Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ENTACAPONE
MEDISPEC (M) SDN.BHD
ENTACAPONE
30 Tablets; 100 Tablets
Sunshine Lake Pharma Co., Ltd.
ENTACAPONE HEC 200MG FILM-COATED TABLETS Entacapone (200mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Entacapone HEC is used for 2. How Entacapone HEC works 3. Before you use Entacapone HEC 4. How to use Entacapone HEC 5. While you are using it 6. Side effects 7. Storage and Disporal of Entacapone HEC 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ENTACAPONE HEC IS USED FOR Entacapone HEC contains entacapone and is used together with levodopa to treat Parkinson’s disease for those who cannot be stabilised on levodapa combinations. HOW ENTACAPONE HEC WORKS Entacapone HEC supports levodopa in relieving the symptoms of Parkinson's disease. Entacapone HEC has no effect on relieving the symptoms of Parkinson´s disease unless taken with levodopa. _ _ BEFORE YOU USE ENTACAPONE HEC _- When you must not use it _ Do not take Entacapone HEC if you are allergic to entacapone, peanut, soya or any of the other ingredients of this medicine; if you have a tumour of the adrenal gland, known as a pheochromocytoma if you are taking certain antidepressants. Ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Entacapone HEC; if you have liver disease; if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS). if you have ever suffered from a rare muscle disorder (rhabdomyolysis), which was not caused by injury. _Pregnancy and breast-feeding _ Do not take Entacapone HEC if you are pregnant, think you may be pregnant or are planning to have a baby. Do not take Entacapone HEC if you are breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine. _- Before you start to use it _ Talk to your doctor or pharmacist before taking Entacapone HEC: if you have ever had a heart attack or any other diseases of the heart if you are taking a medicine which may cause dizziness or light- headedness (l Baca dokumen lengkap
1 Product Name 2 Name & Strength of Active Ingredient(s) and Excipient Full list of Excipients: _Tablet core: _ Microcrystalline cellulose Mannitol Sodium Starch Glycolate (type A) Povidone (K29/32) Magnesium Stearate _Film-coating:_ Polyvinyl Alcohol (Partly hydrolyzed) Talc Titanium Dioxide (E171) Macrogol 3350 Iron Oxide Yellow (E172) Lecithin (Soya) Iron Oxide Red (E172) 3 Dosage Form Film-coated tablet 4 Product Description “S52” on one side and blank on the other side. 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamics Pharmacotherapeutic group: other dopaminergic agents, ATC code: N04BX02. Entacapone belongs to a new therapeutic class, COMT COMT inhibitor designed for concomitant administration with levodopa preparations. Entacapone decreases the metabolic loss of levodopa to 3-O-methyldopa (3-OMD) by inhibiting the COMT enzyme. This leads to a higher levodopa AUC. The amount of levodopa available to the brain is increased. Entacapone thus prolongs the clinical response to levodopa. Entacapone inhibits the COMT enzyme mainly in peripheral tissues. COMT inhibition in red blood cells closely follows the plasma concentrations of entacapone, thus clearly indicating the reversible nature of COMT inhibition. Clinical studies In two phase III, double-blind studies in a total of 376 patients entacapone or placebo was given with each levodopa/dopa decarboxylase inhibitor dose. The results are given in Table 2. In study I, daily On time (hr) was measured from home diaries and in study II, the proportion of daily On time was measured. Table 2. Daily On time (Mean ±SD) Study I: Daily On time (h) Entacapone (n=85) Placebo (n=86) Difference Baseline 9.3±2.2 9.2±2.5 Weeks 8-24 10.7±2.2 9.4±2.6 1 hr 20 min (8.3%) CI 95% 45 min, 1 hr 56 min Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102) Difference Baseline 60.0±15.2 60.8±14.0 Weeks 8-24 66.8±14.5 62.8±16.80 4.5% (0 hr 35 min) CI 95% 0.93%, 7.97% There were corresponding decreases in Off time. The % change from baseline in Off time Baca dokumen lengkap