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
Skin and Subcutaneous Tissue Disorders
Very rare         Allergic contact dermatitis, urticaria, skin atrophy*, pigmentation changes*, exacerbation of underlying symptoms, local skin burning, hypertrichosis, rash, pruritus,
erythema
*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.

Eye disorders

Not known       Vision, blurred
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://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il).
Additionally, you should also report to GSK Israel (il.safety@gsk.com).