Trimedat Valenza - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate - 70 mg or 140 mg, potato starch - 20 mg or 40 mg, povidone - 4 mg or 8 mg, silicon dioxide colloid (aerosil) - 2 mg or 4 mg, magnesium stearate - 2 mg or 4 mg, talc - 2 mg or 4 mg.

Description:Round plain cylindrical tablets of white color with a facet and two overlapping risks on one side for a dosage of 100 mg, with a facet and a risk on one side for a dosage of 200 mg.

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. Acting on the peripheral 5, p and k receptors, including those located directly on the smooth muscles throughout the gastrointestinal tract (GIT),it regulates the motor system without affecting the central nervous system. In this way, trimebutin restores the normal physiological activity of the musculature of the intestine in various gastrointestinal disorders associated with motor disorders.

Normalizing visceral sensitivity, trimebutin provides analgesic effect in abdominal pain syndrome.

Pharmacokinetics:

After oral administration trimebutin quickly absorbed from the digestive tract. The maximum concentration (C_mOh) in the blood plasma is achieved in 1-2 hours Bioavailability is 4-6%. The volume of distribution (Vd) is 88 liters. The degree of binding to plasma proteins is low - about 5%. Trimebutin to a small extent penetrates through the placental barrier. Trimebutin biotransformed in the liver and excreted in the urine primarily as metabolites (approximately 70% during the first 24 hr.). The half-life (T1/2) - about 12 hours.

Indications:Irritable bowel syndrome. Postoperative paralytic intestinal obstruction.

Contraindications:

Hypersensitivity to trimebutine maleate and other components that make up the drug.

Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

Children under 3 years old - for this dosage form.

Pregnancy.

Pregnancy and lactation:

In experimental studies, there was no evidence of teratogenicity and embryotoxicity of the drug. However, due to the lack of the necessary clinical data, the use of the drug Trimedat® Valenta during pregnancy is contraindicated.

It is not recommended to appoint Trimedat® Valenta during lactation, due to the lack of reliable clinical data confirming the safety of the drug during this period. If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Inside. Adults and children from 12 years: 100-200 mg 3 times a day. To prevent the recurrence of irritable bowel syndrome after the course of treatment during remission, it is recommended to continue taking the drug at a dose of 300 mg per day for 12 weeks.

Children 3-5 years: 25 mg 3 times a day. Children 5-12 years: 50 mg 3 times a day.

Side effects:

From the digestive system: dry mouth, unpleasant taste sensations, diarrhea, indigestion, nausea, constipation.

From the nervous system: drowsiness, fatigue, dizziness, headache, anxiety.

Allergic reactions: skin rash.

Other: disorders of the menstrual cycle, painful enlargement of the mammary glands, retention of urine.

Overdose:

To date, cases of an overdose of Trimedat® Valente have not been reported.

Interaction:

Drug interaction of the drug Trimedat® Valenta is not described.

Special instructions:

The course of treatment of irritable bowel syndrome in the acute period of 600 mg a day for 4 weeks and continued after the course of treatment in a dose of 300mg a day for 12 weeks, to avoid recurrence.

Effect on the ability to drive transp. cf. and fur:The drug does not have a sedative effect, does not affect the speed of the psychomotor reaction and can be used in people of various professions, including those requiring increased attention and coordination of movements. However, considering the possible side effects that may affect these abilities (dizziness, etc.), caution should be exercised when driving vehicles and engaging in other potentially hazardous activities.

Form release / dosage:

Tablets of 100 mg and 200 mg.

Packaging:

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

1, 2 or 3 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002527

Date of registration:08.07.2014

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Information update date: & nbsp17.10.2015

Illustrated instructions

Instructions

Trimedat® Valenta (Trimedat Valenta)