Adverse reactions : תופעות לוואי

4.8       Undesirable effects

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 following application of Zovirax Genital • 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 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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form
(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.health.gov.il).
Additionally, you should also report to GSK Israel (il.safety@gsk.com).