SYNALAR N CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

‘Synalar’ N Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Fluocinolone Acetonide Ph. Eur 0.025% w/w

Neomycin Sulfate Ph. Eur            3250 IU/g

3 PHARMACEUTICAL FORM

Cream

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Synalar-N combines the effective topical corticosteroid fluocinolone acetonide with an effective antibacterial agent neomycin sulfate. It is indicated for inflammatory dermatoses including eczema, dermatitis, seborrhoea and intertrigo, where secondary bacterial infection is present or is likely to occur.

4.2 Posology and method of administration

Adults (including the elderly) and Children

A small quantity of the Synalar N preparation is applied lightly to the affected area two or three times a day and massaged gently and thoroughly into the skin. These recommendations apply to both children and adults, including the elderly.

Treatment should not normally be for longer than seven days, and it is preferable to identify’ the causative organism.

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

If an occlusive dressing is indicated, the affected area should first be thoroughly cleansed. The Synalar N preparation is then applied and covered with a suitable dressing.

Synalar N cream is particularly suitable for very inflamed or weeping surfaces and for flexures of the body.

4.3 Contraindications

Synalar N is contra-indicated in primary infections of the skin caused by bacteria, fungi or viruses and in rosacea, acne, perioral dermatitis and napkin eruption.

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

Synalar N is contra-indicated in those patients with a history of hypersensitivity to neomycin.

Topical neomycin preparation should not be applied to the external auditory canal of patients with perforated eardrums.

The eyes should be avoided.

4.4 Special warnings and precautions for use

Long-term continuous topical steroid therapy can produce 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 hypercorticism 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.

In the presence of a viral or fungal infection, the use of an appropriate agent should be instituted. If a favourable response does not occur promptly, Synalar N should be discontinued until the infection has been adequately controlled.

Because of the potential hazard of nephrotoxicity and ototoxicity associated with neomycin, prolonged use or use of large amounts of the product should be avoided in conditions where absorption of neomycin is possible. Care is particularly needed in elderly or renally-impaired patients.

Not for ophthalmic use.

Treatment should be discontinued if unfavourable reactions are seen.

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 by 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 theYellow 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 N contains 7.5mg of steroid and 150mg of neomycin. 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 not likely to have any toxic effects in the quantities in which they occur. Therefore no remedial action is required in the event of 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.

Neomycin sulfate is an aminoglycoside antibacterial agent, which inhibits bacterial protein synthesis.

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.

Neomycin sulfate is not absorbed through intact skin. It is readily absorbed from large denuded, burned or granulating areas. Excretion is then as unchanged drug.

5.3 Preclinical safety data

Fluocinolone acetonide and neomycin sulfate are drugs 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

Propylene Glycol

Ph Eur

Ph Eur

Ph Eur

Ph Eur

BP

Ph Eur

Ph Eur

Ph Eur

Cetostearyl Alcohol

Liquid Paraffin

Polysorbate 60

Sorbitan Monostearate

Methyl Parahydroxybenzoate Propyl Parahydroxybenzoate Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf life

3.5 years.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Collapsible aluminium tubes (30gm).

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 44095/0009

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

29/05/2004