Talinda retard - instructions for use, dose, side effects, contraindications

Active substanceMebeverinMebeverin

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Dosage form: & nbspsustained-release capsules

Composition:

Composition per one capsule

Mebeverine hydrochloride, substance-pellets 70% 285.7 mg

[Active substance:

Mebeverine hydrochloride 200 mg

Excipients:

Cellulose microcrystalline 7.426 mg

Mannitol (mannitol) 18.855 mg

Sucrose (sugar) 34.283 mg

Sodium lauryl sulfate 1.713 mg

Povidone K 30 (polyvinylpyrrolidone) 5.713 mg

Ethyl cellulose 8.57 mg

Hypromellose Phthalate (HP 55) 8.570 mg

(hydroxypropylmethylcellulose phthalate)

Cetyl Alcohol] 0.570 mg

Hard gelatin capsules

[Titanium dioxide 2.0%

Gelatin] Up to 100%.

Description:

Hard gelatin capsules No. 1 in white.

The contents of the capsules are white or almost white spherical pellets.

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

A.03.A.A.04 Mebeverin

A.03.A.A Synthetic holinoblokatory - ethers with tertiary amino group

Pharmacodynamics:Spazmolitik myotropic action, has a direct effect on the smooth muscles of the gastrointestinal tract. Eliminates spasm without affecting normal intestinal motility. The exact mechanism of action is not known, but multiple mechanisms such as reduced permeability of ion channels, blockade of norepinephrine reuptake, local anesthetic effect, and changes in water absorption can cause local action of mebeverine on the gastrointestinal tract; through these mechanisms, spasmolytic action is realized, the intestinal peristalsis is normalized, while there is no constant relaxation of the smooth muscle cells of the gastrointestinal tract ("hypotension"). Systemic side effects, incl. anticholinergic, are absent.

Pharmacokinetics:

Suction

Mebeverin is quickly and completely absorbed after ingestion.The modified release dosage form allows to use the dosing regimen 2 times a day.

Distribution

When taking repeated doses of the drug, significant accumulation does not occur.

Metabolism

Mebeverin is completely metabolized in the human body by esterases, with the formation of veratric acid and mebeverin alcohol. The main metabolite circulating in the plasma is the demethylated carboxylic acid. The half-life in the equilibrium state of the demethylated carboxylic acid is approximately 5.77 hours. At a multiple dose (200 mg twice daily), the maximum concentration of demethylated carboxylic acid in the blood (C_m_Oh) is 804 ng / ml, the time to reach the maximum concentration of demethylated carboxylic acid in the blood (TC_m_Oh) - about 3 hours. The average value of the relative bioavailability after taking modified-release capsules is 97%.

Excretion

Mebeverin is completely metabolized; metabolites are almost completely excreted by the kidneys. The alcohol of mebeverine is excreted partially as a carboxylic acid and partly as a demethylated carboxylic acid.Veratric acid is excreted by the kidneys.

Indications:

Symptomatic treatment of pain, spasms, dysfunction and discomfort in the intestinal tract 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.

Deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.

Age under 18 years (due to insufficient data on efficiency and safety).

Pregnancy (due to lack of data).

Breastfeeding period.

Pregnancy and lactation:

Clinical data on the treatment of pregnant women is not enough. Prescribe a drug to pregnant women is not recommended, due to insufficient data. Information on the excretion of mebeverin in breast milk is not enough. Do not take mebeverin in the period of breastfeeding.

Fertility

Clinical data on the effects of mebeverin on fertility in men or women are not available, however, known studies in animals have not demonstrated adverse effects of mebeverine.

Dosing and Administration:

Take inside without chewing, with enough water (at least 100 ml). One capsule (200 mg) 2 times a day, one in the morning and one in the evening, 20 minutes before meals. Duration of the drug is not limited.

If the patient forgot to take one or more doses, take the drug with the next dose. Do not take one or more missed doses in addition to the usual dose. When using mebeverine in clinical practice, risk factors were not identified in elderly patients, patients with renal and / or hepatic insufficiency. It is not necessary to change the dosage regimen in these populations.

Side effects:

Since reports of undesirable effects of mebeverine were spontaneous, it is impossible to assess the incidence of adverse events. There were allergic reactions, including from the skin.

From the immune system:

Hypersensitivity reactions (anaphylactic reactions).

From the skin:

Urticaria, angioedema, including face, exanthema.

Overdose:

Symptoms: it is possible to increase the excitability of the central nervous system. In the case of an overdose of mebeverine, the symptoms either were absent, or were insignificant and rapidly reversible. Symptoms of an overdose of a neurological and cardiovascular nature were noted.

Treatment: the specific antidote is unknown. 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 the level of absorption are not required.

Interaction:Only studies on the interaction of mebeverin with alcohol were carried out. Studies in animals demonstrated the lack of interaction with ethyl alcohol.

Special instructions:

Effect on the ability to drive transp. cf. and fur:

The drug intake does not affect the ability to drive and other mechanisms.

Form release / dosage:Capsules of prolonged action, 200 mg.

Packaging:

10 capsules per contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered. For 30 capsules in a can of polymer made from low pressure polyethylene.

Each jar or 2, or 3 contour packs of 10 capsules together with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-004297

Date of registration:17.05.2017

Expiration Date:17.05.2022

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Information update date: & nbsp20.06.2017

Illustrated instructions

Instructions

Talinda® retard (Talinda® retard)