Summary of Product Characteristics (SmPC) - Synalar cream
1 NAME OF THE MEDICINAL PRODUCT
Synalar Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluocinolone Acetonide Ph.Eur. 0.025% wlw
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Synalar contains an effective topical steroid and is suitable for treating a wide variety of inflammatory, pruritic and allergic disorders of the skin. Synalar is particularly suitable for topical application in:
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.
4.2 Posology and method of administration
Adults (including the elderly) and children above one
A small quantity of the Synalar preparation is applied lightly to the affected area two 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 thoroughly cleansed. Synalar is then applied and covered with a suitable dressing. Occlusion should not be used for children or for the face.
In some cases, the application of hot, moist compresses may be an advantage. The cream is particularly suitable for moist or weeping surfaces and for flexures of the body.
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’ Cream 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.
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.
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.
The eyes should be avoided.
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.
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.
Some of the ingredients in the cream may cause a reaction:-
Cetostearyl alcohol - may cause local skin reactions (e.g. contact dermatitis). Propylene glycol - may cause skin irritation.
The label will state strong steroid.
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 is not known (cannot be estimated from the available data).
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.
Immune System Disorders
Local hypersensitivity reactions
Endocrine Disorders
Adrenal suppression.
Eye disorders
Vision, blurred (see also section 4.4)
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)
General Disorders and Administration Site Conditions
Irritation at the site of application
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.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, dermatological preparations; Corticosteroids, potent, combinations with antibiotics
ATC code: D07CC02
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.
Clioquinol is a broad spectrum anti-bacterial and anti-fungal agent. Its precise mechanism of action is unknown.
Synalar Cream is classed as a potent corticosteroid product.
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
Benzyl Alcohol Ph Eur
Anhydrous Citric Acid Ph Eur
Cetostearyl Alcohol Ph Eur
Liquid Paraffin Ph Eur
Polysorbate 60 Ph Eur
Sorbitan Monostearate BP
Purified Water Ph Eur
6.2 Incompatibilities
None known
6.3 Shelf life
42 months
6.4 Special precautions for storage
Store below 25ºC
6.5 Nature and contents of container
Collapsible aluminium tube, coated internally with an epoxy resin lacquer and fitted with a white HDPE screw cap.
Pack sizes: 30g and 100g.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Reig Jofre UK Limited
Follaton House, Plymouth Road,
Totnes, Devon, TQ9 5NE,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44095/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
07/09/2005
10 DATE OF REVISION OF THE TEXT
04/09/2026