Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
NEVIRAPINE, ANHYDROUS
Accord Healthcare Limited
J05AG01
NEVIRAPINE, ANHYDROUS
PROLONGED-RELEASE TABLET
NEVIRAPINE, ANHYDROUS 400 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Authorised
1 PACKAGE LEAFLET: INFORMATION FOR THE USER NEVIRAPINE ACCORD 400 MG PROLONGED-RELEASE 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. - 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 Nevirapine Accord is and what it is used for 2. What you need to know before you take Nevirapine Accord 3. How to take Nevirapine Accord 4. Possible side effects 5. How to store Nevirapine Accord 6. Contents of the pack and other information 1. WHAT NEVIRAPINE ACCORD IS AND WHAT IT IS USED FOR Nevirapine Accord 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 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 Accord helps control HIV-1 infection. Nevirapine is indicated for the treatment of HIV-1 infected adults, adolescents and children three years and above and able to swallow tablets. You must take nevirapine together with other antiretroviral medicines. Your doctor will recommend the best medicines for you. Nevirapine Accord should only be used after a two-week treatment with another type of nevirapine medicine (immediate-release tablets or suspension), unless you are currently on these medicines and are switching to the prolonged-release form. 2. WHAT YOU Baca dokumen lengkap
1 1. NAME OF THE MEDICINAL PRODUCT Nevirapine Accord 400 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 400 mg of nevirapine (as anhydrous). Excipient with known effect: each prolonged-release tablet contains 375 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet White to off-white oval shaped, approx. 9.3 x 19.2 mm, biconvex tablets debossed with ‘H’ on one side and ‘N1’ on other side. The prolonged release tablet should not be divided. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nevirapine is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children three years and above and able to swallow tablets (see section 4.2). Nevirapine Accord are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension , may be checked for their availability and used accordingly (see section 4.2). 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 Accord should be administered by physicians who are experienced in the treatment of HIV infection. Posology _Adults _ The recommended dose of nevirapine for patients initiating nevirapine therapy is one 200 mg immediate-release 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 400 mg prolonged-release tablet once daily, in combination with at least two additional antiretroviral agents. Patients currently on a nevirapine immediate-release twice daily regimen: Page 2 of 30 Patients already on a regimen of nevirapin Baca dokumen lengkap