Lidamitol tabs (Tablets) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

M03BX04 (Tolperisone)

Active Substance

Tolperisone (Rec.INN registered by WHO)

Dosage Form

Lidamitol tabs

Film-coated tablets, 150 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets

10 pcs. – blister packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – blister packs (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription

Clinical-Pharmacological Group

Centrally acting muscle relaxant

Pharmacotherapeutic Group

Centrally acting muscle relaxants; other centrally acting muscle relaxants

Pharmacological Action

Centrally acting muscle relaxant. The reduction of pathologically increased skeletal muscle tone is explained by the ability of tolperisone to suppress spinal polysynaptic reflexes and its inhibitory effect on the caudal part of the reticular formation. It has central n-cholinoblocking properties. It does not have a significant effect on the peripheral parts of the nervous system. It has a weak antispasmodic and vasodilating effect.

Indications

Spinal and cerebral palsies (hypertonia, muscle spasm, spinal automatism; limb contracture).

Diseases accompanied by dystonia, rigidity, muscle spasm; obliterating arterial diseases: obliterating atherosclerosis of limb vessels, diabetic angiopathy, obliterating thromboangiitis (Buerger’s disease), Raynaud’s syndrome.

Consequences of disorders of vascular innervation (acrocyanosis, intermittent angioneurotic dysbasia).

Extrapyramidal disorders (postencephalitic and atherosclerotic parkinsonism).

Postthrombotic disorders of lymph circulation and venous circulation, trophic leg ulcer, infantile spastic paralysis (Little’s disease), epilepsy, encephalopathy of vascular origin; hypertonia combined with a violation of muscle tone of another type.

ICD codes

Dosage Regimen

Administer Lidamitol tablets orally with a full glass of water after a meal to minimize potential gastrointestinal discomfort.

Initiate therapy with an initial dose of 50 mg (one-third of a 150 mg tablet) taken two to three times daily.

Gradually titrate the dose upward based on individual patient tolerance and therapeutic response.

The standard maintenance dose for adults is 150 mg (one tablet) taken two to three times daily.

The maximum total daily dose should not exceed 450 mg, equivalent to three 150 mg tablets.

For intramuscular administration, inject 100 mg (1 ml of solution) twice daily deep into the muscle.

For intravenous administration, inject 100 mg (1 ml of solution) once daily as a single, slow injection.

Adhere strictly to the prescribed dosage and frequency; do not adjust the regimen without consulting a physician.

Discontinuation should be performed gradually under medical supervision if long-term therapy is concluded.

Adverse Reactions

Possible headache, myasthenia, arterial hypotension, nausea, vomiting, gastralgia, allergic reactions (anaphylactic shock, bronchospasm, urticaria, erythematous rash, skin itching).

Contraindications

Myasthenia, pregnancy, lactation period, children and adolescents under 18 years of age, hypersensitivity to tolperisone.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 1 year of age.

Special Precautions

Effect on ability to drive vehicles and mechanisms

Use with caution in patients whose activities require increased attention and speed of psychomotor reactions.

Drug Interactions

The effect of tolperisone is enhanced with simultaneous use with drugs for general anesthesia, peripheral muscle relaxants, psychoactive drugs, and with clonidine.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.