Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
MEDISPEC (M) SDN.BHD
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
3 x 10 Tablets
UNISON LABORATORIES CO.LTD
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ PRAMEXOL TABLET PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (0.25 MG, 1 MG) 1 WHAT IS IN THIS LEAFLET 1. What Pramexol is used for 2. How Pramexol works 3. Before you use Pramexol 4. How to use Pramexol 5. While you are using it 6. Side effects 7. Storage and Disposal of Pramexol 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PRAMEXOL IS USED FOR Treat the symptoms of primary Parkinson’s disease _1_ in adults. It can be used alone or in combination with Levodopa (another medicine for Parkinson’s disease). Also, to treat idiopathic Restless Legs Syndrome (a common condition of the nervous system that causes an overwhelming, irresistible urge to move the legs). HOW PRAMEXOL WORKS Pramexol contains the active substance Pramipexole. Pramipexole belongs to a group of medicines known as dopamine agonists, which stimulates dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements. BEFORE YOU USE PRAMEXOL _- When you must not use it _ If you are allergic (hypersensitive) to Pramipexole or any of the other ingredients of this medicine (listed in _Ingredients). _ Pramexol is not recommended for use in children or adolescents under 18 years. _ _ _Pregnancy and breastfeeding_ Do not take Pramexol if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Pramexol if you are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine. _- Before you start to use it _ Talk to your doctor or pharmacist before taking Pramexol. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following: • If you have kidney disease. • If you experience hallucinations (seeing, hearing or feeling things that are not there). • If you have dyskinesia (e.g. abnormal, uncontrolled movement of the limbs). If y Aqra d-dokument sħiħ
1 of 4 PRAMEXOL 0.25 MG TABLET PRAMEXOL 1 MG TABLET Each tablet contains: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG EQ. TO PRAMIPEXOLE BASE 0.18 MG PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG EQ. TO PRAMIPEXOLE BASE 0.7 MG PRODUCT DESCRIPTION: _0.25 MG: _ White, oval, flat-faced tablet with bevelled edge, engraved PM on one side and scored on the other _1 MG: _ White, oval, flat-faced tablet with bevelled edge, engraved PM 1 on one side and crossed-scored on the other MECHANISM OF ACTION: _PHARMACOLOGY _ Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity. Pramipexole alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum. Animal studies have shown that Pramipexole inhibits dopamine synthesis, release, and turnover._ _ _PHARMACOKINETICS _ Absorption Pramipexole is rapidly and completely absorbed following oral administration. The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours. Concomitant administration with food did not reduce the extent of Pramipexole absorption, but the rate of absorption was reduced. Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels. Distribution In humans, the protein binding of Pramipexole is very low (< 20%) and the volume of distribution is large (400 L). High brain tissue concentrations were observed in the rat (approx. 8-fold compared to plasma). Biotransformation Pramipexole is metabolized in man only to a small extent. Elimination Renal excretion of unchanged Pramipexole is the major route of elimination. Approximately 90% of 14C-labelled dose is excreted through the kidneys while less than 2% is found in the feces. The total clearance of Pramipexole is approximately 500 mL/min and the renal clearance is approximately 400 mL/min. The elimination half-life (t½) varies from 8 hours in Aqra d-dokument sħiħ