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DOVOBET 50MICROGRAMS/G + 0.5MG/G GEL

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

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Package leaflet: Information for the user

®

Dovobet 50micrograms/g+0.5mg/g gel
(calcipotriol/betamethasone dipropionate)
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.
The name of your medicine is Dovobet 50micrograms/g+0.5mg/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

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

1. WHAT DOVOBET IS AND WHAT IT IS USED
FOR

3. HOW TO USE DOVOBET

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.

How to put on Dovobet: Cutaneous use.

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
Tell your doctor, pharmacist or nurse if you are taking,
have recently taken or might take 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 this
medicine.

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.
Always use this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
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
Washing your hair before application of Dovobet is not
necessary.
Shake bottle before use.

1
3
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.

2
Apply a drop of
Dovobet to fingertip.

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.

4

6
Wash your hair as usual.
5
Leave the shampoo on the
scalp for a couple of minutes
before washing.
If necessary, repeat steps 4-6 once or twice.

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 use 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 a forgotten dose.
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 on the use of this
medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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
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.
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, 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.
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.
Frequency unknown (frequency cannot be estimated from
the available data):
 White or grey hair can transiently change to a yellowish
colour at the application site when used on the scalp.
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 any 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 use the medicine after the expiry date, which is
stated on the carton and bottle label after ‘Exp’. The
expiry date refers to the last day of that month.
Do not refrigerate. Store in the original package in order
to protect from light.
Discard the bottle with any remaining gel 3 months after
first opening.
If the medicine becomes discoloured or shows any
signs of deterioration, seek the advice of your
pharmacist.
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
One gram of gel contains 50 micrograms calcipotriol (as
monohydrate) and 0.5mg betamethasone (as
dipropionate).
The other ingredients are: liquid paraffin,
polyoxypropylene-11 stearyl ether, hydrogenated castor oil,
butylhydroxytoluene (E321) and alpha-tocopherol.
What Dovobet looks like and the contents of the pack
Dovobet is an almost clear, colourless to slightly off-white
gel.
Dovobet is available in pack size of 30 grams.
Manufactured by: Leo Pharma A/S, 55 Industriparken 2750 Ballerup, Denmark.
OR
LEO Laboratories Ltd (Leo Pharma), 285 Cashel Road,
Dublin 12, Ireland.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Dovobet® 50micrograms/g+0.5mg/g gel; PL 18799/2205
Leaflet date: 18.07.2017
POM
Dovobet is a registered trademark of Leo Pharma.

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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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