Trimedat Forte 300mg, 60 pills

One tablet contains:

active substance:

trimebutin maleate - 300 mg;

Excipients:

microcrystalline cellulose,

povidone (K 25),

hypromellose,

magnesium stearate;

composition of the shell: Opadry II 85F18422: partially hydrolyzed polyvinyl alcohol, macrogol-3350, titanium dioxide E 171, talc.

ATX Code: A03AA05

Trimebutin, acting on the intestinal enkephalinergic system, is a regulator of its peristalsis. Acting on peripheral δ-, μ- and k receptors, including those located directly on smooth muscle throughout the gastrointestinal tract (GIT), it regulates motility without affecting the central nervous system. 

Thus, trimebutin restores the normal physiological activity of intestinal muscles in various gastrointestinal diseases associated with impaired motor skills.

By normalizing visceral sensitivity, trimebutin provides an analgesic effect in abdominal pain.

Pharmacokinetics

After oral administration, trimebutin is rapidly absorbed from the digestive tract. The degree of binding to plasma proteins is about 5%. Trimebutin to a small extent penetrates 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 Trimedat® forte, the pharmacokinetic parameters of the active metabolite of trimebutin - 2-methylamino-2-phenylbutyl-3,4,5-trimethoxybenzoate (desmethyltrimebutin) were: maximum concentration (C _max ) - 441.45 ± 252.99 ng / ml; time to reach it (T _max ) - 2.20 ± 1.01 hours; the average retention time in the body (MRT) is 17.12 ± 3.14 hours; elimination half-life (T _1/2 ) - 12.52 ± 4.54 hours; the distribution volume (V _d ) is 1279.72 ± 1108.53 l, the total clearance (CL _t ) is 66.51 ± 34.34 l / h.

Symptomatic treatment of pain, cramping and discomfort in the abdomen, bloating (flatulence), motor bowel 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; biliary tract dysfunction; irritable bowel syndrome; sphincter of Oddi dysfunction, postcholecystectomy syndrome).

In experimental studies, no data were found on teratogenicity and embryotoxicity of the drug. However, due to the lack of necessary clinical data, the use of the drug Trimedat ^® forte during pregnancy is contraindicated.

Hypersensitivity to the components that make up the drug.

Pregnancy.

Children's age up to 12 years (for this dosage form).

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.

Inside.

Adults and children over 12 years of age, 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 is 28 days.

There are no cases of overdose of the drug Trimedat ^® forte to date.

Round biconvex tablets coated with a white film coating with an extruded symbol in the form of two drop-shaped elements on one side. In a cross section, the core is white or almost white.

To prevent relapse of irritable bowel syndrome after a course of treatment during the period of remission, it is recommended to continue taking 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 and engaging in other potentially dangerous activities.

The original package at a temperature not higher than 25 ^for AS