ALMUS HYDROCORTISONE

Posology For adults, the elderly and children over 10 years of age:

Apply once or twice a day, for a maximum of 7 days. If the condition is not improved, consult your doctor. Dosage recommendations as above for children over 10 years of age. The product should not be used in children under 10 years of age without medical advice.

Method of administration For topical application. Apply accurately and sparingly to a small area. Massage gently into the skin.

If any signs of hypersensitivity, including allergic contact dermatitis or worsening of the original condition appear, treatment should be immediately discontinued. Adverse events which have been associated with topical corticosteroids are given below, tabulated by system organ class and frequency.

Frequencies are defined as:

Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class Frequency Adverse Events Skin and subcutaneous tissue disorders Not known Skin atrophy, telangiectasia, skin striae, acne, rosacea, pigmentation disorder, hypertrichosis. 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.

4). Musculoskeletal and connective tissue disorders Not known Collagen disorder. 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.

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The label will state ‘mild steroid’. 6). If the condition does not improve consult your doctor. 2) as continuous uninterrupted application may cause local atrophy of the skin, striae and superficial vascular dilatation. Topical steroid withdrawal syndrome Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome).

A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated.

Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.

Visual impairment:

Visual impairment may be reported with systemic and topical use of corticosteroids. If patients develop symptoms such as blurred vision or other visual disturbances, consideration should be given to referring the patient to an ophthalmologist to establish the possible cause which may include cataract, glaucoma or rare conditions such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

1. The product should not be used on the eyes or face (for example, in rosacea or perioral dermatoses), the ano-genital area or on broken or infected skin including impetigo, cold sores, acne, athlete's foot, or infected bites and stings.

In the presence of untreated infections of bacterial, viral, tuberculous or fungal origin. Not for use with an occlusive dressing or on large areas of the body.