Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cobicistat
Gilead Sciences International Ltd
V03AX03
Cobicistat
150mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030100; GTIN: 5391507140876
1 B. PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TYBOST 150 MG FILM-COATED TABLETS Cobicistat This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Tybost is and what it is used for 2. What you need to know before you take Tybost 3. How to take Tybost 4. Possible side effects 5. How to store Tybost 6. Contents of the pack and other information 1. WHAT TYBOST IS AND WHAT IT IS USED FOR Tybost contains the active substance cobicistat. Tybost is used in adults aged 18 years and over to treat infection with HIV (human immunodeficiency virus). It is TAKEN WITH ATAZANAVIR OR DARUNAVIR (both protease inhibitors) and acts as a BOOSTER (_pharmacokinetic enhancer_) to help improve their effect. TYBOST DOES NOT DIRECTLY TREAT YOUR HIV, BUT BOOSTS THE LEVELS OF ATAZANAVIR AND DARUNAVIR in the blood. It does this by slowing down the breakdown of atazanavir and darunavir which will make them stay in the body for longer. This medicine is not a cure for HIV infection. While taking Tybost you may still develop infections or other illnesses associated with HIV infection. You can also pass on the virus to others, so it is important to take precautions to avoid infecting other people. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TYBOST DO NOT TAKE TYBOST IF YOU ARE ALLERGIC TO C Læs hele dokumentet
OBJECT 1 TYBOST 150MG FILM COATED TABLET Summary of Product Characteristics Updated 15-Jun-2018 | Gilead Sciences Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Tybost 150 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 150 mg of cobicistat. Excipient(s) with known effect Each tablet contains 59 micrograms sunset yellow FCF (E110). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet (tablet). Orange, round, biconvex, film-coated tablet of diameter 10.3 mm, debossed with “GSI” on one side of the tablet and plain-faced on the other side of the tablet. 4. Clinical particulars 4.1 Therapeutic indications Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults. See sections 4.2, 4.4, 5.1 and 5.2. 4.2 Posology and method of administration Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Tybost is used in combination with atazanavir or darunavir, therefore the atazanavir or darunavir Summary of Product Characteristics should be consulted. Tybost must be co-administered with atazanavir or darunavir, taken orally, once daily with food. The doses of Tybost and the co-administered protease inhibitor, atazanavir or darunavir, are presented in Table 1. TABLE 1: DOSING REGIMENS DOSE OF TYBOST DOSE OF HIV-1 PROTEASE INHIBITOR 150 mg once daily Atazanavir 300 mg once daily Darunavir 800 mg once daily If the patient misses a dose of Tybost within 12 hours of the time it is usually taken, the patient should take Tybost with food as soon as possible and resume their normal dosing schedule Læs hele dokumentet