Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nevirapine
Boehringer Ingelheim Ltd
J05AG01
Nevirapine
200mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030100; GTIN: 5012816050006 5012816050136
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VIRAMUNE 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 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 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 adults, adolescents, and children of any age. You must take Viramune together with other antiretroviral medicines. Your doctor will recommend the best medicines for you. IF VIRAMUNE HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL INFORMATION IN THIS LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD” INSTEAD OF “YOU”). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIRAMUNE DO NOT TAKE VIRAMUNE - if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section 6 _“What Viramune Prečítajte si celý dokument
OBJECT 1 VIRAMUNE 200MG TABLETS Summary of Product Characteristics Updated 02-Oct-2018 | Boehringer Ingelheim Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Viramune 200 mg tablets 2. Qualitative and quantitative composition Each tablet contains 200 mg of nevirapine (as anhydrous). Excipient with known effect Each tablet contains 318 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet White, oval, biconvex tablets. One side is embossed with the code 54 193, with a single bisect separating the 54 and 193. The opposite side is marked with the company symbol. The score line is not intended for breaking the tablet. 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 adults, adolescents, and children of any age (see section 4.2). Most of the experience with Viramune is in combina Prečítajte si celý dokument