Bepanthen ointment

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

dexpanthenol

Available from:

GP Grenzach Produktions GmbH

ATC code:

D03AX03

INN (International Name):

dexpanthenol

Dosage:

50mg/g

Pharmaceutical form:

ointment

Units in package:

aluminium tube 30g, aluminium tube 100g

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2020-02-07

Summary of Product characteristics

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.
_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
Page 2 of 3
Summary of Product Characteristics
Bepanthen
®
, ointment
_4.8 UNDESIRABLE EFFECTS _
The listed adverse drug reactions are based on sp