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DOVOBET 50 MICROGRAM/G + 0.5 MG/G GEL

Active substance(s): BETAMETHASONE DIPROPIONATE / CALCIPOTRIOL

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Scale

Please return to:
LEO Pharma A/S
Internal Market Access

Subject

Item No.

EU

Rev. No.

Date

Colour

Sent by e-mail

ZZ

000000

INS 160 x 600 mm

Date

Date

Sign.

Sign.

02/12/14
Sign.

OMA

Black

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Supplier / Place of production

Daivobet® Gel

Ireland

Comments:

Page 1 of 2

Pointsize: 9.0 pt

Mock-up for registration purpose

160 mm

10 mm (minimum 5 mm)

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. 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.

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 or ringworm)
• Skin infections caused by bacteria
• Skin infections caused by parasites (e.g.
scabies)
• tuberculosis (TB)
• perioral dermatitis (red rash around the mouth)
• thin skin, easily damaged veins, stretch marks
• ichthyosis (dry skin with fish-like scales)
• acne (pimples)
• rosacea (severe flushing or redness of the
skin on the face)
• ulcers or broken skin

10 mm

Warning and precautions
Talk to your doctor/nurse/pharmacist before
using Daivobet® if:
• you are using other medicines that contain
corticosteroids as you may get side-effects
• you have used this medicine for a long time
and plan to stop (as there is a risk your
psoriasis will get worse or ‘flare up’ when
steroids are stopped suddenly)
• you have diabetes mellitus (diabetes) as your
blood sugar/glucose level may be affected by
the steroid
• your skin becomes infected as you may need
to stop your treatment
• you have a certain type of psoriasis called
guttate psoriasis
Special precautions
• Avoid use on more than 30% of your body or
using more than 15 grams per day
• Avoid using under a bathing cap, bandages
or dressings as it increases the absorption of
the steroid
• Avoid use on large areas of damaged skin, on
mucous membranes, or in skin folds (groin,
armpits, under breasts) as it increases the
absorption of the steroid
• Avoid use on your face or genitals (sex organs)
as they are very sensitive to steroids
• Avoid excessive sunbathing, excessive use of
solarium and other forms of light treatment.
Children
Daivobet® is not recommended for the use in
children below the age of 18 years.
Other medicines and Daivobet®
Please tell your doctor, pharmacist or nurse if
you are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

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Pregnancy and breast-feeding
Do not use Daivobet® if you are pregnant (or
might be pregnant) or if you are breast-feeding,
unless you have agreed it with your doctor
first. If your doctor has agreed that you can
breast-feed, take care and do not apply
Daivobet® to the breast area.
Ask your doctor or pharmacist for advice
before taking any medicine
Driving and using machines
This medicine should not have any effect on
your ability to drive or use machines.
Important information about some of the
ingredients of Daivobet®
Daivobet® contains butylated hydroxytoluene
(E321), which may cause local skin reactions
(e.g. contact dermatitis), or irritation to the
eyes and mucous membranes.

3. HOW TO USE DAIVOBET®
Always use Daivobet® exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
How to put on Daivobet®: Cutaneous use.
Instructions for proper use
• Use only on your psoriasis and do not use on
skin which does not have psoriasis
• Shake the bottle before use and remove the cap
• Squeeze the gel onto a clean finger or
directly onto the area affected by psoriasis.
• Apply Daivobet® to the affected area with
your fingertips, and rub it in gently until the
area affected by psoriasis is covered by a thin
layer of gel.
• Do not bandage, tightly cover or wrap the
treated skin area
• Wash your hands well after using Daivobet®.
This will avoid accidentally spreading the gel
to other parts of your body (especially the
face, mouth and eyes)
• Do not worry if some gel accidentally gets on
normal skin near your psoriasis, but wipe it
off if it spreads too far
• In order to achieve optimal effect, it is
recommended not to take a shower or bath
immediately after application of Daivobet® gel
• After applying the gel, avoid contact with
textiles which are easily stained by grease
(e.g. silk).
If you have scalp psoriasis
• Before applying Daivobet® to the scalp, comb
the hair to remove any loose scales. Tilt your
head to make sure Daivobet® does not run
onto your face. It may help to part your hair
before you use Daivobet®. Apply Daivobet®
to the affected area with your fingertips, and
rub it in gently.

