Bepanthen® plus

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BEPANTHEN® PLUS (BEPANTHEN® PLUS)

Composition:

Active substances: dexpanthenol, chlorhexidine dihydrochloride;

1 g of cream contains dexpanthenol 50 mg, chlorhexidine dihydrochloride 5 mg;

Excipients: DL-pantholactone, cetyl alcohol, stearyl alcohol, soft white paraffin, mineral oil, lanolin, polyethylene glycol stearate, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties. Homogeneous cream of almost white color with a slight odor.

Pharmacotherapeutic group.

Dermatologicals. Antiseptics and disinfectants. Chlorhexidine, combinations. ATC code D08AC52.

Pharmacological properties.

Pharmacodynamics.

Chlorhexidine dihydrochloride is a well-tolerated antiseptic with bactericidal activity against gram-positive bacteria, particularly against sensitive strains of Staphylococcus aureus – microorganisms most commonly associated with skin infections. Chlorhexidine dihydrochloride is less active against gram-negative pathogenic microorganisms. Some strains of Pseudomonas and Proteus are resistant to chlorhexidine. It has weak activity against fungi and is not active against viruses.

Dexpanthenol, the active ingredient in Bepanthen® Plus, is rapidly converted into pantothenic acid within cells and acts as a vitamin. However, dexpanthenol has the advantage of being more rapidly absorbed than pantothenic acid when applied topically.

Pantothenic acid is a component of the essential coenzyme A (CoA). In this form, acetyl-coenzyme A (CoA) plays a central role in the metabolism of every cell. Thus, pantothenic acid is essential for the formation and healing of damaged skin and mucous membranes.

Pharmacokinetics.

Absorption of chlorhexidine through intact skin has not been demonstrated. Low blood concentrations of chlorhexidine (1 µg/mL) have been observed in infants bathed in a 4% solution of chlorhexidine gluconate.

Little is known about the distribution of chlorhexidine in organs and tissues due to minimal absorption through the skin. After oral administration of 300 mg in healthy adults, the maximum plasma concentration of 0.2 µg/mL is detectable after 30 minutes.

Chlorhexidine is practically not absorbed after topical application on the skin in adults.

Dexpanthenol is rapidly absorbed through the skin. In skin cells, it is quickly converted into pantothenic acid and contributes to the endogenous stores of this vitamin.

Pantothenic acid binds to plasma proteins (mainly β-globulin and albumin). In healthy adults, the concentration is approximately 500–1000 µg/L in whole blood and 100 µg/L in serum, respectively.

Pantothenic acid is not metabolized in the body and is excreted unchanged. 60–70% of an oral dose is excreted in urine, the remainder in feces. In adults, 2–7 mg is excreted daily in urine; in children, 2–3 mg daily.

Clinical characteristics.

Indications.

• Superficial skin lesions of any origin associated with a risk of infection: scratches, cuts, skin excoriations, skin fissures, burns, abscesses, dermatitis.
• Chronic skin lesions, such as leg ulcers and pressure sores.
• Skin infections, for example, secondarily infected eczema and secondarily infected neurodermatitis.
• Treatment of nipple fissures in breastfeeding women.
• Minor surgery: injuries and surgical wounds.

Contraindications.

Hypersensitivity to dexpanthenol and/or chlorhexidine, or to any of the other components of the medicinal product.

Application on a perforated eardrum is contraindicated.

Interaction with other medicinal products and other forms of interaction.

Chlorhexidine is incompatible with surfactants and other anionic compounds. Bepanthen® Plus is not recommended for simultaneous use with other antiseptics to avoid mutual interference (antagonism or inactivation).

Special precautions for use

Avoid contact with eyes, ears, and mucous membranes.

Bepanthen® Plus is not recommended for the treatment of skin irritations with low risk of infection (e.g., sunburn). In such cases, Bepanthen® cream is recommended. Do not use in allergic skin disorders without infectious complications.

Rarely, when using antiseptic agents containing chlorhexidine, mild to moderate symptoms of allergic reactions may occur, which may affect the skin (e.g., itching, urticaria), face (e.g., angioneurotic edema), respiratory tract (e.g., asthma, wheezing or other breathing difficulties), gastrointestinal tract, and cardiovascular system. If symptoms of a serious allergic reaction occur, use of Bepanthen® Plus should be discontinued immediately and medical advice should be sought to prevent further progression.

Large, heavily contaminated, or deep wounds, as well as wounds resulting from bites or punctures, require medical intervention (risk of tetanus). If the wound size remains extensive or the wound does not heal within 10–14 days, the appropriateness of continued treatment should be reassessed. This is also necessary if pronounced perifocal hyperemia, swelling, severe pain, increased purulent exudation, or fever occur (risk of sepsis). The product should not be used for the treatment of infected wounds with abundant purulent exudation.

If infection persists or worsens, consult a physician.

Bepanthen® Plus must not enter the eyes. Serious cases of persistent corneal damage, potentially requiring corneal transplantation, have been reported following accidental exposure to medicinal products containing chlorhexidine, despite protective measures, due to migration of the solution beyond the intended surgical area. Extreme caution must be exercised during application to ensure that Bepanthen® Plus does not migrate beyond the intended site of application into the eyes. Particular caution is required in anesthetized patients, who may be unable to immediately report exposure to the eyes. If Bepanthen® Plus comes into contact with the eyes, they should be immediately and thoroughly rinsed with water. An ophthalmologist should be consulted.

Use during pregnancy or breastfeeding

Animal reproductive studies have shown no risk to the fetus. However, during pregnancy, Bepanthen® Plus should not be applied over large skin areas, as there are no controlled data available from studies in pregnant women.

The product may be used by breastfeeding women, but application over large skin areas should be avoided. If used to treat nipple fissures, the product should be washed off before breastfeeding.

Ability to affect reaction speed when driving or operating machinery. No effect.

Method of Administration and Dosage.

For adults and children aged 1 year and older: apply the product once or several times daily, as needed, to previously cleansed affected areas of the skin.

The daily dose during repeated application should not exceed 5 g of cream.

If necessary, dressings may be used.

The frequency of cream application and duration of treatment are determined individually by a physician according to clinical signs of skin injury. Application over large skin areas should be avoided.

Children. The product may be used in children aged 1 year and older.

Overdose.

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

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

Elevated aminotransferase levels have been described following self-poisoning with chlorhexidine.

Skin irritation may often occur after repeated topical application to the same skin areas. The product is intended for the treatment of superficial skin injuries. Application over large skin areas should be avoided.

Side effects.

Immune system, skin and subcutaneous tissue disorders. Allergic reactions, including skin allergic reactions such as contact dermatitis, allergic dermatitis, pruritus, erythema, burning sensation, eczema, rash, urticaria, swelling, skin irritation, blisters. Hypersensitivity, anaphylactic reactions and anaphylactic shock (potentially life-threatening) with corresponding laboratory and clinical manifestations, including asthma syndrome, reactions ranging from mild to moderate severity, potentially affecting the skin, respiratory system, gastrointestinal tract, cardiovascular system, including cardiorespiratory failure.

Eye disorders. Corneal erosion, epithelial defect/corneal injury, severe irreversible visual impairment. In the post-marketing period, cases of severe corneal erosion and severe irreversible visual impairment have been reported due to accidental ocular exposure, resulting in corneal transplantation being required for some patients (see section "Special precautions").

Shelf life. 3 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. Keep out of reach of children.

Packaging. 3.5 g, or 30 g, or 100 g of cream in tubes, in a cardboard box.

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

Manufacturer.

GP Grenzach Produktions GmbH.

Manufacturer's address and place of business.

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