Composition

Each tablet contains:
Mebeverine hydrochloride ...................................................................
135 mg

Therapeutic Indications

Primary irritable colon characterized by persistent diarrhoea, alternating constipation and diarrhoea, abdominal pain and postprandial distention.

Secondary irritable colon due to organic lesions such as regional enteritis, diverticulitis, specific and non-specific inflammations of the gastrointestinal tract.


Dosage and Administration

Adults: 1 tablet 3 times daily, preferably before meals.

Not recommended for children.


Contraindications

Hypersensitivity to the product.

Paralytic ileus.


Warnings and Precautions

COLOSPASMIN FORTE should be used with caution in:
Patients with marked hepatic or renal impairment.

Patients with cardiac disorders such as heart block.

Antispasmodics, including COLOSPASMIN FORTE, are not recommended for the symptomatic treatment of distal intestinal syndrome in cystic fibrosis.

Though experiments in rats and rabbits have shown mebeverine hydrochloride not to be teratogenic, COLOSPASMIN FORTE is better avoided during pregnancy.

COLOSPASMIN FORTE is considered to be unsafe in patients with porphyria.

Treatment of overdose: There is no specific antidote; gastric lavage and symptomatic treatment are recommended.


Undesirable Effects

COLOSPASMIN FORTE has proved to be well-tolerated in therapeutic doses.

The side effects are rare; they may include gastrointestinal distrurbances, dizziness, headache, insomnia, and depression.
In very rare cases, allergic reactions have been reported especially erythematous rash, urticaria and angioedema.


Pharmacological Properties

COLOSPASMIN FORTE is a musculotropic antispasmodic used in gastrointestinal disorders.

It has a direct action on colonic muscular activity, especially in colonic hypermotility.

COLOSPASMIN FORTE, being entirely a smooth muscle relaxant without atropine-like effects, is not contraindicated in patients with glaucoma or prostatic hypertrophy.

Pharmacokinetics:
Following oral administration, mebeverine is absorbed from the gastrointestinal tract; peak plasma concentrations are achieved within 1-3 hours after dosing.
Mebeverine is about 75% bound to plasma proteins, and is completely metabolized by hydrolysis to veratric acid and mebeverine alcohol.
The metabolites are excreted in the urine.


Storage

Store at a temperature not exceeding 30°C.


Packaging

COLOSPASMIN FORTE Tablets: Box containing 2 or 100 blisters of 10 tablets each.