ACICLOVIR ZENTIVA 5 % Cr T/10g

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

Excipient with known effect: propylene glycol.

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

Due to 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.

Cutaneous use.

5 applications per day.

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

The duration of treatment is between 5 and 10 days.

• Hypersensitivity to the active substance (aciclovir) or to any of the excipients mentioned in section Composition
• For ocular, intraoral or intravaginal application.

Not applicable.

This medicine contains propylene glycol and may cause skin irritation.

Pregnancy

In animals:

Apart from one isolated study at very high doses, no teratogenic effect of aciclovir has been demonstrated.

In clinical practice:

No particular malformative effect has been demonstrated in a population of several hundred patients exposed to aciclovir during the 1er trimester of pregnancy. In the current state of knowledge, accidental intake of aciclovir at the beginning of pregnancy does not justify its interruption.

No particular foetotoxic effect has been observed following administration of aciclovir during the 2th and 3th trimesters of pregnancy: however, no study allows long-term administration of aciclovir for recurrent herpes in pregnant women, particularly towards the end of pregnancy.

Breast-feeding

After oral administration of aciclovir 200 mg 5 times a day, aciclovir has been detected in breast milk at concentrations ranging from 0,6 to 4,1 times the plasma concentration of aciclovir.

This corresponds to administration to the infant of aciclovir doses not exceeding 0,3 mg/kg/day, a low dose compared with the dosage of 30 mg/kg/day used for the treatment of neonatal herpes infections.

However, aciclovir should be administered with caution to women who are breast-feeding.

• Transient tingling or burning sensations may follow application of the cream.
• In a few patients, erythema or dry skin has been observed.
• Risk of contact eczema, due to the presence of propylene glycol.

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 reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.signalement-sante.gouv.fr.

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.

The passage of aciclovir into the systemic circulation is low after cutaneous application. The plasma concentrations found after repeated applications of aciclovir 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.

No special precautions for storage.

No special requirements.