PACKAGE LEAFLET: INFORMATION FOR USER
Avoid use on more than 30 % of your body or using more than
15 grams per day
Avoid using under bandages or dressings as it increases the
absorption of the steroid
Your medicine is known as Dovobet Ointment but will be referred to
as Dovobet throughout the following leaflet.
Avoid use on large areas of damaged skin or skin folds (groin,
armpits, under breasts) as it increases the absorption of the
Read all of this leaflet carefully before you start using this
Avoid use on the face or genitals (sex organs) as they are very
sensitive to steroids
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
Avoid excessive sunbathing, excessive use of solarium and
other forms of light treatment.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
Dovobet is not recommended for the use in children below the age
of 18 years.
If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Taking other medicines
Pregnancy and breast-feeding
In this leaflet:
1. What Dovobet is and what it is used for
2. Before you use Dovobet
3. How to use Dovobet
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.
4. Possible side effects
Ask your doctor or pharmacist for advice before taking any
5. How to store Dovobet
Driving and using machines
6. Further information
This medicine should not have any effect on your ability to drive or
1. WHAT DOVOBET IS AND WHAT IT IS USED FOR
Important information about some of the ingredients of
Dovobet is used on the skin to treat plaque psoriasis (psoriasis
vulgaris) in adults. Psoriasis is caused by your skin cells being
produced too quickly. This causes redness, scaling and thickness of
Dovobet contains butylhydroxytoluene (E321). This may cause local
skin reactions (e.g. contact dermatitis), or irritation to the eyes and
Dovobet contains calcipotriol and betamethasone. Calcipotriol helps
to bring the rate of skin cell growth back to normal and
betamethasone acts to reduce inflammation.
3. HOW TO USE DOVOBET
2. BEFORE YOU USE DOVOBET
Do not use Dovobet
If you are allergic (hypersensitive) to calcipotriol,
betamethasone or any of the other ingredients of Dovobet
Always use Dovobet exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not
How to put on Dovobet: Cutaneous use.
Instruction for proper use
If you have problems with calcium levels in the body (ask your
Use only on your psoriasis and do not use on skin which does
not have psoriasis
If you have certain types of psoriasis: these are erythrodermic,
exfoliative and pustular (ask your doctor).
Remove the cap and check that the seal in the tube is not
broken before you first use the ointment
To break the seal, use the point in the back of the cap
Squeeze the ointment onto a clean finger
Rub gently into your skin to cover the affected area of psoriasis
until most of the ointment has disappeared into the skin
As Dovobet contains a strong steroid do NOT use on skin affected
infections caused by viruses (e.g. cold sores or chicken pox)
infections caused by a fungus (e.g. athlete’s foot or ringworm)
Do not bandage, tightly cover or wrap the treated skin area
infections caused by bacteria
infections caused by parasites (e.g. scabies)
tuberculosis (TB) or syphilis
Wash your hands well after using Dovobet (unless you are
using the ointment to treat your hands). This will avoid
accidentally spreading the ointment to other parts of your body
(especially the face, scalp, mouth and eyes)
perioral dermatitis (red rash around the mouth)
thin skin, easily damaged veins, stretch marks
Do not worry if some ointment accidentally gets on normal skin
near your psoriasis, but wipe it off if it spreads too far
ichthyosis (dry skin with fish-like scales)
In order to achieve optimal effect, it is recommended not to take
a shower or bath immediately after application of Dovobet
rosacea (severe flushing or redness of the skin on the face)
After applying the ointment avoid contact with textiles which are
easily stained by grease (e.g. silk).
ulcers or broken skin
Duration of treatment
itching of the anus (back passage) or genitals (sex organs).
Use the ointment once a day. It may be more convenient to use
the ointment in the evening
The normal initial treatment period is 4 weeks but 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.
Take special care with Dovobet
Before using this medicine, tell your doctor/nurse/pharmacist 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
you have a certain type of psoriasis called guttate psoriasis
you have serious liver or kidney disease.
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
Uncommon (affect less than 1 in 100 people)
Contact your doctor if you have used more than 15 grams in one
day. Excessive prolonged use of Dovobet may cause a problem
with calcium in your blood, which usually normalises when
Skin pain or irritation
Rash with inflammation of the skin (dermatitis)
Redness of the skin due to widening of the small blood vessels
Inflammation or swelling of the hair root (folliculitis)
Changes in skin colour in the area you have used the ointment.
Your doctor may need to carry out blood tests to check that using
too much ointment has not caused a problem with calcium in your
blood. Excessive prolonged use can also cause your adrenal
glands to stop working properly (these 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
If you stop using Dovobet
Not known frequency
Rebound effect: A worsening of symptoms/psoriasis after
Less serious side effects caused by using betamethasone, include
the following. You should tell your doctor as soon as possible if you
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.
Thinning of the skin
Appearance of surface blood vessels or stretch marks
If you have any further questions about the use of this medicine,
ask your doctor or pharmacist.
Changes in hair growth
Red rash around the mouth (perioral dermatitis)
Skin rash with inflammation or swelling (allergic contact
Shiny brown gel-filled bumps (colloid milia)
Lightening of skin colour (depigmentation).
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dovobet can cause side effects, although not
everybody gets them.
Approximately 1 in 10 people may experience side effects but most
of these are reactions at the site where the ointment has been
applied and are usually mild and temporary.
Less serious side effects known to be caused by calcipotriol include
Serious side effects
Sensitivity of the skin to light resulting in a rash has also been
Uncommon (affects less than 1 in 100 people)
If you notice the above or any other changes in your health while
taking this medicine, tell your doctor.
The following serious effects have been reported for Dovobet:
Worsening of your psoriasis. If your psoriasis gets worse, tell
your doctor as soon as possible.
Rare (affects less than 1 in 1,000 people)
Pustular psoriasis may occur (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.
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:
If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DOVOBET
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Dovobet should not be stored above 25 C. Discard 12 months
after first opening.
Your adrenal glands may stop working properly. Signs are
tiredness, depression and anxiety
Do not use after the expiry date printed on the carton or tube
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
If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.
Infections (because your immune system which fights infections
may be suppressed or weakened)
If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.
Impact on the metabolic control of diabetes mellitus (if you have
diabetes you may experience fluctuations in the blood glucose
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.
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
bandages or dressings or use on large areas of skin.
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 taking Dovobet, tell your doctor immediately or go
to the casualty department at your nearest hospital
Treatment with this ointment may cause the level of calcium in
your blood or urine to increase (usually when too much
ointment has been used). Signs of increased calcium in blood is
bone pain, constipation, poor appetite, nausea and vomiting.
This can be serious and you should contact your doctor as soon
as possible. However, when the treatment is stopped, the levels
return to normal.
6. FURTHER INFORMATION
What Dovobet contains
Dovobet contains calcipotriol 50 micrograms/g (as hydrate) and
betamethasone 500 micrograms/g (as dipropionate) as the
Dovobet also contains the following inactive ingredients: white
soft paraffin, alpha-tocopherol, liquid paraffin and
What Dovobet looks like and contents of the pack
Dovobet is an off white to yellow ointment.
Dovobet is available in tubes of 60g.
Less serious side effects
The following less serious side effects have been reported for
Dovobet. If any of them last a long time or cause you problems, you
should tell your doctor or nurse.
Common side effects (affect less than 1 in 100 people)
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Wembley,
This product is manufactured by Leo Laboratories Limited, Cashel
Road, Dublin, Ireland.
PL No: 19488/0366
Leaflet revision date: 31 July 2012
Dovobet is a registered trade mark of Leo Pharma A/S, Denmark.
S366 LEAFLET Dovobet 20120731
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.