Sinaphlan-viola

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SYNAFLAN-VIOLA (SYNAFLAN-VIOLA)

Composition:

Active ingredient: fluocinoloni acetonidum;

1 g of ointment contains fluocinolone acetonide 0.25 mg;

Excipients: benzyl alcohol, propylene glycol, white soft paraffin, lanolin, ceresin.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of light yellow to yellow color. The ointment should be homogeneous.

Pharmacotherapeutic group.

Corticosteroids for dermatological use. ATC code D07AC04.

Pharmacological properties.

Pharmacodynamics.

The active substance is a synthetic fluorinated glucocorticosteroid for topical use – fluocinolone acetonide. The medicinal product exerts anti-inflammatory, antiallergic, anti-exudative, and antipruritic effects. It reduces and eliminates inflammatory reactions of the skin. It inhibits accumulation of macrophages and leukocytes at the site of inflammation, suppresses formation of T- and B-lymphocytes, disrupts their interaction, reduces vascular-tissue permeability, thus preventing development of inflammatory edema.

It suppresses phagocytosis, release of microsomal enzymes and inflammatory mediators.

Pharmacokinetics.

Fluocinolone acetonide readily penetrates the skin through its outer keratinized layer. Absorption of fluocinolone acetonide through the skin is enhanced when applied to sensitive skin areas such as skin folds and face, as well as to skin with damaged epidermis or inflammatory processes. Application of occlusive dressings increases skin temperature and humidity, which also leads to enhanced absorption of fluocinolone acetonide. In addition, absorption is increased with frequent application of the medicinal product and over large skin areas. Skin absorption is higher in adolescents than in adults. The drug is metabolized mainly in the liver. Minimal absorption of the drug does not produce systemic effects and does not suppress adrenal cortex function. Use of occlusive dressings substantially increases bioavailability, which may lead to development of generalized resorptive effects typical of fluorinated glucocorticosteroids.

It is excreted in urine and in minor amounts – in bile, as glucuronide conjugates and in unchanged form.

Clinical characteristics.

Indications.

Allergic and inflammatory skin diseases of non-microbial etiology (seborrheic dermatitis, eczema of various origins and localizations, psoriasis).

Contraindications.

Skin manifestations of syphilis, cutaneous tuberculosis, pyoderma, varicella, herpes, actinomycosis, blastomycosis, sporotrichosis, diaper dermatitis, anogenital pruritus, nevus, melanoma, sarcoma; atheroma, hemangioma, xanthoma, skin neoplasms, wounds and ulcerative skin lesions, application site wounds, 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), following prophylactic vaccinations, or in cases of confirmed hypersensitivity to fluocinolone acetonide or other glucocorticosteroids or other components of the drug. The drug must not be used in ophthalmology.

Interaction with other medicinal products and other types of interactions.

Concomitant use with systemic-acting glucocorticosteroids increases the drug's efficacy, but also increases the risk of adverse effects.

Concomitant use of the drug with nonsteroidal anti-inflammatory agents increases the risk of 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 likelihood of developing hypokalemia.

During treatment with this drug, vaccination against smallpox and other types of immunization are not recommended (especially during prolonged use over large skin areas) due to the possible absence of an adequate immunological response in the form of specific antibody production.

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

Special precautions for use

Treatment should be carried out under medical supervision.

Before each repeated application of the medicinal product, residual ointment from the previous application should be washed off with a soap solution or an antiseptic solution. Loose-fitting clothing is recommended during treatment. Do not apply the ointment to the skin of the mammary glands.

Do not use the ointment simultaneously with other topical medicinal products.

Periodic monitoring of adrenal gland function by measuring cortisol levels in blood and urine after adrenal stimulation with adrenocorticotropic hormone is recommended during prolonged use.

Particular caution is required when using the ointment in patients with psoriasis, as topical application of glucocorticoids to 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 continuously for more than 2 weeks. With prolonged use over large areas of skin, the frequency of adverse effects increases, along with the risk of developing edema, arterial hypertension, hyperglycemia, and reduced resistance of the body.

With topical application of the medicinal product, the following may occur: decreased production of adrenocorticotropic hormone by the pituitary gland due to suppression of the hypothalamic–pituitary–adrenal axis, reduced cortisol levels in blood, and development of iatrogenic Cushing's syndrome, which resolves 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 product to the eyelids or the skin around the eyes in patients with closed-angle and open-angle glaucoma, as well as in patients with cataracts, due to the potential worsening of disease symptoms.

Use of systemic and topical corticosteroids may lead to visual disturbances.

If symptoms such as blurred vision or other visual disturbances occur, patients should consult an ophthalmologist to evaluate possible causes, including 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 product with the eyes. If skin irritation occurs at the site of ointment application, treatment should be discontinued.

Use on the facial skin and in the axillary area only when strictly necessary, as increased absorption and 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, it may cause a local reaction (e.g., contact dermatitis).

Use during pregnancy or breastfeeding

The product should not be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery

The medicinal product does not impair mental or motor performance and does not affect the ability to drive vehicles or operate machinery.

Method of Administration and Dosage.

The medication is intended for topical use only. Apply a small amount of the medication 1–2 times daily and gently rub in. The duration of treatment depends on the nature of the condition and usually lasts 5–10 days; in prolonged cases, treatment should not exceed 2 weeks. In children aged 2 years and older, use with caution once daily under medical supervision. Do not apply the ointment under occlusive dressings; however, in psoriasis, application under a closed dressing is permitted, which should be changed daily. Do not apply to facial skin for longer than 1 day. The ointment is recommended primarily for dry forms of dermatoses. Duration of use in children should not exceed 5 days.

Children. The medication should be used in children aged 2 years and older with caution, under medical supervision, once daily, and only on small skin areas. Do not apply the ointment to a child's facial skin.

Overdose.

Prolonged application over large skin areas may lead to symptoms of overdose, manifested by an increase in adverse reactions, including burning sensation at the site of application, glucosuria, edema, arterial hypertension, and decreased resistance to infections. Itching, hyperglycemia, and Cushing's syndrome (Izenko–Cushing syndrome) may also occur. Treatment is symptomatic, with gradual discontinuation of the medication.

Adverse Reactions

Skin and subcutaneous tissue disorders

Acneiform eruptions, post-steroidal purpura, epidermal growth suppression, burning, pruritus, irritation, rash, subcutaneous tissue atrophy, dry skin, hypertrichosis or alopecia, depigmentation or hyperpigmentation, 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 rash may occur, or pre-existing pathological skin conditions may worsen.

Eye disorders

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

Visual blurring is possible.

Systemic disorders

Use under occlusive dressing, due to enhanced absorption, may lead to pronounced systemic effects, manifested as edema, arterial hypertension, and decreased resistance to infections.

Systemic adverse effects

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

Immune system disorders

Allergic reactions or hypersensitivity reactions are possible.

Shelf life. 5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C. Do not freeze.

Keep out of reach of children.

Packaging. 15 g in tubes. 1 tube per carton.

Prescription status. Prescription only.

Manufacturer. JSC "FITOFARM".

Manufacturer's address and location of business activity.

2 Sybirtseva Street, Bakhmut, Donetsk Oblast, 84500, Ukraine.

Marketing Authorization Holder. PJSC FF "VIOLA".

Address of Marketing Authorization Holder.

75 Akademika Amosova Street, Zaporizhzhia, Zaporizhzhia Oblast, 69063, Ukraine.