Colofac Mr 200mg Capsules
COLOFAC® MR 200MG CAPSULES
(mebeverine hydrochloride)
Assessed against UK PIL dated August 2010
APPROVED
By Khilod at 9:38 am, Oct 21, 2010
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Colofac MR 200mg Capsules but will be referred to as Colofac MR throughout 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 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 medicines 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.
MOCK UP
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 things 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:
■ You are allergic to mebeverine hydrochloride or any of the capsule ingredients (see section 6 for a list of ingredients)
■ You have 'paralytic ileus' (a lack of the rhythmic squeezing in the gut or intestine).
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 MR
Check with your doctor or pharmacist before taking your medicine if:
■ You have 'porphyria' (a metabolism problem)
■ You have developed new symptoms or your symptoms have become worse.
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, might become pregnant or are breastfeeding.
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.
■ 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
Like all medicines, Colofac MR can cause side effects (unwanted effects or reactions), but not everyone gets them.
Very rare (less than 1 in 10,000 people)
Allergic reactions such as:
■ swelling of your face, lips or tongue
■ a red skin rash, itching, inflamed skin.
If you notice any of the above, stop taking this medicine and see your doctor straight away.
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.
5. How to store Colofac MR
■ Do not store above 30°C.
■ Store in the original package.
■ Do not refrigerate or freeze.
■ Do not take Colofac MR after the expiry date which is stated on the carton and blister pack. The expiry date refers to the last day of that month.
■ Keep out of the reach and sight of children.
■ If your doctor tells you to stop taking the capsules, please take them back to the pharmacist. Only keep the capsules if your doctor tells you to.
■ If the capsules become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will tell you what to do.
■ Medicines should not be disposed of via waste water or household waste. Ask your doctor or 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 capsule contains 200mg of mebeverine hydrochloride in a modified release formulation.
The capsules also contain magnesium stearate, Eudragit E30D, talc, hypromellose 2910, Eudragit L30D and glycerol triacetate. The capsule shell contains gelatin and titanium dioxide (E171).
What Colofac MR looks like and contents of the pack
Colofac MR capsules are white, opaque, printed with "245" on the body and "S" (with an inverted triangle below) on the cap in black ink.
Your medicine is available in blister packs containing 60 capsules.
Manufacturer
Your medicine is manufactured by: Solvay Pharmaceuticals, 01400 Chatillon-sur-Chalaronne, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
POM
PL No: 21828/0379
Leaflet issue and revision date (Ref): 14.10.10
Colofac® is a registered trademark of Solvay Pharmaceuticals B.V.
For information in large print, tape, CD or Braille, telephone 01302 554841
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