DOVOBET 50 MICROGRAM/G + 0.5 MG/G GEL

Active substance: CALCIPOTRIOL MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dovobet® gel
calcipotriol/betamethasone

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 vulgaris) 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
• infections caused by viruses (e.g. cold sores
or chicken pox)
• infections caused by a fungus (e.g. athlete’s
foot or ringworm)
• infections caused by bacteria
• infections caused by parasites (e.g. scabies)
• tuberculosis (TB) or syphilis
• 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
• itching of the anus (back passage) or genitals
(sex organs).
Warning and precautions
Talk to your doctor/nurse/ pharmacist before
using Dovobet® 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
• you have serious liver or kidney disease.
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 or
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
Dovobet® is not recommended for the use in
children below the age of 18 years.
Other medicines and Dovobet®
Please tell your doctor, pharmacist or nurse if
you are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

Pregnancy and breast-feeding
Do not use Dovobet® if you are pregnant (or
might be pregnant) or if you are breastfeeding, 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
Dovobet® 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 Dovobet®
Dovobet® 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 DOVOBET®
Always use Dovobet® exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
How to put on Dovobet®: 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 Dovobet® 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 Dovobet®.
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 Dovobet® 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 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
• 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
Dovobet® is not necessary
• 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.
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.
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.
What should I expect when I use Dovobet®?
Most patients see obvious results after 2
weeks, even if the psoriasis is not yet cleared
at that point.
If you have used more Dovobet® than you
should
Contact your doctor if you have used more
than 15 grams in one day.

025427-03

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.

Excessive prolonged use of Dovobet® 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 Dovobet®
Do not take a double dose to make up for
forgotten individual doses.
If you stop using Dovobet®
The use of Dovobet® 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, Dovobet® can cause side
effects, although not everybody gets them.
Approximately 1 in 12 people may experience
side effects, but most of these are reactions at
the site where the gel has been applied.

Less serious side effects caused by using
betamethasone for a long time, include the
following, and you should tell your doctor or
nurse as soon as possible if you notice any of
them
• 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)
• Small white spots (colloid milia)
• Depigmentation (lightening of skin colour).
Less serious side effects known to be caused
by calcipotriol include the following
• Sensitivity of the skin to light resulting in a
rash
• Eczema.
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 the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this
medicine.

5. HOW TO STORE DOVOBET®
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 Dovobet®
Uncommon (affect less than 1 in 100 people)
• Worsening of your psoriasis. If your psoriasis
gets worse, tell your doctor as soon as
possible.
Some serious side effects are known to be
caused by betamethasone (a strong steroid),
one of the ingredients in Dovobet®. 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 longterm use, or use under occlusion.
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 your
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 Dovobet® 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 Dovobet®, 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 are bone
pain, constipation, poor appetite, nausea and
vomiting. 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 Dovobet®
Common side effects (affect less than 1 in 10
people)
• Itching.
Uncommon (affect less than 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.

• Keep out of the reach and sight of children
• Do not use Dovobet® 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.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Dovobet® 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-11 stearyl ether
• castor oil, hydrogenated
• butylhydroxytoluene (E321)
• all-rac-α-tocopherol.
What Dovobet® looks like and the contents of
the pack
Dovobet® 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, 30, 60, 2 x 60 g and 3 x 60 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder is:
LEO Pharma A/S
Industriparken 55, DK-2750 Ballerup, Denmark
The manufacturer is:
LEO Laboratories Limited (LEO Pharma)
285 Cashel Road, Dublin, Ireland
For further information about this medicine,
contact the local representative of the
Marketing Authorisation Holder:
LEO Laboratories Limited, Hurley, Berkshire
SL6 6RJ, UK.
Tel: (01844) 347333
e-mail: medical-info.uk@leo-pharma.com
This medicine is authorised in the Member
States of the EEA under the following names:
Dovobet® gel: United Kingdom
This leaflet was last revised in October 2013.
For further information about psoriasis, you
can contact:
The Psoriasis Association.
mail@psoriasis-association.org.uk

LEO
025427-03

Package Leaflet: Information for the user

Dovobet® gel
Applicator
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.

