Patient leaflet - Mebeverine Hydrochloride 135 mg film-coated tablets

1. What Mebeverine tablets are and what they are used for

Mebeverine tablets contain the active substance 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.

You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

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 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 tablets

Do not take Mebeverine tablets

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

Warnings and precautions

See your doctor before using any IBS treatment if you:

have not suﬀered from IBS before
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 you 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 Mebeverine tablets.

Other medicines and Mebeverine tablets

No interactions with other medicines are known.

Mebeverine tablets with food, drink and alcohol

You can drink alcohol while you are taking Mebeverine tablets.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is only limited information about the safety of Mebeverine for pregnant women.

Your doctor may advise you to stop taking Mebeverine tablets before you become pregnant or as soon as you know you are pregnant. Mebeverine tablets 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.

Mebeverine tablets contain lactose

This medicine contains 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.

Mebeverine tablets contain sodium

This medicine contains less than 1mmol sodium(23mg) per tablet that is to say essentially 'sodium-free'.

3. How to take Mebeverine tablets

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

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.

Use in adults and the elderly

The recommended dose is 1 tablet three 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.

Use in children and adolescents

Do not give Mebeverine tablets to children or adolescents younger than 18 years.

How to stop taking Mebeverine tablets

You can lower the dose if your symptoms get better.

If you take more Mebeverine tablets than you should

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

If you forget to take Mebeverine tablets

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 take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

210 X 297 mm Front

4. Possible side eﬀects

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

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).

Additional side eﬀects

These other eﬀects are less serious. If they bother you, talk to a pharmacist: • 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 Website

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side eﬀects you can help provide more information on the safety of this medicine.

5. How to store 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 after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 tablets contain

The active substance is mebeverine hydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, povidone K-30, sodium starch glycolate, puriﬁed talc, magnesium stearate, hypromellose, polyethylene glycol/macrogol and titanium dioxide

What Mebeverine tablets look like and contents of the pack

Mebeverine Hydrochloride 135 mg Film-coated Tablets are white to oﬀ white, approximately 11 mm, round, ﬁlm coated biconvex tablets, plain on both sides.

Mebeverine Hydrochloride 135 mg Film-coated Tablets are available in PVC/PVDC-aluminium blister packs containing 15 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dawa Limited

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, UK.

Manufacturer

Drugsrus Limited