Hepiderm-health aerosol

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEPIDERM-ZDOROVYE AEROSOL (HAPPYDERM-ZDOROVYE AEROSOL)

Composition:

Active substance: dexpanthenol;

1 g of the preparation (excluding propellant 134a) contains 50 mg of dexpanthenol;

Excipients: DL-pantolactone, cetyl stearyl alcohol, potassium cetyl phosphate, glycerol, dimethicone DM 100, purified water, propellant 134a; Euxyl® PE 9010 (Euxyl), containing phenoxyethanol and ethylhexylglycerin.

Pharmaceutical form. Topical foam.

Main physicochemical characteristics: the preparation forms a white foam upon release from the can.

Pharmacotherapeutic group. Preparations for the treatment of wounds and ulcers. ATC code D03A X03.

Pharmacological properties.

Pharmacodynamics.

The active substance of the drug is dexpanthenol – a provitamin B5, which has the same biological efficacy as pantothenic acid due to intermediate metabolism. In skin cells, dexpanthenol is rapidly converted into pantothenic acid. Pantothenic acid and its salts are water-soluble vitamins that, as coenzyme A, participate in numerous metabolic processes. Pantothenic acid is essential for the formation and healing of damaged skin and mucous membranes.

Topical application of dexpanthenol may compensate for the increased demand of damaged skin and/or mucous membranes for pantothenic acid.

Pharmacokinetics.

The active substance is absorbed through the skin. More detailed studies on the metabolism of the active substance in the skin and mucous membranes have not been conducted.

Clinical characteristics.

Indications.

Use for various injuries of the skin and mucous membranes, including abrasions, burns, aseptic postoperative wounds, skin grafts, bullous and pemphigoid dermatitis.

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

Interaction with other medicinal products is unknown when the drug is used according to indications.

Special precautions for use.

The aerosol can is under pressure; therefore, avoid dropping, impact, exposure to direct sunlight, and heating to temperatures above 50 °C.

After the medication has been used, do not open or burn the can. Do not spray the medication near open flames or onto hot surfaces. Avoid contact with eyes. In case of accidental contact with eyes, rinse thoroughly with water.

Cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding.

Dexpanthenol crosses the placental barrier via an active transport process and enters breast milk in proportion to its absorption.

Since the systemic availability of dexpanthenol following topical application is unknown, when it is necessary to use the medication during pregnancy or breastfeeding over large skin areas, the potential benefit of the treatment for the mother should be carefully weighed against the possible risk to the fetus/infant. During pregnancy, the medication may be used only as directed by a physician. When used to treat nipple fissures during breastfeeding, the medication should be washed off before nursing.

Ability to affect reaction rate when driving or operating machinery.

No special warnings apply.

Method of Administration and Dosage

Apply the preparation evenly onto the affected area one or several times a day. When spraying, hold the can vertically with the nozzle pointing upwards. To obtain a proper foam, shake the can vigorously before each use, especially if it has not been used for a prolonged period. When the preparation is used for the first time, only gas may be released initially before the foam forms.

The duration of treatment depends on the type and course of the disease and should be determined after consultation with a physician.

When applying the preparation to facial areas, do not spray directly onto the face. It is preferable to spray the preparation onto the hand and then apply it to the appropriate area of the face. Avoid spraying the preparation into the eyes, directly into the mouth, or nose.

Children.

The preparation should be used in children only as directed by a physician and under adult supervision.

Overdose.

Cases of overdose with topical application of the preparation are unknown.

Dexpanthenol is well tolerated even at high doses and is considered non-toxic. Hypervitaminosis has not been reported.

Side effects.

Allergic reactions: allergic contact dermatitis and skin irritation may very rarely occur, manifesting as symptoms such as itching, erythema, eczema, rash, urticaria, and blisters.

If any adverse reactions occur, discontinue use of the medicinal product and consult a physician.

Shelf life.

3 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.

58.5 g or 117 g in a can with a nozzle and protective cap in a box.

Supply category.

Over-the-counter.

Manufacturer.

Limited liability company "Pharmaceutical Company "Zdorovya".

Manufacturer's address and place of business.

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.