Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva, emtricitabine / tenofovir disoproxil, HIV Infections, Date of authorisation: 09/11/2016, Revision: 3, Status: Authorised

Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabine / tenofovir disoproxil) An overview of Emtricitabine/Tenofovir disoproxil Zentiva and why it is authorised in the EU What is Emtricitabine/Tenofovir disoproxil Zentiva and what is it used for?Emtricitabine/Tenofovir disoproxil Zentiva is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).In addition it may be used from the age of 12 years in adolescents with HIV that is resistant to first-line treatments or who cannot take them because of side effects.Emtricitabine/Tenofovir disoproxil Zentiva is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP).It should be used in combination with safer sex practices, such as use of condoms.Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg).It is a 'generic medicine'.This means that Emtricitabine/Tenofovir disoproxil Zentiva contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Truvada.For more information on generic medicines, see the question-and-answer document here. How is Emtricitabine/Tenofovir disoproxil Zentiva used?Emtricitabine/Tenofovir disoproxil Zentiva can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.Emtricitabine/Tenofovir disoproxil Zentiva is available as tablets.The recommended dose for treating or preventing HIV-1 infection is one tablet once a day, preferably taken with food.If patients with HIV-1 infection need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.For more information about using Emtricitabine/Tenofovir disoproxil Zentiva, see the package leaflet or contact your doctor or pharmacist.