Colofac Mr 200mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLOFAC® MR 200mg CAPSULES
(mebeverine hydrochloride)
This medicine is available as the above name but will be referred to as Colofac MR throughout the remainder of this leaflet.
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 gets 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 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 FO
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:
• stomach pain and spasm
• feeling bloated and having wind
• having diarrhoea (with or without constipation)
• small, hard, pellet-like or ribbon-like stools (faeces)
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 M
Do not take Colofac MR if:
• You are allergic to mebeverine hydrochloride or any of the other capsule ingredients (see section 6 for a list of ingredients)
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:
• You have developed new symptoms or your symptoms have become worse
• You have liver or kidney problems.
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 woman. 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 M
Always take Colofac MR as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• Try to take the capsule 20 minutes before a meal - some people find their symptoms to be strongest after they have eaten.
• Swallow the capsule whole with a drink of water. Do not chew the capsule.
How much Colofac MR to take Adults (including the elderly)
• The normal starting dose is one capsule twice a day.
Children
• This medicine is not recommended for use in children.
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:
• Difficulty in breathing, swelling of face, neck, tongue or throat (severe allergic reactions)
These other effects are less serious. If they bother you talk to a pharmacist:
• Skin rash, red itchy skin
Reporting of side effects
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 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 M
• Store Colofac MR in the original package.
• Do not store above 25°C. Do not refrigerate or freeze.
• Do not take Colofac MR after the expiry date.
• Keep all medicines where children cannot see or reach them.
• If the capsules become discoloured or show signs of any deterioration, you should seek the advice of your 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.
6. FURTHER INFORMATION
What Colofac MR contains?
Each modified release capsule contains 200mg of mebeverine hydrochloride as the active ingredient.
The capsules also contain magnesium stearate, glycerol triacetate, Eudragit E30D, talc, hypromellose 2910 and Eudragit L30D. The capsule shell contains gelatin, titanium dioxide (E171).
What Colofac MR looks like and the contents of the pack
Colofac MR are white, opaque and imprinted “245“ with a Solvay logo.
The capsule shell is printed with black printing ink.
POM
Colofac MR is available in blister packs of 30 or 60 capsules. PLPI 15814/0950 Colofac MR 200mg Capsules
The product is made by Solvay Pharmaceuticals, 01400 Chatillon-sur-Chalaronne, France and procured from within the EU and repackaged by the product licence holder: OPD Laboratories Limited, Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 07.03.2014.
Colofac is a registered trademark of Abbott Products Operations AG, Switzerland.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.