Drapolene cream

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Benzalkonium chloride; Cetrimide

Saadav alates:

Supra Enterprises Ltd

ATC kood:

n/a

INN (Rahvusvaheline Nimetus):

Benzalkonium chloride; Cetrimide

Annus:

100microgram/1gram ; 2mg/1gram

Ravimvorm:

Cutaneous cream

Manustamisviis:

Cutaneous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 13020200; GTIN: 5012616171604 5012616171802 5012616172007

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this
leaflet. See section 4.
•
You must talk to a doctor if the symptoms have not resolved or if the
symptoms become worse.
What is in this leaflet:
1. What Drapolene
®
Cream is and what it is used for
2. What you need to know before you use Drapolene
®
Cream
3. How to use Drapolene
®
Cream
4. Possible side effects
5. How to store Drapolene
®
Cream
6. Contents of the pack and other information
1. What Drapolene
®
Cream is and what it is used for
Drapolene
®
Cream contains benzalkonium chloride and cetrimide in a non-greasy,
soothing cream.
These are antiseptics that help stop bacteria growing.
Drapolene
®
Cream is used in the prevention, treatment and effective relief of
nappy rash in babies, from newborn onwards.
Drapolene
®
Cream can also be used for adults with incontinence. It helps treat
and soothe skin that is sore or likely to become
sore because of urine on their skin (urinary dermatitis).
Drapolene
®
Cream can also be used to give soothing, effective relief from minor
burns, such as mild sunburn and sore skin
caused by the effects of weather.
You must talk to a doctor if the symptoms have not resolved or if the
symptoms become worse.
2. What you need to know before you use Drapolene
®
Cream
Do not use Drapolene
®
Cream: If you are allergic (hypersensitive) to benzalkonium chloride
or cetrimide or any of the other
ingredients of this medicine (listed in section 6).
Other medicines and Drapolene
®
Cream: Drapolene
®
Cream is not known to interfere with other medicines.
Warni

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Drapolene Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Drapolene contains:
Benzalkonium chloride solution 0.02% w/w
Equivalent to benzalkonium chloride 0.01% w/w
Cetrimide 0.2% w/w
Excipients with known effect:
Wool fat, cetyl alcohol, cetostearyl alcohol and chlorocresol.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Cream.
A smooth homogenous pink water miscible cream for topical application
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Drapolene is indicated for the relief of nappy rash and for use as an
adjunct to baby
care hygiene for the prevention of nappy rash.
Drapolene is indicated for the relief of urinary dermatitis in adults,
and as an adjunct
to patient care hygiene for the prevention of urinary dermatitis.
Drapolene is indicated for the symptomatic relief of minor burns,
limited sunburn and
the effects of weather.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Babies: The nappy area should be washed then dried thoroughly at each
change of nappy.
Drapolene Cream should be applied, paying particular attention to
folds in the skin.
Adults: The affected area (or the area of application) should be
washed and dried thoroughly
before applying Drapolene. Regular routine application is advised.
Drapolene should be applied as required for minor burns, limited
sunburn and the effects of
weather.
Use in the Elderly: No special comment
Method of administration: Topical
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1.
It is inadvisable to apply Drapolene Cream to a baby or adult who has
an established
hypersensitivity to benzalkonium chloride, cetrimide or wool fat
(lanolin). Use should
be discontinued if an allergic hypersensitivity reaction is suspected.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
DRAPOLENE Cream is for external use only.
Not for application to mucosa.
Drapolene Cream contains wool fat (purified lanolin), cetyl alcohol
and