CYCLOVAX Cream Ref.[28212] Active ingredients: Aciclovir

Cyclovax Cream is not recommended for application to mucous membranes such as in the mouth, eye or vagina, as it may be irritant. Particular care should be taken to avoid contact with the eye.

In severely immunocompromised patients (eg AIDS patients or bone marrow transplant recipients) oral Cyclovax dosing should be considered. Such patients should be encouraged to consult a physician concerning the treatment of any infection.

Cyclovax Cream contains the excipient propylene glycol which can cause skin irritations.

No clinically significant interactions have been identified.

Pregnancy

The use of Cyclovax Cream should be considered only when the potential benefits outweigh the possibility of unknown risks however the systemic exposure to aciclovir from topical application of aciclovir cream is very low.

A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of aciclovir. The registry findings have not shown an increase in the number of birth defects amongst aciclovir exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause.

Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice.

In a non-standard test in rats, foetal abnormalities were observed but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.

Breast-feeding

Limited human data show that the drug does pass into breast milk following systemic administration. However, the dosage received by a nursing infant following maternal use of aciclovir cream would be insignificant.

Fertility

See clinical studies in section 5.3.

Not applicable.

The following convention has been used for the classification of undesirable effects in terms of frequency: very common ≥1/10, common ≥1/100 and <1/10, uncommon ≥1/1000 and <1/100, rare ≥1/10,000 and <1/1000, very rare <1/10,000.

Immune system disorders

Very rare: Immediate hypersensitivity reactions including angioedema and urticaria.

Skin and subcutaneous tissue disorders

Uncommon: Transient burning or stinging or itching following application of Cyclovax Cream, Mild drying or flaking of the skin, Itching.

Rare: Erythema, Contact dermatitis following application.

Where sensitivity tests have been conducted the reactive substances have most often been shown to be components of the cream rather than aciclovir.

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: Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs.

None.