ACICLOVIR VIATRIS 5 % Cr T/10g

Aciclovir................................................................................................................................................................5 g

For 100 g of cream.

Excipients with known effect: propylene glycol, cetyl alcohol.

Treatment of primary genital herpes simplex virus infection and possible subsequent recurrences.

Because of its mode of action, aciclovir does not eradicate latent viruses. After treatment, the patient will therefore remain exposed to the same frequency of recurrence as before.

Dosage

5 applications per day.

Treatment should be started as early as possible, at the first signs of infection.

Treatment must be continued for at least 5 days. The duration of treatment must not exceed 10 days.

Paediatric population

Not applicable.

Method of administration

Cutaneous use.

• Hypersensitivity to the active substance (aciclovir), to valaciclovir, to propylene glycol or to any of the excipients listed in section Composition.

Ocular, intraoral or intravaginal application of the cream is not recommended due to the risk of irritation.

For severely immunocompromised patients (for example, patients with AIDS or patients who have undergone bone marrow transplantation), oral administration of aciclovir should be considered. These patients are advised to consult a physician regarding the treatment of any infection.

Excipients

This medicine contains 15 g of propylene glycol per 100 g of cream and may cause skin irritation.

Do not use this medicine in babies under 4 weeks of age who have open wounds or large areas of damaged or injured skin (burns) without first informing your doctor or pharmacist.

This medicine contains cetyl alcohol and may cause local skin reactions (for example, contact dermatitis).

No clinically significant interaction has been identified.

Pregnancy

The use of aciclovir during pregnancy should only be considered if the expected benefits outweigh the potential risks. However, systemic absorption of aciclovir following topical application of the cream is very low.

A post-marketing pregnancy registry has documented the pregnancy outcomes of women exposed to aciclovir (regardless of the form used). Registry data did not show an increase in the number of malformations in women exposed to aciclovir compared with the general population. No malformation showed an exceptional or recurrent character suggesting a common cause.

Systemic administration of aciclovir in standard international tests did not show embryotoxic or teratogenic effects in rabbits, rats or mice.

In a non-standard test carried out in rats, foetal abnormalities were observed but only at very high subcutaneous doses, which were also toxic to the mother. The clinical relevance of these results is uncertain.

Breast-feeding

Limited data in humans show that aciclovir passes into breast milk after systemic administration. However, the amount received by a breastfed infant after maternal use of the cream should be negligible.

Breastfeeding is possible during treatment with topical aciclovir.

Fertility

There are no data concerning effects on the ability to drive vehicles and use machines.

The following convention was used for classifying adverse effects by frequency: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10.000, < 1/1000); very rare (< 1/10.000).

Clinical trial data were used to assign frequency categories to adverse effects observed during clinical trials with aciclovir 3% ophthalmic ointment. Due to the nature of the adverse effects observed, it is not possible to determine which effects are related to administration of the medicine and which are related to the disease.

Skin and subcutaneous tissue disorders 

Uncommon: transient stinging or burning sensations may follow application of the cream, skin dryness, skin peeling or pruritus.

Rare: erythema, contact eczema after application of the cream. Sensitivity tests showed that the reactions were more often due to components of the cream than to aciclovir itself.

Immune system disorders 

Very rare: immediate hypersensitivity reactions including urticaria and Quincke's oedema.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.signalement-sante.gouv.fr.

There are no expected undesirable effects if the entire content of a cream tube containing 500 mg of aciclovir (10 g tube) is ingested orally.

Pharmacotherapeutic class: antiviral, ATC code: D06BB03.

To be active, aciclovir must be phosphorylated to aciclovir triphosphate. Only cells infected with the herpes virus can carry out this phosphorylation, thanks to a viral enzyme.

Aciclovir triphosphate selectively inhibits viral DNA polymerase. The succession of these two selective steps makes it possible to inhibit viral multiplication without interfering with normal cellular metabolism.

The passage of aciclovir into the systemic circulation is low after cutaneous application.

Plasma concentrations found after repeated applications of cream are negligible (< 0,01 μmol.).

Aciclovir is weakly bound to plasma proteins (9 to 33 %).

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

3 years

This medicine does not require any particular storage precautions.

No special requirements.