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Mylan Ibs Relief Tablets

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Document: leaflet MAH BRAND_PL 04569-0260 change

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Mylan


PACKAGE LEAFLET: INFORMATION FORTHE USER

MYLAN IBS RELIEF TABLETS

(mebeverine hydrochloride 135 mg)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

•    Keep this leaflet. You may need to read it again.

•    Askyour pharmacist if you need more information or advice.

•    If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

•    You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks of treatment.


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 things bring on the symptoms, then it makes sense not to eat them. A high fibre diet may help, but askyour 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 MYLAN IBS RELIEF


Do not take Mylan IBS Relief:

• if you are allergic to mebeverine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).


Warnings and precautions

Talk to your doctor before using any IBS treatment:

•    If this is the first time you have had the symptoms described above. This is to make sure that the treatment is suitable for you.

•    If you have developed new or worsened symptoms.

•    If you have liver or kidney problems.


What is in this leaflet:

1.    What Mylan IBS Relief is and what it is used for.

2.    What you need to know before you take Mylan IBS Relief.

3.    Flow to take Mylan IBS Relief.

4.    Possible side effects.

5.    Flow to store Mylan IBS Relief.

6.    Contents of the packand other information.

1. WHAT MYLAN IBS RELIEF IS AND WHAT IT IS USED FOR

Mylan IBS Relief is a tablet containing mebeverine hydrochloride. This belongs to a group of medicines called antispasmodics.

Mylan IBS Relief 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 and pain.

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 you develop new symptoms or if these symptoms continue for more than 2 weeks.


Do not use this medicine without talking to your doctor if you:

•    are aged 40 years or over and your symptoms have changed or it has been some time since you last had IBS

•    have passed blood in your stools or motions

•    are feeling sick or being sick

•    have lost your appetite or lost weight

•    look pale and feel tired

•    are suffering from severe constipation

•    have a fever

•    have recently travelled abroad

•    are, may be or are planning to become pregnant

•    have abnormal bleeding or discharge from the vagina

•    have difficulty or pain when passing water.

Talk to your doctor if you get new symptoms, your symptoms get worse, or if they do not improve after 2 weeks of treatment.



Mylan IBS Relief with alcohol

You can drink alcohol while you are taking Mylan IBS Relief.


Other medicines and Mylan IBS Relief

Mylan IBS Relief is 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 Mylan IBS Relief.

Pregnancy and breast-feeding

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.


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There is only limited information about the safety of Mebeverine for pregnant woman. Your doctor may advise you to stop taking Mylan IBS Relief before you become pregnant or as soon as you knowyou are pregnant. Mylan IBS Relief should not be used during breast-feeding.

Driving and using machines

Mylan IBS Relief should not affect your ability to drive or use machines.

Mylan IBS Relief contains 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 MYLAN IBS RELIEF


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.

5. HOW TO STORE MYLAN IBS RELIEF

Keep this medicine out of the sightand reach of children.


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



The tablet should be taken 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: Mylan IBS Relief is not recommended for use in children and adolescents below 18 years of age.

Ifyou take more Mylan IBS Relief than you should

Ifyou take more Mylan IBS Relief 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 Mylan IBS Relief

Ifyou forget to take a dose of Mylan IBS Relief at the right time, wait until the next tablet is due.

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

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

4. POSSIBLE SIDE EFFECTS


Do not take this medicine after the expiry date, which is stated on the carton 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 throwaway 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 Mylan IBS Relief tablet 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 Mylan IBS Relief tablet looks like and contents of the pack

Mylan IBS Relief is a white film coated tablet marked 'MV135' on one side. It is available in blister packs of 15.



240mm

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

Ifyou 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.


Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.


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


Ifyou getany side effects, talk to yourdoctoror pharmacist.This includes any side effects not listed in this leaflet.


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This leaflet was last revised in 07/2013    00000000