TRIBUDAT

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT TRIBUDAT (TRIBUDAT)

Composition:

1 tablet contains trimethylbutanoate maleate 200 mg;

excipients: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, povidone, crospovidone, colloidal silicon dioxide, magnesium stearate, talc, patented blue (E-131).

Pharmaceutical form. 200 mg tablets.

Main physico-chemical properties: biconvex blue tablets with a score line.

Pharmacotherapeutic group. Agents used in functional gastrointestinal disorders. ATC code A03A A05.

Pharmacological Properties.

Pharmacodynamics. Trimethobutine is a synthetic agonist of peripheral m, d, and k opioid receptors. Its mechanism of action involves a direct effect on the smooth musculature of the gastrointestinal tract and regulation of motility disorders without affecting the central nervous system (CNS). Unlike other opioids, trimethobutine does not exhibit selectivity for any of the three receptor types, which allows it to either enhance or suppress peristalsis. The normalization of motility begins 30 minutes after administration.

Pharmacokinetics.

Absorption. After oral administration, trimethobutine is almost completely absorbed. Maximum concentration is reached within 30 minutes.

Distribution. Plasma protein binding is approximately 5%. After oral administration, it crosses the placental barrier in an amount of about 0.05% and is excreted into breast milk at approximately 0.04%.

Metabolism. Trimethobutine is metabolized in the liver.

Elimination. It is eliminated in the form of metabolites in urine.

Clinical characteristics.

Indications.

Irritable bowel syndrome; functional gastrointestinal disorders accompanied by abdominal pain, spasms, feeling of fullness, bloating, constipation, or diarrhea.

Contraindications.

Hypersensitivity to trimebutine or to any of the other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with zotepine may prolong anticholinergic effects. Trimebutine prolongs the effect of d-tubocurarine.

Special precautions for use.

The medicinal product Tribudat may cause drowsiness; therefore, it should be used with caution in patients with central nervous system depression.

Tribudat may enhance the sedative effect of medicinal products that depress the central nervous system and of ethanol.

Use during pregnancy or breastfeeding.

Since there is no data available on the use of the drug during pregnancy or breastfeeding, administration of the drug to women during these periods is contraindicated. Breastfeeding should be discontinued during treatment with this drug.

Ability to influence reaction rate when driving or operating machinery.

If dizziness or drowsiness occurs, patients should refrain from driving or operating machinery.

Dosage and Administration.

The tablets are taken orally 3 times a day, swallowed whole with a glass of water.

The single dose for adults is 200 mg (1 tablet).

At the beginning of treatment for irritable bowel syndrome, the maximum daily dose for adults may be 600 mg (3 tablets) when necessary, divided into 3 doses (1 tablet 3 times a day).

The duration of treatment is determined individually. The usual course of therapy is 2–6 weeks, depending on the severity and course of the disease.

Children.

Experience with the use of the drug in children is limited; therefore, it should not be prescribed to this age group.

Overdose.

There is no data on cases of trimetebutin overdose.

An increase in the manifestations of adverse reactions is possible.

Treatment: gastric lavage. Symptomatic therapy.

Side effects.

Gastrointestinal disorders: dry mouth, taste disturbances, diarrhea, dyspepsia, stomach pain, nausea, constipation.

Nervous system disorders: drowsiness, fatigue, dizziness, restlessness, headache, sensation of cold/heat, hearing impairment.

Immune system disorders: allergic reactions, including skin rash.

Reproductive system disorders: menstrual cycle disturbances, painful breast enlargement.

Renal and urinary disorders: urinary retention.

Shelf life. 3 years.

Storage conditions. Store in a place inaccessible to children, at a temperature not exceeding 30 °C, in the original packaging.

Packaging. Tablets of 200 mg, 10 tablets per blister, 1 or 2 blisters per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Fulton Medicinali S.p.A.

Manufacturer's address.

Via G. Marconi, 28/9 – 20020 – Arluno (Milan) – Italy