MEDOVIR Cream Ref.[28215] Active ingredients: Aciclovir

Aciclovir 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 accidental introduction into the eye.

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

Medovir Cream contains a specially formulated base and should not be diluted or used as a base for the incorporation of other medicaments.

This medicine contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

This medicine contains 0.15 g propylene glycol in each gram of cream. Propylene glycol may cause skin irritation. Do not use this medicine in babies less than 4 weeks old with open wounds or large areas of broken or damaged skin (such as burns) without talking to your doctor or pharmacist.

No clinically significant interactions have been identified.

Pregnancy

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.

The use of aciclovir 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.

Teratogenicity

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure to indicate little relevance to clinical use (see section 5.3).

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

There is no information on the effect of aciclovir on human female fertility.

In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1 g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology. See Clinical Studies in section 5.1.

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 to <1/10, uncommon ≥1/1000 to <1/100, rare ≥1/10,000 to <1/1000, very rare <1/10,000, not known (cannot be estimated from the available data).

Immune system disorders

Very rare: Immediate hypersensitivity reactions including angioedema and urticaria.

Skin and subcutaneous tissue disorders

Uncommon: Transient burning or stinging following application of the 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 to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

None known.