Aciclovir EG 5% 3 g cream

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 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.

ACTIVE INGREDIENTS

1 g of cream contains: Active ingredient: acyclovir: 50 mg. Excipients with known effects: 67.5 mg of cetostearyl alcohol, 7.5 mg of sodium lauryl sulfate, 200 mg of propylene glycol (E1520). For the full list of excipients, see section 6.1.

EXCIPIENTS

Poloxamer 407; Cetostearyl alcohol; Sodium lauryl sulfate; White Vaseline; Liquid paraffin; Sucrose monopalmitate; Propylene glycol (E1520); Purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

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.

DOSAGE

ACICLOVIR EG CREMA must be applied 5 times a day at intervals of approximately 4 hours. ACICLOVIR EG cream must be applied to the lesions, or to the areas where they are developing, as soon as possible, preferably during the earliest stages (prodromes or erythema). 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 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 acyclovir 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.

OVERDOSE

Even if the entire contents of a 10 g tube of cream containing 500 mg of acyclovir are swallowed, no undesirable effects should be expected.

PREGNANCY AND BREASTFEEDING

Fertility See Clinical studies in paragraph 5.2. Pregnancy The use of aciclovir should only be considered if the potential benefits outweigh the possibility of unknown risks, however, the systemic exposure to aciclovir following topical application of aciclovir cream is very low. A post-marketing registry on the use of aciclovir in pregnancy provided data on pregnancy outcomes in women exposed to various formulations of aciclovir. These observations did not show an increase in the number of birth defects among subjects exposed to aciclovir compared to the general population and all birth defects did not show any particularity or common characteristics, such as to suggest a single cause. Systemic administration of aciclovir in internationally accepted standard tests did not produce embryonic toxicity or teratogenic effects in rabbits, rats or mice. In an experimental test in rats not included in the classic teratogenesis tests, fetal anomalies were observed after subcutaneous doses of acyclovir so high as to produce toxic effects in the mother. However, 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 an infant following the use of aciclovir cream by the mother should be insignificant.

EFFECTS ON DRIVING ABILITY

None known.