Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
pramipexole dihydrochloride monohydrate
Boehringer Ingelheim International GmbH
N04BC05
pramipexole
Anti-Parkinson drugs
Restless Legs Syndrome; Parkinson Disease
Sifrol 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, though 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).Sifrol is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).
Revision: 37
Authorised
1997-10-13
67 B. PACKAGE LEAFLET 68 PACKAGE LEAFLET: INFORMATION FOR THE USER SIFROL 0.088 MG TABLETS SIFROL 0.18 MG TABLETS SIFROL 0.35 MG TABLETS SIFROL 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 SIFROL is and what it is used for 2. What you need to know before you take SIFROL 3. How to take SIFROL 4. Possible side effects 5. How to store SIFROL 6. Contents of the pack and other information 1. WHAT SIFROL IS AND WHAT IT IS USED FOR SIFROL 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. SIFROL 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 SIFROL DO NOT TAKE SIFROL - 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 SIFROL. Tell your doctor if you 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 visual. - Dyskinesia (e.g. abnormal Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SIFROL 0.088 mg tablets Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole. SIFROL 0.18 mg tablets Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole. SIFROL 0.35 mg tablets Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole. SIFROL 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 SIFROL 0.088 mg tablets The tablets are white, flat, of round shape, and have a code embossed (one side with the code P6, and one side with the Boehringer Ingelheim company symbol). SIFROL 0.18 mg tablets The tablets are white, flat, of oval shape, scored on both sides, and have a code embossed (one side with the code P7, and one side with the Boehringer Ingelheim company symbol). Tablets can be divided into equal halves. SIFROL 0.35 mg tablets The tablets are white, flat, of oval shape, scored on both sides, and have a code embossed (one side with the code P8, and one side with the Boehringer Ingelheim company symbol). Tablets can be divided into equal halves. SIFROL 0.7 mg tablets The tablets are white, flat, of round shape, scored on both sides, and have a code embossed (one side with the code P9, and one side with the Boehringer Ingelheim company symbol). Tablets can be divided into equal halves. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SIFROL is indicated in adults for treatment of the signs and symptoms of idiopathic Aqra d-dokument sħiħ