Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Rasagiline
Krka d.d.
N04BD02
Rasagiline
1mg
tablets
oral use
14, 15, 28, 30 and 112 tablets, in a box
Product subject to prescription which may be renewed (B)
KRKA, d.d
anti-parkinson drugs, monoamine oxidase B inhibitors
Rasagiline Krka 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.
Authorised
2015-10-30
Navodila prepognjena na sredini z vidno prvo stranjo (naslovom); pharma kodi, ki izhajata iz sredine navodila, morata biti vidni! smer vlaken smer branja kode 70 mm ± 0,5 mm 70 mm ± 0,5 mm smer branja kode Šifra: 2xxxxx Emb. mat.: NA.RASAGILINE KRKA IE Dimenzije: 148 ± 0,5 mm x 420 ± 0,8 mm Material: papir tip B PhC št.: 2xxxx Merilo: 1:1 Datum: 09.09.2015 Izdelal: K. Savnik Pregledal: J. Kastelic _Oddelek za oblikovanje_ _ - PMS-433U-KRKA_ _NA.RASAGILINE KRKA TBL IE_ prva stran PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Rasagiline Krka 1 mg tablets Rasagiline READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Rasagiline Krka is and what it is used for 2. What you need to know before you take Rasagiline Krka 3. How to take Rasagiline Krka 4. Possible side effects 5. How to store Rasagiline Krka 6. Contents of the pack and other information 1. What Rasagiline Krka is and what it is used for Rasagiline Krka is used for the treatment of Parkinson’s disease. It can be used together with or without levodopa (another medicine that is used to treat Parkinson’s disease). With Parkinson’s disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a chemical in the brain involved in movement control. Rasagiline Krka helps to increase and sustain levels of dopamine in the brain. 2. What you need to know before you take Rasagiline Krka DO NOT TAKE RASAGILINE KRKA: • if you are allergic to rasagiline or any of the ot read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rasagiline Krka 1mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg rasagiline (as rasagiline hemitartrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to almost white, round, slightly biconvex tablets, 7 mm in diameter, with beveled edges, darker spots may be visible. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rasagiline Krka 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 Krka 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 listed in section 6.1. Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products HEALTH PRODUCTS REGULATORY AUTHORITY ______ read_full_document