It was found necessary to supplement the instructions for the use of medicinal products with the following information:
1. In the subsection "Pharmacokinetics" it is recommended to add information about the effect of sex and age on the pharmacokinetics of the drug.
2. In the section "Application during pregnancy and during breastfeeding" it is recommended to add information on contraception, the effect on fertility.
3. In the section "Method of administration and dose" it is recommended to add information on the algorithm of actions in case of skipping of the drug, according to the features of admission in elderly patients.
4. In the "Side effect" section, it is recommended to add information on the most frequent adverse events recorded during clinical trials, for the most serious adverse events recorded during post-marketing monitoring, and also for describing certain adverse reactions.
5. In the section "Interaction with other medicinal products" it is recommended to update the information, including adding information on the interaction with zidovudine, lopinavir / ritonavir in a liquid dosage form, norethindrone; Update information on interactions with atazanavir / ritonavir, saquinavir / ritonavir. Add information about the effects of certain drugs on nevirapine metabolites.
6. In the section "Special instructions" it is recommended to update the information, including adding information on the frequency of monitoring the liver before and during treatment, information on the risk of developing granulocytopenia when combined with zidovudine. It is recommended to add the subsection "Liver diseases", which, including information about patients with chronic hepatitis B and C and patients who already have liver function disorders. Add a subsection "Weight and Metabolic Parameters" and indicate the relevant information therein.