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 vulgaris) 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:
• infections caused by viruses (e.g. cold sores or chicken pox)
• infections caused by a fungus (e.g. athlete’s foot or ringworm)
• infections caused by bacteria
• infections caused by parasites (e.g. scabies)
• tuberculosis (TB) or syphilis
• 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
• itching of the anus (back passage) or genitals (sex organs).
Warning and precautions
Talk to your doctor/nurse/pharmacist before using Dovobet® 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
• you have serious liver or kidney disease.
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 or 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
Dovobet® is not recommended for the use in children below the age of 18 years.
Other medicines and Dovobet®
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Do not use Dovobet® 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 Dovobet® 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 Dovobet®
Dovobet® contains butylated hydroxytoluene (E321), which may cause local skin reactions
(e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Dovobet® can cause side effects, although not everybody gets them.
Approximately 1 in 12 people may experience side effects, but most of these are reactions at
the site where the gel has been applied.
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 Dovobet®
Uncommon (affect less than 1 in 100 people)
• Worsening of your psoriasis. If your psoriasis gets worse, tell your doctor as soon as possible.
Some serious side effects are known to be caused by betamethasone (a strong steroid), one
of the ingredients in Dovobet®. 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,
or use under occlusion.
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 your 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 Dovobet® 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 Dovobet®, 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 bone
pain, constipation, poor appetite, nausea and vomiting. 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 Dovobet®
Common side effects (affect less than 1 in 10 people)
• Itching.
Uncommon (affect less than 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.
Less serious side effects caused by using betamethasone for a long time, include the following,
and you should tell your doctor or nurse as soon as possible if you notice any of them
• 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)
• Small white spots (colloid milia)
• Depigmentation (lightening of skin colour).
Less serious side effects known to be caused by calcipotriol include the following
• Sensitivity of the skin to light resulting in a rash
• Eczema.
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 the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more
information on the safety of this medicine.

5. HOW TO STORE DOVOBET®
• Keep out of the reach and sight of children
• Do not use Dovobet® after the expiry date, which is stated on the cartridge after EXP. The
expiry date refers to the last day of that month
• Do not refrigerate.
• The Applicator is disposable. Discard the Applicator with any remaining gel 3 months after
first opening.

Always use Dovobet® exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.

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.

How to put on Dovobet®: Cutaneous use.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

3. HOW TO USE DOVOBET®

Dovobet®

gel Applicator included at the end of this
Read the Instructions for Use for the
leaflet carefully before use.
In the Instructions for Use you will find information about assembling, using, cleaning and
storing of the Dovobet® gel Applicator.
The Dovobet® gel Applicator is called ‘the Applicator’ in the remainder of this leaflet.
Instructions for proper use of Dovobet®
• Use only on your psoriasis and do not use on skin which does not have psoriasis
• Apply Dovobet® to the affected area with the Applicator, 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 Dovobet® if you get gel on your fingers. 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 Dovobet® gel
• After applying the gel, avoid contact with textiles which are easily stained by grease
(e.g. silk).
• Washing your hair before application of Dovobet® is not necessary
• 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.
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 (corresponding to 300 pumps)
• For treatment of the scalp usually an amount between 1 g and 4 g per day is sufficient
(corresponding to 20 to 80 pumps)
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.
One full pump delivers 0.05 g Dovobet® gel.
What should I expect when I use Dovobet®?
Most patients see obvious results after 2 weeks, even if the psoriasis is not yet cleared at that
point.
If you have used more Dovobet® than you should
Contact your doctor if you have used more than 15 grams in one day.
Excessive prolonged use of Dovobet® 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).

What Dovobet® 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-11 stearyl ether
• castor oil, hydrogenated
• butylhydroxytoluene (E321)
• all-rac-α-tocopherol.
What Dovobet® looks like and the contents of the pack
Dovobet® is an almost clear, colourless to slightly off-white gel filled in a polypropylene
cartridge (with a high-density polyethylene plunger and screw cap). The cartridge and the
applicator head (polypropylene outer casing, polyoxymethylene lever and thermoplastic
elastomer nozzle) is assembled prior to first use. The polypropylene cover is for storage.
The cartridge(s), applicator head(s) and cover(s) are placed in a carton.
Pack sizes: 60 g (equivalent to 68 ml) and 2 x 60 g (equivalent to 2 x 68 ml)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is:
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
The manufacturer is:
LEO Laboratories Ltd. (LEO Pharma)
285 Cashel Road
Dublin 12
Ireland
Instructions for Use of the Applicator are included at the end of this leaflet.
For further information about this medicine, contact the local representative of the
Marketing Authorisation Holder:
LEO Laboratories Limited, Hurley, Berkshire SL6 6RJ, UK.
Tel: (01844) 347333
e-mail: medical-info.uk@leo-pharma.com
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 revised in June 2014
Detailed information on this medicine is available on the web site of the Medicines and
Healthcare Product Regulatory Agency, www.mhra.gov.uk

If you forget to use Dovobet®
Do not take a double dose to make up for forgotten individual doses.
If you stop using Dovobet®
The use of Dovobet® 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.

