The need to supplement the instructions for the use of medicinal products with the following information is revealed:
1. Bring the text of the sections of the instruction "Pharmacological properties", "Indications for use" in accordance with the current instruction for use on the drug Zovirax®, registered in the Russian Federation, presented on the portal of GRLS in the appropriate dosage form.
2. In the section "Contraindications" it is recommended to delete "The drug is contraindicated during lactation."
3. The section "With caution" is recommended to present in the following edition "pregnancy, the period of breastfeeding, old age, renal failure, dehydration, simultaneous use with other nephrotoxic drugs."
4. Bring the text of the section of the instruction "Method of administration and dose" in accordance with the current instruction for use with the Zovirax® medication, registered in the Russian Federation, presented on the portal of the GRLS in the appropriate dosage form.The title of the subsection "Prevention of recurrence of infection, caused by the herpes simplex virus "correct for" Prevention recurrence of infection due to herpes simplex virus in patients with normal immune status. "In the subsection" Treatment of varicella and herpes zoster "it is recommended to add information that treatment of herpes zoster should be started as soon as possible after the appearance of rashes, since in this case the treatment will be more effective, and also that the treatment of varicella in patients with normal immune status should begin within 24 hours of the onset of the rash.
5. Bring the text of the section of the instruction "Application during pregnancy and during breastfeeding" in accordance with the current instruction for use on the drug Zovirax®, registered in the Russian Federation, presented on the portal of GRLS in the appropriate dosage form. In this section, it is recommended to add information on the effect on fertility.
6. In the "Side effect" section, "From the side of the urinary system," it is recommended to present in the following edition "Rarely: increasethe concentration of urea and creatinine in the blood serum; Very rarely: acute renal failure, renal colic. Renal colic may be associated with renal insufficiency and crystalluria. "
7. The section "Overdose" is recommended to be presented in the following edition "Symptoms. Acyclovir only partially absorbed in the gastrointestinal tract. At a random single dose of acyclovir in a dose of up to 20 g toxic effects are not recorded. When repeated doses within several days of doses exceeding the recommended dose, there were violations of the gastrointestinal tract (nausea, vomiting) and the nervous system (headache and confusion). Treatment. Symptomatic. Patients need careful medical supervision to identify possible symptoms of intoxication. Acyclovir is eliminated from the body by hemodialysis, so hemodialysis can be used in the treatment of overdose. "
8. In the section "Interaction with other drugs" it is necessary to add information that acyclovir enhances AUC theophylline by approximately 50% with simultaneous admission and that it is recommended to measure plasma concentrations of theophylline while concomitant administration of acyclovir.
9. In the section "Special instructions" add "Because acyclovir is excreted by the kidneys, correction of the dose of the drug in patients with impaired renal function is necessary (see section "Method of administration and dose"). In elderly patients, renal dysfunction may be observed, therefore dose adjustment is necessary in this category of patients. "Long or repeated courses of treatment with acyclovir in patients with severe immunodeficiency can lead to the appearance of strains of the virus with reduced sensitivity to acyclovir that do not respond to the continuation of therapy acyclovir "," Available data from clinical studies are not sufficient to conclude that the use of acyclovir reduces the risk of chickenpox from them unokompetentnyh patients "," The risk of kidney failure is increased by concomitant use of other nephrotoxic drugs. "
10. The section "Influence on the ability to drive vehicles and mechanisms" is recommended to be presented in the following edition of "Studies of the effect of acyclovir on the ability to drive vehicles or mechanisms have not been carried out.It is not possible to predict the adverse effect of acyclovir on these activities on the basis of the pharmacological properties of the active substance, but it is necessary to take into account the side effects profile of acyclovir. "