Niaspam, 200 mg capsules 30 pcs

Pharmacodynamics

Myotropic spasmolytic, has a direct effect on the smooth muscles of the gastrointestinal tract, eliminates spasm, does not affect normal intestinal peristalsis. It has no anticholinergic effect.

Pharmacokinetics

Intake

Mebiverine is quickly and completely absorbed after oral administration. The modified-release dosage form allows for a twice-daily dosing regimen.

Distribution

There is no significant accumulation when repeated doses of the drug are taken.

Metabolism

Meberine hydrochloride is primarily metabolized by esterases, which first break down the ester into veric acid and meberine alcohol. The main metabolite circulating in blood plasma is demethylated carboxylic acid. The half-life in equilibrium state of demethylated carboxylic acid is approximately 5.77 hours. With repeated doses (200 mg 2 times per day) the maximum plasma concentration of demethylated carboxylic acid (Cmax) is 804 ng/ml, the time to reach the maximum concentration of demethylated carboxylic acid in blood (Tmax) is about 3 hours.

The average relative bioavailability of the drug in the modified-release capsule is about 97%.

Exhaustion

Meberine as such is not excreted from the body, but is completely metabolized; its metabolites are almost completely excreted from the body. Veratroic acid is excreted by the kidneys. The alcohol of mebeverine is also excreted by the kidneys, partly as carboxylic acid and partly as demethylated carboxylic acid.

Indications

Symptomatic treatment of pain, cramps, dysfunction and discomfort in the intestinal area associated with irritable bowel syndrome.

The symptomatic treatment of gastrointestinal spasms (including those due to organic diseases).

Active ingredient

Composition

One sustained release capsule contains:

the active ingredient:

meberine hydrochloride 200 mg;

excipients:

microcrystalline cellulose 65.60 mg,

vegetable oil hydrogenated type I 85.00 mg,

purified talc 5.50 mg,

magnesium stearate 3.00 mg,

colloidal silicon dioxide 0.90 mg;

capsule shell:

gelatin 64.28 mg, purified water 9.00 mg, methyl parahydroxybenzoate 0.52 mg, propyl parahydroxybenzoate 0.13 mg, brilliant blue dye 0.03 mg, titanium dioxide 1.04 mg.

How to take, the dosage

For oral administration.

The capsules should be swallowed with enough water (at least 100 ml). The capsules should not be chewed because their coating allows prolonged release of the drug.

Take one capsule twice daily 20 minutes before a meal, one capsule in the morning and one capsule in the evening.

The duration of treatment is not limited.

If a patient forgets to take one or more doses, the drug should be continued with the next dose. One or more missed doses should not be taken in addition to the usual dose.

Performance in special patient groups

Elderly patients, patients with hepatic and/or renal impairment do not require dose adjustments.

Interaction

There have only been studies on the interaction of mebeverine with ethanol. Animal studies have shown no interaction between mebeverine and ethanol.

Special Instructions

Impact on driving and operating machinery

Niaspam has no effect on the ability to drive and engage in potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

Hypersensitivity to any component of the drug.

You are under 18 years of age (due to insufficient data on efficacy and safety).

Side effects

The following adverse events have been reported spontaneously, and there are insufficient data to make an accurate estimate of the incidence.

Allergic reactions have been observed predominantly on the skin, but other manifestations of allergy have also been reported.

Skin and subcutaneous tissue disorders: urticaria, angioedema, including facial, exanthema.

Immune system disorders: hypersensitivity reactions (anaphylactic reactions).

Overdose

Symptoms: theoretically, in case of overdose, increased excitability of the central nervous system is possible. In cases of mebeverine overdose, symptoms were either absent or mild and usually quickly reversible. The observed symptoms of overdose were neurological and cardiovascular.

Treatment: symptomatic treatment is recommended. Gastric lavage is necessary only if intoxication is detected within approximately one hour after taking several doses of the drug. Measures to reduce absorption are not required. A specific antidote is not known.

Pregnancy use

Pregnancy

There are only very limited data on the use of mebeverine in pregnant women. The drug is not recommended for use during pregnancy.

Breastfeeding

There is insufficient information about the excretion of mebereurin or its metabolites in breast milk. The drug should not be taken during breastfeeding.

Fertility

There are no clinical data on the effect of the drug on fertility in men or women, but animal studies have not demonstrated adverse effects of the drug.

Similarities