Land: Malta
Tungumál: enska
Heimild: Medicines Authority
RITONAVIR
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
J05AE03
RITONAVIR 100 mg
FILM-COATED TABLET
RITONAVIR 100 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Withdrawn
2017-08-18
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER RITONAVIR ACCORD 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 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 Ritonavir Accord is and what it is used for 2. What you need to know before you or your child takes Ritonavir Accord 3. How to take Ritonavir Accord 4. Possible side effects 5. How to store Ritonavir Accord 6. Contents of the pack and other information 1. WHAT RITONAVIR ACCORD IS AND WHAT IT IS USED FOR Ritonavir Accord 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 Accord 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 ACCORD DO NOT TAKE RITONAVIR ACCORD - 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 (us Lestu allt skjalið
Page 1 of 35 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ritonavir Accord 100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablets contains 100 mg of ritonavir. For the Full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off white, capsule shaped, film-coated tablets, with a dimension of approx. 17.1 mm in length and 9.1 mm in width, debossed with 'H' on one side and 'R9' on 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 should be administered by physicians who are experienced in the treatment of HIV infection. Ritonavir Accord film-coated tablets are administered orally and should be ingested with food (see section 5.2). Ritonavir Accord film-coated tablets should be swallowed whole and not chewed, broken or crushed. Posology _Ritonavir dosed as a pharmacokinetic enhancer_ When ritonavir is used as a pharmacokinetic enhancer with other protease inhibitors (PI) the Summary of Product Characteristics (SmPC) 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 Page 2 of 35 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 1000 mg twice daily with ritonavir 100 mg twice daily in ART experienced patients. Initiate treatment with saquinavir 500 mg twice daily with ritonavir 100 mg twice daily for the first 7 days, then saquinavir 1000 mg twice daily with ritonavir 100 mg twice daily in ART-naïve patien Lestu allt skjalið