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Dovobet® gel
(calcipotriol/betamethasone dipropionate)
Your medicine is known by the above name, but will be referred to as
Dovobet throughout this:
Patient Information Leaflet

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

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
• 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.

Instructions for proper use
• Use only on your psoriasis and do not use on skin which does not have
• Shake the bottle before use and remove the cap
• Squeeze the gel onto a clean finger or directly onto the area affected by
• 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).

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.

How to put on Dovobet: Cutaneous use.

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.

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).

Shake bottle before

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
• 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
• 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.
Dovobet is not recommended for the use in children below the age of 18
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
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
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

3) How to use Dovobet

Apply a drop of
Dovobet to fingertip.

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.

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.

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.

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

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
• 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
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
• 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
• 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: 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 printed on the carton, and bottle
label 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 the first opening.
• If your medicine appears discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
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 monohydrate and betamethasone
dipropionate. Each gram of gel contains 50 micrograms of calcipotriol (as
monohydrate) and 0.5mg of betamethasone (as dipropionate).
The other ingredients are:
• liquid paraffin
• polyoxypropylene-15 stearyl ether
• hydrogenated castor oil
• butylhydroxytoluene (E321)
• α-tocopherol.
What Dovobet looks like and content of the pack
Dovobet is an almost clear, colourless to slightly off-white gel filled in highdensity polyethylene bottles with low-density polyethylene nozzle and a
highdensity polyethylene screw cap.
The bottles are placed in cartons containing 30g, 60g (2 x 30g) and 120g (4 x
30g) of gel.
PL 10383/2148
Who makes and repackages your medicine
Your medicine is manufactured by LEO Pharmaceutical Products Ltd. A/S, 55
Industriparken – 2750 Ballerup, Denmark and LEO Laboratories Limited
(LEO Pharma), 285 Cashel Road, Dublin 12, Ireland. Procured from within
the EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 04/05/2016
Dovobet® is a registered trademark of LEO Pharma A/S, Denmark.

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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.