Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
pramipexole dihydrochloride monohydrate
Krka, d.d., Novo mesto
N04BC05
pramipexole
Anti-Parkinson drugs
Parkinson Disease
Oprymea is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on off" fluctuations).Oprymea is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Revision: 22
Authorised
2008-09-12
92 B. PACKAGE LEAFLET 93 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OPRYMEA 0.088 MG TABLETS OPRYMEA 0.18 MG TABLETS OPRYMEA 0.35 MG TABLETS OPRYMEA 0.7 MG TABLETS OPRYMEA 1.1 MG TABLETS pramipexole 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 Oprymea is and what it is used for 2. What you need to know before you take Oprymea 3. How to take Oprymea 4. Possible side effects 5. How to store Oprymea 6. Contents of the pack and other information 1. WHAT OPRYMEA IS AND WHAT IT IS USED FOR Oprymea contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements. Oprymea is used to: - treat the symptoms of primary Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease). - treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OPRYMEA DO NOT TAKE OPRYMEA - if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before taking Oprymea. Tell your doctor if you have or have had or develop any medical conditions or symptoms, especially any of the following: - Kidney disease - Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visu Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Oprymea 0.088 mg tablets Oprymea 0.18 mg tablets Oprymea 0.35 mg tablets Oprymea 0.7 mg tablets Oprymea 1.1 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Oprymea 0.088 mg tablets Each tablet contains 0.088 mg pramipexole (as 0.125 mg pramipexole dihydrochloride monohydrate). Oprymea 0.18 mg tablets Each tablet contains 0.18 mg pramipexole (as 0.25 mg pramipexole dihydrochloride monohydrate). Oprymea 0.35 mg tablets Each tablet contains 0.35 mg pramipexole (as 0.5 mg pramipexole dihydrochloride monohydrate). Oprymea 0.7 mg tablets Each tablet contains 0.7 mg pramipexole (as 1 mg pramipexole dihydrochloride monohydrate). Oprymea 1.1 mg tablets Each tablet contains 1.1 mg pramipexole (as 1.5 mg pramipexole dihydrochloride monohydrate). _Please note:_ Pramipexole doses as published in the literature refer to the salt form. Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Oprymea 0.088 mg tablets White, round, with bevelled edges and imprint "P6" on one side of the tablet. Oprymea 0.18 mg tablets White, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet. The tablet can be divided into equal doses. Oprymea 0.35 mg tablets White, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet. The tablet can be divided into equal doses. Oprymea 0.7 mg tablets White, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet. The tablet can be divided into equal doses. Oprymea 1.1 mg tablets White, round, with bevelled edges, both sides scored. The tablet can be divided into equal doses. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oprymea is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without l Lesen Sie das vollständige Dokument