What should I expect when I use Daivobet®?
Most patients see obvious results after 2 weeks,
even if the psoriasis is not yet cleared at that
point.
If you have used more Daivobet® than you
should
Contact your doctor if you have used more
than 15 grams in one day.
Excessive use of Daivobet® may also cause a
problem with calcium in your blood, which
usually normalises when discontinuing
treatment.
Your doctor may need to carry out blood tests
to check that using too much gel has not
caused a problem with calcium in your blood.
Excessive prolonged use can also cause your
adrenal glands to stop working properly (the
adrenal glands are found near the kidneys and
produce hormones).
If you forget to use Daivobet®
Do not take a double dose to make up for
forgotten individual doses.
If you stop using Daivobet®
The use of Daivobet® should be stopped as
indicated by your doctor. It may be necessary
for you to stop this medicine gradually,
especially if you have used it for a long time.
If you have any further questions about the use
of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Daivobet® can cause side
effects, although not everybody gets them.
Serious side effects
Tell your doctor/nurse immediately or as soon
as possible if any of the following happens.
You may have to stop your treatment.
The following serious side effects have been
reported for Daivobet®
Uncommon (may affect up to 1 in 100 people)
• Worsening of your psoriasis. If your psoriasis
gets worse, tell your doctor as soon as
possible.

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10 mm

Some serious side effects are known to be
caused by betamethasone (a strong steroid),
one of the ingredients in Daivobet®. You should
tell your doctor as soon as possible if any of the
serious side effects occur. These side effects
are more likely to happen after long-term use,
use in skin folds (e.g. groin, armpits or under
breasts), use under occlusion, or use on large
areas of skin.
The side effects include the following:
• Your adrenal glands may stop working
properly. Signs are tiredness, depression and
anxiety
• Cataracts (signs are cloudy and foggy vision,
difficulty seeing at night and sensitivity to
light) or an increase in pressure inside the
eye (signs are eye pain, red eye, decreased or
cloudy vision)
• Infections (because your immune system,
which fights infections, may be suppressed
or weakened)
• Pustular psoriasis (a red area with yellowish
pustules usually on the hands or feet). If you
notice this, stop using Daivobet® and tell your
doctor as soon as possible
• Impact on the metabolic control of diabetes
mellitus (if you have diabetes you may
experience fluctuations in the blood glucose
levels).
Serious side effects known to be caused by
calcipotriol
• Allergic reactions with deep swelling of the
face or other parts of the body such as the
hands or feet. Swelling of the mouth/throat
and trouble breathing may occur. If you have
an allergic reaction, stop using Daivobet®, tell
your doctor immediately or go to the casualty
department at your nearest hospital
• Treatment with this gel may cause the level
of calcium in your blood or urine to increase
(usually when too much gel has been used).
Signs of increased calcium in blood is
excessive secretion of urine, constipation,
muscle weakness, confusion and coma. This
can be serious, and you should contact your
doctor immediately. However, when the
treatment is stopped, the levels return to
normal.
Less serious side effects
The following less serious side effects have
been reported for Daivobet®
Common side effects (may affect up to 1 in 10
people)
• Itching.
Uncommon (may affect up to 1 in 100 people)
• Eye irritation
• Burning sensation of the skin
• Skin pain or irritation
• Inflammation or swelling of the hair root
(folliculitis)
• Rash with inflammation of the skin (dermatitis)
• Redness of the skin due to widening of the
small blood vessels (erythema)
• Acne (pimples)
• Dry skin
• Rash
• Pustular rash
• Infection of the skin.
Rare (may affect up to 1 in 1,000 people)
• Allergic reactions
• Stretch marks
• Skin exfoliation
• Rebound effect: A worsening of
symptoms/psoriasis after ended treatment.
Less serious side effects caused by using
betamethasone, especially for a long time,
include the following. You should tell your
doctor or nurse as soon as possible if you
notice any of them

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If you use other calcipotriol containing
medicines, the total amount of calcipotriol
medicines must not exceed 15 grams per day
and the area treated should not exceed 30% of
the total body surface.

7.

Daivobet® contains calcipotriol and
betamethasone. Calcipotriol helps to bring the
rate of skin cell growth back to normal and
betamethasone acts to reduce inflammation.

