Trimefor (Tablets) Instructions for Use

Marketing Authorization Holder

Forp, JSC (Russia)

Manufactured By

Pharmproekt, JSC (Russia)

ATC Code

A03AA05 (Trimebutine)

Active Substance

Trimebutine (Rec.INN registered by WHO)

Dosage Form

Trimefor

Tablets 200 mg: 10, 20, 30, 40, 60 or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel on both sides and a cross-shaped score on one side.

Excipients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polysorbate (tween-80).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.

Clinical-Pharmacological Group

Spasmolytic drug

Pharmacotherapeutic Group

Drugs for the treatment of functional gastrointestinal disorders; synthetic anticholinergic agents, esters with a tertiary amino group

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 Trimefor tablets orally with water.

For adults and children over 12 years of age, the standard dosage is one 200 mg tablet taken three times daily before meals.

Adjust the dosage based on clinical response and tolerability. The maximum daily dose should not exceed 600 mg.

For postoperative paralytic ileus, initiate treatment at the same dosage; duration of therapy depends on the resolution of symptoms.

The tablet is scored, allowing it to be broken for ease of swallowing; however, the total daily dose must be maintained.

Do not chew the tablets.

For pediatric patients under 12 years of age, use is contraindicated with this specific 200 mg tablet formulation.

In elderly patients, no specific dosage adjustment is required; however, monitor for potential adverse reactions.

In cases of hepatic or renal impairment, use with caution and consider monitoring patient response due to the primary hepatic metabolism and renal excretion of metabolites.

If a dose is missed, take it as soon as remembered unless it is almost time for the next dose. Do not double the dose to make up for a forgotten one.

The duration of treatment is not limited; continue use as long as symptomatic control is required.

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.

Urinary system disorders: frequency unknown – urinary retention.

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

Contraindications

Hypersensitivity to trimebutine; pregnancy; children’s age – 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

It is possible to use in children according to indications, in doses and dosage forms recommended according to age. 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

The correspondence of the used dosage form to the indications for use must be strictly observed.

Influence on the ability to drive vehicles and mechanisms

During the use of trimebutine, patients should exercise caution when driving vehicles and mechanisms, 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.