Tarlige Special Precautions

Dizziness, somnolence, loss of consciousness: Dizziness, somnolence, and loss of consciousness, which may cause falls and subsequent fractures, etc., may occur. Patients being treated with TARLIGE should be monitored closely; if any abnormalities are noted, appropriate measures, such as discontinuation of treatment or dose reduction, should be taken (see Dosage & Administration and Effects on ability to drive and use machines as follows).
Hepatic function disorder: Hepatic function disorder (e.g., AST increased, ALT increased) may occur. Patients being treated with TARLIGE should be monitored closely; if any abnormalities including early symptoms (e.g., general malaise, anorexia) are noted, treatment should be discontinued and appropriate measures should be taken.
Weight gain: Treatment with TARLIGE may cause weight gain. Caution should therefore be exercised for potential occurrence of obesity. If signs of obesity are noted, appropriate measures, such as diet and/or exercise therapy, should be taken. In particular, since weight gain may be associated with dose increase or long-term use, body weight should be measured regularly.
Withdrawal symptoms: Abrupt discontinuation of treatment with TARLIGE may cause drug withdrawal symptoms (e.g., insomnia, nausea, diarrhea, decreased appetite). Treatment with TARLIGE should be discontinued in a careful manner, such as gradual dose reduction.
Ophthalmic disorders: Treatment with TARLIGE may cause ophthalmic disorders (e.g., amblyopia, abnormal vision, vision blurred, and diplopia). Caution should therefore be exercised for potential occurrence of ophthalmic disorders in medical examinations including careful history taking.
Other Precautions: It should be noted that TARLIGE for neuropathic pain is not a causal therapy but a supportive therapy. Therefore, the underlying disease of the pain should be diagnosed and treated concurrently, and the drug should not be used without intention.
In multinational, placebo-controlled studies conducted in Asian countries, suicide-related adverse events were reported in 5 of 1378 subjects (0.26%; completed suicide, 1 subject; suicidal ideation, 4 subjects) in the mirogabalin groups and in 4 of 869 subjects (0.46%; suicidal ideation, 4 subjects) in the placebo group.
In multinational, placebo-controlled studies conducted in Asian countries, death cases were reported in 3 of 1378 subjects (0.22%) in the mirogabalin groups and in none of 869 subjects in the placebo group.
Effects on ability to drive and use machines: TARLIGE may cause event(s) (e.g., dizziness, somnolence, loss of consciousness). Patients being treated with TARLIGE must be warned not to operate potentially dangerous machinery, such as driving a car.