Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
NEVIRAPINE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
J05AG01
NEVIRAPINE 200 mg
TABLET
NEVIRAPINE 200 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Withdrawn
2013-05-03
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER NEVIRAPINE AUROBINDO 200 MG TABLETS Nevirapine 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 Nevirapine Aurobindo is and what it is used for 2. What you need to know before you take Nevirapine Aurobindo 3. How to take Nevirapine Aurobindo 4. Possible side effects 5. How to store Nevirapine Aurobindo 6. Contents of the pack and other information 1. WHAT NEVIRAPINE AUROBINDO IS AND WHAT IT IS USED FOR Nevirapine belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection. The active substance of your medicine is called nevirapine. Nevirapine reduces the amount of viruses in the blood thus improving your medical condition. Nevirapine belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs in order to multiply. Nevirapine stops reverse transcriptase from working. By stopping reverse transcriptase from working, Nevirapine Aurobindo helps control HIV-1 infection. Nevirapine Aurobindo is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age. You must take Nevirapine Aurobindo together with other antiretroviral medicines. Your doctor will recommend the best medicines for you. IF NEVIRAPINE AUROBINDO HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL INFORMATION IN THIS LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLE Læs hele dokumentet
Page 1 of 27 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nevirapine Aurobindo 200 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of nevirapine (as anhydrous). Excipient with known effect: Each tablet contains 340 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off-white, oval shaped, biconvex tablets, debossed with "J" and "80" on either side of break line on one side and with break line on the other side. The size is 19.2 mm X 9.3 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nevirapine Aurobindo is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age (see section 4.4.). Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nevirapine Aurobindo should be administered by physicians who are experienced in the treatment of HIV infection. Posology _Patients 16 years and older_ The recommended dose of Nevirapine Aurobindo is one 200 mg tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with at least two additional antiretroviral agents. If a dose is recognised as missed within 8 hours of when it was due, the patient should take the missed dose as soon as possible. If a dose is missed and it is more than 8 hours later, the patient should only take the next dose at the usual time. Page 2 of 27 _Dose management considerations_ Patients experiencing rash during the 14-day lead-in period of 200 mg/day should not have t Læs hele dokumentet