Synalar N Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
‘Synalar’ N Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluocinolone Acetonide Ph. Eur 0.025% w/w Neomycin Sulphate Ph. Eur 3250 IU/g
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
‘Synalar’ N combines the effective topical corticosteroid Synalar with an effective antibacterial agent neomycin sulphate Ph Eur. 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.
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 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 national reporting system in the United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
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 sulphate 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 sulphate 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 sulphate 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 List of excipients
|
Propylene Glycol |
Ph Eur |
|
Cetostearyl Alcohol |
Ph Eur |
|
Liquid Paraffin |
Ph Eur |
|
Polysorbate 60 |
Ph Eur |
|
Sorbitan Monostearate |
BP |
|
Methyl Parahydroxybenzoate |
Ph Eur |
|
Propyl Parahydroxybenzoate |
Ph Eur |
|
Purified Water |
Ph Eur |
|
Incompatibilities |
None known.
Shelf life
6.3
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 10, The Barns Farm Road
Caddsdown Industrial Park Bideford
Devon EX39 3BT United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44095/0009
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/05/2004
10
DATE OF REVISION OF THE TEXT
01/07/2015