Long-acting film-coated tablets, 300 mg.
5.10 tablets in blister packs of PVC film and varnished aluminum foil.
On 1, 2, 3, 4 or 6 blister strip packagings together with the application instruction are placed in a cardboard pack.
Pharmacological action of
ATX code: [A03AA05]
Pharmacological properties of
Trimebutin, acting on the enkephalinergic system, is its pericenteric system. Acting on peripheral -, – and – 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 the intestinal muscles in various diseases of the gastrointestinal tract associated with impaired motor skills.
Normalizing visceral sensitivity, trimebutin provides an analgesic effect in abdominal pain.
Absorption and distribution.
After oral administration, trimebutin is rapidly absorbed from the digestive tract. 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 biotransformed in the liver and excreted in the urine mainly in the form of metabolites.
Symptomatic treatment of pain and discomfort in the abdomen, cramping, bloating (flatulence), intestinal motor disorders with a change in stool frequency (diarrhea, constipation or their alternation), changes in stool consistency associated with irritable bowel syndrome.
Postoperative paralytic intestinal obstruction.
Hypersensitivity to the components that make up the drug.
Children under 12 years old.
Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
Use during pregnancy and lactation
In experimental studies, no data were found on teratogenicity and embryotoxicity of trimebutin. However, due to the lack of necessary clinical data, the use of trimebutin during pregnancy is contraindicated.
Breastfeeding period. It is not recommended to use trimebutin during breastfeeding, due to the lack of reliable clinical data confirming the safety of trimebutin during this period.
If you need to use trimebutin during breastfeeding, breastfeeding should be discontinued.
Effect on the ability to drive vehicles and mechanisms
The drug NeobutinÐÂ® retard does not have a sedative effect, does not affect the speed of the psychomotor reaction and can be used in persons 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), you should be careful when driving and engaging in other potentially dangerous activities.
trimebutine maleate 300.0 mg
lactose monohydrate 180.0 mg,
tartaric acid 120.0 mg,
hypromellose 12.0 mg, 20.0 mg 0 mg,
silicon dioxide colloidal 7.5 mg,
magnesium stearate 7.5 mg.
hypromellose 6.82 mg,
talcum 1.35 mg,
Opasprey 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 qs
Tablets, film-coated, white or almost white, biconvex, oblong in shape with rounded ends. In a cross section, the core is white or almost white. In the production of Samil Farm. Co., Ltd. , Republic of Korea, one side of
embossed tablets is additionally labeled with SR
Dosage and administration
Inside, before meals.
Adults and children over 12 years of age, 300 mg 2 times a day.
Maximum daily dose of 600 mg.
Side effects of the
From the digestive system: dry mouth, unpleasant taste, diarrhea, dyspepsia, epigastric pain, nausea, constipation.
From the nervous system: drowsiness, fatigue, dizziness, headache, anxiety, weakness, feeling of heat or cold. Allergic reactions: skin allergic reactions.
Other: menstrual irregularities, painful enlargement of the mammary glands, urinary retention.
Drug Interactions NeobutinÂ® Retard not described. Special instructions
The recommended course of treatment of irritable bowel syndrome in the acute period of 600 mg per day for 4 weeks.
No trimebutin overdose has been reported to date.
In a dark place at a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
3 years. Do not use after the expiration date indicated on the package.
Possible product names
Neobutin retard sustained release tablets 300 mg 20 pcs.