Sinaphlan-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SINAFLAN-ZDOROVYE (SINAFLAN-ZDOROVYE)

Composition:

Active substance: fluocinolone acetonide;

1 g of the preparation contains 0.25 mg of fluocinolone acetonide;

Excipients: propylene glycol, citric acid, lanolin, white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical characteristics: white or almost white, semitransparent, greasy soft mass; a slight specific odor is permissible.

Pharmacotherapeutic group.

Corticosteroids for dermatological use. ATC code D07A C04.

Pharmacological properties.

Pharmacodynamics.

Fluocinolone acetonide is a potent synthetic glucocorticosteroid for topical use. When applied as an ointment at a concentration of 0.25 mg/g, it exerts a strong anti-inflammatory, antipruritic, anti-allergic, and vasoconstrictive effect. It possesses lipophilic properties and is readily absorbed through the skin. Even after application of 2 g of ointment, production of adrenocorticotropic hormone (ACTH) by the pituitary gland may be reduced due to suppression of the hypothalamic–pituitary–adrenal axis.

Pharmacokinetics.

Fluocinolone acetonide readily penetrates the stratum corneum of the skin, where it gradually accumulates and can still be detected even 15 days after application. It is not biotransformed in the skin. After systemic absorption, it is primarily biotransformed in the liver. It is excreted in the urine and, to a lesser extent, in bile, mainly as a conjugate with glucuronic acid, as well as in small amounts in unchanged form.

Absorption of fluocinolone acetonide through the skin is enhanced when applied to sensitive areas such as skin folds, face, or skin with impaired epidermis or inflammatory processes. Use of an occlusive dressing increases skin temperature and moisture, thereby further enhancing absorption of fluocinolone acetonide. In addition, absorption is increased with frequent application and over large skin areas. Skin absorption is higher in adolescents than in adult patients.

Clinical characteristics.

Indications.

Short-term treatment of acute and severe non-infectious inflammatory skin diseases (without exudation) accompanied by persistent itching or hyperkeratosis: seborrheic dermatitis, atopic dermatitis, nodular urticaria (papular urticaria), allergic contact dermatitis, erythema multiforme, lupus vulgaris, psoriasis, lichen planus.

Contraindications.

Skin manifestations of syphilis, cutaneous tuberculosis, pyoderma, varicella, herpes, actinomycosis, blastomycosis, sporotrichosis, diaper dermatitis, anogenital pruritus, nevus; atheroma, hemangioma, xanthoma, skin neoplasms, wounds and ulcerative skin lesions, wounds at application sites, numerous psoriatic plaques, trophic ulcers associated with varicose vein enlargement, erosive-ulcerative lesions of the gastrointestinal tract.

The ointment should not be used in bacterial, viral, and fungal skin infections, common and rosacea acne, perioral dermatitis (dermatitis perioralis), after prophylactic vaccinations, as well as in cases of confirmed hypersensitivity to fluocinolone acetonide or to other glucocorticosteroids and to other components of the drug.

Interaction with other medicinal products and other types of interactions.

The drug can be used in combination with antimicrobial agents of local and systemic action. Concurrent use with systemic glucocorticosteroids increases the efficacy of the drug, but also increases the likelihood of adverse effects. Concurrent use of the drug with non-steroidal anti-inflammatory agents increases the risk of developing systemic and local adverse effects. It may enhance the effects of antihypertensive, diuretic, antiarrhythmic drugs, and potassium preparations. Diuretic drugs (except potassium-sparing ones) increase the risk of hypokalemia. Vaccination against smallpox and other types of immunization should not be performed during treatment with the drug (especially during prolonged use on large skin areas) due to the possible lack of an adequate immunological response in the form of production of specific antibodies.

The drug may enhance the action of immunosuppressive agents and reduce the effect of immunostimulatory drugs.

Special precautions for use

The treatment must be carried out under medical supervision.

Before each repeated application of the drug, residues of ointment from the previous application should be washed off with soapy water or an antiseptic solution. Loose-fitting clothing is recommended during treatment. Do not apply on the skin of the mammary glands.

Do not use simultaneously with other topical medicinal products.

Periodic monitoring of adrenal gland function by measuring cortisol levels in blood and urine after ACTH stimulation of the adrenal glands is recommended during prolonged use.

The ointment should be used with special caution in patients with psoriasis, since topical application of glucocorticoids on areas affected by psoriasis may lead to the spread of the pathological process or relapse due to the development of tolerance, as well as to generalized pustular psoriasis and systemic toxicity caused by skin dysfunction.

