Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Nevirapine anhydrous
Wockhardt UK Limited
J05AG; J05AG01
Nevirapine anhydrous
200 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Non-nucleoside reverse transcriptase inhibitors; nevirapine
Not marketed
2014-05-16
Nevirapine 200mg Tablets 1.3 Product Information Wockhardt UK Ltd Page 2 April 2014 PACKAGE LEAFLET: INFORMATION FOR THE USER [Product Name] 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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. _{The name of this medicine is Nevirapine 200 mg Tablets. In the rest of this leaflet _ _it will be called Nevirapine Tablets.} (IE AND UK ONLY) _ WHAT IS IN THIS LEAFLET: 1. What [Product Name] are and what they are used for 2. What you need to know before you take [Product Name] 3. How to take [Product Name] 4. Possible side effects 5. How to store [Product Name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] ARE AND WHAT THEY ARE USED FOR [Product Name] 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, [Product Name] helps control HIV-1 infection. [Product Name] is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age. You must take [Product Name] together with other antiretroviral medicines. Your doctor will recommend the best medicines for you. IF [PRODUCT NAME] HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL Прочетете целия документ
Health Products Regulatory Authority 12 June 2019 CRN00943V Page 1 of 29 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nevirapine 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of anhydrous nevirapine. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Off-white to pale yellow coloured, capsule shaped, biconvex tablets, debossed with ‘H’ on one side and ‘7’ on the other side with breakline on both sides. The tablets are approximately 14.7mm in length and 5.7mm in width. 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 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 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 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 recognized 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. _Dose management considerations_ Patients experiencing rash during the 14-day lead-in period of 200 mg/day should not have their Nevirapine dose increased until the ra Прочетете целия документ