SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Mebeverine 50mg/5ml Sugar Free Oral Suspension

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Mebeverine pamoate equivalent to 50 mg mebeverine hydrochloride per 5 ml.

3. PHARMACEUTICAL FORM

A yellow, banana flavoured, sugar free suspension.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

1.    For the symptomatic treatment of irritable bowel syndrome and other conditions usually included in this grouping, such as chronic irritable colon, spastic constipation, mucous colitis, spastic colitis. Colofac is effectively used to treat the symptoms of these conditions, such as colicky abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.

2.    For the symptomatic treatment of gastro-intestinal spasm secondary to organic diseases.

4.2. Posology and Method of Administration

Adults (including the elderly) and children 10 years and over: 15 ml (150 mg) three times a day, preferably 20 minutes before meals.

After a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced.

Children under 10 years. Not applicable.

4.3.    Contra-Indications

Hypersensitivity to any component of the product.

4.4.    Special Warnings and Special Precautions for Use

None.

4.5.    Interaction with other Medicinal Products and other Forms of Interaction

None known.

4.6.    Pregnancy and Lactation

Animal experiments have failed to show any teratogenic effects. However, the usual precautions concerning the administration of any drug during pregnancy should be observed.

4.7.    Effects on Ability to Drive and Use Machines

None.

4.8 Undesirable effects

Immune system disorders

Very rare: hypersensitivity

Skin and subcutaneous tissue disorders

Very rare: urticaria, angioedema, face oedema, exanthema/rash Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

On theoretical grounds it may be predicted that CNS excitability will occur in cases of overdosage. No specific antidote is known; gastric lavage and symptomatic treatment is recommended.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Mebeverine is a musculotropic antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility.

5.2. Pharmacokinetic Properties

Mebeverine is rapidly and completely absorbed after oral administration in the form of tablets or suspension. Mebeverine is not excreted as such, but metabolised completely. The first step in the metabolism is hydrolysis, leading to veratric acid and mebeverine alcohol. Both veratric acid and mebeverine alcohol are excreted into the urine, the latter partly as the corresponding carboxylic acid and partly as the demethylated carboxylic acid.

5.3. Pre-clinical Safety Data

None stated.

6. PHARMACEUTICAL PARTICULARS 6.1. List of Excipients

Microcrystalline cellulose, carboxymethylcellulose sodium, citric acid monohydrate, sodium citrate, polysorbate 20, polyoxyl 40 hydrogenated castor oil, disodium pamoate monohydrate, sodium benzoate, saccharin sodium, banana flavour, simethicone emulsion, purified water. The sodium content is 20.5 mg/5 ml.

6.2. Incompatibilities

Not applicable.

6.3. Shelf-Life

5 years.

6.4. Special Precautions for Storage

Do not store above 30°C. Keep container in the outer carton.

6.5. Nature and Content of Container

Amber glass bottle with polyethylene tamper evident cap. Each bottle contains 300 ml.

6.6. Instructions for Use, Handling and Disposal

Shake well before use. Dilution and subsequent storage not recommended. Mebeverine does not produce false positive reactions in standard diagnostic urine tests.

7    MARKETING AUTHORISATION HOLDER

Chemidex Pharma Limited

Trading as Essential Generics

7 Egham Business Village

Crabtree Road

Egham

Surrey

TW20 8RB

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 17736/0084

9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION

21 May 1997

DATE OF REVISION OF THE TEXT

11/11/2015