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DOVOBET 50 MICROGRAM/0.5 MG/G GEL

Active substance(s): BETAMETHASONE / BETAMETHASONE DIPROPIONATE / CALCIPOTRIOL / CALCIPOTRIOL MONOHYDRATE

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Transcript
Ref: 1417/040516/1/F

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
• 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 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 sight and reach of children.
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.
Do not use Dovobet® after the expiry date which is
stated on the bottom of the bottle and carton. The
expiry date refers to the last day of that month.
If your medicine becomes discoloured or show any
other signs of deterioration, ask your pharmacist
who will advise you what to do.
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.
Pack sizes: 30 g and 2 x 30 g.
Manufacturer and Licence Holder
This medicine is manufactured by LEO Pharma
A/S, 55 Industriparken - 2750 Ballerup, Denmark
and procured from within the EU and repackaged
by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/1417

Dovobet® is a registered trademark of LEO
Pharma A/S.
Revision date: 04/05/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon UK Limited
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Dovobet ® 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.
Your medicine is called Dovobet® 50
microgram/0.5 mg/g gel but will be referred to as
Dovobet® throughout this leaflet.
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
DOVOBET®

1. WHAT
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
• 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.
Warnings 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.
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
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.

Duration of treatment

Driving and using machines
This medicine should not have any effect on
your ability to drive or use machines.

Shake bottle before use.

convenient to use the gel in the evening

• The normal initial treatment period is 4 weeks

Dovobet® contains butylated hydroxytoluene
(E321)
Dovobet® contains butylated hydroxytoluene
(E321), which may cause local skin reactions
(e.g. contact dermatitis), or irritation to the
eyes and mucous membranes.

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.

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).

Apply a drop of
Apply directly to scalp
Dovobet® to fingertip. 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.
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:
Apply a mild shampoo
to the dry hair,
especially to those areas
where the gel was
applied.

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.

• Use the gel once a day. It may be more

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 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.

Leave the shampoo
on the scalp for a
couple of minutes
before washing.

Wash your hair as
usual.

If necessary, repeat step 4-6 once or twice.

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, 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 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
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 Dovobet®
Common side effects (may affect up to 1 in
10 people)
• Itching.

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 (may affect up to 1 in 100 people)
• Worsening of your psoriasis. If your psoriasis
gets worse, tell your doctor as soon as
possible.
Ref:1417/040516/1/B

Ref: 1417/040516/2/F

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
• 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 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 sight and reach of children.
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.
Do not use Dovobet® after the expiry date which is
stated on the bottom of the bottle and carton. The
expiry date refers to the last day of that month.
If your medicine becomes discoloured or show any
other signs of deterioration, ask your pharmacist
who will advise you what to do.
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.
Pack sizes: 30 g and 2 x 30 g.
Manufacturer and Licence Holder
This medicine is manufactured by LEO
Laboratories Ltd. (LEO Pharma), 285 Cashel
Road - Dublin 12, Ireland and procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL 15184/1417

Dovobet® is a registered trademark of LEO
Pharma A/S.
Revision date: 04/05/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon UK Limited
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Dovobet ® 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.
Your medicine is called Dovobet® 50
microgram/0.5 mg/g gel but will be referred to as
Dovobet® throughout this leaflet.
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
DOVOBET®

1. WHAT
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
• 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.
Warnings 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.
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
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.

Duration of treatment

Driving and using machines
This medicine should not have any effect on
your ability to drive or use machines.

Shake bottle before use.

convenient to use the gel in the evening

• The normal initial treatment period is 4 weeks

Dovobet® contains butylated hydroxytoluene
(E321)
Dovobet® contains butylated hydroxytoluene
(E321), which may cause local skin reactions
(e.g. contact dermatitis), or irritation to the
eyes and mucous membranes.

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.

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).

Apply a drop of
Apply directly to scalp
Dovobet® to fingertip. 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.
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:
Apply a mild shampoo
to the dry hair,
especially to those areas
where the gel was
applied.

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.

• Use the gel once a day. It may be more

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 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.

Leave the shampoo
on the scalp for a
couple of minutes
before washing.

Wash your hair as
usual.

If necessary, repeat step 4-6 once or twice.

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, 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 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
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 Dovobet®
Common side effects (may affect up to 1 in
10 people)
• Itching.

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 (may affect up to 1 in 100 people)
• Worsening of your psoriasis. If your psoriasis
gets worse, tell your doctor as soon as
possible.
Ref:1417/040516/2/B

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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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