Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
dexpanthenol
GP Grenzach Produktions GmbH
D03AX03
dexpanthenol
50mg/g
ointment
aluminium tube 30g
OTC
Registered
2019-06-28
Page 1 of 3 Summary of Product Characteristics Bepanthen ® , ointment SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BEPANTHEN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cream contains: Dexpanthenol 50 mg 3. PHARMACEUTICAL FORM Ointment 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ ■ Promotion of healing and epithelialization in minor injuries (e.g. minor burns and scrapes), skin irritations (resulting e.g. from radiotherapy, phototherapy or exposure to ultraviolet light), nappy (diaper) rash, chronic and decubitus ulcers, anal fissures, skin grafts and cervical erosions. ■ Care of dry, rough or chapped skin. ■ Off-day or follow-up medication for patients treated with corticosteroids. ■ Breast care in nursing mothers and treatment of sore or cracked nipples. _4.2 _ _POSOLOGY AND METHOD OF ADMINISTRATION _ For external use. Apply one or more times daily, as needed. Breast care in nursing mothers: apply ointment to nipples after each breastfeeding. Infant care: apply at each nappy (diaper) change. Duration of treatment depends on the nature and state of the disease. _4.3 _ _CONTRAINDICATIONS _ Bepanthen Ointment must not be used by persons known to be hypersensitive to any of its ingredients. _4.4 _ _SPECIAL WARNINGS AND PRECAUTIONS FOR USE _ Avoid contact with the eyes. Beeswax, stearyl alcohol and cetyl alcohol may cause local skin reactions (e.g., contact dermatitis). _4.5 _ _INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS _ None known. _Other Forms of Interactions_: Some of the excipients in Bepanthen ointment may reduce the effectiveness of latex products such as condoms and/or diaphragms. . Page 2 of 3 Summary of Product Characteristics Bepanthen ® , ointment _4.6 _ _PREGNANCY AND LACTATION _ There is no evidence to suggest that use during pregnancy or while breastfeeding poses any risk. _4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINERY _ Not applicable. _4.8 UNDESIRABLE EFFECTS _ The listed adverse drug reactions are based on Read the complete document