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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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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dovobet® 50 microgram/0.5 mg/g gel
(calcipotriol/betamethasone)
This product is available as the above name but will be referred to as Dovobet
throughout this leaflet.
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.
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
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.

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 this medicine exactly as your doctor has told you. 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
 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.

1

2

Shake bottle before
use.

3

Apply a drop of
Dovobet to fingertip.

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:

4
Apply a mild shampoo to the
dry hair, especially to those
areas where the gel was
applied.

5
Leave the shampoo on
the scalp for a couple
of minutes before washing.

6
Wash your hair
as usual.

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.

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 national reporting system. For the United Kingdom, via the Yellow
Card Scheme, Website: 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

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.









Keep out of the sight and reach 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.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
If your medicine becomes discoloured or show signs of any deterioration,
consult your doctor or pharmacist who will tell you what to do.

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 liquid paraffin, polyoxypropylene 11 stearyl ether,
hydrogenated castor oil, butylated hydroxytoluene (E321) and all-rac-αtocopherol.
What Dovobet looks like and the contents of the pack
Dovobet is an almost clear, colourless to slightly off-white gel filled in white highdensity polyethylene bottles with white low-density polyethylene nozzle and a red
high-density polyethylene screw cap.
Dovobet is available in bottles of 30 g and 60 g (2 x 30 g).
PL: 15814/1168

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.

POM

Manufactured by LEO Laboratories Ltd. (LEO Pharma), Dublin, Ireland or LEO
Pharma A/S, Ballerup, Denmark.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 04.05.2017.
Dovobet is a registered trademark of LEO Pharma A/S, Denmark.

To request a copy of this leaflet in Braille, large
print or audio please call 01923 332 796.
Detailed information on this medicine is available on the web site of the Medicines
and Healthcare Products Regulatory Agency, www.mhra.gov.uk

+ Expand Transcript

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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