Indications
Symptomatic treatment of post-stroke spasticity in adults.
Contraindications
Hypersensitivity to the active substance tolperisone or to the chemically similar eperisone or to any of the excipients.
Myasthenia gravis.
Compositon/Ingredients
Tolperison 50 mg
Dosage and administration
Usual doses: 50 to 150 mg three times daily.
Patients with hepatic/ renal impairment:
- Moderate impairment: Individual titration with close monitoring.
- Severe impairment: Not recommended.
- Paediatric population: Not been established.
Precaution
The most frequently reported adverse reactions were hypersensitivity reactions.
Symptoms may include erythema, rash, urticaria, pruritus, angioedema, tachycardia, hypotension or dyspnoea.
Females, patients with hypersensitivity to other drugs or with a history of allergy may be at a higher risk.
In case of a known hypersensitivity to lidocaine increased caution during the administration of tolperisone because of possible cross-reactions is warranted.
Myopain 50 should not be used in pregnancy (particularly not in the 1st trimester) unless its expected benefits would undoubtedly outweigh any possible embryotoxicity.
The administration of Myopain 50 is not recommended during breastfeeding.
Patients who experience dizziness, somnolence, disturbance in attention, epilepsy, blurred vision or muscular weakness should not drive or operate machine and consult the doctor.
Storage
Store at temperature below 30°C, protect from light.
