Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nevirapine
Boehringer Ingelheim Ltd
J05AG01
Nevirapine
100mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5012816050143
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VIRAMUNE 100 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 further questions, please 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 Viramune is and what it is used for 2. What do you need to know before you take Viramune 3. How to take Viramune 4. Possible side effects 5. How to store Viramune 6. Contents of the pack and other information 1. WHAT VIRAMUNE IS AND WHAT IT IS USED FOR Viramune 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, Viramune helps control HIV-1 infection. Viramune is indicated for the treatment of HIV-1 infected adolescents and children three years and above and able to swallow tablets. You must take Viramune together with other antiretroviral medicines. Your doctor will recommend the best medicines for you. Viramune prolonged-release tablets should only be used after a two-week treatment with another type of Viramune (immediate-release tablets or suspension) unless you are currently on Viramune and are switching to the prolonged-release form. IF VIRAMUNE HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL INFORMATION IN THIS LEAFL Läs hela dokumentet
OBJECT 1 VIRAMUNE 100 MG PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 28-Nov-2017 | Boehringer Ingelheim Limited 1. Name of the medicinal product Viramune 100 mg prolonged-release tablets 2. Qualitative and quantitative composition Each prolonged-release tablet contains 100 mg of nevirapine (as anhydrous). Excipient with known effect Each prolonged-release tablet contains 100 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged-release tablet Yellow, round and biconvex prolonged-release tablets. The prolonged-release tablets are approximately 9 mm in diameter, debossed with V01 on one side and company symbol on the other side. The prolonged- release tablet should not be divided. 4. Clinical particulars 4.1 Therapeutic indications Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adolescents and children three years and above and able to swallow tablets (see section 4.2). Prolonged-release tablets 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 should be used (see section 4.2). Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1). 4.2 Posology and method of administration Viramune should be administered by physicians who are experienced in the treatment of HIV infection. Posology _Paediatric population_ Children three years and older and adolescents Viramune prolonged-release tablets may be dosed based on a patient's weight or body surface area (BSA). Lead-in dosing with Viramune 200 mg tablets or Viramune 50 mg/5 ml oral suspension (first 14 days): All paediatric patients should initiate therapy with 150 mg/m 2 (calculated using the Mosteller formula) or 4 mg/k Läs hela dokumentet