Mebeverine hydrochloride.
Each capsule contains 200 mg mebeverine hydrochloride.
The capsules are for oral administration only (to be taken by mouth).
Excipients/Inactive Ingredients: Capsule content (granules): Magnesium stearate, polyacrylate dispersion 30%, talc, hypromellose, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, glycerol triacetate.
Capsule shell: Gelatin, titanium dioxide (E171).
Printing ink: Shellac (E904), black iron oxide (E172), propylene glycol, concentrated ammonia solution, potassium hydroxide.
Pharmacotherapeutic group: Synthetic anticholinergics, esters with tertiary amino group. ATC-Code: A03AA04.
Pharmacology: Pharmacodynamics: The following is a detailed description of how the active ingredient of Duspatalin works. For further explanations consult a doctor.
Mechanism of action and pharmacodynamic effects: Mebeverine is a musculotropic antispasmodic with a direct effect on the smooth muscle of the gastro-intestinal tract, relieving spasm without affecting normal gut motility. Since this effect is not mediated by the autonomic nervous system, the typical anti-cholinergic side-effects are absent.
Pharmacokinetics: The following is a detailed description of how the active ingredient of Duspatalin is metabolized by the body. For further explanations consult a doctor.
Absorption: Mebeverine is rapidly and completely absorbed after oral administration of tablets. The modified release formulation permits a twice daily dosing scheme.
Distribution: No significant accumulation occurs after multiple doses.
Biotransformation: Mebeverine hydrochloride is mainly metabolized 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 5.77 h. During multiple dosing (200 mg b.i.d.) the Cmax of DMAC is 804 ng/ml, and tmax is about 3 hrs. The relative bioavailability of the modified release capsule appears to be optimal with a mean ratio of 97%.
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 demethylated carboxylic acid (DMAC).
Paediatric population: No pharmacokinetic studies have been conducted in children with any formulation of mebeverine.
Symptomatic treatment of abdominal pain and cramps, bowel disturbances and intestinal discomfort related to irritable bowel syndrome.
Treatment of gastro-intestinal spasm secondary to organ diseases.
Adults: Take one capsule twice daily, one in the morning and one in the evening.
The capsules should be swallowed with a sufficient amount of water (at least 100 ml of water). They should not be chewed because the coating is intended to ensure a prolonged release mechanism.
Treatment Duration: Symptom relief occurs after a minimum of 2 to 4 weeks of treatment and greater effects can be observed after a prolonged therapy of 6 to 8 weeks.
Always take Duspatalin Retard exactly as the doctor has prescribed. If the patient has any questions, check with the doctor or pharmacist.
In case of one or more dose(s) is (are) missed, the patient should continue with the next dose as prescribed; the missed dose(s) is (are) not to be taken in addition to the regular dose.
Paediatric Population: Duspatalin Retard 200 mg capsules are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy.
Special Population: No posology studies in elderly, renal and/or hepatic impaired patients have been performed. However, 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 these patients.
If the patient had taken too many capsules of Duspatalin contact a doctor. In cases where Duspatalin was taken in overdose, symptoms were either absent or mild and usually rapidly reversible.
Symptoms: Theoretically, central nervous system (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 neurological and cardiovascular nature.
Treatment: No specific antidote is known and symptomatic treatment is recommended. Gastric lavage should only be considered in case of multiple intoxication within about one hour. Absorption reducing measures are not necessary.
Do not take this medicine if the patient is allergic (Hypersensitivity) to the active substance or to any of the excipients.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. 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.
Ask a doctor or pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.
Pregnancy: There is no or limited amount of data from the use of mebeverine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Duspatalin Retard 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. Duspatalin Retard should not be used while breast-feeding.
Fertility: There is no clinical data regarding impact on male or female fertility; however, available animal studies do not indicate harmful effects of mebeverine.
Like all medicines, Duspatalin Retard may have side effects. If the patient notices any side effects not mentioned in this monograph, or if any of the side effects become serious, inform a doctor 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.
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: Hypersensitivity (anaphylactic reactions).
Tell a doctor or pharmacist if the patient is taking or had recently taken any other medicines including medicines obtained without a prescription.
No interaction studies have been performed with the exception of alcohol. In vitro and in vivo studies in animals have demonstrated the absence of any interaction between Duspatalin Retard and ethanol.
Incompatibilities: Not applicable.
Further information: Any unused product or waste material should be disposed of in accordance with local requirements.
Do not store above 30°C and not below 5°C.
Store in the original package.
Shelf life: This product can be stored for up to 3 years.
A03AA04 - mebeverine ; Belongs to the class of synthetic anticholinergics, esters with tertiary amino group. Used in the treatment of functional bowel disorders.
Duspatalin Retard cap 200 mg
30's
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