Aciclovir Mylan Generics 5% 3 g cream

INDICATIONS

Aciclovir Mylan Generics cream is indicated in the treatment of Herpes simplex skin infections such as: primary or recurrent genital herpes and herpes labialis.

ACTIVE INGREDIENTS

One gram of cream contains 50 mg of acyclovir. Excipient with known effects: methyl parahydroxybenzoate. For the full list of excipients, see section 6.1.

EXCIPIENTS

Tefose 1500, glycerol, stearic acid, liquid paraffin, methyl parahydroxybenzoate, purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance, to valaciclovir or to any of the excipients listed in section 6.1.

DOSAGE

Dosage Aciclovir cream must be applied 5 times a day at intervals of approximately 4 hours. Aciclovir cream should be applied to lesions or areas where infections are developing as soon as possible after the infection has started. It is particularly important to begin treatment of recurrent episodes during the prodrome phase or at the first appearance of lesions. Treatment can also be started during the later stages (papules or vesicles). Treatment must continue for at least 4 days for herpes labialis and for 5 days for genital herpes. If there is no healing, treatment can continue for up to a maximum of 10 days.

CONSERVATION

Store at a temperature not exceeding 25°C.

WARNINGS

Aciclovir cream is not recommended for application to mucous membranes, such as those of the mouth, eyes or vagina, as it may be irritating. Particular care must be taken to avoid accidental introduction into the eyes. Animal studies indicate that application of aciclovir cream into the vagina may cause reversible irritation. In severely immunocompromised patients (e.g. AIDS patients or bone marrow transplant patients), oral administration of acyclovir should be considered. Such patients should be advised to consult their doctor regarding the treatment of any infection. The use of the product, especially if prolonged, can give rise to sensitization phenomena, where this occurs it is necessary to interrupt the treatment and consult the doctor. No phenomena of addiction or dependence on the drug have been reported. Contains methyl parahydroxybenzoate, which may cause allergic reactions (even delayed).

INTERACTIONS

No clinically significant interactions have been identified.

SIDE EFFECTS

The following convention was used for the classification of undesirable effects in terms of frequency: very common ≥1/10, common ≥1/100 and <1/10, uncommon 1/1000 and <1/100, rare ≥1/10,000 and <1/1000, very rare <1/10,000. Data from clinical trials were used to assign frequency categories to 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 unambiguously determine which events are related to the administration of the drug and which are related to the disease itself. Data from spontaneous reports were used as a basis to determine the frequency of those events observed post-marketing. Pathologies of the skin and subcutaneous tissue Uncommon: Transient burning or pain after application of aciclovir cream Moderate dryness or peeling of the skin Itching Rare: Erythema. Contact dermatitis following application. Where sensitivity tests were conducted, it was shown that the substances causing reactivity phenomena were the components of the base cream rather than acyclovir. Immune system disorders Very rare: Immediate hypersensitivity reactions including angioedema and urticaria Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system to the Italian Medicines Agency, Website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetti-reazione-avversa.

OVERDOSE

Even if the entire contents of a tube of cream containing 500 mg of aciclovir is ingested, no side effects should occur.

PREGNANCY AND BREASTFEEDING

Pregnancy The use of aciclovir cream should be considered only when the potential benefits outweigh the possibility of unknown risks. However, systemic exposure following topical application of aciclovir cream is very low. A registry on the use of aciclovir in pregnancy provided data on pregnancy outcomes in women exposed to various post-marketing formulations of aciclovir. These observations did not show an increase in the number of birth anomalies among subjects exposed to aciclovir compared to the general population. All defects found at birth did not show any unique or consistent characteristics that would suggest a common cause. Systemic administration of aciclovir, in internationally accepted conventional tests, did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In an experimental test not included in standard teratogenicity tests, in rats, fetal abnormalities were observed after subcutaneous doses of acyclovir so high as to produce toxic effects on the mother. The clinical relevance of these findings is uncertain. Breastfeeding Limited data in humans indicate that aciclovir is found in breast milk after systemic administration. However, the dose received by an infant following use of aciclovir cream by the mother should be insignificant. Fertility See clinical studies in paragraphs 5.2 and 5.3.

EFFECTS ON DRIVING ABILITY

There are no known negative effects of aciclovir cream on the ability to drive and use machines.