Mebeverine 50mg/5ml Sugar Free Oral Suspension

Each 5 ml oral suspension contains 50 mg mebeverine hydrochloride (as pamoate).

Excipient(s) with known effect

Each 5 ml oral suspension contains 1 mg polyoxyl 40 hydrogenated castor oil, 10 mg sodium benzoate and 20.5 mg sodium.

For the full list of excipients, see Section 6.1.

Oral suspension

Yellow sugar free suspension with a flavour of banana.

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. Mebeverine 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.

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.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Sodium benzoate

This medicinal product contains 30 mg sodium benzoate in each 15 ml spoonful of oral suspension which is equivalent to 2 mg/ml.

Polyoxyl 40 hydrogenated castor oil

This medicinal product contains 3 mg polyoxyl 40 hydrogenated castor oil in each 15 ml spoonful of oral suspension which is equivalent to 0.2 mg/ml. Castor oil may cause stomach upset and diarrhoea.

Sodium

This medicinal product contains 61.5 mg of sodium in each 15 ml spoonful of oral suspension, equivalent to 3% of the WHO recommended daily intake of 2 g sodium for an adult.

None known.

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

Mebeverine has no or negligible influence on the ability to drive and use machines

Immune system disorders

Very rare (<1/10,000): hypersensitivity

Skin and subcutaneous tissue disorders

Very rare (<1/10,000): 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

Pharmacotherapeutic group: Synthetic anticholinergics, esters with tertiary amino group, ATC code: A03A A04

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

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.

None stated.

Microcrystalline cellulose

Carboxymethylcellulose sodium

Citric acid monohydrate

Sodium citrate

Polysorbate 20

Polyoxyl 40 hydrogenated castor oil

Disodium pamoate monohydrate

Sodium benzoate (E 211)

Saccharin sodium

Banana flavour

Simethicone emulsion

Purified water.

Not applicable.

5 years.

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

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

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

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Chemidex Pharma Ltd

Trading as Essential Generics

7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB, United Kingdom

PL 17736/0084

21 May 1997

30/01/2020