Adverse reactions : תופעות לוואי

4.8.    Undesirable Effects


Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: 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) and very rare (<1/10,000), including isolated reports.
Post-marketing data

Infections and Infestations
Very rare           Opportunistic infection
Immune System Disorders
Very rare           Hypersensitivity, generalised rash
Endocrine Disorders
Very rare           Hypothalamic-pituitary adrenal (HPA) axis suppression 
Cushingoid features (e.g. moon face, central obesity),
delayed weight gain/growth retardation in children,
osteoporosis, glaucoma, hyperglycaemia/glucosuria,
cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis

Skin and Subcutaneous Tissue Disorders
Common                Pruritus, local skin burning /skin pain

Very rare             Allergic contact dermatitis /dermatitis, erythema, rash, urticaria, pustular psoriasis, skin thinning* / skin atrophy*, skin wrinkling*, skin dryness*, striae*, telangiectasias*,
pigmentation changes*,hypertrichosis, exacerbation of underlying symptoms

General Disorders and Administration Site Conditions

Very rare              Application site irritation/pain
*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.

Eye disorders
Not known                  Vision, blurred (see also section 4.4)

Reporting of suspected 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 should also report to GSK Israel, (il.safety@gsk.com).