Neobutin Retard sustained release pills 300mg, 20pcs

Composition

Active ingredient: trimebutine maleate 300.0 mg; Excipients: Pill Core: lactose monohydrate 180.0 mg, tartaric acid 120.0 mg, hypromellose 120.0 mg, povidone K 30 12.0 mg, colloidal silicon dioxide 7.5 mg, magnesium stearate 7.5 mg. Shell: hypromellose 6.82 mg, talc 1.35 mg, Opaspray white M-1-7111 [titanium dioxide 30.0%, denatured ethanol (methylated alcohol) 10.0%, hypromellose-2910 3.0%, water 57.0%] 2.25 mg, silicon defoamer q. s. Description: Tablets covered with a film-coated white or almost white color, biconvex, oblong shape with rounded ends. On a cross-section, the core is white or almost white in color. In the production of “Samil Pharm. Co., LTD”, Republic of Korea, one side of the tablet is additionally stamped with the label “SR”

Pharmacological action

Pharmacotherapy group: Antispasmodic agent Code ATX: [A 03 AA 05]Pharmacological Propertiespharmacodynamicatrimebutine, 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. Pharmacokineticsabsorption 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 abdominal pain and discomfort, cramps, bloating (flatulence), motor bowel disorders with changes in stool frequency (diarrhea, constipation or alternation), changes in stool consistency associated with irritable bowel syndrome. Postoperative paralytic intestinal obstruction.

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. Special pointsrecommended course of treatment for irritable bowel syndrome in the acute period is 600 mg per day for 4 weeks.

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.

Special instructions

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.

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.

Form of production

Long-acting 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 cardboard pack.

Storage conditions

In a dark place 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