Summary of Product Characteristics (SmPC) - Metosyn ointment
1 NAME OF THE MEDICINAL PRODUCT
Metosyn Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluocinonide 0.05% w/w
3 PHARMACEUTICAL FORM
Ointment
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Metosyn is suitable for treating a wide variety of local inflammatory, pruritic and allergic disorders of the skin. It is indicated in the following conditions:
Eczema and dermatitis: atopic eczema, seborrhoeic dermatitis, discoid eczema, contact dermatitis, neurodermatitis. Prurigo, psoriasis (excluding widespread plaque psoriasis). Lichen planus. Discoid lupus erythematosus.
Metosyn Ointment with its emollient effects, is particularly suitable for dry scaly lesions.
4.2 Posology and method of administration
It is recommended that Metosyn is used undiluted.
Adults
A small quantity of Metosyn Ointment should be applied three to four times daily to the affected area and massaged well in.
Once improvement is apparent, usage may be reduced to twice or even once daily.
Children
Under 1 year: Metosyn preparations are not advised in the treatment of children under
1 year of age.
Over 1 year: As adult dose, however it is recommended that treatment should not normally be extended beyond 5 days and occlusion in such cases should not be used.
Elderly
As adult dose.
4.3 Contraindications
Metosyn is contraindicated in rosacea, acne and peri-oral dermatitis. As with all topical steroids, Metosyn is contraindicated in tuberculous, syphilitic, fungal and viral infections of the skin. The product should not be used for napkin eruption or anogenital pruritus.
4.4 Special warnings and precautions for use
Long-term continuous topical steroid therapy can produce 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.
It is recommended that treatment on the face should not normally be extended beyond 5 days, and occlusion in such cases should not be used.
Where there is bacterial infection associated with an inflammatory skin condition, Metosyn should only be administered if adequate antibacterial cover is also given.
When using topical steroids to treat psoriasis there are risks 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. Absorption is greatest where the skin is thin or raw.
Visual disturbance
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.
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 topical steroid treatment is considered necessary for other parts of the body, 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 required.
4.8 Undesirable effects
With Metosyn side effects are extremely rare but, as with all topical steroids, the occasional patient may show an adverse reaction such as hypersensitivity. Irritation at the site of application may occur infrequently. 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, and systemic effects such as adrenal suppression.
The use of topical steroids on infected lesions, without the addition of appropriate anti-infective therapy, can result in the spread of opportunist infection.
The eyes should be avoided.
Local side effects include contact dermatitis, perioral dermatitis, acne, or worsening of acne or acne rosacea, mild depigmentation which may be reversible and hypertrichosis.
Eye disorders - vision, blurred (see also section 4.4). The frequency of this adverse reaction is not known (cannot be estimated from the available data).
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). The frequency of this adverse reaction is not known (cannot be estimated from the available data).
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
A 25 g tube of Metosyn contains 12.5 mg of fluocinonide. Toxic effects are not likely to occur following accidental ingestion. Similarly, the components of the vehicles, singly or collectively, have not been shown to produce toxic effects in these quantities.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, dermatological preparations; Corticosteroids, potent (group III)
ATC code: D07AC08
Fluocinonide 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.
Metosyn Ointment is classed as a potent corticosteroid product.
5.2 Pharmacokinetic properties
The extent of percutaneous absorption of fluocinonide is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. Following absorption, fluocinonide is metabolised primarily in the liver and excreted by the kidneys.
5.3 Preclinical safety data
Fluocinonide is a drug on which extensive clinical experience has been obtained. All relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Amerchol Cab
Propylene Carbonate
Propylene Glycol
White Soft Paraffin
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
Aluminium tubes of 25 g and 100 g.
6.6 Special precautions for disposal
Use undiluted, as directed by the prescriber.
7 MARKETING AUTHORISATION HOLDER
Reig Jofre UK Limited
Follaton House, Plymouth Road,
Totnes, Devon,
TQ9 5NE
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44095/0015
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
12/04/2005
10 DATE OF REVISION OF THE TEXT
24/09/2026