Aciclovir Mylan 5%

Cream

Composition :

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

Excipients

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

Therapeutic indications

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

Contraindications

Aciclovir cream is contraindicated in patients with known hypersensitivity to aciclovir, valaciclovir or to any of the excipients.

Dosage

Posology Aciclovir cream should be applied 5 times a day at approximately 4 hour intervals. Aciclovir cream should be applied to the lesions or areas where infections are developing as early as possible after the infection begins. It is especially important to start treatment for recurrent episodes during the prodrome phase or when lesions first appear. Treatment should continue for at least 5 days and up to a maximum of 10 if there is no healing.

Warnings and Precautions

Aciclovir cream is not recommended for application to mucous membranes, such as those in the mouth, eyes or vagina, as it can be irritating. Particular care should be taken to avoid accidental introduction into the eye. In severely immunocompromised patients (e.g. AIDS patients or bone marrow transplant patients) oral administration of aciclovir should be considered. Such patients should be advised to consult their physician regarding the treatment of any infection. The use, especially if prolonged of the product, can give rise to sensitization phenomena, where this happens it is necessary to interrupt the treatment and consult the attending physician. Warnings about some excipients: Methyl parahydroxybenzoate can cause allergic reactions (even delayed).

Interactions

No clinically significant interactions have been identified.

Side effects

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 1/1000 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 studies performed with aciclovir 3% ophthalmic ointment. Due to the nature of the adverse events observed, it is not possible to uniquely determine which events are related to drug administration and which are related to the disease itself. Data from spontaneous reporting was used as a basis for determining the frequency of those events observed after marketing. Skin and subcutaneous tissue disorders Uncommon: Transient burning or pain after application of aciclovir cream, moderate skin dryness or peeling, pruritus Rare: Erythema. Contact dermatitis following application. Where susceptibility tests were conducted, it was shown that the reactive substances were the components of the base cream rather than acyclovir. Immune system disorders Very rare: Immediate hypersensitivity reactions including angioedema and urticaria medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system to the Italian Medicines Agency, Website: www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Fertility See clinical studies in section 5.3. Pregnancy The use of aciclovir cream should only be considered when the potential benefits outweigh the possibility of unknown risks. However, the systemic exposure following topical application of aciclovir cream is very low. A registry of aciclovir use in pregnancy provided data on pregnancy outcomes in women exposed to the various formulations of aciclovir after marketing. These observations did not show an increase in the number of birth abnormalities among subjects exposed to aciclovir compared to the general population. All the birth defects found showed no unique or constant feature to 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 the standard teratogenic tests, fetal abnormalities were observed in rats after subcutaneous doses of aciclovir so high as to produce toxic effects on the mother. The clinical relevance of these findings is uncertain. Lactation Limited data in humans indicate that aciclovir is found in breast milk after systemic administration. However, the dose received by an infant following the use of aciclovir cream in the mother should be insignificant.