מדינה: שוודיה
שפה: שוודית
מקור: Läkemedelsverket (Medical Products Agency)
pramipexoldihydrokloridmonohydrat
Hexal A/S
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
Avregistrerad
2014-11-06
PACKAGE LEAFLET: INFORMATION FOR THE USER Pramipexole Hexal 0.26 mg prolonged-release tablets Pramipexole Hexal 0.52 mg prolonged-release tablets Pramipexole Hexal 1.05 mg prolonged-release tablets Pramipexole Hexal 1.57 mg prolonged-release tablets Pramipexole Hexal 2.1 mg prolonged-release tablets Pramipexole Hexal 2.62 mg prolonged-release tablets Pramipexole Hexal 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 or nurse . - 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pramipexole Hexal is and what it is used for 2. What you need to know before you take Pramipexole Hexal 3. How to take Pramipexole Hexal 4. Possible side effects 5. How to store Pramipexole Hexal 6. Contents of the pack and other information 1. WHAT PRAMIPEXOLE HEXAL IS AND WHAT IT IS USED FOR Pramipexole Hexal 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 Hexal is used in adults 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 PRAMIPEXOLE HEXAL DO NOT TAKE PRAMIPEXOLE HEXAL - 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 Pramipexole Hexal. Tell your doctor IF YOU קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pramipexole Hexal 0.26 mg prolonged-release tablets Pramipexole Hexal 0.52 mg prolonged-release tablets Pramipexole Hexal 1.05 mg prolonged-release tablets Pramipexole Hexal 1.57 mg prolonged-release tablets Pramipexole Hexal 2.1 mg prolonged-release tablets Pramipexole Hexal 2.62 mg prolonged-release tablets Pramipexole Hexal 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:_ 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 Prolonged-release tablet. Pramipexole Hexal 0.26 mg prolonged-release tablets: The tablets of 9 mm are white or nearly white, cylindrical, plans, with beveled edges and marked with 026 on one side Pramipexole Hexal 0.52 mg prolonged-release tablets: The tablets of 10 mm are white or nearly white, cylindrical, biconvex and marked with 052 on one side Pramipexole Hexal 1.05 mg prolonged-release tablets: The tablets of 10 mm are white or nearly white, cylin קרא את המסמך השלם