Dovobet 50 microgram/g + 0.5 mg/g gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcipotriol; Betamethasone

Available from:

LEO Pharma A/S

ATC code:

D05AX; D05AX52

INN (International Name):

Calcipotriol; Betamethasone

Dosage:

50 mcg/g + 0.5 milligram(s)/gram

Pharmaceutical form:

Gel

Prescription type:

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

Therapeutic area:

Other antipsoriatics for topical use; calcipotriol, combinations

Authorization status:

Marketed

Authorization date:

2008-09-12

Patient Information leaflet

600 mm
160 mm
IIE015-02 - 160 x 600 mm - Page 1 of 2
105 mm
105 mm
300 mm
OMA
08/06/2018
Insert, 2 columns Page 1
160 x 600 mm
IIE015-02
08/09/2010
JUG
100%
Daivobet
®
, Dovobet
®
, Xamiol
®
gel.
Space for text: 2 X 67,5 x 580 mm.
Material number must be printed on both sides
Material number on page 1, OCRB 8pt
kerning+10(Quark)/
OCRB MEDIUM 8pt kerning+50(Indesign)
Used for:
Comments:
If you have scalp psoriasis
• Before applying Dovobet to the scalp, comb
the hair to remove any loose scales. Tilt your
head to make sure Dovobet does not run
onto your face. It may help to part your hair
before you use Dovobet. Apply Dovobet to
the affected area with your fingertips, and
rub it in gently.
WASHING YOUR HAIR BEFORE APPLICATION OF
DOVOBET IS NOT NECESSARY.
DOVOBET
® GEL
DOVOBET
® GEL
1
4
2
5
3
6
SHAKE bottle before
use.
DOVOBET
® GEL
DOVOBET
® GEL
1
4
2
5
3
6
Apply a drop of
Dovobet to fingertip.
Apply directly to scalp
areas where you can
feel the raised plaque
and rub the Dovobet
gel on to the skin.
_Depending on the _
_affected area 1-4 g _
_(up to 1 teaspoon) is _
_normally enough._
DOVOBET
® GEL
DOVOBET
® GEL
1
4
2
5
3
6
IN ORDER TO ACHIEVE OPTIMAL EFFECT, IT IS
RECOMMENDED THAT THE HAIR IS NOT WASHED
IMMEDIATELY AFTER APPLICATION OF DOVOBET.
LET DOVOBET REMAIN ON THE SCALP DURING THE
NIGHT OR DURING THE DAY. WHEN WASHING HAIR
AFTER APPLICATION THE FOLLOWING INSTRUCTIONS
MIGHT BE USEFUL:
IF NECESSARY, REPEAT STEPS 4-6 ONCE OR TWICE.
Leave the shampoo
on the scalp for a
couple of minutes
before washing.
Wash your hair as
usual.
DOVOBET
® GEL
DOVOBET
® GEL
1
4
2
5
3
6
DOVOBET
® GEL
DOVOBET
® GEL
1
4
2
5
3
6
Apply a mild shampoo
to the DRY HAIR,
especially to those
areas where the gel
was applied.
Duration of treatment
• Use the gel once a day. It may be more
convenient to use the gel in the evening
• The normal initial treatment period is 4 weeks
for scalp areas and 8 weeks for non-scalp
areas
• Your doctor may decide on a different
treatment period
• Your doctor may decide on repeated
treat

Summary of Product characteristics

Health Products Regulatory Authority
13 November 2019
CRN0098Z2
Page 1 of 8
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) 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
Dovobet 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 Dovobet 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 Dovobet gel in patients with severe renal
insufficiency or severe hepatic disorders have not been
evaluated.
_Paediatric population_
The safety and efficacy of Dovobet 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
Dovobet gel should not be applied direc