liquid. Remember to shake the bottle before taking a dose.

Usual Doses:

CAPSULES:

Adults and children weighing more than 40kg (88lb)


For most infections the dose will be 500mg (1 capsule) or 1g (2 capsules) twice a day. This depends on the type of infection that you have and how severe it is. In some infections, including some of the skin and mild infections of the urinary tract, your doctor may ask you to take 1g (2 capsules) once a day.

Children weighing less than 40 kg (88lb)


For children over 6 years old, the usual dose will be 500mg (1 capsule) twice daily. For children under 6 years old, who need to take a lower dose, your doctor will prescribe Baxan Suspension.

SUSPENSIONS:

Adults and children weighing more than 40 kg (88lb)


For most infections the dose will be 500mg (e.g. 5ml of the 500mg per 5ml strength) or 1g (10ml of the 500mg per 5ml strength) twice a day. This depends on the type of infection that you have and how severe it is. In some infections, including some of the skin and mild infections of the urinary tract, your doctor may ask you to take 1g (10ml of the 500mg per 5ml strength) once a day.

Children weighing less than 40 kg (88lb)

Under 1 year old: The dose is dependent on the weight of the child. The usual dose is 25mg of Baxan for each kilogram that your child weighs, per day, taken in divided doses. For example, if your child weighs 5kg the daily dose will normally be (5 x 25) = 125mg. An appropriate way of taking this dose would be to take 2.5ml of the 125mg per 5ml strength, twice a day. For a child weighing 10kg, the usual daily dose will be (10 x 25) = 250mg. This can be taken as 5ml of the 125mg per 5ml strength, twice a day.

Children aged from 1 to 6 years old:


The usual dose is 250mg twice a day. The easiest method of taking this dose is to take 5ml of the 250mg per 5ml strength twice a day.

Children over 6 years old (but weighing less than 40kg (88lb):


The usual dose is 500mg twice a day. The easiest method of taking this dose is to take 5ml of the 500mg per 5ml strength, twice a day.

THIS MEDICINE SHOULD BE TAKEN UNTIL THE COURSE PRESCRIBED BY YOUR DOCTOR IS COMPLETED. THIS WILL HELP TO CLEAR UP THE INFECTION COMPLETELY. DO NOT STOP JUST BECAUSE YOU, OR YOUR CHILD FEELS BETTER.

For infections caused by certain types of bacteria known as beta-haemolytic streptococci, your doctor will prescribe a course of Baxan which will last at least 10 days. Beta-haemolytic streptococci are commonly found in infections which cause sore throats and in infected wounds.

Should Baxan be taken before or after meals?

It does not matter. If this medicine upsets your stomach it may help to take it with food.

How long should Baxan be taken for?

Carry on taking Baxan for the length of time advised by your doctor and pharmacist and printed on the label of your medicine.

What if too much Baxan is taken?

Go to your nearest Casualty Department or tell your doctor immediately. If you are going to the hospital, take the empty container and any remaining medicine with you.

What if a dose is missed?

If a dose is missed it should be taken as soon as possible. This will help to keep a constant amount of medicine in the body. Try not to miss any doses. If a dose is missed and it is almost time for the next dose, take a dose now and the next dose in 5-6 hours' time, then go back to the prescribed dosing instructions.

Undesirable Effects:

Are there any unwanted effects of Baxan?

All medicines may cause some unwanted or 'side-effects' in a few patients. If the medicine causes swelling of lips, tongue or difficulty in breathing. TELL YOUR DOCTOR IMMEDIATELY. If a nettle rash or other spots develop this may be due to an allergy to the medicine. Stop taking it or giving it to your child and tell your doctor as soon as possible. Sometimes Baxan causes upset tummy, abdominal pain or discomfort, joint pain, dizziness, fever, headache or vaginal fungal infection. Very rarely, blood/liver disorders occur and any diarrhoea with blood and mucus should be reported to your doctor. Tell your doctor or pharmacist if you notice any other troublesome side effects.

Looking After Your Medicine:

You will see an 'EXPIRY DATE' on the outer packaging of Baxan Capsules and Suspension. Do not use after this date. Keep Baxan Capsules in a locked cabinet, OUT OF CHILDREN'S REACH. The capsules should be kept at room temperature and should not get too hot or damp, so do not leave them near a radiator, on a windowsill or in the bathroom. Keep Baxan Suspension in a refrigerator between doses. However, do not let it freeze. If your doctor decides to stop this medicine, ask your pharmacist to tell you what to do with any you have left.

Date of last revision: June 2005

Pilopine HS Gel

Pronunciation: pye-loe-KAR-peen
Generic Name: Pilocarpine
Brand Name: Pilopine HS

Pilopine HS Gel is used for:

Treating certain types of glaucoma (increased pressure in the eye) alone or in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Pilopine HS Gel is a direct-acting miotic. It works by lowering the fluid pressure inside the eyeball by increasing fluid drainage from the eyeball. It also causes the pupils to constrict or get smaller (miosis).

Do NOT use Pilopine HS Gel if:

• you are allergic to any ingredient in Pilopine HS Gel


• you have a certain type of glaucoma (eg, pupillary block glaucoma), eye inflammation, or a severe eye infection

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pilopine HS Gel:

Some medical conditions may interact with Pilopine HS Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a detached retina, an eye infection, asthma, or chronic obstructive pulmonary disease


• if you have had a heart attack

Some MEDICINES MAY INTERACT with Pilopine HS Gel. However, no specific interactions with Pilopine HS Gel are known at this time.

Ask your health care provider if Pilopine HS Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pilopine HS Gel:

Use Pilopine HS Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pilopine HS Gel is only for the eye. Do not get it in your nose or mouth.


• Pilopine HS Gel may be used around the eye or in the eye. To use Pilopine HS Gel in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using Pilopine HS Gel, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• If you miss a dose of Pilopine HS Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Pilopine HS Gel.

Important safety information:

• Pilopine HS Gel may cause blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pilopine HS Gel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Pilopine HS Gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pilopine HS Gel while you are pregnant. It is not known if Pilopine HS Gel is found in breast milk. If you are or will be breast-feeding while you use Pilopine HS Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Pilopine HS Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; change in vision; eye irritation; eyelid twitching; headache at the temples or around the eyes; increased tearing; nearsightedness; redness or swelling of the eye; temporary stinging or burning.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); detachment of the retina; poor vision at night.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pilopine HS side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include asthma; blurred vision; diarrhea; fainting; increased saliva; increased sweating; irregular heartbeat; low blood pressure; nausea; slow pulse; tremor; vomiting.

Proper storage of Pilopine HS Gel:

Store Pilopine HS Gel between 36 and 80 degrees F (2 and 27 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Pilopine HS Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Pilopine HS Gel, please talk with your doctor, pharmacist, or other health care provider.


• Pilopine HS Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pilopine HS Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Pilopine HS resources

• Pilopine HS Side Effects (in more detail)
• Pilopine HS Use in Pregnancy & Breastfeeding
• Pilopine HS Drug Interactions
• Pilopine HS Support Group
• 0 Reviews for Pilopine HS - Add your own review/rating

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• Glaucoma
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