Myopain 150

Rx

Indications

• Symptomatic treatment of post-stroke spasticity in adults.

Dosage

• 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.
• The safety and efficacy of tolperisone in children have not been established.

Usage

• Myopain 150 is administered orally during or after meals.

• Hypersensitivity to the active substance tolperisone or to the chemically similar eperisone or to any of the excipients.
• Myasthenia gravis.
• Lactation.

• The most frequently concerned system organ classes are skin and subcutaneous tissue disorders, general disorders, neurological disorders and gastrointestinal disorders.
• Hypersensitivity reactions: The majority of the cases express non-serious and self-limiting conditions.
• Anorexia.
• Insomnia, sleep disturbance.
• Headache, dizziness, drowsiness.
• Hypotension.
• Abdominal pain, diarrhoea, dry mouth, dyspepsia, nausea.
• Muscle weakness, myalgia, limb pain.
• Asthenia, malaise, fatigue.

• 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 150 should not be used in pregnancy (particularly not in the first trimester) unless its expected benefits would undoubtedly outweigh any possible embryotoxicity. The administration of Myopain 150 is not recommended during breastfeeding.
• Patients who experience dizziness, somnolence, disturbance in attention, epilepsy, blurred vision or muscular weakness should not drive or operate machines.