ACTIVIR 5 % Cream Tube/2g

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

For 100 g of cream.

Excipients with known effect: Propylene glycol (400 mg/g), sodium lauryl sulfate (7,5 mg/g), cetostearyl alcohol (67,5 mg/g).

ACTIVIR 5 % cream is indicated for the treatment of episodes of localised herpes labialis (also called "cold sores") in adults and children over 6 years of age.

Dosage

Cutaneous use.

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.

Paediatric population

ACTIVIR 5 % cream must not be used in children under 6 years of age.

Method of administration

Instructions for use of the pump:

It is recommended to perform at least 3 to 4 slow and complete presses, so as to fully prime the pumping device from the first use and thus ensure optimal delivery of the product.

• Child under 6 years of age.

• History of hypersensitivity to aciclovir, to valaciclovir, to propylene glycol or to any of the excipients mentioned in section Composition.

Aciclovir cream is not recommended for application to mucous membranes such as those of the mouth, eye and vagina, as it may be irritating.

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 had a bone marrow transplant), oral administration of aciclovir should be considered. These patients should consult a doctor regarding the treatment of any infection.

This medicine contains 40 g of propylene glycol and 6,75 g of cetostearyl alcohol per 100 g of cream. The excipient propylene glycol may cause skin irritation and cetostearyl alcohol may cause local skin reactions (for example: contact dermatitis).

This medicine contains 0,75 g of sodium lauryl sulfate per 100 g of cream. Sodium lauryl sulfate may cause local skin reactions (such as a tingling or burning sensation) or increase skin reactions caused by other products applied to the same area.

No clinically significant interaction has been identified.

Pregnancy

Analysis of about one thousand pregnancies exposed to aciclovir revealed no malformative or foetotoxic effect specific to 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 (≥ 1/1000 and < 1/100), rare (≥ 1/10000 and < 1/1000), very rare (< 1/10000).

Clinical trial data were used to assign frequency categories to adverse reactions observed during clinical trials with ACICLOVIR 3 % 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 tingling or burning sensations, dry skin, 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 disorder

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

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: https://signalement.social-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.

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.

Aciclovir does not eradicate latent viruses.

The passage of aciclovir into the general circulation, after repeated applications, is very low.

Tube (polypropylene): 3 years.

Tube (varnished aluminium): 3 years.

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

No special requirements.