Mebeverine

50 mg/5 ml Sugar Free Oral Suspension

Mebeverine

ESSENTIAL GENERICS

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Read all of this leaflet carefully before you start using this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before you take

3.    How to take

4.    Possible side effects

5.    How to store

6.    Further information

1. What this medicine is and what it is used for

Important information about some of the ingredients of Mebeverine Oral Suspension

•    sodium

Each 5 ml of suspension contains 20.5 mg of sodium.

This should be taken into consideration by patients on a controlled sodium diet.

•    castor oil

This may cause stomach upset and diarrhoea.

Mebeverine suspension contains mebeverine which is an antispasmodic. It is used to treat the symptoms of a variety of bowel problems and works by relaxing the muscles in the gut, thereby relieving the symptoms of irritable bowel:

•    colicky abdominal pain and cramps

•    persistent diarrhoea where there is no obvious cause (this may or may not occur between bouts of constipation)

•    wind.

Mebeverine can also be used for spasm in the gut resulting from certain other diseases.

3. How to take

2. Before you take

Do NOT take Mebeverine suspension if you:

• are allergic to mebeverine or to any of the other ingredients (see Section 6).

If this applies to you, speak to your doctor or pharmacist.

Taking other medicines

It is generally safe to take the suspension with other medicines. However, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations.

Pregnancy and breast-feeding

Ask your doctor for advice before taking Mebeverine if you are pregnant, think you might be pregnant or are breast-feeding.

Driving and using machines

Mebeverine is unlikely to affect your ability to operate machinery or to drive.

Always take Mebeverine suspension exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.

•    Shake the suspension before taking.

•    Take the suspension preferably 20 minutes before meals to reduce symptoms after eating.

Doses

Adults and children over 10 years of age: the usual dose is 15 ml three times a day.

The dose may be gradually reduced after a few weeks when your condition improves.

Children under 10 years: this medicine is NOT suitable for children under 10 years.

If you take more than you should

1.    Tell your doctor, pharmacist or nearest hospital casualty department immediately.

2.    Take the bottle and any remaining suspension with you so that people can see what you have taken.

3.    Do this even if you feel well.

If you forget to take

If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.

Do not use a double dose to make up for a missed dose.

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

4. Possible side effects

the unwanted medicine to your pharmacist. This will help to protect the environment.

Like all medicines, Mebeverine suspension can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.

STOP taking the suspension and seek medical help immediately if you

have any of the following allergic reactions:

•    difficulty breathing or swallowing, swelling of the face, lips, tongue or throat

•    severe itching of the skin, with a red rash or raised lumps.

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. m h ra. g ov. u k/ye 11 owca rd

By reporting side effects you can help provide more information on the safety of this medicine.

6. Further information

5. How to store

•    Keep out of the reach and sight of children.

•    Do not take after the expiry date which is stated on the bottle label and on the carton. The expiry date refers to the last day of that month.

•    Do not store above 30°C.

•    Keep container in the outer carton.

•    Do not throw it away with your household waste or in water. Return all

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What Mebeverine Oral Suspension contains

•    The active ingredient is mebeverine pamoate (equivalent to 50 mg mebeverine hydrochloride per 5 ml).

•    The other ingredients are:

microcrystalline cellulose, carmellose sodium, citric acid monohydrate, sodium citrate, polysorbate 20, hydrogenated polyoxyl castor oil, disodium pamoate monohydrate, sodium benzoate (E211), saccharin sodium, banana flavour, simethicone emulsion and purified water.

(See end of Section 2 for further information on sodium and castor oil).

What Mebeverine Oral Suspension looks like and contents of the pack

Mebeverine Oral Suspension is a yellow, banana flavoured suspension.

It is available in amber glass bottles of 300 ml.

Marketing Authorisation Holder

Chemidex Pharma Ltd., trading as Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB.

Manufacturer

Famar Nederland BV, Industrieweg 1,5531 AD Bladel, The Netherlands.

This leaflet was last revised in

06/2015

ESSENTIAL GENERICS