País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Emtricitabine; Tenofovir disoproxil fumarate
Tillomed Pharma GmbH
J05AR; J05AR03
Emtricitabine; Tenofovir disoproxil fumarate
200/245 milligram(s)
Film-coated tablet
Antivirals for treatment of HIV infections, combinations; tenofovir disoproxil and emtricitabine
Not marketed
2020-10-02
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EMTRICITABINE/TENOFOVIR DISOPROXIL TILLOMED 200 MG/245 MG FILM-COATED TABLETS Emtricitabine/tenofovir disoproxil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Emtricitabine/Tenofovir disoproxil is and what it is used for 2. What you need to know before you take Emtricitabine/Tenofovir disoproxil 3. How to take Emtricitabine/Tenofovir disoproxil 4. Possible side effects 5. How to store Emtricitabine/Tenofovir disoproxil 6. Contents of the pack and other information 1. WHAT EMTRICITABINE/TENOFOVIR DISOPROXIL IS AND WHAT IT IS USED FOR Emtricitabine/Tenofovir disoproxil 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. • Emtricitabine/Tenofovir disoproxil is used to treat Human Immunodeficiency Virus 1 (HIV-1) infection in adults • IT IS ALSO USED TO TREAT HIV IN ADOLESCENTS AGED 12 TO LESS THAN 18 YEARS WHO WEIGH AT LEAST 35 KG, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects. o Emtricitabine/Tenofovir disoproxil should always be used combined with other Llegiu el document complet
Health Products Regulatory Authority 23 January 2023 CRN00D780 Page 1 of 32 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Emtricitabine/Tenofovir disoproxil Tillomed 200 mg/245 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir). Excipient with known effect: each film-coated tablet contains 0.76 mg of soya lecithin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off white, modified capsule shaped, film-coated tablets, debossed with "EM" on one side and "144" on other side of the tablet. The dimensions of the tablet are approximately 19.20 mm x 9.70 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Treatment of HIV-1 infection:_ Emtricitabine/Tenofovir disoproxil is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1). Emtricitabine/Tenofovir disoproxil is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents (see sections 4.2, 4.4 and 5.1). _Pre-exposure prophylaxis (PrEP):_ Emtricitabine/Tenofovir disoproxil is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Emtricitabine/Tenofovir disoproxil should be initiated by a physician experienced in the management of HIV infection. Posology Treatment _of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg: _One tablet, once daily. _ _ _Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg: _One tablet, once daily. Separate preparations of emtricitabine and tenofovir disoproxil are available for treatment of H Llegiu el document complet