Document: Contra 5% cream ENG SmPC change

• Contra cream SmPC
• Contra 5% cream ENG SmPC

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summary of the product characteristics

Contra 5 % cream

1 g cream contains: Aciklovir 50 mg

Excipients with known effect: Propylene glycol, cetyl alcohol. For the full list of excipients, see section 6.1.

Cream

White, shiny cream

Symptomatic treatment of prodrome and early forms of recurring herpes labialis caused by herpes simplex virus.

Adults and children 12 years and older: The cream is applied on the site of the infection every four hours, five times daily.

The treatment should start as soon as there are symptoms of an infection, preferable within four hours. Normally the treatment with Contra 5 % cream should be continued for five days.

Hypersensitive to aciclovir, valaciclovir, propylene glycol or to any of the excipients listed in section 6.1.

The cream should be applied only to lesions on the lips or in the face. 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.

For severely immunocompromised patients, such as AIDS-patients or patients undergone transplantation, oral aciclovir dosing should be considered. Such patients should be encouraged to consult a physician concerning the treatment of any infection.

Treatment of HSV-infection in patients with simultaneous dermatitis or eczema in the treatment area has not been studied.

Contra contains cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis) and propylene glycol, which may cause skin irritation.

Paediatric population

There is no experience of treatment of children younger than 12 years.

No clinically significant interactions have been identified.

Fertility

See section 5.2

Pregnancy

The use of aciclovir 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 teratogeniceffects in rabbits, rats or mice.

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

Lactation

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.

Contra has none known influence on the ability to drive and use machines.

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, not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders

Common: Numbness on the site of application.

Uncommon: Transient burning or stinging following application of aciclovir 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.

Immune system disorders

Very rare: Immediate hypersensitivity reactions including angioedema 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 reactions via the national reporting system listed in Appendix V*.

No untoward effects would be expected if the entire contents of the tube or dispenser were ingested orally.

Pharmacotherapeutic group: Antiviral agents, ATC-code: D06B B03

After entry into a cell infected with herpes simplex virus, acyclovir is converted into aciclovir-triphosphate. The triphosphate inhibits replication of virus-DNA. Aciclovir does not eliminate latent virus species.

Concentration in plasma is minimal and consequently there will be no systemic effect.

Preclinical data reveal no special hazard for humans based on conventional studies on safety pharmacology, repeated dose toxicity, and carcinogenicity at parenteral or oral administration of aciclovir. In some genotoxicity studies positive results were found. Systemic administration of aciclovir in the normal animal studies did not show any embryotoxic or teratogenic effects. Teratogenic effects such as anomalies of the skeleton and abnormal forms of the head have been observed in rat embryos in in vitroculture and in rat studies where high subcutaneous doses of aciclovir were given one day in early gestagen phase.

Stearoyl macrogolglycerides, dimeticone, cetyl alcohol, light liquid paraffin, white vaseline, propylene glycol and purified water.

Not applicable.

3 years

Do not store above 25 °C.

Aluminium tubes 2g and 5g.

Plastic bottle (PP) with pump dispenser 2 g.

No special requirements.

Meda OTC AB, Box 906, 170 09 Solna, Sweden

17841

11 January 2002/ 11 January 2007

21 January 2016