This information is intended for use by health professionals

1. Name of the medicinal product

Synalar Gel

2. Qualitative and quantitative composition

Fluocinolone Acetonide Ph. Eur. 0.025% w/w

3. Pharmaceutical form

Gel

4. Clinical particulars
4.1 Therapeutic indications

Synalar gel is an effective topical steroid formulated as a clear, non-greasy gel. It is designed for application to the scalp and other hairy regions, but can equally well be applied elsewhere on the body. Specific indications for 'Synalar' Gel are Seborrhoea, seborrhoeic dermatitis and psoriasis of the scalp, but it may be applied satisfactorily to inflammatory dermatoses on other parts of the body.

4.2 Posology and method of administration

Adults (including the elderly) and children

A small quantity of the Synalar Gel is massaged into the scalp night and morning using the fingertips. For maintenance therapy, treatment should be repeated once or twice weekly.

4.3 Contraindications

Synalar 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.

'Synalar' Gel should not be used in patients that are hypersensitive to any of the ingredients.

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

4.4 Special warnings and precautions for use

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 hypercorticalism 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, Synalar 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 unfavourable reactions are seen. Some of the ingredients in the gel may cause a reaction: -

Methyl and propylparahydroxybenzoates – may cause local skin reactions (possibly delayed).

Propylene glycol – may cause skin irritation.

The eyes should be avoided.

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6 Fertility, pregnancy and lactation

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. 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 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 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.

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: The 30g tube of Synalar contains 7.5mg of the steroid. No toxic effects are likely to occur even if the full contents of a 30g 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.

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

Fluocinolone acetonide is a drug on which extensive clinical experience has been obtained. All relevant information for the prescriber is provided elsewhere in the in the summary of product characteristics.

6. Pharmaceutical particulars
6.1 List of excipients

Propylene Glycol

Ph Eur

Industrial Methylated Spirit

BP

Anhydrous Citric Acid

Ph Eur

Disodium Edetate

EP

Methyl Parahydroxybenzoate

EP

Propyl Parahydroxybenzoate

EP

Carboxy Polymethylene

HSE

Purified Water

Ph Eur

Triethanolamine

BP

6.2 Incompatibilities

None known

6.3 Shelf life

36 months

6.4 Special precautions for storage

Store below 25°C

6.5 Nature and contents of container

Collapsible aluminium tubes 30g and 60g.

6.6 Special precautions for disposal and other handling

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 44095/0004

9. Date of first authorisation/renewal of the authorisation

03/03/2011

10. Date of revision of the text

29/03/2019