Trimedat forte tablets 300mg, No. 20

Trimedat forte tablets 300mg, No. 20; 'Symptomatic treatment of pain, cramps and discomfort in the abdomen, bloating (flatulence), intestinal motor disorders with changes in stool frequency (diarrhea or constipation), dyspepsia, heartburn, belching, nausea , vomiting associated with functional diseases of the gastrointestinal tract and biliary tract (non-erosive form of gastroesophageal reflux disease; gallstone disease; dysfunction of the biliary tract; irritable bowel syndrome; dysfunction of the sphincter of Oddi, postcholecystectomy syndrome).

Inside. Adults and children over 12 years old take 1 tablet 2 times a day (with a break of 12 hours). The course of treatment for abdominal pain associated with functional diseases of the digestive tract and biliary tract - 28 days

One tablet contains:

active substance: trimebutine maleate - 300 mg;

excipients: microcrystalline cellulose, povidone (K 25), hypromellose, magnesium stearate; shell composition: Opadray II 85F18422: partially hydrolyzed polyvinyl alcohol, macrogol-3350, titanium dioxide E 171, talc.

Hypersensitivity to the components of the drug. Pregnancy. Children under 12 years of age (for this dosage form).

Pharmacodynamics

Trimebutin, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis. Acting on peripheral ? -, ? - and k receptors, including those located directly on smooth muscles throughout the gastrointestinal tract (GIT), it regulates motility without affecting the central nervous system. Thus, trimebutin restores the normal physiological activity of the intestinal musculature in various diseases of the gastrointestinal tract associated with motility disorders. By normalizing visceral sensitivity, trimebutin provides an analgesic effect in abdominal pain syndrome.

Pharmacokinetics

After oral administration, trimebutin is rapidly absorbed from the gastrointestinal tract. The degree of binding to plasma proteins is about 5%. Trimebutin slightly crosses the placental barrier. Trimebutin is biotransformed in the liver and excreted in the urine mainly in the form of metabolites. In a study in healthy volunteers with a single dose of TrimedatЃ Forte, the pharmacokinetic parameters of the active metabolite of trimebutin, 2-methylamino-2-phenylbutyl-3,4,5-trimethoxybenzoate (desmethyltrimmebutin), were as follows: maximum concentration (Cmax) - 441.45 ± 252 .99 ng / ml; time to reach it (Tmax) - 2.20 ± 1.01 hours; mean retention time in the body (MRT) - 17.12 ± 3.14 hours; half-life (T1 / 2) - 12.52 ± 4.54 hours; volume of distribution (Vd) - 1279.72 ± 1108.53 l, total clearance (CLt) - 66.51 ± 34.34 l / h.

Application during pregnancy and during breastfeeding

Experimental studies have not revealed data on the teratogenicity and embryotoxicity of the drug. However, due to the lack of the necessary clinical data, the use of the drug TrimedatЃ forte during pregnancy is contraindicated. It is not recommended to prescribe TrimedatЃ forte during lactation, due to the lack of reliable clinical data confirming the safety of the drug during this period. If necessary, the use of the drug during lactation should stop breastfeeding.

Side effect

From the digestive system: dry mouth, unpleasant taste, diarrhea, dyspepsia, nausea, constipation. From the nervous system: drowsiness, fatigue, dizziness, headache, anxiety. Allergic reactions: skin rash. Others: menstrual irregularities, painful enlargement of the mammary glands, urinary retention.

Overdose

To date, no cases of overdose of TrimedatЃ forte have been registered. Treatment: drug withdrawal, gastric lavage, activated charcoal prescription, symptomatic therapy. There are no specific antidotes.

Interaction with other medicinal products

The drug interaction of the drug TrimedatЃ forte has not been described.

special instructions

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

Influence on the ability to drive vehicles and control mechanisms:

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, given the 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.