Neobutin Retard - instructions for use, dose, side effects, contraindications

Core tablet: lactose monohydrate 180.0 mg, tartaric acid 120.0 mg, hypromellose 120.0 mg, povidone KZO 12.0 mg, silicon dioxide colloid 7.5 mg, magnesium stearate 7.5 mg.

Sheath: hypromellose 6.82 mg, talc 1.35 mg, Oprasprey white M-1-7111 [titanium dioxide 30.0%, ethanol denatured (methylated alcohol) 10.0%, hypromellose-2910 3.0%, water 57.0 %] 2.25 mg, silicon defoamer q.s.

Description:Tablets covered with a film membrane white or almost white, biconvex, oblong with rounded ends. On the cross section, the nucleus is white or almost white in color. In the production of Samil Pharmaceutical Co., LTD, Republic of Korea, on one side of the tablet, the "SR" marking is additionally affixed with the embossing method.

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

A.03.A.A.05 Trimebutin

Pharmacodynamics:

Trimebutin, 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 the smooth muscles throughout the gastrointestinal tract (GIT), it regulates the motor function without affecting the central nervous system. In this way, trimebutin restores the normal physiological activity of the musculature of the intestine in various gastrointestinal disorders associated with motor disorders.

Normalizing visceral sensitivity, trimebutin provides an anergic effect in abdominal pain syndrome.

Pharmacokinetics:

Suction and distribution.

After oral administration trimebutin quickly absorbed from the digestive tract. Volume of distribution (Vd) - 88 liters. The degree of binding to plasma proteins is low - about 5%. Trimebutin to a small extent penetrates through the placental barrier.

Metabolism and excretion.

Trimebutin is biotransformed in the liver and excreted in the urine mainly in the form of metabolites.

Indications:

Symptomatic treatment of pain, cramps and discomfort in the abdomen, feeling of bloating (flatulence), motor disorders of the intestine with a change in frequency of stool (diarrhea or constipation), indigestion, heartburn, belching, nausea, vomiting associated with functional disorders of the gastrointestinal tract and biliary tract (non-erosive gastroesophageal reflux disease form; cholelithiasis, biliary tract dysfunction, irritable bowel syndrome, sphincter of Oddi dysfunction, postcholecystectomical syndrome). Postoperative paralytic intestinal obstruction.

Contraindications:

- Hypersensitivity to the components included in the composition of the drug.

- Children under 12 years.

- Pregnancy.

- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Pregnancy and lactation:

Pregnancy. In the experimental studies, there was no evidence of teratogenicity and embryotoxicity of trimebutin. However, due to the lack of clinical data the use of trimebutine in pregnancy is contraindicated.

Breastfeeding period. It is not recommended to apply trimebutin in the period of breastfeeding, due to the lack of reliable clinical data confirming the safety of the use of trimebutin during this period. If trimebutin is needed during breastfeeding, breastfeeding should be discontinued.

Dosing and Administration:

Inside, before eating.

Adults and children over 12 years of 300 mg twice a day.

The maximum daily dose is 600 mg.

Side effects:

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

From the nervous system: drowsiness, fatigue, dizziness, headache, anxiety, weakness, a feeling of heat or cold.

Allergic reactions: skin allergic reactions.

Other: disorders of the menstrual cycle, painful enlargement of the mammary glands, retention of urine.

Overdose:Until now, no cases of thymebumin overdose have been reported.

Interaction:Drug Interactions of the drug® retard is not described.

Special instructions:

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

Effect on the ability to drive transp. cf. and fur:

The drug is Neobutin® retard 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, taking into account possible side effects that may affect these abilities (dizziness and others), care should be taken when driving vehicles and engaging in other potentially hazardous activities.

Form release / dosage:Tablets of prolonged action, film-coated, 300 mg.

Packaging:

5, 10 tablets in a planar cell pack of film polyvinylchloride and aluminum foil printed lacquered.

By 1, 2, 3, 4 or 6 contour mesh packages together with the instruction for use are placed in a cardboard pack.

Storage conditions:

In the dark place at temperature not higher than 25 С.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003209

Date of registration:22.09.2015 / 15.12.2016

Expiration Date:22.09.2020

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

SAMIL PHARM., Co., Ltd. The Republic of Korea

Information update date: & nbsp19.06.2018

Illustrated instructions

Instructions

Neobutin® Retard (Neobutine® Retard)