ACICLOVIR BIOGARAN CONSEIL 5 % Cr T/2g

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

For 100 g of cream.

Excipients with known effect: propylene glycol, cetyl alcohol.

ACICLOVIR BIOGARAN CONSEIL is indicated for the treatment of outbreaks of localised herpes labialis (also called "cold sores") in adults and children over 6 years of age.

Dosage

Apply the cream 5 times daily to herpetic lesions located exclusively on the lips, each application being spaced at least 3 to 4 hours apart and without nighttime application. It is recommended to apply the cream extending well beyond the lesions.

Treatment is more effective if started at the first symptoms announcing an outbreak of herpes labialis.

The duration of treatment must not exceed 5 days, without medical advice. Wash hands thoroughly before and after applying the cream to the lesion.

Paediatric population

ACICLOVIR BIOGARAN CONSEIL must not be used in children under 6 years of age.

Method of administration

Cutaneous use.

• Hypersensitivity to aciclovir, to valaciclovir or to any of the excipients listed in section Composition including propylene glycol;
• child under 6 years of age.

Aciclovir cream is not recommended for application to mucous membranes such as those of the mouth, eye and vagina as it may be irritant. Precautions should be taken to avoid accidental introduction of the cream into the eye.

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 should consult a doctor regarding treatment of any infection.

This medicine contains 150 mg of propylene glycol per 1 g of cream. Propylene glycol may cause skin irritation.

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

No clinically significant interaction has been identified.

Pregnancy

Analysis of about a thousand pregnancies exposed to aciclovir revealed no particular malformative or foetotoxic effect of aciclovir.

Consequently, use of aciclovir by the cutaneous route is possible in pregnant women within the scope of the indications.

Breast-feeding

If the maternal condition permits, breastfeeding is possible during treatment with this medicine.

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 (≥ 1/1 000 and < 1/100), rare (≥ 1/10 000 and < 1/1 000), very rare (< 1/10 000).

Data from clinical trials were used to assign frequency categories to adverse effects observed during clinical trials with aciclovir at 3 % in ophthalmic 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 stinging or burning sensations, skin dryness, skin desquamation 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 disorder

Very rare: Immediate hypersensitivity reactions including cases of Quincke's oedema and urticaria.

Reporting of suspected adverse reactions

Reporting suspected adverse effects after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse effects via the national reporting system: Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.signalement-sante.gouv.fr.

No adverse effects are expected if the entire content of a cream tube (tube of 2 g) is ingested orally.

Pharmacotherapeutic class: ANTIVIRALS, ATC code: D06BB03.

Aciclovir itself is a pharmacodynamically inactive compound. After penetration into cells infected by herpes simplex virus (HSV), aciclovir is converted into its active form, aciclovir triphosphate.

This conversion is catalysed by HSV thymidine kinase, an enzyme essential for viral replication. HSV thus ensures the synthesis of its own antiviral agent. The affinity of aciclovir for viral DNA polymerase is 10-20 times higher than its affinity for cellular DNA polymerase.

Aciclovir thus selectively inhibits viral enzymatic activity. Viral DNA polymerase incorporates aciclovir into viral DNA.

Aciclovir lacks a 3'-hydroxyl group; as a result, no other nucleotide can be added by formation of 3'-5' bonds, which causes chain termination and therefore effective reduction of viral replication.

Both herpes simplex virus species, type 1 and type 2, are highly sensitive to aciclovir.

In profoundly immunocompromised patients, prolonged or repeated treatment with aciclovir may lead to the selection of viral strains with reduced sensitivity.

Consequently, these patients will no longer respond to aciclovir treatment.

Aciclovir penetrates the skin. At steady state, intradermal aciclovir concentrations are above the tissue minimum inhibitory concentration. Aciclovir is not detectable in blood after application to the skin. The results reported below concern oral or intravenous administration.

The main metabolite is 9-(carboxymethoxymethyl) guanine. It represents 10 to 15 % of the medicinal product excreted via the renal route. The majority of the amount of aciclovir reaching plasma is eliminated unchanged by the kidneys (both by glomerular filtration and tubular excretion).

The plasma half-life of aciclovir in patients with normal renal function is approximately 3 hours. Binding to plasma proteins is relatively low (9-33 %). Interactions through displacement from protein binding sites are therefore unlikely.

A large number of in vitro tests have shown that chromosomal damage is possible at very high doses. In in vivo studies, chromosomal damage was not observed. Long-term studies in rats and mice did not reveal any carcinogenic effect of aciclovir. In standardised tests according to international standards, systemic administration of aciclovir to different animal species did not produce embryotoxic or teratogenic effects. In a non-standardised test in rats, effects on the foetus were observed only at very high doses that also caused maternal toxicity.

2 years.

Store at a temperature between 15°C and 25°C.

No special requirements.