Expiration date: 12/2025
Composition
One tablet contains:
active substance: trimebutin maleate - 300 mg,
excipients: microcrystalline cellulose, povidone (K 25), hypromellose, magnesium stearate, shell
composition: Opadry II 85F18422: polyvinyl alcohol partially hydrolyzed, macrogol-3350, titanium dioxide E 171, talc.
Pharmacological action
Trimebutin, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis. Acting on the peripheral ?- ,- and ? receptors, including those located directly on smooth muscles throughout the gastrointestinal tract (GI), it regulates motor skills without affecting the Central nervous system. Thus, trimebutin restores normal physiological activity of the intestinal muscles in various diseases of the gastrointestinal tract associated with motor disorders.
Normalizing visceral sensitivity, trimebutin provides an analgesic effect in abdominal pain.
Indications
Symptomatic treatment of pain, spasms and discomfort in the abdomen, bloating (flatulence), motor bowel disorders with changes in the frequency of stool (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, syndrome irritable bowel, Oddi sphincter dysfunction, postcholecystectomy syndrome).
Postoperative paralytic intestinal obstruction.
Use during pregnancy and lactation
Experimental studies have not revealed data on teratogenicity and embryotoxicity of the drug. However, due to the lack of necessary clinical data, the use of Trimedat ® Forte during pregnancy is contraindicated.
It is not recommended to prescribe Trimedat ® Forte during lactation, due to the lack of reliable clinical data confirming the safety of the drug during this period. If it is necessary to use the drug during lactation, stop breastfeeding.
Recommendations for use
Inside. Adults and children over 12 years of age: 1 tablet 2 times a day (with a break of 12 hours). The course of treatment of abdominal pain associated with functional diseases of the digestive tract and bile ducts is 28 days.
Contraindications
Hypersensitivity to the components that make up the drug.
Pregnancy.
Children under 12 years of age (for this dosage form).
With caution:
Trimedat ® Forte should be used with Caution during breastfeeding, as there is no data on its ability to penetrate into breast milk.
Side effect
From the digestive system: dry mouth, unpleasant taste, diarrhea, dyspepsia, nausea, constipation.
From the nervous system: drowsiness, fatigue, dizziness, headache, anxiety.
Allergic reactions: skin rash.
Other: menstrual disorders, painful breast enlargement, urinary retention.
Interaction
The drug interaction of Trimedat ® Forte is not described.
Overdose
No cases of overdose of Trimedat ® Forte have been reported to date.
Treatment: withdrawal of the drug, gastric lavage, administration of activated carbon, symptomatic therapy. There are no specific antidotes.
Special instruction
To prevent a relapse of irritable bowel syndrome after a course of treatment during remission, it is recommended to continue taking 300 mg per day for 12 weeks.
The impact on the ability to manage transp. Ms. and fur.:
The drug 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), you should be careful when driving vehicles and engaging in other potentially dangerous activities.
Form release
Round biconvex tablets covered with a white film shell with an embossed symbol in the form of two drop-shaped elements on one side. The cross-section shows the core as white or almost white.
Storage conditions
In the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life
2 years. Do not use after the expiration date indicated on the package.
