PACKAGE LEAFLET: INFORMATION FOR THE USER

MEBEVERINE 135 mg FILM-COATED TABLETS

(mebeverine hydrochloride)

(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.

•    Ifyou getany side effects, talk to yourdoctoror 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. Whatyou need to know before you take Mebeverine Film-coated Tablets.

3.    Flow to take Mebeverine Film-coated Tablets.

4.    Possible side effects.

5.    Flow to store Mebeverine Film-coated Tablets.

6.    Contents of the pack and other information.

1.WHAT MEBEVERINE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

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. Ifyou find that certain foods bring on the symptoms, then it makes sense not to eat them.

A high fibre diet may help, butaskyour 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-COATED TABLETS

Do not take Mebeverine Film-coated Tablets:

Ifyou 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.

Mebeverine Film-coated Tablets contain mebeverine hydrochloride.This belongs to a group of medicines called antispasmodics.

Consult your doctor ifyou have developed new symptoms, or if the symptoms worsen, or if they do not improve after 2 weeks of treatment.

Mebeverine Film-coated Tablets helpto 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, oralternating 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.

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 ifyou 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

Ifyou 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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170 mm

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

Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOWTO TAKE MEBEVERINE FILM-COATED TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou are not sure.

Other side effects (frequency unknown): allergic reactions may occur, such as skin reactions (inflamed or reddened skin, itching or skin rashes).

Ifyou 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 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

_ 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 =cn- 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.

Ifyou take more Mebeverine Film-coated Tablets than you should

Ifyou or someone else take more MebeverineTablets than you should (overdose), contact your doctor or hospital emergency department immediately.Take this leaflet and any remaining tablets with you.

Ifyou forget to take Mebeverine Film-coated Tablets

Ifyou 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 foryour next dose. Do not take a double dose to make up for the forgotten tablet.

Ifyou stop taking Mebeverine Film-coated Tablets

Do not stop taking the tablets without talking to your doctor, even ifyou feel better.

5.    HOWTO STORE FILM-COATED MEBEVERINETABLETS

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°Cand protect from light.

Do not throw away any medicines via wastewater or household waste. Askyour 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.

240 mm

Ifyou have any further questions on the use of this medicine, askyour doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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.

Ifyou sufferfrom 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.

Marketing Authorisation Holder:

Mylan, Potters Bar, Hertfordshire, EN6 1TL,

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 07/2013.    00000000