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Tribux<SUP>®</SUP> Tribux®




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Tribux

Trimebutini maleas
100 mg tablet

Composition

Each tablet contains the active pharmaceutical ingredient: 100 mg of trimebutine maleate as well as auxiliary substances: anhydrous lactose, maize starch, microcrystalline cellulose and magnesium stearate.

Mechanism of action

The active substance of TRIBUX is trimebutine, a synthetic agonist of peripheral opioid receptors of m, d and k subtypes. The mechanism of action involves direct on the gastrointestinal smooth muscle cells and regulatory activity in case of motor function disturbances, without exerting any effect on the central nervous system. In contrast to other opioids, such as morphine or codeine, trimebutine is not selective for any of the 3 opioid receptor subtypes, thus possessing both stimulatory, as well as inhibitory activities on the gastrointestinal peristalsis. Normalization of the motor functions begins as shortly as 30 minutes following drug administration.

Therapeutic indications

  • Disturbed gastrointestinal motor functions, referred to as irritable bowel syndrome;

  • Functional disturbances of gastrointestinal system: diarrhea, constipation, stomach aches, intestinal spasms.

Contraindications

Hypersensitivity to trimebutin or any of the components of the pharmaceutical composition.

Special warnings and precautions

No special precautions are indicated when taking Tribux.

Use during pregnancy and lactation

Data regarding usage of trimebutine during pregnancy are insufficient. Therefore it is not recommended to use Tribux during the first trimester of pregnancy. The drug may be used in the second and third trimester of pregnancy as well as during breast-feeding only if it is considered necessary. Animal studies did not reveal teratogenic, mutagenic nor embryotoxic potential of the compound for the developing fetus. No influence on lactation has been determined, either.

Influence on ability to drive and operate machinery

When given in recommended doses, TRIBUX does not negatively influence the ability to drive, operate machinery and does not lead to decreased psychomotor ability.

Interactions with other drugs

Zotepine, when administered simultaneously with trimebutine, may lead to increased anticholinergic activity.

Dosage and administration

Adults: 100 mg trimebutine maleate (1 tablet) given three times daily. In special cases the dose may be increased up to 6 tablets (each containing 100 mg trimebutine) daily, given in divided doses.
The tablets should be swallowed as a whole and taken with a glass of boiled water

Overdose

If drug overdose is suspected, immediately seek medical advice. Symptomatic treatment is recommended.

Undesirable effects

When administered within the recommended dose range, Tribux may rarely cause skin allergic reactions. If any undesirable effects occur, inform your doctor about this fact.

Available packages

Cartoon containing 2 blisters of 10 tablets each.



Before using the drug, read the information leaflet which contains indications, contraindications, data concerning adverse effects and dosaging as well as information relating to the use of the medical product, or consult your physician or pharmacist.

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