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COLOFAC (MEBEVERINE HYDROCHLORIDE): PRECAUTIONS

Although not reported, Mebeverine Hydrochloride (Colofac) tablets should be used with caution in patients with the following conditions on the basis of potential clinical significance:

  • Cardiac dysrhythmia; in particular patients with partial or complete atrioventricular heart block, and/or angina or severe ischaemic heart disease.
  • Hepatic dysfunction i.e. patients with advanced liver disease e.g. cirrhosis (because of metabolic pathway). Liver function tests may be indicated if patient develops gastrointestinal symptoms or jaundice suggesting hepatic sensitivity.
  • Advanced renal disease (because of excretory pathway).

    Pharmaceutical Precautions

    Colofac (Mebeverine HCl) tablets contain lactose (80 mg per tablet) and consideration should be given to patients with a potential diagnosis of lactose intolerance simulating irritable bowel syndrome. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

    Mebeverine (Colofac) tablets also contain sucrose and should not be used by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

    Use in Pregnancy

    Pregnancy Category B2 in Australia and B in The USA. It means that no evidence of risk in humans.

    Safe use in pregnancy has not been established relative to adverse effects on foetal development. Therefore Colofac (Mebeverine Hydrochloride) tablets are not recommended during the first trimester of pregnancy, and otherwise risk-benefit must be considered in its use in pregnant women.

    Teratogenicity has not been demonstrated in teratology studies in rats and rabbits.

    Use in Lactation

    Mebeverine is secreted in breast milk ( < 10 mcg/mL following an oral dose of 100 mg mebeverine hydrochloride). Although problems have not been documented, as a general rule Mebeverine HCl (Colofac) tablets should not be given to a woman who is breast feeding unless the anticipated benefits outweigh possible risks.

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