Daivobet 50 micrograms/0.5mg/g gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BETAMETHASONE, CALCIPOTRIOL

Available from:

LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark

ATC code:

D05AX52

INN (International Name):

BETAMETHASONE 0.5 mg/g CALCIPOTRIOL 50 µg/g

Pharmaceutical form:

GEL

Composition:

BETAMETHASONE 0.5 mg/g CALCIPOTRIOL 50 µg/g

Prescription type:

POM

Therapeutic area:

ANTIPSORIATICS

Authorization status:

Withdrawn

Authorization date:

2012-01-16

Patient Information leaflet

PAGE 1 OF 19
PACKAGE LEAFLET: INFORMATION FOR THE USER
DAIVOBET 50 MICROGRAMS/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 Daivobet
is
and what it_ _is used for
2.
What you need to know before you use Daivobet
3.
How to use Daivobet
4.
Possible side effects
5.
How to store Daivobet
6.
Contents of the pack and other information
1.
WHAT DAIVOBET IS AND WHAT IT IS USED FOR
Daivobet 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
vulgaris) in adults.
Psoriasis is caused by your skin cells being produced too quickly.
This causes redness,
scaling and thickness of your skin.
Daivobet 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 DAIVOBET
DO NOT USE DAIVOBET:
■
if you_ _are allergic (hypersensitive)_ _to calcipotriol,
betamethasone or any of the
other ingredients of Daivobet_ _(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 Daivobet 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

Summary of Product characteristics

Page 1 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Daivobet 50 micrograms/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) 160 micrograms/g gel
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
An almost clear, colourless to slightly off-white gel.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment of scalp psoriasis in adults. Topical treatment of
mild to moderate “non-scalp”
plaque psoriasis vulgaris in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Daivobet gel should be applied to affected areas once daily. The
recommended treatment period is
4 weeks for scalp areas and 8 weeks for “non-scalp” areas. If it
is necessary to continue or restart
treatment after this period, treatment should be continued after
medical review and under regular
medical supervision.
When using calcipotriol containing medicinal products, the maximum
daily dose should not exceed
15 g. The body surface area treated with calcipotriol containing
medicinal products should not
exceed 30% (see section 4.4).
_If used on the scalp _
All the affected scalp areas may be treated with Daivobet gel. Usually
an amount between 1 g and 4
g per day is sufficient for treatment of the scalp (4 g corresponds to
one teaspoon).
Special populations
_Renal and hepatic impairment _
The safety and efficacy of Daivobet gel in patients with severe renal
insufficiency or severe hepatic
disorders have not been evaluated.
Page 2 of 10
_Paediatric population _
The safety and efficacy of Daivobet gel in children below 18 years
have not been established.
Currently available data in children aged 12 to 17 years are described
in section 4.8 and 5.1, but no
recommendation on a posology can be made.
Method of administration
Daivobet gel should not be applied directly to the face or eyes. In
order to achieve optimal effect, it
is