Structure
Active substance: trimebutin maleate 300.0 mg;
Excipients:
Tablet core: lactose monohydrate 180.0 mg, tartaric acid 120.0 mg, hypromellose 120.0 mg, povidone K30 12.0 mg, colloidal silicon dioxide 7.5 mg, magnesium stearate 7.5 mg.
Shell: hypromellose 6.82 mg, talc 1.35 mg, Opasprey 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 antifoam qs
Description: Tablets, film-coated, white or almost white, biconvex, oblong 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 on one side
embossed tablets are additionally marked with "SR"
Pharmachologic effect
Pharmacotherapeutic group: antispasmodic
ATX code: [A03AA05]
Pharmacological properties
Pharmacodynamics
Trimebutin, acting on the enkephalinergic system of the intestine, is a regulator of its motility. Acting on peripheral δ, μ, and κ 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.
Pharmacokinetics
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.
Indications
Symptomatic treatment of pain and discomfort in the abdomen, cramping, bloating (flatulence), motor bowel 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.
Contraindications
Hypersensitivity to the components that make up the drug.
Children's age up to 12 years.
Pregnancy.
Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
Side effects
From the digestive system: dry mouth, unpleasant taste, diarrhea, dyspepsia, 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: menstrual irregularities, painful enlargement of the mammary glands, urinary retention.
Interaction
The drug interaction of the drug Neobutin® retard is not described. Cautions The
recommended course of treatment of irritable bowel syndrome in the acute period of 600 mg per day for 4 weeks.
How to take, course of administration and dosage
Inside, before eating.
Adults and children over 12 years of age, 300 mg 2 times a day.
The maximum daily dose of 600 mg.
Overdose
To date, cases of an overdose of trimebutin have not been reported.
Special instructions
Effect on the ability to drive vehicles and mechanisms
The drug 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, 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.
Pregnancy. 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.
The period of breastfeeding. 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.
Release form
300 mg film-coated sustained-release tablets.
5.10 tablets each in blister packs made 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.
Storage conditions
In the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Shelf life
3 years. Do not use after the expiration date indicated on the package.
Active substance
Trimebutin
Sale Terms
Without recipe
Dosage form
prolong tablets.
