Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
pramipexole dihydrochloride monohydrate
Accord Healthcare S.L.U.
N04BC05
pramipexole
Anti-Parkinson drugs
Parkinson Disease; Restless Legs Syndrome
Pramipexole Accord is indicated in adults 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).
Revision: 10
Authorised
2011-09-29
36 B. PACKAGE LEAFLET Medicinal product no longer authorised 37 PACKAGE LEAFLET: INFORMATION FOR THE USER PRAMIPEXOLE ACCORD 0.088 MG TABLETS PRAMIPEXOLE ACCORD 0.18 MG TABLETS PRAMIPEXOLE ACCORD 0.35 MG TABLETS PRAMIPEXOLE ACCORD 0.7 MG TABLETS PRAMIPEXOLE ACCORD 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 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 Accord is and what it is used for 2. What you need to know before you take Pramipexole Accord 3. How to take Pramipexole Accord 4. Possible side effects 5. How to store Pramipexole Accord 6. Contents of the pack and other information 1. WHAT PRAMIPEXOLE ACCORD IS AND WHAT IT IS USED FOR Pramipexole Accord 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 ACCORD 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 PRAMIPEXOLE ACCORD DO NOT TAKE PRAMIPEXOLE ACCORD: • 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 Accord. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Pramipexole Accord 0.088 mg tablets Pramipexole Accord 0.18 mg tablets Pramipexole Accord 0.35 mg tablets Pramipexole Accord 0.7 mg tablets Pramipexole Accord 1.1 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pramipexole Accord 0.088 mg tablet Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole. Pramipexole Accord 0.18 mg tablet Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole. Pramipexole Accord 0.35 mg tablet Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole. Pramipexole Accord 0.7 mg tablet Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole. Pramipexole Accord 1.1 mg tablet Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.1 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 Accord 0.088 mg tablet The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I1’ on one side and plain on the other side. Pramipexole Accord 0.18 mg tablet The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I’ and ‘2’ on either side of the breakline on one side and breakline on the other side. The tablet can be divided into two equal doses. Pramipexole Accord 0.35 mg tablet The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I’ and ‘3’ on either side of the breakline on one side and breakline on the other side. Medicinal product no longer authorised 3 The tablet can be divided into two equal doses. Pramipexole Leggi il documento completo