Description
Instructions for medical use of
BEPANTHEN®
Trade name:
BEPANTHEN®
International nonproprietary name
Dexpanthenol
Dosage form
Ointment for outward application, 5%
Composition
1 g of ointment includes:
active substance: dexpanthenol 50 mg;
adjuvants: Protegin X, cetyl alcohol, stearyl alcohol, lanolin, white bees wax, white soft paraffin, almond oil, liquid paraffin, purified water.
Description
Soft, elastic, homogeneous ointment of creany-white color with specific odor of lanolin.
Pharmacotherapeutic group
Dermatology. Drugs for treatment of wounds and ulcer. Wound-healthing drugs. Wound-healthing drugs, other. Dexpanthenol.
Code АТХ D03AX03
Pharmacological properties
Pharmacokinetics
Dexpanthenol is quickly absorbed by skin. Dexpanthenol transforms in pantothenic acid and add endogenous reserve of the Vitamine B. In blood pantothenic acid binds to plasma proteins (especially with β-globulin and albumen); is excreted in unchanged form – 60-70% with urine, the remained part through gastrointestinal system.
Pharmacodynamics
Dexpanthenol is active component of Bepanthene, quickly transforms in cells into pantothenic acid and Vitamin of B complex, that allows to have the same activity as the Vitamin. However Dexpanthenol has advantage, it is easier reabsorbable during local application. Pantothenic acid is component essential coenzyme A. In form of acetyl coenzyme A, coenzyme A takes an important part in cell metabolism. Correspondingly, pantothenic acid is necessary for formation and regeneration of skin and mucous membranes of body.
Indications
- prophylaxis and treatment of diaper rash of breast-feeding infants
- care after glandula mammaria during breast-feeding:treatment of dry and cracked nipples
- for improvement (activation) of skin healing in case of small damages, chapped skin, scratch , skin irrigations, erythemas due to diaper, easy burn,chronic ulcer, bedsores, skin transplantation, anal fissure and cervical erosion
- preventative measures and treatment of dry skin in case of damage of integrity of its cover including during use ofcorticosteroid drugs.
Dosage and methods of use
Outward application. Ointment shall be applied on damaged or irrigated skin once or several times per day as and when necessary.
Care after nursing infant: ointment shall be applied during each replacement of diaper (napkin).
Care after glandula mammaria of nursing mothers: ointment is applied on nipple after each breast-feeding proced. Prior to the next bearst-feeding it is reuired to remove remains of ointment by napkin or soft tissue.
Period of treatment depends on indications and effectiveness of therapy.
Adverse reaction
Very rear:
- allergic dermatitis
- contact dermatitis, irritation, redness
- eczema, rash, nettle rash
- skin irritation and pomphus
Contraindications
- increased individual sensitivity to drug components
Drug interaction
Cases of interaction with other drugs are not registered.
Other interaction
During treatment in genital or anal region excipients included in the ointment lead to decrease of reliability and damage of latex condoms decreasing their safety.
Special indications
Avoid eye contact with ointment.
Lanolin, stearyl and cetyl alcohols can lead to skin irrigation (for example, contact dermatitis)
Pregnancy and breast-feeding
The ointment can be used during pregnancy and breast-feeding period.
Effects on ability to drive and use potentially dangerous machines
No effects.
Overdosage
Cases of overdosage is not registered, even after use of high dosages of the ointment.
Form of output and packing
3.5 g, 30 g or 100 g of drug is placed in an aluminum tube. 1 tube with medical instruction in Kazakh and Russian is placed in cardboard package.
Storage conditions
Do not store above 25 °C.
Keep out of the reach of children!
Shelf life
3 years.
Do not use after the expiration date indicated on the package.
Conditions for drug supply
Over the counter.
Manufacturer/ Packer
GP Grenzach Produktions GmbH, Emil-Barell-Strasse 7, D-79639 Grenzach-Wyhlen, Germany
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Peter Merian-Strasse 84, Basel , Switzerland
Address of the organization receiving claims (offers) from consumers regarding the quality of products on the territory of the Republic of Kazakhstan:
«Bayer KAZ» LLP.
Timiryazev Street, 42, “Expo City” Business Center, Pav. 15
050057 Almaty, Republic of Kazakhstan
tel.: +7 727 258 80 40, fax: +7 727 258 80 39
e-mail: kz.claims@bayer.com
Address of the organization responsible for post-registration supervision over the drug safety on the territory of the Republic of Kazakhstan:
«Bayer KAZ» LLP.
Timiryazev Street, 42, “Expo City” Business Center, Pav. 15
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 – round the clock
Tel.: +7 727 258 80 40 (106) – during working hours
Fax: +7 727 258 80 39
e-mail: pv.centralasia@bayer.com
