Spazmavexim (Tablets) Instructions for Use

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Avexima Siberia LLC (Russia)

Or

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

ATC Code

A03AA05 (Trimebutine)

Active Substance

Trimebutine (Rec.INN WHO registered)

Dosage Forms

	Spazmavexim	Tablets 100 mg: 10, 20 or 30 pcs.
		Tablets 200 mg: 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a cross-shaped score line.

Excipients: lactose monohydrate, corn starch, colloidal silicon dioxide, magnesium stearate.

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. – jars – cardboard packs.
20 pcs. – jars – cardboard packs.
30 pcs. – jars – cardboard packs.

Tablets white or almost white, round, biconvex, with a score line.

Excipients: lactose monohydrate, corn starch, colloidal silicon dioxide, magnesium stearate.

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. – jars – cardboard packs.
20 pcs. – jars – cardboard packs.
30 pcs. – jars – 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.

Plasma protein binding 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 with water.

Select the appropriate tablet strength (100 mg or 200 mg) based on the prescribed dose.

For adults and children over 12 years, the typical dose is 100-200 mg three times daily.

Adjust the total daily dose within the range of 300 mg to 600 mg.

For the 100 mg tablets, administer 1 to 2 tablets per dose.

For the 200 mg tablets, administer half to one tablet per dose.

Break the 200 mg tablet along the score line to achieve a 100 mg dose.

The duration of treatment is determined by the physician based on the indication and clinical response.

For postoperative paralytic ileus, initiate treatment as directed, typically for a short course.

Do not use in children under 12 years unless a specific pediatric dosage form is prescribed.

Strictly adhere to the dosing schedule prescribed by your physician.

Do not exceed the recommended daily dose.

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; pediatric age – depending on the dosage form.

Use in Pregnancy and Lactation

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

Pediatric Use

Use in children is possible according to indications, in age-appropriate 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

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

Effect on 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.