Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Fluocinolone acetonide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR Synalar ointment contains fluocinolone acetonide which is a corticosteroid (also referred to as a steroid) and reduces inflammation. It is used to treat certain inflammatory, itchy or allergic skin conditions such as eczema, dermatitis, prurigo, psoriasis, lichen planus and discoid lupus erythematosus. It is not normally used to treat large areas of psoriasis because the likelihood of side effects is greater. Corticosteroid creams, ointments and other topical preparations come in four different potencies or strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Synalar ointment is classed as a strong corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
E SYNALAR OINTMENT Do not use Synalar ointment: • If you are allergic to fluocinolone acetonide or any of the other ingredients of this medicine (listed in section 6). • Where infection is the main cause of the skin problem. • For acne. • For nappy rash or itchiness around the genital area. • If you have a skin condition called rosacea which is red rash, sometimes with spots and
• • •
pustules,on the cheeks of the face. If you have a skin condition called perioral dermatitis which is a dry sore red rash around the mouth If it is for a child under the age of one. If breast-feeding, do not apply to the breasts prior to nursing.Make sure your doctor knows if any of the above affects you.
Warnings and precautions • Synalar ointment should be kept away from the eyes. If using Synalar ointment on the face or on children (over the age of 1 year), do not use for • morethan 5 days. Your doctor will tell you if your treatment should be longer than this. • Waterproof dressings should not be used for children, or the face, and only in adults if your doctor tells you. The affected area should be thoroughly cleaned before putting on a waterproof dressing. Ask your doctor for instructions. Do not use more ointment than the doctor tells you, especially if you are pregnant or • breast-feeding. • If there is a worsening of your condition during use consult your prescriber – you may be experiencing an allergic reaction, have an infection or your condition requires a different treatment. If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not restart using the ointment without consulting your prescriber unless your prescriber has previously advised you to do so. If your condition has resolved and on recurrence the redness extends beyond the initial treatment area and you experience a burning sensation, please seek medical advice before restarting treatment. • If too much ointment is used for too long, you may develop stretch marks, thinning of the skin, or visible small veins. Other medicines and Synalar ointment Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. If you go into hospital, let the medical staff know that you are using Synalar ointment. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Driving and using machines Synalar ointment should not affect your ability to drive or use machinery. Important information about some of the ingredients of Synalar ointment Some of the ingredients in your ointment may cause a reaction, such as: Propylene glycol [E1520] -may cause skin irritation, Wool fat (lanolin) may cause local skin reactions (e.g. contact dermatitis).
SYNALAR OINTMENT Always use Synalar ointment exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Unless your doctor tells you differently, put a small amount of ointment onto the affected area, twoor three times a day. Rub it gently and thoroughly into the skin. Try to apply your ointment at the same times each day. Use the ointment for as long as directed by your doctor (normally 5 days on the face and on children, and 7 days otherwise).
If you forget to use Synalar ointment If you forget to apply the ointment at the correct time, do so as soon as you remember. If accidentally swallowed If you accidentally swallow the ointment, contact your nearest doctor or hospital. If you have any further questions on the use of this medicine ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines Synalar ointment can cause side effects, although not everybody gets them. Thefollowing side effects have been reported but how often they occur is unknown:
not listed in this leaflet. You can also report side effects directly via the Yellow Card Schemeat www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
SYNALAR OINTMENT Keep this medicine out of the sight and reach of children. It could harm them. Store Synalar ointment below 25°C. Keep the ointment in the tube it came in. Do not use this medicine after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Synalar ointment contains The active substance is fluocinolone acetonide. Synalar ointment contains 0.025% w/w fluocinolone acetonide. The other ingredients are citric acid, wool fat (lanolin), propylene glycol [E1520], and white soft paraffin.
What Synalar ointment looks like and contents of the pack Synalar ointment comes in tubes of 30 and 100 grams. Marketing authorisation holder: Reig Jofre UK Ltd, Follaton House, Plymouth Road, Totnes, Devon, TQ9 5NE, UK. Manufacturer: Bioglan AB, PO Box 50310, S-202 13 Malmö, Sweden. 'Synalar' is a registered trademark. This leaflet was last revised in July 2025
SYNALAR (Fluocinolone Acetonide 0.025%) Ointment 30g comes as ointment containing 30g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in SYNALAR (Fluocinolone Acetonide 0.025%) Ointment 30g is fluocinolone acetonide.
This leaflet reproduces the patient information leaflet approved for SYNALAR (Fluocinolone Acetonide 0.025%) Ointment 30g, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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, the Synalar preparations 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 creams are particularly suitable for moist or weeping surfaces and for flexures of the body, the ointments are suitable for dry, scaly lesions.
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' ointment 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.
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.
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.
The eyes should be avoided.
Some of the ingredients in the cream may cause a reaction:-
Wool fat (lanolin) - may cause local skin reactions (e.g. contact dermatitis).
Propylene glycol - may cause skin irritation.
The label will state strong steroid.
None known
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.
No precautions are necessary.
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.
Accidental ingestion: The 30g tube of Synalar contains 7.5mg of the steroid other tubes containing proportionately less. 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.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about SYNALAR (Fluocinolone Acetonide 0.025%) Ointment 30g. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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