Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
ritonavir
Mylan S.A.S
J05AE03
ritonavir
Antivirals for systemic use
HIV Infections
Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV 1 infected patients (adults and children of 2 years of age and older).
Revision: 14
Authorised
2017-11-09
52 B. PACKAGE LEAFLET 53 PACKAGE LEAFLET: INFORMATION FOR THE USER RITONAVIR MYLAN 100 MG FILM-COATED TABLETS ritonavir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU OR YOUR CHILD. - 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. 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 Ritonavir Mylan is and what it is used for 2. What you need to know before you or your child takes Ritonavir Mylan 3. How to take Ritonavir Mylan 4. Possible side effects 5. How to store Ritonavir Mylan 6. Contents of the pack and other information 1. WHAT RITONAVIR MYLAN IS AND WHAT IT IS USED FOR Ritonavir Mylan contains the active substance ritonavir. Ritonavir is a protease inhibitor used to control HIV infection. Ritonavir is used in combination with other anti-HIV medicines (antiretrovirals) to control your HIV infection. Your doctor will discuss with you the best combination of medicines for you. Ritonavir Mylan is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS. 2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD TAKES RITONAVIR MYLAN DO NOT TAKE RITONAVIR MYLAN - if you are allergic to ritonavir or any of the other ingredients of this medicine (see section 6). - if you have severe liver disease. - if you are currently taking any of the following medicines: - astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available without prescription); - amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine (used to correct irregular heartbeats); - dihydroergotamine, ergotamine (used to Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ritonavir Mylan 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of ritonavir. Excipient with known effect Each film-coated tablet contains 87.75 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Yellow, capsule shaped, biconvex, beveled edge film-coated tablet, approximately 19.1 mm x 10.2 mm, debossed with ‘M163’ on one side and blank on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infected patients (adults and children of 2 years of age and older). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ritonavir Mylan should be administered by physicians who are experienced in the treatment of HIV infection. Posology _ _ _Ritonavir dosed as a pharmacokinetic enhancer _ When ritonavir is used as a pharmacokinetic enhancer with other protease inhibitors the Summary of Product Characteristics for the particular protease inhibitor must be consulted. The following HIV-1 protease inhibitors have been approved for use with ritonavir as a pharmacokinetic enhancer at the noted doses. _ _ _Adults _ Amprenavir 600 mg twice daily with ritonavir 100 mg twice daily. Atazanavir 300 mg once daily with ritonavir 100 mg once daily. Fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily. Lopinavir co-formulated with ritonavir (lopinavir/ritonavir) 400 mg/100 mg or 800 mg/200 mg. Saquinavir 1,000 mg twice daily with ritonavir 100 mg twice daily in antiretroviral treatment (ART) experienced patients. Initiate treatment with saquinavir 500 mg twice daily with ritonavir 100 mg twice daily for the first 7 days, then saquinavir 1,000 mg twice daily with ritonavir 100 mg twice daily in ART-naïve patients. Tipranavir 500 mg twice daily with ritonavir 200 mg twice daily. Tipranavir with ritonavir should not be used in tr Aqra d-dokument sħiħ