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 treatment
• Do not use more than 15 grams in one day.

600 mm

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.

300 mm

1. WHAT DAIVOBET® IS AND WHAT IT IS
USED FOR

• For treatment of the scalp usually an amount
between 1 g and 4 g per day is sufficient
(4 g corresponds to one teaspoon)
• Washing your hair before application of
Daivobet is not necessary
• In order to achieve optimal effect, it is
recommended that the hair is not washed
immediately after application of Daivobet.
Let Daivobet remain on the scalp during the
night or during the day.

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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

Scale

Please return to:
LEO Pharma A/S
Internal Market Access

Subject

Item No.

EU

Rev. No.

Sent by e-mail

ZZ

000000
Date

INS 160 x 600 mm
Colour

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Date

Date

Sign.

Sign.

02/12/14
Sign.

OMA

Black

Supplier / Place of production

Daivobet® Gel

Ireland

Comments:

Page 2 of 2

160 mm

Page 2

10 mm (minimum 5 mm)










Thinning of the skin
Appearance of surface veins or stretch marks
Changes in hair growth
Red rash around the mouth (perioral
dermatitis)
Skin rash with inflammation or swelling
(allergic contact dermatitis)
Golden coloured gel-filled bumps (colloid milia)
Lightening of skin colour (depigmentation).
Inflammation or swelling of the hair root
(folliculitis).

Less serious side effects known to be caused
by calcipotriol include the following
• Dry skin
• Sensitivity of the skin to light resulting in a rash
• Eczema
• Itching
• Skin irritation
• Burning and stinging sensation
• Redness of the skin due to widening of the
small blood vessels (erythema)
• Rash
• Rash with inflammation of the skin (dermatitis)
• Worsening of psoriasis
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
[To be completed nationally, cf. the national
reporting system listed in Appendix V]. By
reporting side effects, you can help provide
more information on the safety of this medicine.
[*For the printed material, please refer to the
guidance of the annotated QRD template]

5. HOW TO STORE DAIVOBET®
• Keep out of the reach and sight of children
• Do not use Daivobet® after the expiry date,
which is stated on the bottle after EXP. The
expiry date refers to the last day of that month
• Do not refrigerate. Keep the bottle in the
outer carton in order to protect from light
• Discard the bottle with any remaining gel
3 months after first opening.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

What Daivobet® looks like and the contents of
the pack
Daivobet® is an almost clear, colourless to
slightly off-white gel filled in high-density
polyethylene bottles with low-density
polyethylene nozzle and a high-density
polyethylene screw cap.
The bottles are placed in cartons.
Pack sizes: 15 g, 30 g, 60 g, 80 g, 2 x 60 g,
2 x 80 g and 3 x 60 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder is:
[To be completed nationally]
The manufacturers are:
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark
LEO Laboratories Ltd. (LEO Pharma)
285 Cashel Road
Dublin 12
Ireland
For further information about this medicines,
contact the local representative of the
Marketing Authorisation Holder
Local Representative
[To be completed nationally]
This medicine is authorised in the Member
States of the EEA under the following names:
Daivobet®: Austria, Bulgaria, Czech Republic,
Denmark, Estonia, Finland, France, Germany,
Hungary, Iceland, Latvia, Lithuania, Malta,
Norway, Poland, Portugal, Romania, Slovak
Republic, Slovenia, Spain, Sweden
Dovobet®: Belgium, Cyprus, Greece, Ireland,
Italy, Luxembourg, Netherlands, United
Kingdom
This leaflet was last approved in {MM/YYYY}
[To be completed nationally]
Detailed information on this medicine is
available on the web site of {name of
MS/Agency}

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Daivobet® contains
The active substances are:
Calcipotriol and betamethasone.
One gram of gel contains 50 micrograms of
calcipotriol (as monohydrate) and 0.5 mg of
betamethasone (as dipropionate).
The other ingredients are:
• paraffin, liquid
• polyoxypropylene stearyl ether
• castor oil, hydrogenated
• butylhydroxytoluene (E321)
• all-rac-α-tocopherol.

LEO

10 mm

300 mm

10 mm

600 mm

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10 mm (minimum 5 mm)

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v9.0

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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