COLOSPASMINE FORTE 135 MG ( MEBEVERINE ) 20 TABLETS

Composition

Each sugar coated tablet contains:

Mebeverine hydrochloride                                                         135 mg

Inactive ingredients:

Calcium sulfate dihydrate, maize starch, croscarmellose sodium, magnesium stearate, povidone K30, colloidal silicon dioxide 200, talc, purified, sodium carboxymethyl cellulose, polyethylene glycol 6000, polyethylene glycol 35000, polysorbate 20, calcium carbonate PPT, titanium dioxde,  povidone K25, sucrose, lactose monohydrate, eudragit EN 30D.

Therapeutic Indications

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. 

COLOSPASMIN FORTE is effectively used to treat the symptoms of these conditions such as: colicky abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.

Dosage and Administration

Dosage:

Duration of use is not limited.

If one or more doses are missed, the patient should continue with the next dose as prescribed; the missed dose(s) should not be taken in addition to the regular dose.

Adults (including the Elderly):

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.

Pediatric population:

COLOSPASMIN FORTE 135 mg Sugar-coated Tablets are not recommended for use in children and adolescents below 18 years, due to insufficient data on safety and efficacy.

Special population:

No posology studies in elderly, renal and/or hepatic impaired patients have been performed. No specific risk for elderly, renal and/or hepatic impaired patients could be identified from available post-marketing data. No dosage adjustment is deemed necessary in elderly, renal and/or hepatic impaired patients.

Administration:

For oral use.

The sugar coated tablets should be swallowed with a sufficient amount of water (at least 100 ml water). Tablets should not be chewed because of the unpleasant taste.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Warnings and Precautions

If this is the first time you have had these symptoms talk to your doctor before using this medicine. This is to make sure it is suitable for you..

Do not use this medicine without talking to your doctor if you:

- are over 40 years of age.

- have passed blood in your stools or motions.

- are feeling sick or being sick.

- have lost your appetite or lost weight.

- look pale and feel tired.

- are very constipated.

- have a fever.

- have recently travelled abroad.

- are or may be pregnant.

- have abnormal vaginal bleeding or discharge.

- have difficulty or pain passing water.

Talk to your doctor if you get new symptoms, your symptoms get worse or if they do not improve after 2 weeks of treatment.

Excipients:

Since COLOSPASMIN FORTE Sugar-coated Tablets contain lactose and sucrose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Drug Interactions

No interaction studies have been performed, except with alcohol. In vitro and in vivo studies in animals have demonstrated the absence of any interaction between mebeverine hydrochloride and ethanol.

Pregnancy and Lactation

Pregnancy:

There are no or limited amounts of data from the use of mebeverine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. COLOSPASMIN FORTE is not recommended during pregnancy.

Lactation:

It is unknown whether mebeverine or its metabolites are excreted in human milk. The excretion of mebeverine in milk has not been studied in animals. COLOSPASMIN FORTE should not be used during breast-feeding.

Fertility:

There are no clinical data on male or female fertility; however, animal studies do not indicate harmful effects of mebeverine.

Effects on ability to drive and to use machines

No known studies on the effects on the ability to drive and to use machines have been performed. The pharmacodynamic and pharmacokinetic profiles as well as postmarketing experience do not indicate any harmful effect of mebeverine on the ability to drive or to use machines.

Undesirable Effects

The following adverse reactions have been reported spontaneously during postmarketing use. A precise frequency cannot be estimated from available data.

Allergic reactions mainly but not exclusively limited to the skin have been reported.

Immune system disorders:

Hypersensitivity (anaphylactic reactions).

Skin and Subcutaneous tissue disorders:

Urticaria, angioedema, face oedema and exanthema.

Overdose

Theoretically CNS excitability may occur in cases of overdose. In cases where mebeverine was taken in overdose, symptoms were either absent or mild and usually rapidly reversible. Observed symptoms of overdose were of a neurological and cardiovascular nature.

No specific antidote is known and symptomatic treatment is recommended.

Gastric lavage should only be considered in case of multiple intoxication or if discovered within about one hour. Absorption reducing measures are not necessary.

Pharmacological Properties

Pharmacodynamic Properties:

Pharmacotherapeutic group: Synthetic anticholinergics, esters with tertiary amino group.

Mebeverine is a musculotropic antispasmodic drug with a direct action on the smooth muscle of the gastrointestinal tract, without affecting normal gut motility. The exact mechanism of action is not known, but multiple mechanisms, such as a decrease in ion channel permeabilities, blockade of noradrenaline reuptake, a local anesthetic effect, changes in water absorption as well as weak anti-muscarinergic and phosphodiesterase inhibitory effect might contribute to the local effect of mebeverine on the gastrointestinal tract.

Systemic side-effects as seen with typical anticholinergics are absent.

Clinical efficacy and safety:

All formulations of mebeverine were generally safe and well tolerated in the recommended dose regimen.

Pediatric population:

The safety and efficacy of the product has only been evaluated in adults.

Pharmacokinetic Properties:

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 metabolised by esterases, which split the ester bonds into veratric acid and mebeverine alcohol firstly.

The main metabolite in plasma is DMAC (demethylated carboxylic acid).

The steady state elimination half-life of DMAC is 2.45 h. During multiple dosing Cmax of DMAC for the film-coated tablets with 135 mg is 1670 ng/ml and tmax is 1 h.

Elimination:

Mebeverine is not excreted as such, but metabolised 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 demethylated carboxylic acid (DMAC).

Pediatric population:

The safety and efficacy of the product has only been evaluated in adults.

Storage

Store in a dry place at a temperature not exceeding 30°C.

Packaging

COLOSPASMIN FORTE Sugar coated Tablets:  Box containing blisters of 10 tablets each.

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