FLUCINAR gel 15g.

Composition
Medicinal substance
Fluocinolone acetonide 0.25 mg / 1 g
Excipients
Propylene glycol, citric acid, ethyl alcohol 96%, methylhydroxybenzoate,
propylhydroxybenzoate, carbopol 940, triethanolamine, disodium edetate, purified water to 1 g.

Properties and action
Fluocinolone acetonide is a synthetic glycocorticosteroid for topical administration. It has lipophilic properties. It has long lasting anti-inflammatory, anti-aging and anti-allergic effects, much stronger than hydrocortisone. It easily passes through the skin and accumulates in the corneal layer. It can be found within 15 days after topical application. Systemic action possible.
Fluocinolone acetonide is mainly processed in the liver. It is excreted in the urine in small amounts unchanged or in the form of glucuronide conjugates. Absorption of fluocinolone acetonide is enhanced upon application to the face or on an inflamed, sensitive or damaged epidermis skin as well as under a covering dressing. The extent of systemic absorption of fluocinolone acetonide through the skin in children is higher than in adults.

Indications
Not responding to other steroids:
• Psoriasis, especially on the scalp
Seborrheic dermatitis, especially on the scalp
• Flat red lichen
• Prurigo
• Eczema

Contraindications
• Do not use in bacterial, viral and fungal skin infections, especially acne, rosacea, and parietal dermatitis.
• Do not use after vaccination and in case of hypersensitivity to the ingredients of the product.

Adverse drug reactions
It is possible to develop acne caused by purple steroids, inhibiting the growth of the epidermis, subcutaneous tissue atrophy, skin dryness, hirsutism or alopecia, skin depigmentation, skin atrophy, streaming, telangiectasia, perioral dermatitis, folliculitis, secondary infections. In some cases, urticaria and maculopapular rash may be possible, and possible exacerbation of existing disabilities. After administration under a covering dressing, the product can be absorbed and cause chronic effects, including edema, hypertension, weakened immunity. After application to the skin of the eyelids, glaucoma or cataracts may develop.

Drug and other interactions
Not known.

Dosage and route of administration
• Flucinzine is for topical use. It is only available on medical prescription, only at the recommended by the doctor. Do not use a cover bandage without special instructions.
• Carefully apply a small amount of product to the affected area of the skin, no more than 1-2 times and no more than 2 g of gel over 24 hours.
• Treatment is not recommended for more than 2-3 weeks. Do not apply more than 1 week.
• Do not use in children under 2 years of age.
For children over 2 years of age to be given once daily attention on small skin areas.

Special contraindications and special warnings for use
• Prolonged administration on a large skin surface may impair immunity, edema, and hypertension.
• In case of infections at the site of application of the gel, appropriate antibacterial or antimycotic treatment should be undertaken.
• If the signs of the infection do not reduce the fluconazole use until it is masked.
• Apply the product cautiously to the eyelids in patients with glaucoma or with cataracts.
• Apply gently to the skin of the face
• To be used with caution in existing atrophy of the subcutaneous tissue.
• The product contains parabens that can cause urticaria. Typically, these are delayed type reactions, e.g. contact dermatitis. Rarely, they cause a rapid-type sensitivity response with urticaria and bronchospasm.

• Flucinar gel is used topically in the first phase of treatment of acute and severe uninfected dry dermatoses, resulting from hyperglycaemia, which responds to steroids (before ointment). It is well applied to the skin of the skin and to patients sensitive to ointment and cream. The gel allows to cover a larger area of the treated skin with less product.
The patient should report any adverse drug reactions occurring during the use of the product.

Pregnancy and breastfeeding
Pregnancy
Flucinzine can only be used in pregnant women for short periods of time on small skin surfaces only when the benefits outweigh the risk. Do not use during the first three months of pregnancy. Safety in use during pregnancy: Category C
Breastfeeding
Careful use of fluconazole in nursing mothers is only recommended for short periods of time on small skin areas, but not on the chest.

Effects on ability to drive and use machines
It does not impair psychomotor functions, ability to drive and operate machinery.

Shelf life
3 years

Special storage conditions
Store below 25 0 C. Do not freeze.
Keep out of the reach and sight of children.

Package
A literographed tube containing 15 g of gel packed in a cardboard box with all the necessary indications and a leaflet.

 

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