SYNALAR C

Topical Administration A small quantity of the ‘Synalar’ C preparation is applied lightly to the affected area two or three times a day, and massaged gently and thoroughly into the skin. These recommendations apply to both children and adults, including the elderly.

Treatment should not normally be for longer than seven days and it is preferable to identify the causative organism. If used in childhood or on the face, courses should be limited to five days and occlusion should not be used. If an occlusive dressing is indicated, the affected area is first thoroughly cleansed.

The ‘Synalar’ C preparation is then applied and covered with a suitable dressing. ‘Synalar’ C Cream is particularly suitable for very inflamed or weeping surfaces and for flexures of the body, whilst ‘Synalar’ C ointment is more suitable for dry scaly lesions.

As with all topical steroids the occasional patient may develop an adverse reaction. Adverse reactions are listed by system organ class. The frequency of adverse reactions is not known (cannot be estimated from the available data). Immune System Disorders Local hypersensitivity reactions Skin and Subcutaneous Tissue Disorders Dermatitis Perioral dermatitis Acne or worsening of acne Acne rosacea Extensive treatment, particularly involving occlusive dressings or where skin folds are involved, can result in both local atrophic changes, such as striae, skin thinning and telangiectasia.

Mild depigmentation, which may be reversible, hypertrichosis and irreversible striae. Local application of clioquinol in creams or ointments may occasionally cause severe irritation, which may be less marked because of the fluocinolone acetonide.

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) Endocrine Disorders Adrenal suppression. General Disorders and Administration Site Conditions Irritation at the site of application Staining may occur due to breakdown of the clioquinol.

A protective covering may be placed over the application to prevent staining of clothing or linen. The eyes should be avoided. Infections and Infestations The use of topical steroids on infected lesions, without the addition of appropriate anti-infective therapy, can result in the spread of opportunist infections.

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 the Google Play or Apple App Store.

Long term continuous topical steroid therapy can produce local atrophic skin changes and dilation of the superficial blood vessels, particularly when occlusive dressings are used or where skin folds are involved. Prolonged use of topical steroids or treatment of extensive areas, even without occlusion, can result in sufficient absorption of the steroid to produce the features of hypercorticalism and underlying adrenal suppression, especially in infants and children.

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 advise is recommended in these cases or other treatment options should be considered. In the presence of a viral infection, the use of an appropriate agent should be instituted. If a favourable response does not occur promptly ‘Synalar’ C should be discontinued until the infection has been adequately controlled.

Treatment should be discontinued if unfavourable reactions are seen. This product should not be used by patients with known iodine-sensitivity. g. contact dermatitis). Methyl and propylparahydroxybenzoates - may cause local skin reactions (possibly delayed).

Propylene glycol - may cause skin irritation. The label will state strong steroid.

‘Synalar’ C preparations are contra-indicated in primary infections of the skin caused by bacteria, fungi or viruses and in rosacea, acne, perioral dermatitis and napkin eruptions. ‘Synalar’ C preparations should not be used in patients that are hypersensitive to any of the ingredients.

‘Synalar’ C preparations are not advised in the treatment of children under one year of age.