Trimedat Forte pills 300mg, 20pcs

Composition

One tablet contains:

Active ingredient: trimebutinamaleate-300 mg;

excipients:

microcrystalline cellulose,

povidone (K 25),

hypromellose,

magnesium stearate;

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

Pharmacological action

Antispasmodic agent

ATX:  A 03 AA 05

Pharmacodynamicatrimebutine, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis. Acting on peripheral δ -, mk-and k receptors, including those located directly on smooth muscles throughout the gastrointestinal tract (GIT), it regulates motor skills without affecting the central nervous system.

Thus, trimebutine restores the normal physiological activity of the intestinal muscles in various diseases of the gastrointestinal tract associated with motor disorders.

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

Pharmacokinetics

After oral use, trimebutine is rapidly absorbed from the gastrointestinal tract. The degree of binding to plasma proteins is about 5%. Trimebutine only slightly penetrates the placental barrier. Trimebutine is biotransformed in the liver and is mainly excreted in the urine as metabolites.

In a study in healthy volunteers with a single dose of Trimedat forte, the pharmacokinetic parameters of the active metabolite of trimebutine-2-methylamino-2-phenylbutyl-3,4,5-trimethoxybenzoate (desmethyltrimebutine) were as follows: : the maximum concentration (C_max) – 441,45±252,99 ng/ml; the time to achieve it (T_max) to 2.20±1.01 hours; the average retention time in the body (MRT) – 17,12±3.14 hours; the elimination half-life (T_1/2) of 12,52±4.54 hours; volume of distribution (V_d) – 1279,72±1108,53 liters, total clearance (CL_t) – 66,51±34,34 l/h.

Indications

Symptomatic treatment of pain, abdominal cramps and discomfort, 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; cholelithiasis; biliary tract dysfunction; biliary tract syndrome irritable bowel; Oddi sphincter dysfunction, postcholecystectomy syndrome).

Postoperative paralytic intestinal obstruction.

Use during pregnancy and lactation

Experimental studies have not revealed data on teratogenicity and embryotoxicity of the drug. However, due to the lack of necessary clinical data, the use of Trimedat forte during pregnancy is contraindicated.

It is not recommended to prescribe Trimedat® forte during lactation, due to the lack of reliable clinical data confirming the safety of using the drug during this period. If it is necessary to use the drug during lactation, stop breastfeeding.

Contraindications

Hypersensitivity to the components that make up the drug.

Pregnancy.

Children under 12 years of age (for this dosage form).

Side effects

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

Nervous system disorders:  drowsiness, fatigue, dizziness, headache, restlessness.

Allergic reactions:  skin rash.

Other services:  menstrual disorders, painful breast enlargement, urinary retention.

Interaction

The drug interaction of Trimedat® forte is not described.

How to take, course of use and dosage

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 of abdominal pain associated with functional diseases of the digestive tract and biliary tract is 28 days.

Overdose

No overdose cases of Trimedat forte have been reported to date.

Treatment:  discontinuation of the drug, gastric lavage, use of activated charcoal, symptomatic therapy. There are no specific antidotes.

Description

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

Special instructions

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

Form of production

10 tablets in a contour cell package or contour cell package with perforation made of polyvinyl chloride film and aluminum foil. 1,2 or 6 contour packages together with the instructions for use are placed in a pack of cardboard.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Trimebutin

Dosage form

Tablets

Description

For adults, Children over 3 years old

Indications

Spasm of the gastrointestinal tract, Preparation for ultrasound and X-ray of the abdominal cavity, Gastrointestinal motility disorders, Constipation, Flatulence, Reflux esophagitis, Diarrhea