Colofac/Colofac Retard

Colofac/Colofac Retard

mebeverine

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Mebeverine HCl.
Description
Each Colofac tablet also contains the following excipients: Tablet Core: Lactose monohydrate, starch (potato), povidone, talc, magnesium stearate. Tablet Coating: Talc, sucrose, gelatine, acacia, canuba wax.
Each Colofac Retard prolonged-release capsule also contains the following excipients: Magnesium stearate, copolymer of ethyl acrylate and methyl methacrylate, talc, methylhydroxypropylcellulose, methacrylic acid-ethyl acrylate copolymer (1:1) and glycerol.
Action
Pharmacotherapeutic Group: Synthetic musculotropic antispasmodic with no anticholinergic activity, esters with tertiary amino group.
Pharmacology: Pharmacodynamics: Musculotropic antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility. Since this action is not mediated by the autonomic nervous system, the usual anticholinergic side effects are absent.
Colofac Retard is suitable for patients with prostatic hypertrophy and glaucoma.
Clinical Efficacy and Safety: Colofac: The clinical efficacy and safety of different formulations of mebeverine were evaluated in >1500 patients. Considerable improvements in the predominant symptoms of irritable bowel syndrome (eg, abdominal pain, stool characteristics) were generally observed in reference or baseline-controlled clinical studies.
All formulations of mebeverine were generally safe and well tolerated in the recommended dose regimen.
Pharmacokinetics: The prolonged-release formulation permits a twice daily dosing scheme.
Colofac: Absorption: Mebeverine is rapidly and completely absorbed after oral administration of tablets.
Distribution: No significant accumulation occurs after multiple doses.
Biotransformation: Mebeverine hydrochloride is mainly metabolized by esterases, which initially split the ester bonds into veratric acid and mebeverine alcohol.
The main metabolite in plasma is demethylated carboxylic acid (DMAC). The steady state elimination half-life of DMAC is 2.45 hrs. During multiple dosing, the peak plasma concentration (Cmax) of DMAC for the coated tablets with 135 mg is 1670 ng/mL and time to reach the peak plasma concentration (tmax) is 1 hr.
Colofac/Colofac Retard: Elimination: Mebeverine is not excreted as such, but metabolized completely; the metabolites are excreted nearly completely. Veratric acid is excreted into the urine, mebeverine alcohol is also excreted into the urine, partly as the corresponding carboxylic acid (MAC) and partly as the DMAC.
Indications/Uses
Adults: Symptomatic treatment of abdominal pain and cramps, bowel disturbances and intestinal discomfort related to irritable bowel syndrome. Treatment of gastrointestinal spasm secondary to organic diseases.
Dosage/Direction for Use
Adult: Colofac: 1 tablet thrice daily, taken approximately 20 min before meals.
The physician will advice the patient on the duration of use of Colofac. Duration of use is not limited, however, after a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced.
Missed Dose: If ≥1 dose is missed, continue with the next dose as prescribed. Do not take the missed dose(s) in addition to the regular dose.
Colofac Retard: 1 capsule twice daily, to be given in the morning and evening.
Administration: The tablet/capsule should be swallowed with at least 100 mL (Colofac) water and should not be chewed because of the unpleasant taste.
Overdosage
If too many tablets of Colofac is taken, contact a physician.
In cases where Colofac was taken in overdose, symptoms were either absent or mild and usually rapidly reversible.
On theoretical grounds, it may be predicted that central nervous system excitability will occur in cases of overdosage.
Observed symptoms of overdose were of neurological and cardiovascular nature. No specific antidote is known. Symptomatic treatment is recommended. Gastric lavage should only be considered in case of a severe overdosing which is discovered within about 1 hr. Absorption reducing measures are not necessary.
Contraindications
Hypersensitivity to mebeverine HCl or to any of the excipients of 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.
Use In Pregnancy & Lactation
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.
Adverse Reactions
Colofac: Like all medicines, Colofac may have side effects. If any side effect not mentioned is noticed or if any of the side effects become serious, please inform the physician or pharmacist immediately.
The following adverse events have been reported spontaneously during post-marketing use. A precise frequency cannot be estimated from the available information.
Allergic reactions, mainly but not exclusively, limited to the skin have been observed.
Although adverse effects appear rare, gastrointestinal disturbances, dizziness, headache, insomnia, anorexia and decreased heart rate have been reported in patients receiving mebeverine.
Skin and Subcutaneous Tissue Disorders: Hives (urticaria), sudden onset of face swelling (edema), neck or limb swelling (angioedema), skin eruptions/rash (exanthema).
Immune System Disorders: Allergic (hypersensitivity) reactions (anaphylactic reactions).
Colofac Retard: Very rarely, hypersensitivity reactions may occur, in particular urticaria, angioedema, face edema and exanthema.
Drug Interactions
Colofac: Tell the physician or pharmacist if taking or have recently taken any other medicines including medicines obtained without a prescription.
Interaction studies have only been performed with alcohol. In vitro and in vivo studies in animals have shown no significant interaction between Colofac and ethanol. No other interaction studies have been performed.
Incompatibilities: Not applicable.
Storage
Colofac: Do not store above 30°C.
Shelf-Life: 5 years.
Colofac Retard: Do not store below 5°C.
Shelf-Life: 3 years at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
A03AA04 - mebeverine ; Belongs to the class of synthetic anticholinergics, esters with tertiary amino group. Used in the treatment of functional bowel disorders.
Presentation/Packing
Colofac: Tab 135 mg (round, white, sugar-coated) x 50's.
Colofac Retard: PR cap 200 mg (prolonged-release, opaque white, hard-gelatin) x 30's.
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