Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The incidence of allergic hypersensitivity reactions to neomycin sulphate in the general population is low. There is, however, an increased incidence of hypersensitivity to neomycin in certain selected groups of patients in dermatological practice, particularly those with venous stasis eczema and ulceration, and chronic otitis externa.

Allergic hypersensitivity reactions following topical application of polymyxin B sulphate and Dexamethasone are rare.

Allergic hypersensitivity to neomycin following topical use may manifest itself as an eczematous exacerbation with reddening, scaling, swelling and itching or as a failure of the lesion to heal.

Stinging and burning have occasionally been reported when Desoren Ear Drops gained access to the middle ear.

Postmarketing Data
Immune System Disorders
Rare: Application site hypersensitivity

General Disorders and Administration Site Conditions
Rare: Headache, application site reaction including: pain, irritation, oedema, burning sensation, rash

Skin and Subcutaneous Tissue Disorders
Rare: Local exfoliative dermatitis, skin atrophy, telangiectasia, striae, exacerbation of underlying skin conditions, including eczema.

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