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DOVOBET 50MICROGRAMS/G + 0.5MG/G GEL

Active substance(s): 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

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
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 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.
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.

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
Washing your hair before application of Dovobet is
not necessary.
Shake bottle before use.

1

2

Apply a drop of
Dovobet to
fingertip.

3

Apply directly to scalp areas where
you can feel the raised plaque and rub
the Dovobet 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.
4

5

6

Leave the shampoo on the Wash your hair as usual.
scalp for a couple of minutes
before washing.

If necessary, repeat step 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 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.
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 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
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 use Dovobet 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.
If the medicine becomes discoloured or shows any
signs of deterioration, seek the advice of your
pharmacist. 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
One gram of gel contains 50micrograms 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 30grams.
Manufactured by: Leo Pharma A/S, 55 Industriparken 2750 Ballerup, Denmark. - lot number preceded by the
letter D.
OR
LEO Laboratories Ltd (Leo Pharma), 285 Cashel Road,
Dublin 12, Ireland. - lot number preceded by the
letter E.
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
POM
Leaflet date: 17.06.2016
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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