Ülke: Hollanda
Dil: Hollandaca
Kaynak: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EMTRICITABINE ; TENOFOVIRDISOPROXIL
Hetero Europe S.L. Viladecans Business Park, Edificio Brasil, Catalunya 83-85 08840 VILADECANS (SPANJE)
J05AR03
EMTRICITABINE ; TENOFOVIRDISOPROXIL
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; TITAANDIOXIDE (E 171),
Oraal gebruik
Tenofovir Disoproxil And Emtricitabine
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; TITAANDIOXIDE (E 171);
2017-07-17
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EMTRICITABINE/TENOFOVIRDISOPROXIL HETERO 200/245 MG FILMOMHULDE TABLETTEN 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 or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Emtricitabine/Tenofovir disoproxil Hetero is and what it is used for 2. What you need to know before you take Emtricitabine/Tenofovir disoproxil Hetero 3. How to take Emtricitabine/Tenofovir disoproxil Hetero 4. Possible side effects 5. How to store Emtricitabine/Tenofovir disoproxil Hetero 6. Contents of the pack and other information 1. WHAT EMTRICITABINE/TENOFOVIR DISOPROXIL HETERO IS AND WHAT IT IS USED FOR Emtricitabine/Tenofovir disoproxil Hetero 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 Hetero is used to treat Human Immunodeficiency Virus 1 (HIV-1) infection, in adults aged 18 years and over. Emtricitabine/Tenofovir disoproxil Hetero should always be used combined with other medicines to treat HIV infection. Emtricitabine/Tenofovir disoproxil Hetero can be administered in place o Belgenin tamamını okuyun
Emtricitabine/Tenofovir disoproxil film-coated tablets 200/245 mg Module 1.3.1 Page 1 of 28 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET 1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Emtricitabine/Tenofovirdisoproxil Hetero 200/245 mg filmomhulde tabletten 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 136 mg of tenofovir). Excipient(s) with known effect: Each tablet contains 227.20 mg Lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Blue, capsule shaped, film-coated tablets with a dimension of approximate 19.20 mm in length and approximate 8.70 mm in width debossed with 'H' on one side and 'E29' on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Treatment of HIV-1 infection: _ Emtricitabine/Tenofovir disoproxil Hetero is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults(see section 5.1). _Pre-exposure prophylaxis (PrEP):_ Emtricitabine/Tenofovir disoproxil Hetero is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Emtricitabine/Tenofovir disoproxil Hetero should be initiated by a physician experienced in the management of HIV infection. Posology _Treatment or prevention of HIV in adults: One tablet, once daily._ _ _ Separate preparations of emtricitabine and tenofovir disoproxil are available for treatment of HIV-1 infection if it becomes necessary to discontinue or modify the dose of one of the Emtricitabine/Tenofovir disoproxil film-coated tablets 200/245 mg Module 1.3.1 Page 2 of 28 components of Emtricitabine/Tenofovir disoproxil Hetero. Please refer to the Summary of Product Characteristics for these medicinal products. If dose of Emtricitabine/Tenofovir disoproxil Hetero is missed w Belgenin tamamını okuyun