Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Pemafibrate
DKSH MALAYSIA SDN. BHD.
Pemafibrate
100 Tablets
Kowa Company, Ltd, Nagoya Factory
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ PARMODIA ® FILM-COATED TABLETS 0.1 MG Pemafibrate (0.1 mg) 1 WHAT IS IN THIS LEAFLET 1. What PARMODIA is used for 2. How PARMODIA works 3. Before you use PARMODIA 4. How to use PARMODIA 5. While you are using it 6. Side effects 7. Storage and Disposal of PARMODIA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT PARMODIA IS USED FOR PARMODIA is used as adjunctive therapy to diet or other nonpharmacological treatment (e.g. exercise) to reduce triglyceride (TG) and to increase high-density lipoprotein cholesterol (HDL-C) in patients with dyslipidemia characterised by high TG ≥150 mg/dL, particularly when there is evidence of associated risk such as hypertension and smoking. Dyslipidemia is an abnormal level of lipids such as TG and cholesterol, also called fats, in the blood. HOW PARMODIA WORKS PARMODIA contains a medicine called pemafibrate. Pemafibrate activates nuclear receptor (PPARα) by binding to this receptor and regulates the target gene expression, leading to decreased TG and increased HDL-C. If you have any questions about how PARMODIA works or why this medicine has been prescribed to you, ask your doctor. BEFORE YOU USE PARMODIA - _When you must not use it _ Follow all instructions given to you by your doctor or pharmacist carefully, even if they differ from the general information contained in this leaflet. Do not take PARMODIA If you are allergic (hypersensitivity) to pemafibrate or to any of the excipients (listed in Section Product Description). If you have severe liver problems, moderate or severe cirrhosis, or biliary obstruction. If you have cholelithiasis (gallstones). If you are pregnant or possibly pregnant women. If you are receiving cyclosporine or rifampicin. If any of these apply to you, tell your doctor and do not take PARMODIA. If you are not sure, talk to your doctor or pharmacist before taking PARMODIA. - _Pregnancy and breast-feeding _ Do not ta Lugege kogu dokumenti
Kowa Company, Ltd. PARMODIA film-coated tablets 0.1 mg 1. NAME OF THE MEDICINAL PRODUCT PARMODIA film-coated tablets 0.1 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.1 mg of pemafibrate. For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White round film-coated tablets with a score line debossed ‘Kowa 217’ on one face and a score line on the reverse. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PARMODIA is indicated as adjunctive therapy to diet or other nonpharmacological treatment (e.g. exercise) to reduce TG and to increase HDL-C in patients with dyslipidemia characterised by high TG ≥150 mg/dL, particularly when there is evidence of associated risk such as hypertension and smoking. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Patients should be on a lipid-lowering diet before the initiation of PARMODIA, and should continue dietary control during treatment. Serum lipid levels should be monitored periodically. If an adequate response has not been achieved, complementary or different therapeutic measures should be considered. POSOLOGY Adult The usual adult dose is 0.1 mg twice daily. The dose may be individualized according to the patient’s age and symptoms. The maximum dose is 0.2 mg twice daily. Elderly No dose adjustment is necessary. Since elderly patients often have reduced physiological function, PARMODIA should be carefully administered with close monitoring for signs of adverse reactions and clinical status of the patient. Pediatric population The safety of PARMODIA in low birth weight infants, newborns, infants, and children has not been established. No data are available. Patients with renal impairment PARMODIA should be used with caution in patients with renal impairment defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m 2 . A lower starting dose or prolonged dosing intervals should be considered. The maximum dose is 0.2 mg daily (see section 5.2). Lugege kogu dokumenti