PANTHENOL

INSTRUCTIONS for medical use of the medicinal product Panthenolum (Panthenolum)

Composition:

Active ingredient: dexpanthenol;

1 canister with a capacity of 58 g contains 2.5 g of dexpanthenol;

1 canister with a capacity of 116 g contains 5.0 g of dexpanthenol;

Excipients: phenoxyethanol, squalane, propylene glycol, cetearyl alcohol (i) sodium lauryl sulfate (i) sodium cetearyl sulfate, potassium dihydrogen phosphate, anhydrous disodium phosphate, purified water, propellant HFC-134a.

Medicinal form. Topical foam.

Main physicochemical characteristics: white foam with a faint specific odor.

Pharmacotherapeutic group.

Preparations for the treatment of wounds and ulcers. ATC code D03AX03.

Pharmacological properties.

Pharmacodynamics.

Dexpanthenol is an alcohol analogue of pantothenic acid and has the same biological efficacy as pantothenic acid due to intermediate metabolism. Pantothenic acid and its salts are water-soluble vitamins which, as part of coenzyme A, participate in numerous metabolic processes. 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 ingredient in the skin and mucous membranes have not been conducted.

Clinical characteristics.

Indications.

Used for various skin and mucous membrane injuries, including abrasions, burns, aseptic postoperative wounds, skin grafts, and bullous and pemphigoid dermatitis.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other types of interactions.

Cases of interaction are unknown.

Special precautions for use

Pressurized container. Avoid exposure to direct sunlight and temperatures above 50 °C. Do not pierce or burn, even after complete use of the foam. Dispose only after complete release of the gas. Do not spray near open flame or heated objects.

For first use, shake the container well, release the first portion until foam appears, and only then apply the medicinal product to the affected area.

Avoid contact of the foam with eyes. In case of accidental contact with eyes, rinse thoroughly with water.

Cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis), and propylene glycol may cause skin irritation.

When using the medicinal product "Panthenol" in patients with bronchial asthma or bronchopulmonary diseases, inhalation of the propellant should be avoided, as it may irritate mucous membranes or even provoke an asthma attack.

The medicinal product "Panthenol" can be used in all age groups.

Use in children only under adult supervision.

Use during pregnancy or breastfeeding

Pantothenate crosses the placental barrier via an active transport process and is excreted into breast milk in proportion to its absorption.

Since the systemic availability of dexpanthenol after topical application is unknown, the benefit of treatment for the mother and the potential risk for the fetus/infant should be carefully weighed when use of "Panthenol" is required during pregnancy or breastfeeding, especially over large skin areas. Use during pregnancy is possible under medical supervision. When used to treat nipple fissures during breastfeeding, the medicinal product should be thoroughly washed off before nursing.

Ability to influence reaction rate when driving or operating machinery

No special precautions are required.

Method of Administration and Dosage

"Pantanol" is evenly sprayed or applied to the affected area once or several times daily.

When spraying the medication, hold the container vertically with the valve facing upwards. To obtain a proper foam, shake the container vigorously before each use, especially if it has not been used for a prolonged period. When the product is used for the first time, initially only the propellant may be released before the foam forms.

Pressing the nozzle gently, evenly spray the medicinal product onto the affected area from a distance of 10–20 cm for 1–2 seconds.

The medication should not be sprayed directly onto the face. It is advisable to spray the product onto the hand first and then apply it to the affected facial area. Do not spray the medication into the eyes, directly into the mouth, or nose.

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

Children.

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

Overdose.

Overdose is unlikely when "Pantanol" is used according to the instructions.

In case of accidental ingestion of a large amount of the product, toxic effects are not expected. In the event of gastrointestinal disturbances, symptomatic treatment should be administered.

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 side effects occur, treatment should be discontinued and medical advice should be sought.

Shelf life. 2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C. Do not freeze. Keep out of reach of children.

Packaging.

58 g or 116 g in aluminum containers (tubes) in a cardboard box.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

LLC "Multispray".

Manufacturer's address and place of business.

24, Bldg. A-2, Valeriy Petrosov Street, Kharkiv, Kharkiv Oblast, 61052, Ukraine.