DERMAFLUCIN

Dermaflucin

Gel, 0.25 mg/g

One gram of gel contains the active substance fluocinolone acetonide 0.25 mg.

Excipients with known effect: propylene glycol 150 mg/g (may cause skin irritation), methyl parahydroxybenzoate (E218) 1.5 mg/g and propyl parahydroxybenzoate (E216) 0.8 mg/g (may cause allergic reactions, even delayed ones). Other excipients: ethanol 96 %, disodium edetate, citric acid, carbomer, triethanolamine, purified water.

A potent topical corticosteroid for the local treatment of acute, severe, non-infectious inflammatory skin diseases responsive to corticosteroids, accompanied by persistent itching and hyperkeratosis: seborrhoeic dermatitis, atopic dermatitis, neurodermatitis (lichen simplex chronicus), allergic contact dermatitis, erythema multiforme, lupus erythematosus, psoriasis (especially of hairy skin areas), long-term psoriasis, lichen planus.

Fluocinolone acetonide is a potent synthetic glucocorticoid with anti-inflammatory, antipruritic and vasoconstrictive action. The gel penetrates the skin easily due to its lipophilic properties and acts rapidly in foci of inflammation. Even small amounts (from 2 g of gel) can suppress the pituitary-adrenal axis.

Apply a thin layer to the affected area 2–3 times a day, massaging gently. After acute inflammation subsides, reduce the frequency to once or twice a day.

Treatment must not exceed 2 weeks; on the face, no more than 1 week. The maximum amount is 15 g (1 tube) per week. Do not use occlusive dressings; if a dressing is needed, use a breathable one.

Children over 2 years: only if strictly necessary, once a day, on a small area; do not apply to the face. Contraindicated in children under 2 years.

Important to know

Like any potent corticosteroid, do not apply to large areas, under occlusive dressings, or on the face, armpits or groin more than strictly necessary: absorption increases, raising the risk of systemic effects (Cushing's syndrome, hypertension, hyperglycaemia, immunosuppression, adrenal suppression). Children are at greater risk of systemic absorption. Stop treatment if irritation or hypersensitivity reactions occur.

Avoid contact with the eyes, mucous membranes and wounds; do not apply around the eyes (risk of glaucoma or cataract). If vision disturbances occur, consult an ophthalmologist. The gel contains parabens (E218, E216) and propylene glycol. Use with caution during pregnancy; during breast-feeding, the decision is made together with your doctor. Read the package leaflet carefully before use.

Possible side effects

Local (frequency not known): burning, itching, irritation, skin rash, dry skin, acne-like eruptions, pigmentation changes, skin atrophy, stretch marks, telangiectasia, perioral dermatitis, folliculitis, secondary infections; occasionally urticaria or worsening of existing lesions.

Eye-related: blurred vision; risk of glaucoma or cataract with application to the eyelids.

Systemic (with prolonged use, large areas or in children): suppression of the pituitary-adrenal axis, Cushing's syndrome, growth retardation in children, hyperglycaemia, oedema, hypertension, immunosuppression.

If side effects occur, stop using the product and consult a doctor or pharmacist.

Store below 25 °C. Keep out of the reach of children. Shelf life: 36 months.

For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.

Brief information prepared on the basis of the approved Summary of Product Characteristics. It does not replace consultation with a doctor or pharmacist and does not contain all information about the medicine. Always read the package leaflet.