Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Table 1: Treatment-related adverse reactions reported with Elocom by body system and frequency Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10 000,); not known (cannot be estimated from available data) Infections and infestations
Not known                                               Infection, furuncle 
Very rare                                               Folliculitis

Nervous system disorders
Not known                                               Paraesthesia, 
Very rare                                               Burning sensation 
Skin and subcutaneous tissue disorders
Not known                                               Dermatitis contact, skin hypopigmentation, hypertrichosis, skin striae, dermatitis acneiform,
skin atrophy
Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation,
itch, skin peeling, oozing pustules (see section
4.4).

Very rare                                               Pruritus

General disorders and administration site conditions
Not known                                               Application site pain, application site reactions 
Eye disorders
Not known                                               Vision blurred (see also section 4.4) 

Local adverse reactions reported infrequently with topical dermatologic corticosteroids include: skin dryness, irritation, dermatitis, perioral dermatitis, maceration of the skin, miliaria and telangiectasiae.
Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. Chronic corticosteroids therapy may interfere with the growth and development of children.

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