Niaspam capsules of prolonged action 200mg, No. 30

• symptomatic treatment of bowel pain, spasms, dysfunction and discomfort associated with irritable bowel syndrome;

• symptomatic treatment of spasms of the gastrointestinal tract (including those caused by organic diseases).

For oral administration.

The capsules must be swallowed with a sufficient amount of water (at least 100 ml). The capsules should not be chewed because their shell provides a sustained release of the drug.

Take 1 capsule 2 times / day 20 minutes before meals, 1 capsule in the morning and 1 capsule in the evening.

The duration of the drug intake is not limited.

If the patient has forgotten 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.

Application in special patient groups

Elderly patients, patients with hepatic and / or renal insufficiency, dose adjustment is not required.

Sustained-release hard gelatin capsules No. 1, transparent body, blue cap; the contents of the capsules are white to almost white powder, clumping and compaction of the powder in a column is allowed.

1 caps.

mebeverine hydrochloride 200 mg

Excipients: microcrystalline cellulose - 65.6 mg, hydrogenated vegetable oil (type I) - 85 mg, purified talc - 5.5 mg, magnesium stearate - 3 mg, colloidal silicon dioxide - 0.9 mg.

• hypersensitivity to any component of the drug;

• age up to 18 years (due to insufficient data on efficacy and safety);

• pregnancy (due to insufficient data);

• period of breastfeeding.

Trade name of the drug : Niaspam

International non-proprietary name : mebeverine

Dosage form : sustained-release capsules

Composition

One capsule of prolonged action contains:
active substance: mebeverine hydrochloride 200 mg;
excipients: microcrystalline cellulose 65.60 mg, hydrogenated vegetable oil, 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.

Description

Hard gelatin capsules No. 1, transparent body, blue cap. The contents of the capsules are white to almost white powder, clumping and compaction of the powder into a column is allowed.

Pharmacotherapeutic group Antispasmodic agent

ATX code : A03AA04

Pharmacological properties

Pharmacodynamics
Myotropic antispasmodic, has a direct effect on the smooth muscles of the gastrointestinal tract, eliminates spasm, does not affect the normal intestinal motility. Has no anticholinergic effect.
Pharmacokinetics
Absorption
Mebeverine is rapidly and completely absorbed after oral administration. The modified release dosage form allows the use of a dosing regimen 2 times a day.
Distribution
When taking repeated doses of the drug, significant accumulation does not occur.
Metabolism
Mebeverine hydrochloride is mainly metabolized by esterases, which at the first stage break down the ester into veratric acid and mebeverine alcohol. The main metabolite circulating in blood plasma is demethylated carboxylic acid. The equilibrium half-life of demethylated carboxylic acid is approximately 5.77 hours. When taking repeated doses (200 mg 2 times a day), the maximum concentration of demethylated carboxylic acid in the blood plasma (Cmax) is 804 ng / ml, the time to reach the maximum concentration of demethylated carboxylic acid in the blood (Tmax) is about 3 hours.
The average value of the relative bioavailability of the drug in a modified release capsule is about 97%.
Withdrawal
Mebeverine as such is not excreted from the body, but is completely metabolized; its metabolites are almost completely eliminated from the body. Veratric acid is excreted by the kidneys. Mebeverine alcohol is also excreted by the kidneys, partly as carboxylic acid and partly as demethylated carboxylic acid.

Indications for use

Symptomatic treatment of pain, spasms, dysfunction and discomfort in the intestinal region associated with irritable bowel syndrome.
Symptomatic treatment of spasms of the gastrointestinal tract (including those caused by organic diseases).

Contraindications

Hypersensitivity to any component of the drug.
Age up to 18 years (due to insufficient data on efficacy and safety).
Pregnancy (due to insufficient data), breastfeeding period.

Use during pregnancy and breastfeeding, effects on fertility

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 period
There is insufficient information on the excretion of mebeverine 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, however, animal studies have not demonstrated adverse effects of the drug.

Method of administration and dosage

For oral administration.
The capsules must be swallowed with a sufficient amount of water (at least 100 ml). The capsules should not be chewed, as their shell provides a long-term release of the drug.
Take one capsule 2 times a day 20 minutes before meals, one capsule in the morning and one capsule in the evening.
The duration of the drug intake is not limited.
If the patient has forgotten 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.
Application in special groups of patients
Elderly patients, patients with hepatic and / or renal insufficiency, dose adjustment is not required.

Side effect

The side effects listed below have been reported spontaneously and the available data are insufficient to accurately estimate the incidence.
Allergic reactions were observed mainly on the part of the skin, but other manifestations of allergy were also noted.
On the part of the skin and subcutaneous tissues: urticaria, angioedema, including the face, exanthema.
From the immune system: hypersensitivity reactions (anaphylactic reactions).

Overdose

Symptoms: theoretically, in case of an overdose, an increase in the excitability of the central nervous system is possible. In cases of mebeverine overdose, symptoms were either absent or mild and, as a rule, quickly reversible. The observed symptoms of overdose were of neurological and cardiovascular nature.
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. Absorption reduction measures are not required. The specific antidote is unknown.

Interaction with other medicinal products

Only studies were conducted to study the interaction of mebeverine with ethanol. Animal studies have shown the absence of any interaction between mebeverine and ethanol.

Influence on the ability to drive vehicles, mechanisms

Studies of the effect of the drug on the ability to drive a car and other mechanisms have not been conducted. The pharmacological properties of the drug, as well as the experience of its use, do not indicate any adverse effect of mebeverine on the ability to drive a car and other mechanisms.

Release form

Sustained-release capsules 200 mg.
10 capsules in a strip of aluminum foil. 3 strips in a cardboard box along with instructions for use.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life

2 years.
Do not use after the expiration date.

Vacation conditions

On prescription.