Sinoderm gel 0.25 mg/g (fluocinolone acetonide) – seborrhoea and psoriasis of the scalp and inflammatory skin conditions

Sinoderm gel is a medicine for use on the skin containing fluocinolone acetonide, a synthetic potent corticosteroid (group III) that reduces inflammation. One gram of gel contains 0.25 mg fluocinolone acetonide; the medicine is made by Galenika a.d. Belgrade.

The gel is colourless and clear and is particularly suitable for the scalp and other hairy areas of the body. According to the leaflet it is used for seborrhoea and psoriasis of the scalp and other hairy areas, and for certain inflammatory skin conditions elsewhere on the body. This text refers only to Sinoderm gel; other forms and Sinoderm N (with neomycin) have separate leaflets.

What is Sinoderm gel used for and how should it be applied?

Key facts about the medicine

What is Sinoderm gel used for?

According to the official leaflet, Sinoderm gel is used to treat:

• seborrhoea and psoriasis of the scalp;
• seborrhoea and psoriasis of other hairy areas of the body;
• certain inflammatory skin conditions on other parts of the body.

The gel does not treat skin infections – when bacteria, fungi or viruses are the main cause, the medicine is not used.

How is it used and dosed?

• Open the tube by piercing the protective foil with the other end of the cap; squeeze the gel from the bottom of the tube and apply it directly to the affected skin at the hair roots.
• Unless the doctor advises otherwise, rub a small amount of gel into the affected skin every evening and every morning, at about the same time.
• Once symptoms are under control, use can be reduced to once or twice a week.
• The duration is set by the doctor; on the face and in children it is usually no longer than 5 days.
• A waterproof (occlusive) dressing is used only in adults and only on medical advice, after thorough cleaning of the skin – never on the face or in children.
• Avoid the area around the eyes and do not apply more gel than prescribed.

Special patient groups

• Children under 1 year: the medicine must not be used.
• Children over 1 year: limit treatment to 5 days, without occlusive dressing; the risk of systemic side effects (e.g. rounded face, fluid retention) is higher in children.
• Pregnant and breastfeeding women: do not apply more gel than prescribed; breastfeeding women should not apply the gel to the breasts just before feeding.
• Adults and elderly: use as directed by the doctor, avoiding prolonged use on large areas.

Contraindications – when the medicine must not be used

Sinoderm gel must not be used:

• if you are allergic to fluocinolone acetonide or any of the excipients;
• if infection is the main cause of the skin problem;
• for acne;
• for nappy rash or itching in the genital area;
• for rosacea (red rash on the cheeks, sometimes with pimples);
• for perioral dermatitis (red inflammatory rash around the mouth);
• in children under 1 year.

The other situations described are not contraindications but require caution and medical advice.

Precautions and warnings

• If the condition worsens during use, an allergic reaction or infection may have developed – contact your doctor.
• If symptoms return soon (within 2 weeks) after stopping, do not restart without consulting your doctor.
• If symptoms return after clearing, with redness in new areas and stinging, consult your doctor before reuse (possible withdrawal reaction).
• Excessive and prolonged use can cause stretch marks, skin thinning and telangiectasia, and some of the medicine may enter the bloodstream.
• In psoriasis, topical corticosteroids carry a risk of relapse with tolerance and of generalised pustular psoriasis – medical monitoring is needed.
• Use on infected lesions without appropriate anti-infective therapy may lead to spreading of infection.
• Treatment should be stopped if side effects occur.
• The medicine contains methyl and propyl parahydroxybenzoate (may cause allergic reactions, possibly delayed) and propylene glycol (may cause skin irritation); it also contains ethanol.

Interactions with other medicines, alcohol and food

• No clinically relevant interactions are described in the leaflet for this medicine.
• Tell your doctor or pharmacist about all medicines you use, including non-prescription medicines.
• If you go to hospital, tell the medical staff that you use Sinoderm gel.

Pregnancy and breastfeeding

There are no adequate data on safe use in pregnant women. Topical corticosteroids caused fetal development abnormalities in animals, so a very small risk in humans cannot be excluded. Medical advice is needed before use in pregnancy.

During breastfeeding the gel should not be applied to the breasts before feeding; if treatment is necessary, the amount and duration should be kept to a minimum.

Driving and using machines

Sinoderm gel has no effect on the ability to drive or use machines.

Possible side effects

The frequency of side effects is not known (cannot be estimated from the available data). Reported effects include:

• allergic reaction to the gel (with itching) and irritation at the application site;
• dermatitis, worsening of acne, rosacea and dermatitis around the mouth;
• pale patches (depigmentation) or mild pigmentation, increased hair growth at the site;
• with long-term use of large amounts: stretch marks, skin thinning, visible small blood vessels; possible systemic effects such as rounded face, muscle wasting and fluid retention, adrenal suppression;
• withdrawal reaction after long continuous use: redness spreading beyond the treated area, stinging, intense itching, peeling, oozing;
• spread of opportunistic infections if the gel is applied to infected lesions.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Accidental swallowing: contact a doctor or the nearest hospital. According to the summary of product characteristics, a 30 g tube contains 7.5 mg corticosteroid and no toxic effects are expected even if the whole tube is swallowed.
• Missed application: apply the gel as soon as you remember. Do not apply a double amount.
• Stopping treatment: after longer use, consult your doctor, as redness, stinging and itching may occur after stopping.

Related information

• Dandruff vs. dry scalp – how to tell the difference

For additional care and support with dandruff and seborrhoea, see also the Preparations against dandruff and seborrhoeic category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Active substance: fluocinolone acetonide 0.25 mg per 1 g gel.
• Excipients: propylene glycol, ethanol 96% v/v, citric acid monohydrate, disodium edetate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), carbomer 940, sodium hydroxide, purified water.
• Pack: lacquered aluminium tube with 30 g gel and a plastic cap with piercing spike, in a carton with leaflet.
• Marketing authorisation holder and manufacturer: GALENIKA AD BEOGRAD, Batajnički drum b.b., Belgrade.
• Authorisation number: 515-01-03614-21-001 of 11.07.2022.

Storage

• Store below 25 °C in the original package.
• After first opening store below 25 °C in the original package for no longer than 30 days.
• Shelf life of the unopened medicine is 2 years; do not use after the expiry date.
• Keep out of the sight and reach of children; return unused medicine to a pharmacy.

Frequently asked questions

Can Sinoderm gel be used on the face?

Only if prescribed by a doctor, avoiding the area around the eyes. On the face treatment is limited to 5 days and no waterproof dressing is used. The gel must not be applied in acne, rosacea or perioral dermatitis.

How long can Sinoderm gel be used?

For as long as your doctor prescribes. It is usually applied morning and evening until symptoms settle, then reduced to once or twice a week. In children over 1 year and on the face – no more than 5 days.

Does Sinoderm gel help with fungal infection or acne?

No. A corticosteroid does not treat infections, and in acne and when infection is the main cause the medicine is contraindicated. On infected skin it may help spread the infection.

How long does a tube last after opening?

After first opening, the gel is stored below 25 °C in the original package and can be used for no longer than 30 days.

Sources

• ALIMS – Patient leaflet Sinoderm®, 0.25 mg/g, gel (July 2022, Serbian)
• ALIMS – Summary of product characteristics Sinoderm®, 0.25 mg/g, gel (Serbian)

Sources checked on: 24 October 2026.