Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting.
The most frequently reported adverse reaction during treatment is pruritus.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common ≥ 1/10
Common ≥1/100 and <1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000
Not known (cannot be estimated from the available data)
Immune system disorders
Uncommon:                           Hypersensitivity
(≥1/1,000 and <1/100)
Eye disorder
Not known                           Vision, blurred*
Skin and subcutaneous tissue disorders
Uncommon:                           Dermatitis contact
(≥1/1,000 and <1/100)               Eczema (condition aggravated)
Skin burning sensation
Pruritus
Dry skin
Rare:                               Erythema
(≥1/10,000 and <1/1,000)            Urticaria
Rash (including rash erythematous and rash generalised)
Not known                           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*

General disorders and administration site conditions
Uncommon:                           Application site pain
(≥1/1,000 and <1/100)               Application site irritation
Rare:                               Application site swelling
(≥1/10,000 and <1/1,000)            Application site vesicles
*See also section 4.4

Systemic undesirable class effects of corticosteroids like betamethasone valerate include adrenal suppression especially during prolonged topical administration (see section 4.4).

Raised intra-ocular pressure, glaucoma or cataract may also occur after topical use of corticosteroids near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma and cataract (see section 4.4).

Dermatological undesirable class effects of potent corticosteroids include: Atrophy, dermatitis (including dermatitis contact and dermatitis acneiform), perioral dermatitis, skin striae, telangiectasia, rosacea, erythema, hypertrichosis, hyperhidrosis and depigmentation.
Ecchymosis may also occur with prolonged use of topical corticosteroids.

Class effects for corticosteroids have been uncommonly reported for Fucicort as described in the frequency table above.

Paediatric population
The observed safety profile is similar in children and adults (see section 4.4).

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