1 tablet contains:
active substance: trimebutin maleate 200 mg;
excipients: lactose monohydrate 81.6 mg, corn starch 32 mg, colloidal silicon dioxide (Aerosil) 3.2 mg, magnesium stearate 3.2 mg.
Trimebutin, acting on the enkephalinergic system of the intestine, 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.
Suction and distribution. After oral administration, trimebutin is rapidly absorbed from the gastrointestinal tract, the maximum concentration in the blood plasma (Cmax) is reached after 1-2 hours. Bioavailability is 4-6%. Distribution volume (Vd) - 88 l. The degree of binding to plasma proteins is low - about 5%. Trimebutin to a small extent penetrates the placental barrier.
Metabolism and excretion. Trimebutin is metabolized in the liver and excreted through the kidneys mainly in the form of metabolites (approximately 70% during the first 24 hours). The half-life (T1 / 2) is about 12 hours.
Irritable bowel syndrome. Postoperative paralytic intestinal obstruction.
Hypersensitivity to trimebutine maleate and other components that make up the drug.
Children's age up to 3 years (for this dosage form). Pregnancy. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
From the digestive system: dry mouth, unpleasant taste, diarrhea, dyspepsia, nausea, constipation.
From the nervous system: drowsiness, fatigue, dizziness, headache, anxiety, a feeling of heat or cold.
Allergic reactions: skin rash.
Other: menstrual irregularities, painful enlargement of the mammary glands, urinary retention.
The drug interaction of the drug Neobutin® is not described.
How to take, course of administration and dosage
Inside, before eating.
Adults and children over 12 years of age: 100-200 mg 3 times a day.
To prevent relapse of irritable bowel syndrome after a course of treatment during the period of remission, it is recommended to continue taking the drug at a dose of 300 mg per day for 12 weeks.
Children aged 5-12 years: 50 mg 3 times a day.
Children aged 3-5 years: 25 mg 3 times a day.
To date, cases of an overdose of trimebutin have not been reported.
The course of treatment of the irritable bowel syndrome in the acute period at a dose of 600 mg per day for four weeks and the continuation of treatment after the course at a dose of 300 mg per day for 12 weeks avoids relapse. Effect on the ability to drive vehicles and 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.
Round biconvex tablets of white or almost white color with a risk.