Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
RASAGILINE TARTRATE
Accord Healthcare Limited
N04BD02
RASAGILINE TARTRATE
1 Milligram
Tablets
oral use
Pack sizes of 7, 10 , 28, 30, 60,100, 112 tablets.
Product subject to prescription which may be renewed (B)
Accord Healthcare Limited
Anti-Parkinson-Drugs, Monoamine oxidase -B inhibitors
rasagiline
Rasagiline Accord 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.
Marketed
2015-11-27
200 mm 300 mm 10 mm 10 mm Pre-Folded Leaflet H x W mm (300 x 200 mm) 10 mm 10 mm - dry mouth - nausea and vomiting - flatulence - abnormal results of blood tests (leucopenia) - joint pain (arthralgia) - musculoskeletal pain - joint inflammation (arthritis) - numbness and muscle weakness of the hand (carpal tunnel syndrome) - decreased weight - abnormal dreams - difficulty in muscular coordination (balance disorder) - depression - dizziness (vertigo) - prolonged muscle contractions (dystonia) - runny nose (rhinitis) - irritation of the skin (dermatitis) - rash - bloodshot eyes (conjunctivitis) - urinary urgency Uncommon _(may affect up to 1 in 100 people)_: - stroke (cerebrovascular accident) - heart attack (myocardial infarction) - blistering rash (vesiculobullous rash) In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials. Nevertheless, scientific evidence suggests that Parkinson’s disease, and not any medicine in particular, is associated with a higher risk of skin cancer (not exclusively melanoma). You should speak with your doctor about any suspicious skin changes. Parkinson's disease is associated with symptoms of hallucinations and confusion. In post marketing experience these symptoms have also been observed in Parkinson's disease patients treated with Rasagiline Accord . There have been cases of patients who, while taking one or more medications for the treatment of Parkinson’s disease, were unable to resist the impulse, drive or temptation to perform an action that could be harmful to themselves or others. These are called impulse control disorders. In patients taking Rasagiline Accord and/or other medications used to treat Parkinson’s disease, the following have been observed: - Obsessive thoughts or impulsive behaviour. - Strong impulse to gamble excessively despite serious personal or family consequences. - Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive. - Unc Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rasagiline Accord 1mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg rasagiline (as rasagiline tartrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, round, flat, bevelled tablets (6.5 mm). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rasagiline Accord 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa. It may be taken with or without food. Elderly: No change in dose is required for elderly patients. Paediatric population: Rasagiline Accord is not recommended for use in children and adolescents due to lack of data on safety and efficacy. Patients with hepatic impairment: Rasagiline use in patients with severe hepatic impairment is contraindicated (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). Patients with renal impairment: No change in dose is required for renal impairment. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients see section 6.1. Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) or pethidine (see section 4.5). At least 14 days must elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine. Rasagiline is contraindicated in patients with severe hepatic impairment. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R Lees het volledige document