Land: Sydafrika
Sprog: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Cipla Medpro (Pty) Ltd
200,0 mg, 25,0 mg & 25,0 mg
TABLET
EACH TABLET CONTAINS EMTRICITABINE 200,0 mg RILPIVIRINE HYDROCHLORIDE EQUIVALENT TO RILPIVIRINE 25,0 mg TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25,0 mg
Registered
Cipla Medpro (Pty) Ltd. Page 1 of 11 PATIENT INFORMATION LEAFLET FOR TALIPHIO SCHEDULING STATUS: TALIPHIO 200/25/25 MG, FILM-COATED TABLETS EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE AND TENOFOVIR ALAFENAMIDE FUMARATE CONTAINS SUGAR: 411,055 MG ANHYDROUS LACTOSE AND 129,450 MG LACTOSE MONOHYDRATE. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING TALIPHIO • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet (see section 4). • TALIPHIO has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET: 1. What TALIPHIO is and what is used for 2. What you need to know before you take TALIPHIO 3. How to take TALIPHIO 4. Possible side effects S4 Cipla Medpro (Pty) Ltd. Page 2 of 11 5. How to store TALIPHIO 6. Contents of the pack and other information. 1. WHAT TALIPHIO IS AND WHAT IT IS USED FOR TALIPHIO is indicated in combination with other antiretroviral medicines for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TALIPHIO DO NOT TAKE TALIPHIO: • if you are hypersensitive (allergic) to emtricitabine, rilpivirine, tenofovir alafenamide or any of the other ingredients of TALIPHIO (listed in section 6) • in combination with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, dexamethasone (except as a single dose treatment) rifabutin, rifampicin, rifapentine, St. John’s Wort, proton-pump inhibitors (PPIs) such as lansoprazole, dexlansoprazole, omeprazole, rabeprazole, pantoprazole and esomeprazole as co-administration may result in loss of therapeutic effect of TALIPHIO. WARNINGS AND PRECAUTIONS Special care should be taken with TALIPHIO: • if you have pain i Læs hele dokumentet
Cipla Medpro (Pty) Ltd. Page 1 of 60 PROFESSIONAL INFORMATION TALIPHIO SCHEDULING STATUS S4 1. NAME OF THE MEDICINE TALIPHIO (200/25/25 mg, film-coated tablets) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg emtricitabine, rilpivirine hydrochloride equivalent to 25 mg rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg tenofovir alafenamide. Contains sugar: 411,055 mg anhydrous lactose and 129,450 mg lactose monohydrate per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Pink coloured, capsule shaped biconvex film-coated tablets plain on both sides. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS TALIPHIO is indicated in combination with other antiretroviral medicines for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) (see sections 4.2 and 5.1). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Cipla Medpro (Pty) Ltd. Page 2 of 60 POSOLOGY Adults, weighing at least 35 kg. The recommended dose is one TALIPHIO tablet once a day with food. SPECIAL POPULATIONS _Elderly patients _ No dose adjustment of TALIPHIO is required in elderly patients. _ _ _Paediatric population _ The safety and efficacy of TALIPHIO in children younger than 12 years of age, or weighing < 35 kg, have not been established. No data is available. _ _ _Renal impairment _ No dose adjustment of TALIPHIO is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min. TALIPHIO should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see sections 4.4 and 5.2). No dose adjustment of TALIPHIO is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, TALIPHIO should generally be avoided but may be used in these patients (see sections 4.4 and 5.2). On days of haemodialysis, TALIPHIO should be administered after completion of haemod Læs hele dokumentet