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, hyperglycaemia/glucosuria, hypertension,

increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis

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

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

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.
(see section 4.4)

*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.

General Disorders and Administration Site Conditions

Very rare                 Application site irritation/pain
Eye disorders

Very rare                 Cataract, central serous chorioretinopathy, glaucoma 
Not known (cannot be estimated from available data): Vision, blurred (see also 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 risk/benefit 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).