TRIBUDAT

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

Composition:

Active substance: trimebutine;

One tablet contains trimebutine maleate 100 mg;

Excipients: talc; magnesium stearate; lactose monohydrate; microcrystalline cellulose; povidone K30; sodium croscarmellose; povidone; patented blue (E131).

Pharmaceutical form. Tablets of 100 mg.

Main physicochemical properties: biconvex blue tablets with a score line.

Pharmacotherapeutic group.

Agents used in functional gastrointestinal disorders.

ATC code A03A A05.

Pharmacological properties.

Pharmacodynamics.

Trimebutine is a synthetic agonist of peripheral m, d, and k opioid receptors. Its mechanism of action involves direct effects on the smooth muscle of the gastrointestinal tract and regulation of motility disorders without affecting the central nervous system. Unlike other opioids, trimebutine does not exhibit selectivity for any of the three receptor types, enabling it to either enhance or suppress peristalsis. The normalization of motility begins within 30 minutes after administration.

Pharmacokinetics.

Absorption.

After oral administration, trimebutine 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 approximately 0.05% and is excreted into breast milk at about 0.04%.

Metabolism.

Trimebutine is metabolized in the liver.

Elimination.

It is eliminated in the form of metabolites via 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 excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use.

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

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

The preparation contains lactose and therefore should not be used in patients with rare hereditary disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

Since data on the use of trimebutine during pregnancy or breastfeeding are lacking, the administration of this medicinal product to women during these periods is contraindicated. Breastfeeding should be discontinued during treatment with this medicinal product.

Ability to affect reaction speed when driving or operating machinery.

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

Dosage and Administration.

Take tablets orally 3 times a day, swallowing whole with a glass of water.

The single dose for adults is 100–200 mg (1–2 tablets).

At the beginning of treatment for irritable bowel syndrome, the maximum daily dose for adults may be increased, if necessary, to 600 mg (6 tablets), divided into 3 doses (2 tablets 3 times daily).

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 trimebutine in children is limited; therefore, the drug should not be prescribed to this age group.

Overdose.

There are no data regarding cases of trimebutine overdose.

Possible intensification of adverse reactions.

Treatment: gastric lavage. Symptomatic therapy.

Adverse Reactions.

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 rashes.

Reproductive system disorders: menstrual cycle disturbances, breast pain.

Urinary system disorders: urinary retention.

Shelf life.

4 years.

Storage conditions.

Store in the original packaging, protected from light, at a temperature not exceeding 30 °C. Keep out of reach of children.

Packaging.

10 tablets per blister pack, 1 or 2 blisters per cardboard box.

Prescription category.

Prescription only.

Manufacturer.

Fulton Medicinale S.p.A.

Manufacturer's address and place of business.

Via G. Marconi, No. 28/9 – 20020 – Arluno (Milan) – Italy