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

Description:Round biconvex tablets covered with a white film shell with a squeezed out symbol in the form of two drop-shaped elements on one side. On the cross section, the nucleus is white or almost white in color.

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 peripheral δ-, μ- and κ receptors, including those located directly on the smooth muscle throughout the gastrointestinal tract (GIT), it regulates motility 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 degree of binding to plasma proteins is about 5%. Trimebutin to a small extent penetrates through the placental barrier. Trimebutin biotransformiruetsya in the liver and excreted in the urine, mainly in the form of metabolites.

A study in healthy volunteers with single dose of the drug Trimedat® forte values of pharmacokinetic parameters of the active metabolite of trimebutine - 2-methylamino-2-phenylbutyl-3,4,5-trimetoksibenzoata (desmetiltrimebutina) were: maximum concentration (C_m_Oh) - 441.45 ± 252.99 ng / ml; time of its achievement (T_m_Oh) - 2.20 ± 1.01 hours; mean retention time in the body (MRT) - 17.12 ± 3.14 hours; the half-life (T1 / 2) is 12.52 ± 4.54 hours; volume of distribution (Vd) - 1279.72 ± 1108.53 l, the total ground clearance (SC) is 66.51 ± 34.34 l / h.

Indications:

Symptomatic treatment of pain, cramps and discomfort in the abdomen, feeling of bloating (flatulence), motor disorders of the intestine with a change in frequency of stool (diarrhea or constipation), indigestion, heartburn, belching, nausea, vomiting associated with functional disorders of the gastrointestinal tract and biliary tract (non-erosive form of gastroesophageal reflux disease, cholelithiasis, bile duct dysfunction, irritable bowel syndrome, Oddi sphincter dysfunction, postcholecystectomy syndrome).

Postoperative paralytic intestinal obstruction.

Contraindications:

Hypersensitivity to the components that make up the drug.

Pregnancy.

Children under 12 years (for this dosage form).

Carefully:

The drug Trimedat® forte should be used with caution in the period of breastfeeding, as there is no data on its ability to penetrate into breast milk.

Pregnancy and lactation:

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

It is not recommended to appoint Trimedat® forte 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 over 12 years of age take 1 tablet 2 times a day (with a break of 12 hours). The course of treatment of abdominal pain associated with functional diseases of the digestive tract and biliary tract is 28 days.

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:

The cases of an overdose of Trimedat® forte have not been reported to date.

Treatment: cancellation of the drug, gastric lavage, the appointment of activated charcoal, symptomatic therapy. Specific antidotes are absent.

Interaction:Drug interaction of the drug Trimedat® forte is not described.

Special instructions:

To prevent the recurrence of irritable bowel syndrome after the course of treatment during the remission period, it is recommended to continue taking the dose at a dose of 300 mg per day for 12 weeks.

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, taking into account possible side effects that may affect these abilities (dizziness and others), care should be taken when driving vehicles and engaging in other potentially hazardous activities.

Form release / dosage:Tablets with prolonged release, film-coated, 300 mg.

Packaging:

For 10 tablets in a contour mesh package or contour mesh packaging with a perforation made of a polyvinylchloride film and aluminum foil.

1, 2 or 6 contour packs, together with instructions for use, are placed in a pack of cardboard.

Storage conditions:

In the original packaging 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 expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004600

Date of registration:20.12.2017

Expiration Date:20.12.2022

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

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Information update date: & nbsp24.01.2018

Illustrated instructions

Instructions

Trimedat® forte (Trimedat forte)