Dovobet 50 microgram/g + 0.5 mg/g gel

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Calcipotriol; Betamethasone

Beschikbaar vanaf:

PCO Manufacturing Ltd.

ATC-code:

D05AX; D05AX52

INN (Algemene Internationale Benaming):

Calcipotriol; Betamethasone

Dosering:

50 mcg/g +

farmaceutische vorm:

Gel

Prescription-type:

Product subject to prescription which may not be renewed (A)

Therapeutisch gebied:

Other antipsoriatics for topical use; calcipotriol, combinations

Autorisatie-status:

Authorised

Autorisatie datum:

2012-07-06

Bijsluiter

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOVOBET
® 50 MICROGRAMS/G + 0.5 MG/G GEL
calcipotriol/betamethasone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.

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.
WHAT IS IN THIS LEAFLET:
1.
What Dovobet is and what it is used for
2.
What you need to know before you use Dovobet
3.
How to use Dovobet
4.
Possible side effects
5.
How to store Dovobet
6.
Contents of the pack and other information
1.
WHAT DOVOBET IS AND WHAT IT IS USED FOR
Dovobet is used as topical treatment of scalp psoriasis in adults and
on
the skin of other body areas to treat mild to moderate plaque
psoriasis
(psoriasis vulgararis) in adults. Psoriasis is caused by your skin
cells
being produced too quickly. This causes redness, scaling and thickness
of your skin.
Dovobet contains calcipotriol and betamethasone.
Calcipotriol helps to bring the rate of skin cell growth back to
normal and
betamethasone acts to reduce inflammation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DOVOBET
DO NOT USE DOVOBET:
•
If you are allergic (hypersensitive) to calcipotriol, betamethasone or
any of the other ingredients of Dovobet (listed in section 6)
•
If you have problems with calcium levels in your body (ask your
doctor)
•
If you have certain types of psoriasis: these are erythrodermic,
exfoliative and pustular (ask your doctor)
As Dovobet contains a strong steroid, do NOT use it on skin affected
by:
•
skin infections caused by viruses (e.g. cold sores or chicken pox)
•
skin infections caused by a fungus (e.g. athlete’s foot or ringworm)
•
skin i

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dovobet 50 microgram/g + 0.5 mg/g gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains 50 micrograms of calcipotriol (as
monohydrate) and 0.5 mg of betamethasone (as
dipropionate).
Excipient with known effect:
Butylhydroxytoluene (E321)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel.
_Product imported from Norway, the UK and Greece:_
An almost clear, colourless to slightly off-white gel.
4 CLINICAL PARTICULARS
As per PA1025/001/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1025/001/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Paraffin, liquid
Polyoxypropylene stearyl ether
Castor oil, hydrogenated
Butylhydroxytoluene (E321)
All-rac-
-tocopherol
6.2 INCOMPATIBILITIES
In the absence of compatibility studies, this medicinal product must
not be mixed with other medicinal products
6.3 SHELF LIFE
Unopened container: The shelf life expiry date of this product is the
date shown on the container and outer carton of the
product as marketed in the country of origin.
After first opening: 3 months.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not refrigerate. Keep the bottle in the outer carton in order to
protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
High-density polyethylene bottles