DIODERM

For adults, the elderly and children Apply to the affected areas twice daily. For infants, the treatment period should not normally exceed 7 days.

Reported side effects of corticosteroids include skin thinning and striae. Although rare, these could occur even with hydrocortisone, especially when used under occlusion or in the folds of the skin. Dioderm is usually well tolerated but in the event of a hypersensitivity reaction (allergic contact dermatitis) treatment should be discontinued.

Adverse drug reactions 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), very rare (<1/10,000) and not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse reaction Skin and Subcutaneous Tissue Disorders 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.

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. uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store.

Although generally regarded as safe, even for long-term administration in adults, there is a potential for overdosage in infancy. Extreme caution is required in dermatoses in infancy, including napkin eruption. In such patients, courses of treatment should not normally exceed 7 days.

Prolonged or extensive uninterrupted application should be avoided, particularly if used on the face or with occlusive dressings. The excipient propylene glycol may on rare occasions cause skin irritation in sensitive people. Keep out of the sight and reach of children.

Keep away from the eyes. For external use only. 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. The label will state mild steroid. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use.

If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

3 Contra-Indications As with all topical steroids, Dioderm is not to be used where there is bacterial, viral or fungal infection. Not to be used on open wounds, ulcers or broken skin. Not to be used in cases of sensitivity to any of the ingredients.