Acyclovir 5% - cream for the treatment of herpes labialis 3 g

 

Store at a temperature not exceeding 25 degrees C. Do not refrigerate.

 

Use only for cold sores on the lips. The medicine is not for ophthalmic use, nor is it recommended for application to the mucous membranes of the mouth, eyes, or nose, as it may cause irritation. The product should not be used in the treatment of genital herpes. Particular care should be taken to avoid accidental application to the eyes. Use of the product, especially if prolonged, may result in sensitization. If this occurs, treatment should be discontinued. No signs of habituation or dependence on the drug have been reported. It is recommended that people with particularly severe forms of recurrent cold sores consult their doctor. Those suffering from cold sores should avoid transmitting the virus, especially when active lesions are present. Safety and efficacy have not been studied in patients with compromised immune systems; therefore, use is not recommended in severely immunocompromised patients (AIDS patients or bone marrow transplant patients). In these patients, oral acyclovir administration should be considered. Furthermore, it is recommended that these patients consult their doctor regarding the treatment of any infection. The methyl-parahydroxybenzoate contained in the medicine can cause allergic reactions (even delayed).

 

You should not apply other types of dermatological products (such as cosmetics, sunscreens, cocoa butter) or drugs that treat herpes at the same time as the medicine. No clinically significant interactions have been identified.

 

The following convention has been used for the classification of undesirable effects in terms of frequency: very common (>=1/10), common (>=1/100 and <1/10), uncommon (>=1/1,000 and <1/100), rare (>=1/10,000 and <1/1,000), very rare (<1/10,000). Data from clinical trials have been used to assign frequency categories to the adverse reactions observed during clinical trials with aciclovir 3% ophthalmic ointment. Due to the nature of the adverse events observed, it is not possible to determine unequivocally which events were related to the administration of the drug and which were related to the disease. Data from spontaneous reports have been used as the basis for assigning frequencies for those events from post-marketing observation. >>Skin and subcutaneous tissue disorders. Uncommon: transient burning or stinging after application, moderate dryness, skin peeling, and itching; rare: erythema, contact dermatitis following application. Where sensitivity testing has been conducted, the reactivity phenomena have been shown to be related to the components of the cream rather than to aciclovir. >>Immune system disorders. Very rare: immediate hypersensitivity reactions including angioedema and urticaria.

 

>>Pregnancy. Use should be considered only when the potential benefits outweigh the possibility of unknown risks; however, systemic exposure to acyclovir following topical application of acyclovir cream is very low. A post-marketing registry of acyclovir use during pregnancy has provided data on pregnancy outcomes in women exposed to various acyclovir formulations. These observations have not shown an increase in the number of birth defects among subjects exposed to acyclovir compared to the general population, and all birth defects observed did not show any unique or common characteristics that would suggest a single cause. In conventional, internationally accepted tests, systemic administration of acyclovir did not produce embryotoxic or teratogenic effects in rabbits, rats, or mice. In an experimental trial not included in classical teratogenicity tests, fetal abnormalities were observed after subcutaneous doses of acyclovir high enough to produce toxic effects in the mother. The clinical relevance of these findings is uncertain. >>Breastfeeding. Limited data indicate that the drug is found in breast milk following systemic administration. However, the dose received by a nursing infant following maternal use of aciclovir cream is expected to be insignificant.

 

3g tube.