Brand name: Colofac

Active ingredient (generic name): Mebeverine

Manufacturer: Sandoz

Importer: Behestan Darou

Pharmacotherapeutic group: Synthetic anticholinergics

Pharmaceutical form: 135MG Tablet

Pharmacodynamic:  

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

 

Pharmacokinetic:

Mebeverine is rapidly and completely absorbed after oral administration in the form of tablets or suspension. Mebeverine is not excreted as such, but metabolized 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.

Therapeutic indication:

Mebeverine is used 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 diarrhea (with or without alternating constipation) and flatulence.

 

Dosage and administration:

Method of administration is one tablet 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.

 

 

 

`Adverse reaction:

Allergic reactions mainly but not exclusively limited to the skin have been observed. Immune system disorders like hypersensitivity and skin and subcutaneous tissue disorders: urticaria, angioedema, erythematous rash.

 

Contraindication:

It is prohibited in case of hypersensitivity to the active substance or to any of the excipients.

 

Pharmacokinetic interactions:

 

No interaction studies have been performed.

Special warnings:

Since Mebeverine coated tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The coated tablets contain sucrose and should not be used by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

 

Pregnancy and lactation:

It is in group C and animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development; however, Caution should be exercised when prescribing to pregnant women.

 

Storage temperature:  

Room temperature (15-25 C)

 

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