Expiration date: 08/2025

Structure and Composition:

One tablet contains active substance:

trimebutine maleate 100 or 200 mg

Excipients: lactose - 87 mg / 36 mg colloidal silicon dioxide - 4 mg / Talc 7 mg - 2 mg / mg cornstarch 3 - 31 mg / 30 mg magnesium stearate - 6 mg / 4 mg

in blisters made of PVC film and aluminum foil printed patent 10 items. In the paper cartons 1, 2 and 3 of packing.

Description pharmaceutical form:

100 mg Tablets: white, Valium, with an embossed symbol represents two letters TM at one side, above and below which are arranged in a line on the two and three triangles intersect risks - on the other side.

Tablets 200 mg: white, round, biconvex, embossed with a symbol in the form of two drop-like elements on one side and Valium - on the other side.

Pharmacokinetics:

After oral administration, trimebutine is rapidly absorbed from the gastrointestinal tract. Cmax is achieved within 1-2 hours in the blood plasma. Bioavailability is 4-6%. The volume of distribution (Vd) - 88 l.

The degree of binding to plasma proteins is low - about 5%. Trimebutin slightly crosses the placental barrier.

Metabolism and excretion. Trimebutine biotransformed in the liver and excreted in the urine primarily as metabolites (approximately 70% during the first 24 h). T1 / 2 - about 12 hours.

Description of the pharmacological actions:

Trimebutine, acting enkephalinergic intestinal system, it is a regulator of motility. With an affinity for receptor stimulation and suppression, it has a stimulating effect in hypokinetic conditions of smooth muscles of the intestine and skin - with hyperkinetic.

The drug acts throughout the gastrointestinal tract and reduces esophageal sphincter tone, promotes gastric emptying and intestinal peristalsis strengthening, and promotes the response of smooth muscles of the colon to food stimuli. Trimebutin restores the normal physiological activity of intestinal muscles in various diseases of the gastrointestinal tract associated with impaired motility.

Indications:

• motor disorders in functional diseases of the gastrointestinal tract, gastroesophageal reflux disease, diarrhea disorders with gastroduodenal disorders (abdominal pain, indigestion, nausea, vomiting), irritable bowel syndrome (functional gastrointestinal disorder, which manifests itself, in particular, pain and cramps in the abdomen, cramps intestine, flatulence, diarrhea and / or constipation)
  
• postoperative paralytic ileus, preparation for radiological and endoscopic gastrointestinal investigations
  
• Use in children - diarrheal disorders associated with impaired GI motility.
  

Contraindications:

• Hypersensitivity to the components within the drug
  
• Children under 3 years - for this dosage form.
  

Application of pregnancy and breastfeeding:

Do not use the drug in the I trimester of pregnancy.

Do not appoint Trimedat lactation, due to the lack of reliable clinical data supporting the safety of the drug during this period.

In experimental studies revealed no data on the teratogenicity and embryotoxicity drug.

Side effect:

Rare: skin reactions.

Drug Interactions:

Drug Interactions Trimedat preparation is not described.

Dosage and administration:

Inside.

Adults and children from 12 years: 100-200 mg 3 times a day.

Children 3 to 5 years: 25 mg 3 times a day.

Children from 5 to 12 years old: 50 mg 3 times a day.

Overdose:

So far, cases of drug overdose Trimedat were reported.