LEO
000000-XX

Instructions for Use
Dovobet® gel Applicator
Before use, you should read all of the patient information and the Instructions for Use
carefully – even if you have used Dovobet® gel before.
The Dovobet® gel Applicator is designed to apply Dovobet® gel to your skin and scalp
affected by plaque psoriasis. Using the Dovobet® gel Applicator, you can apply
Dovobet® gel without getting any gel on your fingers.

Your Dovobet® gel Applicator
Cartridge cap
(removable)

Cover

Always follow your doctor’s instructions on the treatment of your psoriasis.
Do not share the Dovobet® gel or the Applicator with others.
Keep this medicine out of the sight and reach of children.

Cartridge
Small spreading
surface
Larger
spreading surface

Applicator
nozzle

Lever

Preparing your Dovobet® gel Applicator
xxx

x

xxx
x

A) Check the expiry date on the cartridge
Check the expiry date on the cartridge label.
Do not use if expired.
The expiry date on the cartridge refers to the last day of that
month.
Write the date that you assembled the Applicator on the
cartridge label. Do not use the Applicator more than 3 months
after this date.

Plunger (visible
from the bottom
of the cartridge)

H) After application
Check that the affected areas are sufficiently covered.
If needed, ask someone to help you apply the Dovobet® gel to areas you cannot reach or see.
Wash hands after use, if you, or someone assisting you, get Dovobet® gel on the fingers.
This will avoid accidentally spreading the gel to other parts of your body (especially the
face, mouth and eyes).
After use
I) Clean your Dovobet® gel Applicator after each use
Following use, wipe the applicator head with a clean, dry tissue.
Avoid pumping while cleaning.
Note:
• Do not wash the Applicator with water, detergents or any other
substances.
• Do not use moist or wet materials to wipe the Applicator.

B) Remove the cartridge cap
Holding the cartridge upright, twist the cap anti-clockwise to remove.
Avoid tipping the cartridge as this may result in spilling the gel.
Discard the cap after removing.

J) Cover the Applicator
Replace the cover after each use to keep the applicator head clean.
Always ensure the cover is clicked in place to prevent dispensing
Dovobet® gel during storage and transportation.

C) Attach applicator head tightly
Keep the cartridge upright and align the applicator head.
Screw the applicator head clockwise until the applicator head feels
tightly sealed.
Clicking sounds will be heard until it is tightly sealed.
Note:
Do not disassemble the Applicator. Attempts to do so may break
the Applicator.

K) Estimate the amount of remaining Dovobet® gel
To estimate the amount of remaining Dovobet® gel, look in the
bottom of the cartridge to see the plunger position. The plunger
moves upwards as the gel is used.

D) Prime before first use
To prime:
Make sure that the applicator head and cartridge are tightly assembled.
Gently push up on the centre of the plunger while squeezing the lever
until you see gel at the nozzle tip.
Before Use again
x
xxx

If you fly with your assembled Dovobet® gel Applicator, you may need to pump the lever a few
times to re-prime before applying.
Applying the Dovobet® gel to the affected area

Release the lever fully between each pump to get a full dispense.
One full pump delivers 0.05 g Dovobet® gel.

The expiry date on the cartridge refers to the last day of that month.
xxxx

E) Apply to the affected area
Place the applicator nozzle close to the affected area and press the
lever one or more times to dispense the Dovobet® gel.

L) Check expiry date
Always check the expiry date on the cartridge label before use.
Do not use if the expiry is exceeded or 3 months after opening the
cartridge.

M) Remove cover
Remove the cover by lifting the tab at rear.

F) Use spreading surfaces to massage
Dovobet® gel across plaques
Use the spreading surfaces to gently massage
the Dovobet® gel into the affected skin.
Be careful not to press the lever
when spreading.

G) To apply to scalp and hairline
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®.
Locate the area to treat using your fingers and part your hair.
Use the nozzle directly on the scalp to dispense and massage in the
Dovobet® gel.

Storage
Always ensure the cover is clicked in place to prevent dispensing the gel during storage
and transportation.
See further information about storage in section 5, ‘How to store Dovobet®‘.
Disposal
See information about disposal in section 5, ‘How to store Dovobet®‘.

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Dovobet® gel
Applicator
calcipotriol/betamethasone

Instructions for Use
Dovobet® gel Applicator

Expand view ⇕

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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