Colofac/Colofac Retard Special Precautions

Colofac: Based on theoretical concerns, it should be used with caution in patients with marked hepatic or renal impairment, and those with cardiac disorders eg, heart block.
Cystic Fibrosis: It was recommended that antispasmodics eg, mebeverine should not be used for the symptomatic treatment of distal intestinal syndrome in cystic fibrosis.
Porphyria: Mebeverine hydrochloride is considered to be unsafe in patients with porphyria because it has been shown to be porphyrinogenic in in vitro systems.
Colofac coated tablets contain lactose, if the patient has intolerance to lactose (or other types of sugar), contact the physician before taking Colofac.
Furthermore, the patient should not take Colofac if any of the following hereditary problems is present: Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
The coating of the tablets contains sucrose. The patient should not take Colofac if any of the following hereditary problems is present: Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Effects on the Ability to Drive or Operate Machinery: No studies on the effects on the ability to drive and operate machines have been performed.
Colofac: The pharmacodynamic and pharmacokinetic profile, as well as post-marketing experience, do not indicate any harmful effect of mebeverine on the ability to drive or to use machines.
Impairment of Fertility: There is no clinical information on mebeverine’s influence on male or female fertility; however, animal studies do not indicate harmful effects.
Use in Pregnancy: Colofac: Only a very limited amount of information on the use of mebeverine in pregnant women is available. Animal studies are insufficient with respect to reproductive toxicity. Do not take Colofac if pregnant.
Colofac Retard: Animal experiments have failed to show any teratogenic effects. However, the usual precautions concerning the administration of any drug during pregnancy should be observed.
Use in Lactation: Colofac: It is unknown whether mebeverine or its metabolites is excreted in human milk. The excretion of mebeverine in milk has not been studied in animals. Do not take Colofac while breastfeeding.
Colofac Retard: Colofac Retard is not excreted in milk of lactating women after therapeutic doses.
Use in Children: Colofac should not be used in children.