- Approval Id
- 2017a77e2b0ea709
- Drug Approval Emc Name
- SYNALAR (Fluocinolone Acetonide 0.00625% w/w) 1:4 Ointment 50g
- Drug Name
- SYNALAR (Fluocinolone Acetonide 0.00625% w/w) 1:4 Ointment 50g
- Company Name
- Reig Jofre UK Ltd
- Company Address
- Follaton House, Plymouth Road, Totnes, Devon, TQ9 5NE, UK
- Company Website
- //www.reigjofre.com/en
- Company Telephone
- 01803 300401
- Company Medical Info Direct Line
- 0330 1359 434
- Company Medical Info Email
- MedInfoUK@reigjofre.com
- Company Customer Care Direct Line
- 01803 300401
- Atc Code
- D07AC04
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Reig Jofre UK Limited
Follaton House, Plymouth Road, Totnes, Devon, TQ9 5NE,
United Kingdom
- Authorisation Number
- PL 44095/0006
- Authorisation Date
- 08/05/2007
- Instruction Authorisation Holder
- Reig Jofre UK Limited
Follaton House, Plymouth Road, Totnes, Devon, TQ9 5NE,
United Kingdom
- Instruction Authorisation Number
- PL 44095/0006
- Instruction Authorisation Date
- 08/05/2007
- Instruction Composition
- Fluocinolone Acetonide Ph. Eur. 0.00625% w/w
- Instruction Dosage Form
- Ointment
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Suitable for:
- Treating the milder forms of a wide variety of inflammatory, pruritic and allergic disorders of the skin such as:
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.
- Maintaining therapy when control has been achieved with 'Synalar'.
- Use under occlusive dressings.
- Paediatric usage where diluted topical steroids are indicated e.g. infantile eczema.
Administration is by the topical route.4.2 Posology and method of administration
A small quantity of 'Synalar' Ointment 1 in 4 Dilution is applied lightly to the affected area two or three times a day, and massaged gently and thoroughly into the skin. 'Synalar' Ointment 1 in 4 Dilution is particularly suitable for dry, scaly lesions.
The above recommendations apply to both children and adults, including the elderly.
When an occlusive dressing is required, the affected area should first be thoroughly cleansed. 'Synalar' Ointment 1 in 4 Dilution is then applied and covered with a suitable dressing. The treatment of children or the face should not normally be for longer than five days, and occlusion should not be used.4.3 Contraindications
'Synalar' Ointment 1 in 4 Dilution is contraindicated in primary infections of the skin caused by bacteria, fungi or viruses and in rosacea, acne, peri-oral dermatitis, anogenital pruritus and napkin eruption.4.4 Special warnings and precautions for use
'Synalar' preparations are not advised in the treatment of children under one year of age. The eyes should be avoided.
Long-term continuous topical steroid therapy can produce local 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 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.
When there is an infection associated with an inflammatory skin condition, 'Synalar' preparations should only be administered if adequate anti-infective cover is given.
When using topical corticosteroids 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.
The label will state strong steroid.4.5 Interaction with other medicinal products and other forms of interaction
None.4.6 Fertility, pregnancy and lactation
Pregnancy: There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids 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 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 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:
Toxic effects are not likely to occur following accidental ingestion of the contents of a 50 g tube. If greater quantities are ingested and toxicity develops, symptomatic treatment should be given.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, dermatological preparations; Corticosteroids, potent (group III)
ATC code: D07AC04
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.
Synalar Ointment 1 in 4 Dilution 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
None stated.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Citric Acid Ph. Eur.
Wool Fat
Propylene Glycol Ph. Eur.
White Soft Paraffin B.P.6.2 Incompatibilities
None known.6.3 Shelf life
2 years.6.4 Special precautions for storage
Store below 25°C.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 size: 50g6.6 Special precautions for disposal and other handling
Not applicable.
- Instruction Content
- ## Composition
Fluocinolone Acetonide Ph. Eur. 0.00625% w/w
## Pharmaceutical Form
Ointment
## Clinical Particulars
4.1 Therapeutic indications
Suitable for:
- Treating the milder forms of a wide variety of inflammatory, pruritic and allergic disorders of the skin such as:
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.
- Maintaining therapy when control has been achieved with 'Synalar'.
- Use under occlusive dressings.
- Paediatric usage where diluted topical steroids are indicated e.g. infantile eczema.
Administration is by the topical route.4.2 Posology and method of administration
A small quantity of 'Synalar' Ointment 1 in 4 Dilution is applied lightly to the affected area two or three times a day, and massaged gently and thoroughly into the skin. 'Synalar' Ointment 1 in 4 Dilution is particularly suitable for dry, scaly lesions.
The above recommendations apply to both children and adults, including the elderly.
When an occlusive dressing is required, the affected area should first be thoroughly cleansed. 'Synalar' Ointment 1 in 4 Dilution is then applied and covered with a suitable dressing. The treatment of children or the face should not normally be for longer than five days, and occlusion should not be used.4.3 Contraindications
'Synalar' Ointment 1 in 4 Dilution is contraindicated in primary infections of the skin caused by bacteria, fungi or viruses and in rosacea, acne, peri-oral dermatitis, anogenital pruritus and napkin eruption.4.4 Special warnings and precautions for use
'Synalar' preparations are not advised in the treatment of children under one year of age. The eyes should be avoided.
Long-term continuous topical steroid therapy can produce local 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 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.
When there is an infection associated with an inflammatory skin condition, 'Synalar' preparations should only be administered if adequate anti-infective cover is given.
When using topical corticosteroids 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.
The label will state strong steroid.4.5 Interaction with other medicinal products and other forms of interaction
None.4.6 Fertility, pregnancy and lactation
Pregnancy: There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids 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 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 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:
Toxic effects are not likely to occur following accidental ingestion of the contents of a 50 g tube. If greater quantities are ingested and toxicity develops, symptomatic treatment should be given.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, dermatological preparations; Corticosteroids, potent (group III)
ATC code: D07AC04
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.
Synalar Ointment 1 in 4 Dilution 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
None stated.
## Pharmaceutical Particulars
6.1 List of excipients
Citric Acid Ph. Eur.
Wool Fat
Propylene Glycol Ph. Eur.
White Soft Paraffin B.P.6.2 Incompatibilities
None known.6.3 Shelf life
2 years.6.4 Special precautions for storage
Store below 25°C.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 size: 50g6.6 Special precautions for disposal and other handling
Not applicable.
