Karbamid Evolan 50 mg/g Kräm

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

urea

Tillgänglig från:

Evolan Pharma AB

ATC-kod:

D02AE01

INN (International namn):

urea

Dos:

50 mg/g

Läkemedelsform:

Kräm

Sammansättning:

propylenglykol Hjälpämne; etylparahydroxibensoat Hjälpämne; cetostearylalkohol Hjälpämne; metylparahydroxibensoat Hjälpämne; urea 50 mg Aktiv substans

Receptbelagda typ:

Receptfritt

Produktsammanfattning:

Förpacknings: Burk med pump, 500 g

Bemyndigande status:

Godkänd

Tillstånd datum:

2018-10-09

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
KARBAMID EVOLAN 50 MG/G CREAM
Urea
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 have 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 you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Karbamid Evolan is and what it is used for
2.
What you need to know before you use Karbamid Evolan
3.
How to use Karbamid Evolan
4.
Possible side effects
5.
How to store Karbamid Evolan
6.
Contents of the pack and other information
1.
WHAT KARBAMID EVOLAN IS AND WHAT IT IS USED FOR
Karbamid Evolan is a white emollient cream containing 5 % urea. The
water-binding ability
of urea contributes to normalization of dry skin.
Karbamid Evolan is used to moisturise dry skin of different origin and
to prevent relapses of
atopic eczema.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE KARBAMID EVOLAN
DO NOT USE KARBAMID EVOLAN
-
if you are allergic to urea or any of the other ingredients of this
medicine (listed in section
6).
WARNINGS AND PRECAUTIONS
-
Avoid application into eyes, nose, ears or to open wounds or mucous
membranes.
PREGNANCY AND BREAST-FEEDING
Karbamid Evolan can be used during pregnancy and breast-feeding.
DRIVING AND USING MACHINES
Karbamid Evolan has no effect on the ability to drive or use machines.
KARBAMID EVOLAN CONTAINS ETHYL AND METHYL PARAHYDROXYBENZOATE,
CETOSTEARYL ALCOHOL
AND PROPYLENE GLYCOL
Ethyl and methyl parahydroxybenzoate may cause allergic reactions
(possibly delayed).
Cetostearyl alcohol may cause local skin reactions (e.g. contact
dermatitis).
Propylene glycol may cause skin irritation. Do not use this medicine
in

Produktens egenskaper

S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Karbamid Evolan 50 mg/g cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cream contains: urea 50 mg.
Excipient(s) with known effect
Ethyl parahydroxybenzoate, methyl parahydroxybenzoate, cetostearyl
alcohol, propylene
glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
White cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For moisturising of dry skin of different origin and for prevention of
relapse of atopic eczema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For moisturising of dry skin of different origin: The cream can be
applied when needed,
preferably several times daily and always after contact with water.
For prevention of relapse of atopic eczema: Apply at least twice daily
and preferably after
contact with water.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid application into eyes, nose, ears or to open wounds or mucous
membranes.
Karbamid Evolan cream contains ethyl and methyl parahydroxybenzoate,
which may cause
allergic reactions (possibly delayed).
Karbamid Evolan cream contains cetostearyl alcohol, which may cause
local skin reactions
(e.g. contact dermatitis).
Karbamid Evolan cream contains propylene glycol, which may cause skin
irritation.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies have been performed.
4.6
FERTILITY, PREGNANCY AND LACTATION
Karbamid Evolan can be used during pregnancy and lactation.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
There is no indication that Karbamid Evolan has any effect on the
ability to drive or use
machines.
4.8
UNDESIRABLE EFFECTS
The cream can give transient, local sensation of burning and heat. The
face is most sensitive.
Common
(>1/100)
_Skin_
: Transient sensations of burning or heat
Reporting of suspected adverse reactions
Reporting suspected adverse reactions