Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE
PAHANG PHARMACY SDN. BHD.
TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE
30tablet Tablets
Mylan Laboratories Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ RICOVIR-EM 200MG/300MG TABLETS Tenofovir Disoproxil Fumarate/Emtricitabine (300mg/200mg) 1 WHAT IS IN THIS LEAFLET 1. What _Ricovir-EM _ is used for 2. How _Ricovir-EM _ works 3. Before you use _Ricovir-EM_ 4. How to use _Ricovir-EM_ 5. While you are using it 6. Side Effects 7. Storage and Disposal of _Ricovir-_ _EM_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT _RICOVIR-EM _IS USED FOR _Ricovir-EM _ is indicated in combination with other antiretroviral agents for the treatment of HIV-1 in adults. _ _ HOW _RICOVIR-EM _WORKS _Ricovir-EM _ tablet contains two active substances, emtricitabine and tenofovir disoproxil. Both of these active substances are antiretroviral medicines which are used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor. However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself. BEFORE YOU USE _RICOVIR-EM _ - _When you must not use it_ Do not take _Ricovir-EM_ If you are allergic (hypersensitive) to emtricitabine, tenofovir, tenofovir disoproxil fumarate, or any of the other ingredients of _Ricovir-EM _ listed at the end of this leaflet. If this applies to you, tell your doctor immediately. - _Before you start use it_ Tell your doctor if you have had kidney disease, or if tests have shown problems with your kidneys. _Ricovir-EM _ may affect your kidneys. Before starting treatment, your doctor may order blood tests to assess kidney function. Your doctor may also order blood tests during treatment to monitor your kidneys and may advise you to take the tablets less often. _Ricovir-EM _ is not recommended if you have severe kidney disease or are receiving haemodialysis. _Ricovir-EM _ is not usually taken with other medicines that can damage your kidneys (see T read_full_document
RICOVIR-EM 200MG/300MG TABLETS LABEL CLAIM Each film coated tablet contains Emtricitabine 200mg Tenofovir disoproxil fumarate 300 mg is equivalent to 245 mg of Tenofovir Disoproxil. EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE TABLETS 200MG/ 300MG : PRODUCT DESCRIPTION : Blue colored, oval shaped, film coated tablets debossed with “M117” on one side and plain on other side THERAPEUTIC INDICATIONS RICOVIR-EM is indicated in combination with other antiretroviral agents (such as non- nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults. The following points should be considered when initiating therapy with RICOVIR EM for the treatment of HIV-1 infection: - It is not recommended that RICOVIR EM be used as a component of a triple nucleoside regimen. - RICOVIR EM should not be co-administered with Lamivudine + Tenofovir Disoproxil Fumarate + Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate or Lamivudine- containing products. In treatment experienced patients, the use of RICOVIR EM should be guided by laboratory testing and treatment history. POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. POSOLOGY The dosage of RICOVIR EM is one tablet (containing 200 mg of Emtricitabine and 300 mg of Tenofovir Disoproxil Fumarate) once daily taken orally with or without food. Dose adjustment for renal impairment significantly increased drug exposures occurred when Emtricitabine or Tenofovir Disoproxil Fumarate were administered to patients with moderate to severe renal impairment. Therefore, the dosing interval of RICOVIR EM should be adjusted in patients with baseline creatinine clearance of 30-49mL/min using the recommendations in Table 1. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated; therefore, clinical response to treatment and renal function should be closely monitored in these patients. No dose adjustment i read_full_document