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

Excipients - wheat starch 36.5 mg; mannitol 25.0 mg; cellulose 25.0 mg; silicon dioxide colloid 0.5 mg; giprolose 2.5 mg; povidone 4.0 mg; croscarmellose sodium 2.0 mg; magnesium stearate 4.5 mg.

Description:

Round, biconvex tablets are white or almost white with a risk on one side. On the one hand, the risks of embossing are inscribed "Samil", on the other - "PB1".

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

A.03.A.A.05 Trimebutin

Pharmacodynamics:Trimebutin, acting on the enkephalinergic system of the intestine, is the regulator of its peristalsis. Possessing affinity for the receptors of excitation and suppression, it has a stimulating effect in hypokinetic states of smooth muscles of the intestine and spasmolytic - in hyperkinetic. Trimebutin, changing visceral sensitivity, reduces visceral pain and provides analgesic effect in abdominal pain syndrome. The drug acts throughout the gastrointestinal tract, reduces the pressure of the sphincter esophagus, promotes the emptying of the stomach and enhances intestinal peristalsis, and also promotes the response of the smooth muscles of the colon to food stimuli. Trimebutin restores the normal physiological activity of the musculature of the intestine for various diseases of the gastrointestinal tract associated with motor disorders.

Pharmacokinetics:

After oral administration trimebutin quickly absorbed from the gastrointestinal tract, the maximum concentration in the blood plasma (Cmax) is achieved after 1-2 hours. Bioavailability is 4-6%. Volume of distribution (Vd) - 88 liters. The degree of binding to plasma proteins is low - about 5%. Trimebutin to a small extent penetrates through the placental barrier.

Metabolism and excretion.

Trimebutin is biotransformed in the liver and excreted in the urine mainly in the form of metabolites (approximately 70% within the first 24 hours).

The half-life (T1 / 2) is about 12 hours.

Indications:

Treatment and alleviation of symptoms associated with irritable bowel syndrome (functional gastrointestinal disease, manifested, in particular, by pain and colic in the abdominal cavity, intestinal spasms, flatulence, diarrhea and / or constipation).

Treatment of postoperative paralytic obstruction of the intestine in order to accelerate the renewal of intestinal transit after abdominal surgery.

Contraindications:

Hypersensitivity to the components that make up the drug.

Celiac disease (gluten enteropathy), wheat allergy - the presence of wheat starch in the composition.

Children under 12 years old.

Pregnancy and lactation:

Neobutin® is contraindicated during pregnancy.

It is not recommended to prescribe Nehutin during lactation, due to the lack of reliable clinical data confirming the safety of the drug during this period.

Dosing and Administration:

Inside adults and children over 12 years of 100-200 mg 3 times a day.

The maximum daily dose is 600 mg.

Side effects:

From the digestive system: rarely dry mouth, diarrhea, indigestion, epigastric pain and constipation.

From the nervous system: rarely - weakness, a feeling of heat or cold, a headache.

Allergic reactions: very rarely skin allergic reactions.

Overdose:Up to now, cases of drug overdose trimebutin not reported.

Interaction:

Drug interaction of the drug is not described.

Special instructions:

Precautions for use

Special precautions when using the drug are not required.

The indication, if necessary, of the characteristics of the action of the drug at the first admission or when it is abolished

The characteristics of the drug Neomutin® at the first admission and with the withdrawal of the drug is not described.

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

The drug Neobutin does not affect the ability to drive vehicles, mechanisms and to perform work that requires increased attention and speed of motor reactions.

Form release / dosage:Tablets of 100 mg.

Packaging:

At packing on Joint-Stock Company "the Siberian Center of pharmacology and biotechnology":

For 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil printed lacquered. For 1, 2, 3 or 6 contour squares, together with instructions for use in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Special precautions for the destruction of unused medicines

Special precautions for the destruction of unused medications are not required.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002145

Date of registration:15.07.2013

Expiration Date:15.07.2018

The owner of the registration certificate:SEGMENTA FARM, LLC SEGMENTA FARM, LLC Russia

Manufacturer: & nbsp

SAMIL PHARM., Co., Ltd. The Republic of Korea

Representation: & nbspSCFB, CJSCSCFB, CJSCRussia

Information update date: & nbsp19.06.2018

Illustrated instructions

Instructions

Neobutin® (Neobutine)