Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Mylan Pharmaceuticals Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN Ireland
Rasagiline Mylan is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
The recommended dose of rasagiline is 1 mg (one tablet of Rasagiline Mylan) once daily, to be taken with or without levodopa.
No change in dose is required for elderly patients (see section 5.2).
Rasagiline is contraindicated in patients with severe hepatic impairment (see section 4.3). Rasagiline use in patients with moderate hepatic impairment should be avoided. Caution should be used when initiating treatment with rasagiline in patients with mild hepatic impairment. In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4 and 5.2).
No special precautions are required in patients with renal impairment.
The safety and efficacy of rasagiline in children and adolescents have not been established. There is no relevant use of rasagiline in the paediatric population in the indication Parkinson’s disease.
For oral use.
Rasagiline may be taken with or without food.
Symptoms reported following overdose of rasagiline in doses ranging from 3 mg to 100 mg included dysphoria, hypomania, hypertensive crisis and serotonin syndrome.
Overdose can be associated with significant inhibition of both MAO-A and MAO-B. In a single-dose study healthy volunteers received 20 mg/day and in a ten-day study healthy volunteers received 10 mg/day. Adverse reactions were mild or moderate and not related to rasagiline treatment. In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg/day of rasagiline, there were reports of cardiovascular adverse reactions (including hypertension and postural hypotension) which resolved following treatment discontinuation. These symptoms may resemble those observed with non-selective MAO inhibitors.
There is no specific antidote. In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.
30 months.
Do not store above 25°C.
oPA/Al/PVC/Al. Blister packs of 7, 10, 28, 30, 100 or 112 tablets
PVC/PVDC/Al. Blister packs of 7, 10, 28, 30, 100 or 112 tablets
PVC/PVDC/Al. Perforated unit dose blister packs of 7 × 1, 10 × 1, 28 × 1, 30 × 1, 100 × 1 or 112 × 1.
Not all pack sizes may be marketed.
No special requirements for disposal.
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