Duspatalin - instructions for use, dose, side effects, contraindications

Excipients: magnesium stearate-13.1 mg, methyl methacrylate and ethyl acrylate copolymer [1: 2] -10.4 mg, talc-4.9 mg, hypromellose 0.1 mg, methacrylic acid and ethyl acrylate copolymer [1: 1] -15, 2 mg, triacetin - 2.9 mg.

Treturning the gelatin capsule: gelatin - 75.9 mg, titanium dioxide (E 171) - 1.5 mg.

Composition of ink: shellac (E 904), propylene glycol. ammonia water, potassium hydroxide, ferric oxide black oxide (E 172).

Description:

Hard gelatin capsules №1, opaque, white color with the marking "245" on the capsule body. The contents of the capsules are white or almost white granules.

Pharmacotherapeutic group:antispasmodic

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 without affecting the normal peristalsis of the intestine. The exact mechanism of action is unknown, but numerous mechanisms such as decreased 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 mebeverin has an antispasmodic effect, normalizing peristalsis of the intestine and not causing a permanent relaxation of the smooth muscle tissue of the gastrointestinal tract ("hypotension"). Systemic side effects, including 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

Mebeverina hydrochloride is mainly metabolized by esterases, which in the first stage split the ether into veratric acid and mebeverine alcohol. The main metabolite circulating in the plasma is the dismantled carboxylic acid. The half-life in the equilibrium state of the demethylated carboxylic acid is approximately 5.77 hours. With repeated doses (200 mg twice daily), the maximum concentration of demethylated carboxylic acid in the blood (C_max) is 804 ng / ml. time to reach the maximum concentration of demethylated carboxylic acid in the blood (T_mOh) - about 3 hours.

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

Excretion

Mebeverin as such is not deduced of organism, but 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 in the form of a carboxylic acid and partly as a demethylated carboxylic acid.

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.

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

Pregnancy (due to lack of data).

Pregnancy and lactation:

Pregnancy

There are only very limited data on the use of mebeverin by pregnant women. Animal studies are not sufficient to assess reproductive toxicity. Do not use Duspatalin^® during pregnancy.

Breastfeeding period

Information on the excretion of mebeverin or its metabolites in breast milk is not enough. Studies of the excretion of mebeverin in milk in animals have not been conducted. Do not take Duspatalin^® during lactation.

Fertility

Clinical data on the effect of the drug on fertility in men or women are not available, however, known animal studies have not demonstrated adverse effects of the drug Duspatalin^®.

Dosing and Administration:

For oral administration.

Capsules must be swallowed by washing with a sufficient amount of water (at least 100 ml). Capsules should not be chewed, as their shell provides a prolonged release of the drug.

One capsule 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.

Studies of the dosing regimen in elderly patients, patients with renal and / or liver failure were not performed. Available data on post-marketing use of the drug did not reveal specific risk factors for its use in elderly patients and patients with renal and / or liver failure. Changes in the dosing regimen in elderly patients and patients with renal and / or liver failure are not required.

Side effects:

Reports of the following adverse events were received during the postmarketing period and were of a spontaneous nature; to accurately assess the frequency of the cases of available data is not enough.

Allergic reactions were observed mainly from the skin, but other manifestations of allergy were also noted.

FROMabout the skin:

Urticaria, angioedema, including face, exam theme.

FROMabout the parties immune systems:

Hypersensitivity reactions (anaphylactic reactions).

Overdose:

FROMImplications

Theoretically, in case of an overdose, it is possible to increase the excitability of the central nervous system. In cases of an overdose of mebeverine, the symptoms either were absent or were minor and. as a rule, quickly reversible. The symptoms of overdose were neurological and cardiovascular.

LThreatening

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 absorption are not required.

Interaction:

Only studies on the interaction of this drug with alcohol were carried out. Animal studies have demonstrated the absence of any interaction between the drug Duspatalin^® and ethyl alcohol.

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

Studies of the effect of the drug on the ability to drive and other mechanisms have not been carried out. The pharmacological properties of the preparation, as well as the experience of its use, do not indicate any adverse effect of mebeverin on the ability to drive and other mechanisms.

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

Packaging:

10 capsules per blister of aluminum foil and PVC film. On 1,2,3,5 blisters in a cardboard pack together with the instruction on application.

15 capsules per blister of aluminum foil and PVC film. On 2,4,6 blisters in a cardboard pack together with the instruction on application.

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 expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N011303 / 01

Date of registration:18.11.2009 / 27.06.2016

Expiration Date:Unlimited

The owner of the registration certificate:Abbott Helskea Products BVAbbott Helskea Products BV Netherlands

Manufacturer: & nbsp

ABBOTT HEALTHCARE, SAS Netherlands

Representation: & nbspABBOTT LABORATORIES LLC ABBOTT LABORATORIES LLC Russia

Information update date: & nbsp20.08.2016

Illustrated instructions

Instructions

Duspatalin® (Duspatalin®)