Panthenol spray

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANTENOL SPRAY (PANTHENOLSPRAY)

Composition:

Active substance: dexpanthenol;

100 g of topical foam contains 4.63 g of dexpanthenol;

Excipients: cetostearyl alcohol (type A) emulsified, liquid light paraffin wax, light mineral oil, acetic acid, purified water, propellant (butane, isobutane, propane).

Pharmaceutical form. Topical foam.

Main physicochemical characteristics: white foam with a slightly sour odor.

Pharmacotherapeutic group.

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

Pharmacological properties.

Pharmacodynamics. The active ingredient of the medicinal product is dexpanthenol — a provitamin B5 that 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 which, in the form of coenzyme A, participate in numerous metabolic processes. Thus, 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 injured skin and/or mucous membranes for pantothenic acid. Pharmacokinetics. Studies using tritium-labeled pantenol have shown that the substance is absorbed through the skin. Detailed studies on the metabolism of the active ingredient in the skin and mucous membranes have not been conducted. There is also no information regarding pharmacokinetic studies of pantenol application to the eyes.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

When using the medicinal product "Panthenol spray" according to indications, no interactions with other medicinal products have been identified.

Special precautions for use

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

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

If the medicinal product is applied to the genital or anal area and condoms are used, their strength may be reduced due to the presence of light mineral oil in the foam. Thus, the integrity of condoms may be compromised.

Use in specific age groups

"Pantenol spray" can be used in all age groups.

Children should only use the product under adult supervision.

Appropriate safety measures during use

Pressurized container. Protect from sunlight and temperatures above 50°C. Do not pierce or burn, even after complete use of the foam. Dispose only after complete release of gas. Do not spray near open flames or hot surfaces.

When using the medicinal product "Pantenol spray", patients with bronchial asthma or bronchopulmonary disorders should avoid inhaling the propellant, as it may irritate mucous membranes or even provoke an asthma attack.

Use during pregnancy or breastfeeding

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

Since the systemic bioavailability of dexpanthenol after topical application is unknown, when use of "Pantenol spray" is required during pregnancy or breastfeeding, especially over large skin areas, the potential benefit to the mother should be carefully weighed against the possible risk to the fetus or infant. Use during pregnancy is possible under medical supervision. When used to treat nipple fissures during breastfeeding, "Pantenol spray" should be washed off before each feeding.

Ability to influence reaction speed when driving or operating machinery

No special precautions are required. Studies evaluating such effects have not been conducted. Given the adverse reaction profile, no influence on reaction speed during driving or operating machinery is expected.

Method of administration and dosage.

"Pantanol spray" should be evenly sprayed or applied to the affected area once or several times a day.

When spraying the medication, hold the container vertically with the nozzle facing upwards. To obtain a proper foam, the container must be shaken vigorously before each use, especially if it has not been used for a prolonged period. When the medication is used for the first time, only the propellant 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 "Pantanol spray" to facial areas, do not spray it directly onto the face. It is advisable to spray the medication onto the hand first and then apply it to the appropriate area of the face. Avoid spraying "Pantanol spray" into the eyes, directly into the mouth or nose.

Children. This medication should be used in children only as directed by a physician and under adult supervision.

Overdose.

Overdose is unlikely when using "Pantanol spray" according to the instructions.

Even if a large amount of the medication is ingested, toxic effects are not expected. In case 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 reactions occur, discontinue use of the medicinal product and consult a physician.

Shelf life.

24 months.

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

Storage conditions. Store at a temperature not exceeding 25 °C.

Packaging. 130 g in a pressurized container; 1 pressurized container in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer. Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH.

Bausch + Lomb Ireland Limited.

Manufacturer's name and address of the place of business.

Brunsbütteler Damm 165/173, 13581 Berlin, Germany.

3013 Lake Drive, Citywest Business Campus, Dublin 24, D24 PPTZ, Ireland.