Patient Leaflet Updated 26-Aug-2016 | Mylan
Colofac MR
colofac®MR Capsules
Mebeverine hydrochloride
1 What Colofac MR is and what it is used for
2 Before you take Colofac MR
3 How to take Colofac MR
4 Possible side effects
5 How to store Colofac MR
6 Further information
Colofac MR is a capsule 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, pain and other symptoms of IBS.
The main symptoms of irritable bowel syndrome (IBS) include:
These symptoms may vary from person to person.
Talk to your doctor or pharmacist if these symptoms do not improve after a while, if you develop new symptoms, or you are concerned about your symptoms.
How you restrict your diet depends on the way IBS affects you. If you find that certain foods bring on the symptoms, then it makes sense not to eat them. A high fibre diet may help, but ask your doctor or 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.
If the above applies to you, do not take this medicine and talk to your doctor or pharmacist.
Check with your doctor or pharmacist before taking your medicine if:
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
You can drink alcohol while you are taking Colofac MR.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
You should talk to your doctor or pharmacist before taking Colofac MR if you are pregnant or might become pregnant. There is only limited information about the safety of Mebeverine for pregnant women. Your doctor may advise you to stop taking Colofac MR before you become pregnant or as soon as you know you are pregnant. Colofac MR should not be used during breast-feeding.
This medicine is not likely to affect you being able to drive or use any tools or machines.
Always take Colofac MR as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults (including the elderly)
Children
If you or someone else takes too much Colofac MR (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you miss a capsule, take it when you remember. However, if it is nearly time for the next dose, skip the missed dose and carry on as normal with the next dose. Do not take a double dose to make up for a forgotten dose.
Do not stop taking Colofac MR without talking to your doctor, even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Most people will not have problems, but some may get some side effects (unwanted effects or reactions).
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the United Kingdom national reporting system The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Each capsule contains 200 mg of mebeverine hydrochloride in a modified release formulation.
The capsules also contain magnesium stearate, polyacrylate dispersion 30% , talc, hypromellose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% and glycerol triacetate. The capsule shell contains gelatine and titanium dioxide (E171). The printing inks contain shellac (E904), black iron oxide (E172), propylene glycol, concentrated ammonia solution and potassium hydroxide.
Colofac MR Capsules are white, opaque and marked with the number 245.
Packs may contain 10 or 60 capsules. Not all pack sizes may be marketed.
The Marketing Authorisation holder is:
The Manufacturer is:
This leaflet was last revised in June 2016.
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+44 (0)1707 853 000
+44 (0)1707 853 000
+44 (0)1707 853 000 select option 2