Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Summary of the safety profile

Fenlips / Fenlips Color has been well-tolerated in human studies. Clinical trial experience has shown that there was no difference between Fenlips / Fenlips Color and placebo in the rate or type of adverse reactions reported.

The most common events are application site adverse events.

Tabulated list of adverse reactions
Adverse reactions are listed below by system organ class and frequency.
Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); unknown (cannot be estimated from available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

General disorders and administration     Application site reactions (including skin site condition: Common                   burning sensation, pain of skin, hypoaesthesia)

Post-marketing surveillance has revealed the following adverse events (all reactions were either localised or generalised). Adverse events from post- marketing experience are difficult to calculate a frequency and therefore the events are listed as unknown frequency.

Immune System disorders:
Not known                                hypersensitivity, urticarial 
Skin and subcutaneous disorders:
Not known                                dermatitis allergic (including rash, pruritus, blisters and oedema)


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.

Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form (https://sideeffects.health.gov.il/).

Additionally, you can also report to www.perrigo-pharma.co.il.