Negara: Swedia
Bahasa: Swedia
Sumber: Läkemedelsverket (Medical Products Agency)
pramipexoldihydrokloridmonohydrat
G.L. Pharma GmbH
N04BC05
dihydrochloride monohydrate
0,26 mg
Depottablett
pramipexoldihydrokloridmonohydrat 0,375 mg Aktiv substans
Apotek
Receptbelagt
Pramipexol
Förpacknings: Blister, 10 tabletter; Blister, 100 tabletter; Blister, 30 tabletter
Godkänd
2014-01-16
PACKAGE LEAFLET: INFORMATION FOR THE USER Calmolan 0.26 mg prolonged-release tablets Calmolan 0.52 mg prolonged-release tablets Calmolan 1.05 mg prolonged-release tablets Calmolan 1.57 mg prolonged-release tablets Calmolan 2.1 mg prolonged-release tablets Calmolan 2.62 mg prolonged-release tablets Calmolan 3.15 mg prolonged-release 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 Calmolan is and what it is used for 2. What you need to know before you take Calmolan 3. How to take Calmolan 4. Possible side effects 5. How to store Calmolan 6. Contents of the pack and other information 1. WHAT CALMOLAN IS AND WHAT IT IS USED FOR Calmolan 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. Calmolan 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). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALMOLAN DO NOT TAKE CALMOLAN - 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 Calmolan. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following: - Kidney disease. - Hallucinations (seeing, he Baca dokumen lengkapnya
Page 1 of 13 Produktinformationen för Calmolan 0,26 mg, 0,52 mg, 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg, 3,15 mg depottablett, MTnr 48395, 48396, 48397, 48398, 48399, 48400, 48401, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige är referensland. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. PDF rendering: Titel 00848887, Version 0.2, Namn Calmolan prolonged-release tablet SmPC Page 2 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Calmolan 0.26 mg prolonged-release tablets Calmolan 0.52 mg prolonged-release tablets Calmolan 1.05 mg prolonged-release tablets Calmolan 1.57 mg prolonged-release tablets Calmolan 2.1 mg prolonged-release tablets Calmolan 2.62 mg prolonged-release tablets Calmolan 3.15 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 0.375 mg Pramipexole dihydrochloride monohydrate equivalent to 0.26 mg Pramipexole. Each prolonged-release tablet contains 0.75 mg Pramipexole dihydrochloride monohydrate equivalent to 0.52 mg Pramipexole. Each prolonged-release tablet contains 1.5 mg Pramipexole dihydrochloride monohydrate equivalent to 1.05 mg Pramipexole. Each prolonged-release tablet contains 2.25 mg Pramipexole dihydrochloride monohydrate equivalent to 1.57 mg Pramipexole. Each prolonged-release tablet contains 3 mg Pramipexole dihydrochloride monohydrate equivalent to 2.1 mg Pramipexole. Each prolonged-release tablet contains 3.75 mg Pramipexole dihydrochloride monohydrate equivalent to 2.62 mg Pramipexole. Each prolonged-release tablet contains 4.5 mg Pramipexole dihydrochloride monohydrate equivalent to 3.15 mg Pramipexole. _Please note:_ Prami Baca dokumen lengkapnya