Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LAMIVUDINE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
LAMIVUDINE
28Tablet Tablets
Delpharm Poznan Spolka Akcyjna
Consumer Medication Information Leaflet (RiMUP) ZEFFIX TABLET Lamivudine (100 mg) 1 What is in this leaflet 1. What ZEFFIX is used for 2. How ZEFFIX works 3. Before you use ZEFFIX 4. How to use ZEFFIX 5. While you are using it 6. Side Effects 7. Storage and Disposal of ZEFFIX 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision What ZEFFIX is used for Zeffix is used to treat hepatitis B for individuals more than 16 years old. How ZEFFIX works Zeffix is a type of medicine known as an antiviral. It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs). Zeffix does not completely cure hepatitis B infection; it reduces the amount of virus in your body, and keeps it at a low level. However, this may stop your hepatitis B disease progressing and causing serious damage to your liver. Not everyone responds to treatment with Zeffix in the same way. Your doctor will monitor the effectiveness of your treatment. Before you use ZEFFIX - When you must not use it Do not take Zeffix if you are allergic (hypersensitive) to lamivudine or any of the other ingredients of Zeffix. Check with your doctor if you think this applies to you. - Before you start to use it Your doctor needs to know: if you have ever had kidney disease if you are taking medications for the treatment of HIV infection Check with your doctor if you think any of these may apply to you. Your doctor may need to adjust your dose, or Zeffix may not be suitable for you. Pregnancy and breast-feeding If you are pregnant or think you could be, or if you are planning to become pregnant: Talk to your doctor about the risks and benefits of taking Zeffix Zeffix can pass into breast milk. If you are breast-feeding, you must check with your doctor before you take Zeffix. - Taking other medicines Tell your doctor or pharmacist if you are taking any other medicines, if you have taken any recently, or if you start taking new ones. This includes medicines bought without a prescripti Baca dokumen lengkapnya
CONFIDENTIAL 1 [GSK LOGO] ZEFFIX LAMIVUDINE (HEPATITIS B) QUALITATIVE AND QUANTITATIVE COMPOSITION Lamivudine 100 mg _ZEFFIX _ tablets are butterscotch-coloured, film-coated, capsule-shaped, biconvex with 'GX CG5' engraved on the upper tablet face. CLINICAL INFORMATION INDICATIONS _ _ _ZEFFIX _ is indicated for the treatment of patients ≥ 16 years of age with chronic hepatitis B and evidence of hepatitis B virus (HBV) replication. DOSAGE AND ADMINISTRATION Pharmaceutical Form Film-coated tablets The recommended dosage of _ZEFFIX _ is 100 mg once daily. _ZEFFIX _ can be taken with or without food. Patient compliance should be monitored while on _ZEFFIX _ therapy. Discontinuation of _ZEFFIX _ may be considered in immunocompetent patients when HBeAg and/or HBsAg seroconversion occurs. Discontinuation may also be considered when loss of efficacy occurs, as indicated by recurrent signs of hepatitis. If _ZEFFIX _ is discontinued, patients should be periodically monitored for evidence of recurrent hepatitis ( _see Warnings and Precautions_ ). Discontinuation of treatment is not recommended in patients with decompensated liver disease. There are limited data regarding the maintenance of seroconversion long term after stopping treatment with _ZEFFIX_ . _ZEFFIX _ should be used in accordance with available official recommendations. CONFIDENTIAL 2 POPULATIONS • RENAL IMPAIRMENT Lamivudine serum concentrations (AUC) are increased in patients with moderate to severe renal impairment due to decreased renal clearance. The dosage should therefore be reduced for patients with a creatinine clearance of less than 50 ml/min. Data available in patients undergoing intermittent haemodialysis (less than or equal to 4 hours dialysis 2 to 3 times weekly), indicate that following the initial dosage reduction of _ZEFFIX _ to correct for the patient's creatinine clearance, no further dosage adjustments are required while undergoing dialysis. • HEPATIC IMPAIRMENT Data obtained in patients with hepatic impairment, including those with en Baca dokumen lengkapnya