Mylan Ibs Relief Tablets
PACKAGE LEAFLET: INFORMATION FORTHE USER
MEBEVERINE 135 mg FILM-COATED TABLETS
(mebeverine hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only.
Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Mebeverine Film-coated Tablets are and what they are used for.
2. What you need to know before you take Mebeverine Film-coated Tablets.
3. How to take Mebeverine Film-coated Tablets.
4. Possible side effects.
5. Howto store Mebeverine Film-coated Tablets.
6. Contents of the pack and other information.
1 .WHAT MEBEVERINE FILM-COATED TABLETS ARE AND WHATTHEY ARE USED FOR
Mebeverine Film-coated Tablets contain mebeverine hydrochloride. This belongs to a group of medicines called antispasmodics.
Mebeverine Film-coated Tablets help to relax the muscles of the gastro-intestinal tract (gut). They are used in conditions such as irritable bowel syndrome and similar problems such as chronic irritable colon, spastic constipation, mucous colitis and spastic colitis.
Irritable bowel syndrome (IBS) 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
• persistent diarrhoea, or alternating constipation and diarrhoea
• flatulence (wind) and feeling bloated
• small, hard, pellet-like or ribbon-like stools (faeces). These symptoms may vary from person to person.
Talk to your doctor 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 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 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEBEVERINE FILM-COATEDTABLETS
Do not take Mebeverine Film-coated Tablets:
If you are allergic to mebeverine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Check with your doctor or pharmacist before taking this medicine if:
• You have developed new symptoms or your symptoms have become worse.
• You have liver or kidney problems.
If the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
Consult your doctor if you have developed new symptoms, or if the symptoms worsen, or if they do not improve after 2 weeks of treatment.
Mebeverine Film-coated Tablets with alcohol
You can drink alcohol while you are taking mebeverine Film-coated tablets.
Other medicines and Mebeverine Film-coated Tablets
Mebeverine Film-coated Tablets are not known to interact with other medicines but you should tell your doctor or pharmacist if you are taking or have recently taken any other medicines and notice any strange side effects when you start taking Mebeverine Film-coated Tablets.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, askyour doctor or pharmacist for advice before taking this medicine.
There is only limited information about the safety of Mebeverine Film-coated Tablets for pregnant women. Your doctor may advise you to stop taking Mebeverine Film-coated Tablets before you become pregnant or as soon as you know you are pregnant. Mebeverine Film-coated Tablets should not be used during breast-feeding.
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Driving and using machines
Mebeverine Film-coated Tablets are not likely to affect your ability to drive or use machines.
Mebeverine Film-coated Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOWTOTAKE MEBEVERINE FILM-COATED TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Try to take the tablet 20 minutes before a meal -some people find their symptoms to be strongest after they have eaten. Swallow the tablet whole with water. Do not chew the tablet.
Adults (including the elderly):
•The recommended dose is one tablet three times a day. Do not take more than three tablets per day. •The number of tablets you take may be lowered if your symptoms improve.
Children and adolescents: Mebeverine Film-coated Tablets are not recommended for use in children and adolescents below 18 years of age.
If you take more Mebeverine Film-coated Tablets than you should
If you or someone else take more Mebeverine Tablets than you should (overdose), contact your doctor or hospital emergency department immediately.Take this leaflet and any remaining tablets with you.
If you forget to take Mebeverine Film-coated Tablets
If you forget to take a dose of Mebeverine Film-coated Tablets at the right time, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Mebeverine Film-coated Tablets
Do not stop taking the tablets 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, this medicine can cause side effects, although not everybody gets them.
If you suffer from difficulty in breathing, swelling of the face, neck, lips, tongue or throat (severe allergic reactions), stop taking the tablets and go to your doctor immediately, or your nearest hospital.
Other side effects (frequency unknown): allergic reactions may occur, such as skin reactions (inflamed or reddened skin, itching or skin rashes).
If you get any side effects, talk to your doctor or pharmacist.This includes any side effects not listed in this leaflet.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. HOWTO STORE FILM-COATED MEBEVERINE TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or label after 'EXP'. The expiry date refers to the last day of that month.
Store this medicine in a dry place below 30°C and protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Mebeverine Film-coated Tablets contains
The active substance is 135 mg of mebeverine hydrochloride.
The other ingredients are: microcrystalline cellulose lactose monohydrate povidone talc
magnesium stearate sodium starch glycollate.
The tablet coating includes hydroxypropyl methylcellulose (E464), titanium dioxide (El 71) and polyethylene glycol.
What Mebeverine Film-coated Tablets look like and contents of the pack
Mebeverine tablets are white-coated tablets marked 'MV135' on one side.
The medicine is available in either plastic bottles or blister packs of 12,15,18,20,21,28,30,56,60,84,90 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Milpharm Limited, Ares Block,
Odyssey Business Park, West End Road Ruislip HA4 6QD, United Kingdom.
Manufacturer:
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
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This leaflet was last revised in 08/2015.