Each 1 gram of ointment contains:

active ingredient: fluocinolone acetonide – 0.25 mg;

excipients: citric acid monohydrate, propylene glycol, lanolin anhydrous, wax 533 D, vaseline white (petrolatum white).

Fluocinolone acetonide is a synthetic anti-inflammatory corticosteroid. Its mechanisms of action are related to vasoconstriction and suppression of membrane permeability, mitotic activity, the immune response and release of inflammatory mediators.

• Eczema and dermatitis; atopic eczema, seborrheal eczema, discoid eczema, otitis externa, contact dermatitis, neurodermatitis.
• Prurigo
• Psoriasis (Excluding widespread plaque psoriasis)
• Lichen Planus, Discoid Lupus Erythematosus.

Adults (including the elderly) and children above one.

A small quantity of the Fluocinolone preparation is applied lightly to the affected areatwo or three times a day, and massaged gently and thoroughly into the skin. When an occlusive dressing is required, the affected area should first be thoroughlycleansed, the Fluocinolone preparations is then applied and covered with a suitabledressing.Occlusion should not be used for children or for the face. In some cases, the application ofhot, moist compresses may be an advantage.

Long term continuous steroid therapy can produce local atrophic skin changes and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or when 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 hypercorticoidism and underlying adrenal suppression, especially in infants and children.

It is recommended that treatment on the face and for children should not normally be extended beyond five days, and occlusion in such cases should not be used.

When there is an infection associated with an inflammatory skin condition, Fluocinolone should only be administered if adequate anti-infective cover is given.

When using topical steroids to treat psoriasis there are risks both of rebound relapse following the development of tolerance, and of generalised pustular psoriasis.Impairment of the barrier function of the skin may lead to local and systemic toxicity. Careful patient supervision is important.

Treatment should be discontinued if unfavorable reactions are seen.

The eyes should be avoided.

Axiller, the groin and other intertriginous areas, as well as an eye region should not be treated other than briefly with strong glucocorticoids.

Some of the ingredients in the cream may cause a reaction:

• Lanolin – may cause local skin reactions (e.g. contact dermatitis).
• Propylene glycol – may cause skin irritation.

Effects on ability to drive and use machines

• No precautions are necessary.

Accidental ingestion: The 15 g tube of Fluocinolon contains 3.75 mg of the steroid.

No toxic effects are likely to occur even if the full contents of a 15g tube are ingested. Similarly the ingredients of the base are unlikely to have any toxic effect in the quantities in which they occur; therefore no remedial action is required in the event of accidental ingestion.

• Fluocinolone is contraindicated in primary infections of the skin caused by bacteria, fungi or viruses and in rosacea, acne, perioral dermatitis, anogenital pruritus and napkin eruptions.
• Fluocinolone ointment should not be used in patients that are hypersensitive to any of the ingredients. Fluocinolone preparations are not advised in the treatment of children under one year of age.

Immune System Disorders

• Local hypersensitivity reactions

Skin and Subcutaneous Tissue Disorders

• Dermatitis
• Perioral dermatitis
• Acne or worsening of acne
• Acne rosacea
• Hypertrichosis

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.

Endocrine Disorders

• Adrenal suppression

General Disorders and Administration Site Conditions

• Irritation at the site of application.

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.

Adverse systemic effects may occur when used on large areas of the body, intertriginous areas, for prolonged periods of time, or with an occlusive dressing.

Pregnancy

There is inadequate evidence of safety in human pregnancy. Topical administration of steroids to pregnant animals can cause abnormalities of foetal development. Including cleft palate and intrauterine growth retardation.
During the long-term treatment the risk of adrenal cortical suppression of a newborn exists.
Therefore with regard to the above-mentioned treatment of larger body areas during pregnancy for a longer period of time, primarily low-potency steroids should be prescribed.

Lactation

Topical steroids should not be applied to the breasts prior to nursing.
When steroid treatment is considered necessary during breast feeding, both the amount applied and the length of treatment should be minimised.

None known.

White or slightly yellowish ointment.

Aluminium tube containing 15 g ointment. The tube is packed and inserted with the leaflet into cardboard boxes.

5 years. Do not use after the expiration date.

To be dispensed with prescription.

Store at a room temperature (15-25⁰C), in a dry place, out of the reach of children. Protect from light.