Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
UNIMED SDN BHD
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
10 x 10 Tablets; 3 x 10 Tablets
Aurobindo Pharma Limited, Unit-VII (SEZ)
PRAMISON (PRAMIPEXOLE TABLETS 0.125 MG) PRAMISON ( PRAMIPEXOLE TABLETS 0.25 MG) PRAMISON ( PRAMIPEXOLE TABLETS 1 MG) Pramipexole Dihydrochloride Monohydrate (0.125mg, 0.25mg and 1mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What PRAMISON is used for 2. How PRAMISON works 3. Before you use PRAMISON 4. How to use PRAMISON 5. While you are using it 6. Side effects 7. Storage and Disposal of PRAMISON Product Description 8. Manufacturer and Product Registration Holder 9. Date of revision WHAT PRAMISON IS USED FOR PRAMISON used to treat the sign and symptoms of advanced idiopathic parkinson’s disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease). PRAMISON is also used to treat the symptoms of idiopathic Restless Legs Syndrome. HOW PRAMISON WORKS PRAMISON contains the active ingredient Pramipexole which is a highly selective dopamine receptor activator in the brain. PRAMISON alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the brain. Pramipexole protect dopamine neurons from degeneration in response to low oxygen or methamphetamine neurotoxicity. BEFORE YOU USE PRAMISON -When you must not use it If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will then discuss with you if you should continue to take PRAMISON. The effect of PRAMISON on the unborn child is not known. Therefore, do not take PRAMISON if you are pregnant unless your doctor tells you to do so. PRAMISON should not be used during breastfeeding. PRAMISON can reduce the production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of PRAMISON is unavoidable, breast- feeding should be stopped. - Before you start use it Do not take PRAMISON if you are allergic to pramipexole or to any of the other ingredients of this medicine. WARNING AND PRECAUTION FOR USE PRAMISON has been associate Lees het volledige document
PRAMISON (PRAMIPEXOLE TABLETS 0.125MG) PRAMISON (PRAMIPEXOLE TABLETS 0.25MG) PRAMISON (PRAMIPEXOLE TABLETS 0.1MG) Each tablet in the form of uncoated tablet. DESCRIPTION Pramison Tablets 0.125mg (Pramipexole 0.088mg) White to off-white, round, flat, bevelled edge uncoated tablets, debossed with ‘Y’ on one side ‘41’ on the other side with the presence of score line and the dimension of the tablet is 5.5mm. Each uncoated tablet contains Pramipexole Dihydrochloride Monohydrate 0.125 mg. Pramison Tablet 0.25mg (Pramipexole 0.18mg) White to off-white, oval, biconcave, bevelled edge uncoated tablets, debossed with ‘Y’ and ‘42’ separated by score line on one side and plain with score line on other side and the dimension of the tablet is 6.5mm x 4.5mm Each uncoated tablet contains Pramipexole Dihydrochloride Monohydrate 0.25 mg Pramison Tablet 1mg (Pramipexole 0.7mg) White to off-white, round, flat, bevelled edge uncoated tablets debossed with ‘Y’ and ‘45’ separated by score line on one side and plain with score line on other side and the dimension of the tablet is 9.3mm. Each uncoated tablet contains Pramipexole Dihydrochloride Monohydrate 1 mg PHARMACODYNAMICS Pramipexole, active ingredient of PRAMISON is a dopamine-agonist and binds with high selectivity and specificity to the dopamine D2-subfamily receptors and has a preferential affinity to D3-receptors; it has full intrinsic activity. PRAMISON alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum. Pramipexole protect dopamine neurons from degeneration in response to ischaemia or methamphetamine neurotoxicity. The precise mechanism of action of PRAMISON as a treatment for restless leg syndrome (RLS) is not known. Although the pathophysiology of RLS is largely unknown, neuropharmacological evidence suggests primary dopaminergic system involvement. Positron emission tomographic studies suggest that a mild striatal presynaptic dopaminergic dysfunction may be involved in the pathogenesis of RLS. PHARMACOKINET Lees het volledige document