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COLOFAC (MEBEVERINE HYDROCHLORIDE): PRESCRIBING INFORMATION

DESCRIPTION

Mebeverine Hydrochloride is 4-[ethyl-[2-(4-methoxyphenyl)-1-methylethyl] aminobutyl veratrate hydrochloride, a derivative of phenylethylamine. It is a white to almost white, crystalline powder having a very bitter taste, very soluble in water, freely soluble in ethanol and practically insoluble in ether. The empirical formula is C25H35NO5 x HCl. MW:466.0

Each Colofac tablet contains Mebeverine Hydrochloride 135 mg. The tablets also contain carnauba wax, acacia, gelatine, magnesium stearate, lactose, povidone, sucrose, potato starch, and purified talc.


CLINICAL PHARMACOLOGY

Colofac clinical pharmacology


INDICATIONS AND USAGE

Colofac (Mebeverine) tablets are indicated in the management of the irritable bowel syndrome (spastic colon, irritable colon, functional bowel disorders, nervous diarrhoea, spastic constipation). Colofac is used to treat the symptoms of this condition - i.e. abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.


CONTRAINDICATIONS

Hypersensitivity to any component of Colofac (Mebeverine) tablets.


PRECAUTIONS

Colofac precautions


ADVERSE EFFECTS

Because of the low incidence of adverse drug effects reported a meaningful estimate of adverse reactions is difficult to obtain.

The following side effects have been reported in clinical studies: heartburn, indigestion, dizziness, anorexia, insomnia, headache, constipation, decrease in pulse rate, general malaise.

In very rare cases allergic reactions have been reported, in particular hypersensitivity, angiodema, urticaria, face oedema and exanthem.

Side effects reported during post-marketing of Colofac (Mebeverine HCl) tablets use have been consistent with those reported in clinical studies, with the following additional side effect reported:

Immune system disorders: hypersensitivity (anaphylactic reactions)


DOSAGE AND ADMINISTRATION

The recommended adult dose is one Mebeverine HCl (Colofac) tablet 135 mg three times daily, preferably before or with food. In case one or more doses are missed, the patient should continue with the next dose as prescribed, the missed doses are not to be taken in addition to the regular dose.

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


OVERDOSAGE

On theoretical grounds, it may be predicted that CNS excitability might occur in cases of overdosage. Observed symptoms of overdose have included those of neurological and cardiovascular nature.

No specific information is available on the treatment of overdosage of Mebeverine Hydrochloride (Colofac) and no specific antidote is available. Therapy with Colofac tablets should be discontinued, and the patients vital functions monitored closely. Treatment is symptomatic and supportive.

In case of overdose, contact a local poisons information centre for advice on management.


PRESENTATION AND STORAGE CONDITIONS

Colofac (Mebeverine) tablets are sugar-coated, white, round, biconvex, and 11 mm in diameter. Colofac tablets are available in cartons of 10, 30 and 90 tablets in blister packs.

Store this medication below 30°C.

Manufactured and distributed by Abbott pharmaceutical company and its divisions.

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