Do not use the medicinal product for longer than 2 weeks without interruption. With prolonged use over large skin areas, the frequency of adverse effects increases, as well as the risk of developing edema, arterial hypertension, hyperglycemia, and reduced body resistance.

With topical use of the drug, suppression of adrenocorticotropic hormone (ACTH) production by the pituitary gland due to inhibition of the hypothalamic-pituitary-adrenal axis, decreased cortisol levels in blood, and development of iatrogenic Cushing's syndrome may occur; these effects resolve after discontinuation of the drug.

If infection develops at the site of ointment application, appropriate antibacterial or antifungal treatment should be initiated. If infection symptoms do not resolve, the use of the drug should be discontinued during the treatment of the infection.

Avoid applying the drug to the eyelids or skin around the eyes in patients with closed-angle and open-angle glaucoma, as well as in patients with cataract, due to possible worsening of disease symptoms.

Use of systemic and topical corticosteroids may cause visual disturbances.

If symptoms such as blurred vision or other visual disturbances occur, the patient should consult an ophthalmologist to evaluate possible causes, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported with the use of systemic and topical corticosteroids.

Avoid contact of the drug with the eyes.

If skin irritation occurs at the site of ointment application, discontinue use.

Use on the facial skin and in the axillary area only when absolutely necessary, as increased absorption and a high risk of adverse effects (e.g., telangiectasia, dermatitis perioralis) may occur even after short-term use.

Use with caution in patients with subcutaneous tissue atrophy, particularly in elderly individuals.

Since the medicinal product contains propylene glycol, it may cause skin irritation upon application.

Since the medicinal product contains lanolin, its use may cause local skin reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding

The drug is contraindicated during pregnancy. Breastfeeding should be discontinued for the duration of treatment with this drug.

Ability to affect reaction speed when driving or operating machinery

The medicinal product does not impair mental or motor performance, nor the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

The medication is intended for topical use. Apply the ointment in a thin layer to the affected skin area 1–2 times daily.

Do not use the ointment under occlusive dressings. Only in cases of psoriasis may a closed dressing be used, which must be changed daily.

Treatment should not be continued continuously for more than 2 weeks. Do not apply to facial skin for longer than 1 week. It is recommended not to exceed 15 g of ointment (1 tube) per week.

Use with caution under medical supervision in children aged 2 years and older, only once daily and on a small skin area; do not apply to the facial skin.

Children

Do not use the medication in children under 2 years of age.

Overdose

With prolonged application over large skin areas, symptoms of overdose may occur, manifested by an increase in adverse reactions, including burning sensation at the site of application, glucosuria, edema, arterial hypertension, and decreased resistance to infections. Pruritus, hyperglycemia, and Cushing's syndrome are possible. Treatment is symptomatic, with gradual discontinuation of the medication.

Adverse Reactions.

Skin and subcutaneous tissue disorders

Acneiform eruptions, steroid purpura, epidermal growth suppression, burning, itching, irritation, rash, subcutaneous tissue atrophy, dry skin, hypertrichosis or alopecia, depigmentation or hyperpigmentation of the skin, atrophy and impaired skin integrity, telangiectasias, furunculosis, atrophic striae, secondary infections, local skin reactions (including perioral, contact, allergic dermatitis). In individual cases, urticaria or maculopapular eruptions may occur, and exacerbation of pre-existing skin lesions is also possible.

Eye disorders

When applied externally to the skin of the eyelids, cataract or glaucoma may occasionally develop.

Blurred vision is possible.

Systemic disturbances

Application of the ointment under an occlusive dressing, due to enhanced absorption, may cause a pronounced systemic effect manifested as edema, arterial hypertension, and decreased resistance to infections.

Systemic adverse effects

Secondary immunodeficiency (exacerbation of chronic infectious diseases, generalization of infection, development of opportunistic infections), gastritis, steroid-induced gastric ulcer, hyperglycemia, glucosuria, delayed reparative processes, adrenal cortex insufficiency, growth and development retardation in children, Cushing's syndrome.

Immune system disorders

Allergic reactions or hypersensitivity reactions are possible.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 15 g in a tube, 1 tube in a cardboard box.

Prescription status. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and location of manufacturing activities.

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, 22.

(all manufacturing stages, quality control, batch release)

Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, 100, lit. B-II (building 4).

(all manufacturing stages, batch release)