Neobutin Retard sustained release pills 300mg, 60pcs

Composition

1 tablet contains:

active ingredient: trimebutin maleate 300 mg;

excipients: lactose monohydrate, tartaric acid, hypromellose (hydroxypropylmethylcellulose), povidone K 30, colloidal silicon dioxide (aerosil), magnesium stearate.

excipients for the shell: hypromellose (hydroxypropylmethylcellulose), talc, Opaspray white M-1-7111 [titanium dioxide, denatured ethanol (methylated alcohol), hypromellose-2910, water], silicon defoamer.

Pharmacological action

Pharmacotherapeutic group: antispasmodic agent.

ATX code: [A 03 AA 05]

Pharmacological properties

Pharmacodynamics

Trimebutine, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis. Acting on peripheral δ -, μ-and κ 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

Suction and distribution.

After oral use, trimebutine is rapidly absorbed from the gastrointestinal tract. Volume of distribution (Vd) – 88 liters. The degree of binding to plasma proteins is low – about 5%. Trimebutine only slightly penetrates the placental barrier.

Metabolism and elimination.

Trimebutine is biotransformed in the liver and is mainly excreted in the urine as metabolites.

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

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

Breast-feeding period. It is not recommended to use trimebutine during breastfeeding, due to the lack of reliable clinical data confirming the safety of using trimebutine during this period. If it is necessary to use trimebutine during breastfeeding, breast-feeding should be discontinued.

Contraindications

Hypersensitivity to the components that make up the drug.

Children under 12 years of age.

Pregnancy.

Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Side effects

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

Nervous system disorders: drowsiness, fatigue, dizziness, headache, restlessness, weakness, feeling hot or cold.

Allergic reactions: skin allergic reactions.

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

Interaction

The drug interaction of Nebutin® retard is not described.

How to take, course of use and dosage

Inside, before meals.

Adults and children over 12 years of age: 300 mg 2 times a day.

The maximum daily dose is 600 mg.

Overdose

To date, no cases of trimebutine overdose have been reported.

Description

Oblong shape with rounded ends biconvex tablets covered with a film-coated white or almost white color.

Special instructions

The recommended course of treatment for acute irritable bowel syndrome is 600 mg per day for 4 weeks.

Influence on the ability to drive vehicles and mechanisms

Nebutin ® retard does not have a sedative effect, does not affect the speed of psychomotor reaction, and can be used in people of various professions, including those requiring increased attention and coordination of movements. However, taking into account possible side effects that may affect these abilities (dizziness and others), caution should be exercised when driving vehicles and engaging in other potentially dangerous activities.

Form of production

Extended-release film-coated tablets,300 mg.

5,10 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil printed varnished.

1,2,3,4 or 6 contour cell packages together with the instructions for use are placed in a pack of cardboard.

Storage conditions

Store at a temperature not exceeding 25 ° C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Trimebutin

Dosage form

long-acting tablets