Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
pramipexole dihydrochloride monohydrate
Teva Pharma B.V.
N04BC05
pramipexole
Anti-Parkinson drugs
Parkinson Disease
Pramipexole Teva 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).Pramipexole Teva 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
2008-12-18
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE USER PRAMIPEXOLE TEVA 0.088 MG TABLETS PRAMIPEXOLE TEVA 0.18 MG TABLETS PRAMIPEXOLE TEVA 0.35 MG TABLETS PRAMIPEXOLE TEVA 0.7 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 of the 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 Pramipexole Teva is and what it is used for 2. What you need to know before you take Pramipexole Teva 3. How to take Pramipexole Teva 4. Possible side effects 5. How to store Pramipexole Teva 6. Contents of the pack and other information 1. WHAT PRAMIPEXOLE TEVA IS AND WHAT IT IS USED FOR Pramipexole Teva 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. Pramipexole Teva 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 PRAMIPEXOLE TEVA DO NOT TAKE PRAMIPEXOLE TEVA • if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before taking Pramipexole Teva. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the foll Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pramipexole Teva 0.088 mg tablets Pramipexole Teva 0.18 mg tablets Pramipexole Teva 0.35 mg tablets Pramipexole Teva 0.7 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pramipexole Teva 0.088 mg tablets Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole. Pramipexole Teva 0.18 mg tablets Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole. Pramipexole Teva 0.35 mg tablets Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole. Pramipexole Teva 0.7 mg tablets Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole. _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 Pramipexole Teva 0.088 mg tablets White, round, flat face bevel edge tablet, 5.55 mm diameter, embossed with “93” on one side and “P1” on the other side. Pramipexole Teva 0.18 mg tablets White, round, flat face bevel edge tablet, 7.00 mm diameter, embossed with "P2" over "P2" on the scored side and "93" on the other side. The tablet can be divided into equal halves. Pramipexole Teva 0.35 mg tablets White to off-white, oval, biconvex tablets, engraved with 9 vertical scoreline 3 on the scored side, and 8023 on the other side. The tablet can be divided into equal halves. Pramipexole Teva 0.7 mg tablets White, round, flat face bevel edge tablet, 8.82 mm diameter, embossed with "8024" over "8024" on the scored side and "93" on the other side. The tablet can be divided into equal halves. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pramipexole Teva is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson’s disease Lesen Sie das vollständige Dokument