Document: leaflet BOOTS_PL 46302-0022 change

• leaflet BOOTS_PL 43900-0058
• leaflet BOOTS_PL 46302-0022
• leaflet MAH BRAND_PL 43900-0058
• leaflet MAH BRAND_PL 46302-0022

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

IBS Relief 135 mg Tablets

Mebeverine Hydrochloride

IBS Relief is a tablet 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 and pain.

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

Your diet and lifestyles 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 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. Before you take IBS Relief

Do not take IBS Relief if:

•    You are allergic to any of the tablet ingredients (see section 6 for a list of ingredients)

•    You are younger than 18 years of age

If any of the above applies to you, do not take this medicine and talk to your doctor or pharmacist.

Take special care with IBS Relief

See your doctor before using any IBS treatment if you:

•    have not suffered from IBS before, or

•    have developed new symptoms or your symptoms have become worse

•    have liver or kidney problems

Talk to your doctor or pharmacist if any of the

following applies to you:

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

•    You have blood in your stools (faeces)

•    You are feeling sick (nauseous) or are sick (vomiting)

•    You are looking pale and feeling tired

•    You have constipation

•    You have a fever

•    You have recently travelled abroad

•    You are pregnant, or planning to become pregnant

•    You are a woman and have unusual bleeding or discharge from your vagina

•    You have difficulty or pain when passing water (urinating)

Your doctor will tell you whether it is safe for you to start taking IBS Relief.

Taking IBS Relief with food and drink

You can drink alcohol while you are taking IBS Relief. Taking other medicine

No interactions with other medicines are known.

Pregnancy or breast-feeding

Ask your doctor or pharmacist for advice before taking IBS Relief if you are pregnant or might become pregnant. There is only limited information about the safety of Mebeverine for pregnant women. Your doctor may advise you to stop taking IBS Relief before you become pregnant or as soon as you know you are pregnant. IBS Relief 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.

Important information about some of the ingredients of IBS Relief

This medicine contains lactose and sucrose (types of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugar (have an intolerance to some sugars), talk to your doctor before taking this medicine.

3. How to take IBS Relief

How to take IBS Relief

•    Try to take the tablets 20 minutes before a meal - some people find their symptoms to be strongest after they have eaten.

•    Swallow the tablets whole with water. Do not chew the tablets.

How much IBS Relief to take

Adults and the elderly:

•    Take 1 tablet 3 times a day

•    The number of tablets you take can be lowered if your symptoms improve

• Do not take more than 3 tablets per day Do not give IBS Relief to children or adolescents younger than 18 years.

How to stop taking IBS Relief

You can lower the dose if your symptoms get better.

If you take more IBS Relief than you should

If you or someone else takes too much IBS Relief (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take IBS Relief

If you miss a tablet, wait until the next dose is due. Do not try to make up for the dose you have missed. Do not double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, 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 tablets. See a doctor at once:

•    Difficulty in breathing, swelling of face, neck, tongue or throat (severe allergic reactions)

If you get any of the following side effects see your pharmacist or doctor:

•    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.aov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store IBS Relief

•    Keep out of the reach and sight of children.

•    You should lock this medicine in a cupboard or medicine cabinet.

•    Do not use the tablet after the expiry date which is printed on the carton and blister pack.

•    Do not store your tablets above 30°C and keep them in the original container.

If your doctor stops your treatment, return any unused tablets to a 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 IBS Relief contains

Each tablet contains 135 mg Mebeverine Hydrochloride which is the active ingredient.

The tablets also contain lactose, starch (potato), povidone, talc, magnesium stearate, sucrose, gelatin, acacia, carnauba wax.

What IBS Relief looks like and contents of the pack

IBS Relief tablets are white, round and sugar coated with no markings.

IBS Relief is available in packs containing 15 tablets in blister strips.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Mylan Products Ltd.,

20 Station Close,

Potters Bar,

Herts, EN61TL UK

The Manufacturer is:

Mylan Laboratories SAS,

01400 Chatillon-sur-Chalaronne, France Distributor:

The Boots Company PLC, Nottingham, NG2 3AA To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information: Product name: Boots IBS Relief 135 mg Tablets Reference number: 46302/0022 This is a service provided by the Royal National Institute of Blind People.

The leaflet was last approved in June 2016