Aciclovir EG 5% 3 g cream

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

ACICLOVIR EG cream is indicated in the treatment of Herpes Simplex skin infections such as: primary or recurrent genital herpes and Herpes labialis.

CONTRAINDICATIONS

ACICLOVIR EG cream is contraindicated in patients with known hypersensitivity to aciclovir, valaciclovir, propylene glycol or any of the excipients listed in section 6.1.

WARNINGS AND PRECAUTIONS FOR USE

Aciclovir cream is not recommended for ophthalmic use, nor is application to the mucous membranes of the mouth or vagina as it may be irritating. Particular care should be taken to avoid accidental application into the eyes. Animal studies indicate that the application of ACICLOVIR EG cream into the vagina may cause reversible irritation. In severely immunocompromised patients (patients with AIDS or patients with bone marrow transplant) the administration of aciclovir in oral formulations should be considered. It should be recommended that such patients consult their doctor regarding the treatment of any infection. The use of the product, especially if prolonged, can give rise to sensitization phenomena, if this happens it is necessary to interrupt the treatment and consult the doctor. No phenomena of addiction or dependence on the drug have been reported. Important information about some excipients This medicine contains cetostearyl alcohol which may cause localized skin reactions (e.g. contact dermatitis). This medicine contains 7.5 mg of sodium lauryl sulphate per g of cream. Sodium lauryl sulfate may cause skin irritation (stinging or burning sensation) or intensify skin reactions caused by other medicines when applied to the same area. This medicine contains 200 mg of propylene glycol per g of cream.

INTERACTIONS

No clinically significant interactions have been identified.

SIDE EFFECTS

The following convention was used for the classification of side 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. To assign frequency categories to the adverse reactions observed during clinical studies on the use of aciclovir cream, data from these clinical studies were used. 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 detected by post-marketing pharmacovigilance. Pathologies of the skin and subcutaneous tissue. Uncommon: Transient burning or pain after application of aciclovir cream. Moderate dryness and flaking of the skin. Itching. Rare: Erythema. Contact dermatitis after application. Where sensitivity tests had been conducted, it was demonstrated that the substances causing reactivity phenomena were the components of the base cream rather than aciclovir. 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 reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.