- mebeverine hydrochloride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL46302/0023.
Package Leaflet: Information for the user
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
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
1. What Colofac MR is and what it is used for
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.
Your diet and lifestyle can also help to treat IBS:
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.
2. Before you take Colofac MR
Do not take Colofac MR if:
If the above applies to you, do not take this medicine and talk to your doctor or pharmacist.
Take special care with Colofac MR
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.
Taking Colofac MR with food and drink
You can drink alcohol while you are taking Colofac MR.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
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.
Driving and using machines
This medicine is not likely to affect you being able to drive or use any tools or machines.
3. How to take Colofac MR
Always take Colofac MR as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How much Colofac MR to take
Adults (including the elderly)
If you take more Colofac MR than you should
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 forget to take Colofac MR
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.
If you stop taking Colofac MR
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.
4. Possible side effects
Most people will not have problems, but some may get some side effects (unwanted effects or reactions).
If you get any of these serious side effects, stop taking the capsules. See a doctor at once:
These other effects are less serious. If they bother you talk to a pharmacist:
Reporting of suspected adverse 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.
5. How to store Colofac MR
6. Further information
What Colofac MR contains
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.
What Colofac MR looks like and the contents of the pack
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.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is:
The Manufacturer is:
This leaflet was last revised in June 2016.
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