Trimedat^® (Tablets, Powder) Instructions for Use

ATC Code

A03AA05 (Trimebutine)

Active Substance

Trimebutine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Spasmolytic drug

Pharmacotherapeutic Group

Spasmolytic agent

Pharmacological Action

Trimebutine, by influencing the enkephalinergic system of the intestine, regulates its peristalsis.

By acting on peripheral σ-, µ- and κ-opioid receptors, including those located directly on the smooth muscle throughout the gastrointestinal tract, it regulates motility without affecting the central nervous system.

Thus, Trimebutine restores the normal physiological activity of the intestinal musculature in various gastrointestinal diseases associated with motility disorders.

By normalizing visceral sensitivity, Trimebutine provides an analgesic effect in abdominal pain syndrome.

Pharmacokinetics

After oral administration, Trimebutine is rapidly absorbed from the gastrointestinal tract.

C_max in blood plasma is reached after 1-2 hours. Bioavailability is 4-6%. V_d is 88 L. Binding to plasma proteins is low – about 5%. Trimebutine slightly penetrates the placental barrier.

It is biotransformed in the liver and excreted in the urine mainly as metabolites (approximately 70% within the first 24 hours). T_1/2 is about 12 hours.

Indications

Symptomatic treatment of pain, spasms and discomfort in the abdominal area, flatulence, intestinal motility disorders with changes in stool frequency (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, irritable bowel syndrome, sphincter of Oddi dysfunction, postcholecystectomy syndrome).

Postoperative paralytic ileus.

ICD codes

Dosage Regimen

Administer orally. The dosage regimen is set individually, depending on the patient’s age and the specific dosage form used.

For adults and children over 12 years of age, the typical dosage is 100 mg to 200 mg three times daily, before meals.

For children aged 5 to 12 years, use a reduced dosage of 50 mg two to three times daily.

For children aged 3 to 5 years, the recommended dosage is 25 mg two to three times daily.

For the treatment of postoperative paralytic ileus, initiate therapy with a higher initial dose as directed by a physician, typically via intravenous administration, followed by oral maintenance.

Adjust the duration of treatment based on the underlying condition and symptomatic response. For chronic functional disorders, treatment courses may extend for several weeks.

For the powder formulation, reconstitute the contents of one sachet in a half glass of water immediately prior to administration.

Do not exceed the maximum daily dose specified for the respective age group and indication.

Adverse Reactions

Nervous system disorders: frequency unknown – drowsiness, feeling of tiredness, dizziness, headache, anxiety.

Gastrointestinal disorders: frequency unknown – dry mouth, unpleasant taste sensations, diarrhea, dyspepsia, nausea, constipation.

Skin and subcutaneous tissue disorders: frequency unknown – skin rash.

Renal and urinary disorders: frequency unknown – urinary retention.

Reproductive system and breast disorders: frequency unknown – menstrual cycle disorder, painful breast enlargement.

Contraindications

Hypersensitivity to trimebutine; pregnancy; childhood – depending on the dosage form.

Use in Pregnancy and Lactation

Contraindicated during pregnancy. If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Pediatric Use

Use in children is possible according to indications, in age-recommended doses and dosage forms. It is necessary to strictly follow the instructions in the trimebutine drug leaflets regarding contraindications for the use of specific trimebutine dosage forms in children of different ages.

Special Precautions

It is necessary to strictly observe the correspondence of the used dosage form to the indications for use.

Effect on the ability to drive vehicles and machinery

During the use of trimebutine, patients should exercise caution when driving vehicles and machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.