ACICLOVIR BIOGARAN 5% Cream Tube/10g

Aciclovir..................................................................................................................................................................... 5,00 g

For 100 g of cream

Excipients with known effect:

Each gram of cream contains 400 mg of propylene glycol, 7,5 mg of sodium lauryl sulfate and 67,5 mg of cetostearyl alcohol.

Treatment of primary genital herpes simplex virus infection and any 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.

• Hypersensitivity to 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 doctor regarding the treatment of any infection.

This medicine contains 400 mg of propylene glycol per gram of cream. Propylene glycol may cause skin irritation. Do not use this medicine in babies less than 4 weeks old who have open wounds or large areas of damaged or injured skin (burns) without first informing your doctor or pharmacist.

This medicine contains 7,5 mg of sodium lauryl sulfate per gram of cream. Sodium lauryl sulfate may cause local skin reactions (such as a stinging or burning sensation) or increase skin reactions caused by other products when applied to the same area.

This medicine contains cetostearyl 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 pregnancy outcomes in 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.

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

The following convention has been used for classifying adverse effects according to their frequency:

Very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10000 and < 1/1000), very rare (< 1/10000).

Data from clinical trials were used to assign frequency categories to the undesirable effects observed during clinical trials with aciclovir 3 % eye ointment.

Due to the nature of the undesirable 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 tingling 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 the 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.

No adverse effects are expected if the entire contents of a cream tube containing 500 mg of aciclovir (10 g tube) are 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 general circulation is low after cutaneous application; the plasma concentrations found after repeated applications of cream are insignificant (less than 0,01 micromoles).

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

3 years.

Store at a temperature not exceeding 25°C. Do not refrigerate.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.