BEPANTHEN®

INSTRUCTIONS for medical use of the medicinal product BEPANTHEN® (BEPANTHEN®)

Composition:

Active substance: dexpanthenol;

1 g of cream contains dexpanthenol 50 mg;

Excipients: DL-pantolactone, phenoxyethanol, Amphizol K, cetyl alcohol, stearyl alcohol, lanolin, isopropyl myristate, propylene glycol, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous opaque cream of white or white with a yellowish tint, with a faint odour.

Pharmacotherapeutic group. Agents for treatment of wounds and ulcerative lesions. Agents promoting wound healing (scar formation). Dexpanthenol.

ATC code D03A X03.

Pharmacological properties.

Pharmacodynamics.

Dexpanthenol, the active ingredient of Bepanthen® cream, is rapidly converted into pantothenic acid within cells and acts as a vitamin. Following topical application, dexpanthenol is absorbed more readily than pantothenic acid.

Pantothenic acid is a component of the essential coenzyme A (CoA). Acetyl-coenzyme A (acetyl-CoA) plays a central role in cellular metabolic processes. Thus, pantothenic acid is essential for the restoration and regeneration of damaged skin and mucous membranes.

Pharmacokinetics.

Dexpanthenol is rapidly absorbed through the skin. It is then immediately converted into pantothenic acid and incorporated into the body's endogenous pool of this vitamin.

In the bloodstream, pantothenic acid binds to plasma proteins (primarily to β-globulins and albumin). In healthy adults, concentrations are approximately 500–1000 μg/L in whole blood and 100 μg/L in blood serum, respectively.

Pantothenic acid is not metabolized in the body and is excreted unchanged. After oral administration, 60–70% of the dose is excreted in the urine and the remainder in the feces. Adults excrete 2–7 mg of pantothenic acid per day in the urine, children excrete 2–3 mg.

Clinical characteristics.

Indications.

Bepanthen®, cream, is indicated in the following cases:

• prophylactic treatment of dry, reddened skin or skin with cracks;
• acceleration of healing and epithelialization of skin in minor injuries (mild burns and abrasions); in skin irritations (e.g., due to radiotherapy, phototherapy, or ultraviolet radiation); diaper dermatitis; chronic skin ulcers and pressure sores; anal fissures; cervical erosions and after skin grafting;
• skin care in patients during and after topical application of corticosteroids;
• prophylactic care of mammary glands in breastfeeding women and for treatment of irritation and fissures of the nipples.

Contraindications.

Hypersensitivity to dexpanthenol or to any of the excipients of the product.

Interaction with other medicinal products and other forms of interaction.

Cases of interaction with other medicinal products are unknown.

Special precautions for use.

When using the product, avoid contact with the eyes.

Cetyl alcohol, stearyl alcohol, and lanolin may cause local skin reactions (e.g., contact dermatitis). Propylene glycol may cause skin irritation.

Use during pregnancy or breastfeeding.

There are no grounds to consider the use of the product during pregnancy or breastfeeding as hazardous. During pregnancy, the product should be used only as prescribed by a physician.

When used to treat nipple fissures during breastfeeding, the product should be washed off before each feeding.

Ability to influence reaction rate while driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

Accelerating healing and epithelialization, regular skin care: apply Bepanthen®, cream, 1 or several times a day as needed.

Care of mammary glands in breastfeeding women: apply the cream to the nipples after each breastfeeding session.

Treatment of cervical mucosa defects: apply the cream 1 or several times a day under medical supervision.

Infant care: apply Bepanthen®, cream, after each diaper (nappy) change.

Bepanthen®, cream, rapidly penetrates the skin and is therefore suitable for the care of weeping wounds, exposed skin surfaces (face), and hairy areas of skin. It spreads easily over the surface, making it suitable for treating painful sunburns and other mild burns.

Children. The product can be used in children of all age groups, including infants.

Overdose.

Even inappropriate application of a larger amount of Bepanthen®, cream, does not lead to toxic adverse reactions.

Side effects.

Immune system, as well as skin and subcutaneous tissue disorders. In rare cases (<1/10,000), allergic reactions and allergic skin reactions have been reported: contact dermatitis, allergic dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.

Shelf life. 3 years.

Storage conditions.

Store at temperatures not exceeding 25 °C. Keep out of reach of children.

Packaging.

30 g or 100 g in a tube, 1 tube per cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer.

GP Grenzach Produktions GmbH

Manufacturer's address.

Emil-Barell-Strasse 7, 79639 Grenzach-Wyhlen, Germany