SYNALAR OINTMENT 1 IN 4 DILUTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

‘Synalar’ Ointment 1 in 4 Dilution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Fluocinolone Acetonide Ph. Eur. 0.00625% w/w

Ointment

4.1 Therapeutic indications

Suitable for:

– Treating the milder forms of a wide variety of inflammatory, pruritic and allergic disorders of the skin such as:

Eczema and dermatitis: atopic eczema, seborrhoeic eczema, discoid eczema, otitis externa, contact dermatitis, neurodermatitis.

Prurigo.

Psoriasis (excluding widespread plaque psoriasis). Lichen planus. Discoid lupus erythematosus.

– Maintaining therapy when control has been achieved with ‘Synalar’.

– Use under occlusive dressings.

– Paediatric usage where diluted topical steroids are indicated e.g. infantile eczema.

Administration is by the topical route.

4.2 Posology and method of administration

A small quantity of ‘Synalar’ Ointment 1 in 4 Dilution is applied lightly to the affected area two or three times a day, and massaged gently and thoroughly into the skin. ‘Synalar’ Ointment 1 in 4 Dilution is particularly suitable for dry, scaly lesions.

The above recommendations apply to both children and adults, including the elderly.

When an occlusive dressing is required, the affected area should first be thoroughly cleansed. ‘Synalar’ Ointment 1 in 4 Dilution is then applied and covered with a suitable dressing. The treatment of children or the face should not normally be for longer than five days, and occlusion should not be used.

4.3 Contraindications

‘Synalar’ Ointment 1 in 4 Dilution is contraindicated in primary infections of the skin caused by bacteria, fungi or viruses and in rosacea, acne, peri-oral dermatitis, anogenital pruritus and napkin eruption.

4.4 Special warnings and precautions for use

‘Synalar’ preparations are not advised in the treatment of children under one year of age. The eyes should be avoided.

Long-term continuous topical steroid therapy can produce local atrophic skin changes and dilatation 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 continuous or inappropriate 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.

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, ‘Synalar’ preparations should only be administered if adequate anti-infective cover is given.

When using topical corticosteroids 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 unfavourable reactions are seen.

4.5 Interaction with other medicinal products and other forms of interaction

None.

4.6 Fertility, Pregnancy and lactation

Pregnancy: There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects on the human foetus.

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

4.7 Effects on ability to drive and use machines

No precautions are necessary.

4.8 Undesirable effects

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.

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. (see section 4.4)

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.

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. Healthcare professionals are asked to report any suspected adverse reactions via the: Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Accidental Ingestion:

Toxic effects are not likely to occur following accidental ingestion of the contents of a 50 g tube. If greater quantities are ingested and toxicity develops, symptomatic treatment should be given.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

The extent of percutaneous absorption of fluocinolone acetonide is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. Following absorption, fluocinolone acetonide is metabolised primarily in the liver and excreted by the kidneys.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Citric Acid Ph. Eur.

Lanolin Anhydrous

Propylene Glycol Ph. Eur.

White Soft Paraffin B.P.

6.2 Incompatibilities

None known.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

50g Tube.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Reig Jofre UK Limited

Unit 9A Caddsdown Business Support Centre

Caddsdown Industrial Park

Bideford

Devon

EX39 3DX

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 44095/0006

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

08/05/2007