Sunday, 16 September 2012

Colofac IBS







Colofac


IBS



Mebeverine Hydrochloride



Read all of this leaflet carefully before you start taking this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:



  • 1. What Colofac IBS is and what it is used for


  • 2. Before you take Colofac IBS


  • 3. How to take Colofac IBS


  • 4. Possible side effects


  • 5. How to store Colofac IBS


  • 6. Further information




What Colofac IBS is and what it is used for


Colofac IBS is a tablet containing Mebeverine hydrochloride. This belongs to a group of medicines called antispasmodics.


This medicine is used to treat the symptoms of irritable bowel syndrome (IBS).


This is a very common condition which causes spasm and pain in the gut or intestine.


The intestine is a long muscular tube which food passes down so it can be digested. If the intestine goes into spasm and squeezes too tightly, you get pain. The way this medicine works is by relieving the spasm and pain.


The main symptoms of irritable bowel syndrome (IBS) include:


  • stomach pain and spasm

  • feeling bloated and having wind

  • having diarrhoea or constipation

  • small, hard, pellet-like or ribbon-like stools (faeces)

These symptoms may vary from person to person.


Talk to your doctor if you develop new symptoms or if these symptoms continue for more than 2 weeks.



Your diet and lifestyle can also help treat IBS:


How you restrict your diet depends on the way IBS affects you. If you find that certain things bring on the symptoms, then it makes sense not to eat them. A high fibre diet may help, but ask your pharmacist for more information.


Some people find that learning to relax can help to lessen their symptoms of IBS. You may find it helpful to set aside a few moments each day to relax and gently unwind.




Before you take Colofac IBS



Do not take Colofac IBS if:


  • You are allergic to any of the tablet ingredients (see section 6 for a list of ingredients)

  • You are younger than 18 years of age

If any of the above applies to you, do not take this medicine and talk to your doctor or pharmacist.




Take special care with Colofac IBS



See your doctor before using any IBS treatment if you:


  • have not suffered from IBS before or

  • have developed new symptoms or your symptoms have become worse


Talk to your doctor or pharmacist if any of the following applies to you:


  • You are 40 years of age or over and your symptoms have changed or it has been some time since you last had IBS

  • You have blood in your stools (faeces)

  • You are feeling sick (nauseous) or are sick (vomiting)

  • You are looking pale and feeling tired

  • You have constipation

  • You have a fever

  • You have recently travelled abroad

  • You are pregnant, or planning to become pregnant

  • You are a woman and you have unusual bleeding or discharge from your vagina

  • You have difficulty or pain when passing water (urinating)

Your doctor will tell you whether it is safe for you to start taking Colofac IBS.




Taking Colofac IBS with food and drink


You can drink alcohol while you are taking Colofac IBS.




Taking other medicine


No interactions with other medicines are known.




Pregnancy and breast-feeding


Ask your doctor or pharmacist for advice before taking Colofac IBS if you are pregnant or might become pregnant. Colofac IBS should not be used during breast-feeding.




Driving and using machines


This medicine is not likely to affect you being able to drive or use any tools or machines.




Important information about some of the ingredients of Colofac IBS


This medicine contains lactose and sucrose (types of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.





How to take Colofac IBS



How to take Colofac IBS


  • Try to take the tablets 20 minutes before a meal – some people find their symptoms to be strongest after they have eaten.

  • Swallow the tablets whole with water. Do not chew the tablets.



How much Colofac IBS to take



Adults and the elderly:


  • Take 1 tablet 3 times a day

  • The number of tablets you take can be lowered if your symptoms improve


  • Do not take more than 3 tablets per day.

Do not give Colofac IBS to children or adolescents younger than 18 years.




How to stop taking Colofac IBS


You can lower the dose if your symptoms get better.




If you take more Colofac IBS than you should


If you or someone else takes too much Colofac IBS (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.




If you forget to take Colofac IBS


If you miss a tablet, wait until the next dose is due. Do not try to make up for the dose you have missed. Do not double dose to make up for a forgotten dose.



If you have any further questions on the use of this product, ask your doctor or pharmacist.




Colofac IBS Side Effects


Like all medicines Colofac IBS can cause side effects (unwanted effects or reactions), but not everyone gets them.


  • allergic reactions such as swollen or reddened skin, itching or a skin rash

  • swelling of your face, lips or tongue

If any of the side effects become serious, or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist.




How to store Colofac IBS



  • Keep out of the reach and sight of children.

  • You should lock this medicine in a cupboard or medicine cabinet.

  • Do not use the tablets after the expiry date which is printed on the carton and blister pack.

  • Do not store your tablets above 30°C and keep them in the original container.

If your doctor stops your treatment, return any unused tablets to a pharmacist.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further information



What Colofac IBS contains


Each tablet contains 135 mg mebeverine hydrochloride


The tablets also contain lactose, starch (potato or maize), povidone, talc, magnesium stearate, sucrose, gelatin, acacia and carnauba wax.




What Colofac IBS looks like and contents of the pack


Colofac IBS tablets are white, round and sugar coated with no markings.


Colofac IBS is available in packs containing 10, 15, 84 or 100 tablets in blister strips or in pots containing 500 tablets.


Not all pack sizes may be marketed.




Marketing Authorisation Holder and Manufacturer


The Marketing Authorisation Holder is:



Solvay Healthcare Ltd.

Southampton

SO18 3JD

UK


The Manufacturer is:



Solvay Pharmaceuticals

01400 Châtillon-sur-Chalaronne

France





This leaflet was last approved in November 2009.


Registered trademark


0000000 CL000





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