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DOVOBET OINTMENT

Active substance(s): BETAMETHASONE DIPROPIONATE / CALCIPOTRIOL MONOHYDRATE

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

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.
Important information about some of the ingredients of Dovobet
Dovobet contains butylhydroxytoluene (E321). This may cause local skin
reactions (e.g. contact dermatitis), or irritation to the eyes and mucous
membranes.

1) What Dovobet is and what it is used for

3) How to use Dovobet

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 your skin.

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.

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 the 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 on skin affected by
 infections caused by viruses (e.g. cold sores or chicken pox)
 infections caused by a fungus (e.g. athlete’s foot or ringworm)
 infections caused by bacteria
 infections caused by parasites (e.g. scabies)
 tuberculosis (TB) or syphilis
 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
 itching of the anus (back passage) or genitals (sex organs).
Warning and precaution
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
 you have serious liver or kidney disease.
Special precautions
 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
 Avoid use on large areas of damaged skin or skin folds (groin, armpits,
under breasts) as it increases the absorption of the steroid
 Avoid use on the 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.

Instruction for proper use
 Use only on your psoriasis and do not use on skin which does not have
psoriasis
 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
 Do not bandage, tightly cover or wrap the treated skin area
 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)
 Do not worry if some ointment 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 ointment
 After applying the ointment avoid contact with textiles which are easily
stained by grease (e.g. silk).
Duration of treatment
 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.
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 prolonged use of Dovobet may 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
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 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.
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.
Serious side effects
The following serious effects have been reported for Dovobet:
Uncommon (affects less than 1 in 100 people)
 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:
 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)
 Impact on the metabolic control of diabetes mellitus (if you have diabetes
you may experience fluctuations in the blood glucose levels).
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 using 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.
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 10 people)
 Itching
 Rash
 Burning sensation.
Uncommon (affect less than 1 in 100 people)
 Skin pain or irritation
 Rash with inflammation of the skin (dermatitis)
 Redness of the skin due to widening of the small blood vessels
(erythema)
 Inflammation or swelling of the hair root (folliculitis)
 Changes in skin colour in the area you have used the ointment.
Not known frequency
 Rebound effect: A worsening of symptoms/psoriasis after ended
treatment.
Less serious side effects caused by using betamethasone, include the
following. You should tell your doctor as soon as possible if you notice
them.
 Thinning of the skin
 Appearance of surface blood vessels or stretch marks
 Changes in hair growth
 Red rash around the mouth (perioral dermatitis)
 Skin rash with inflammation or swelling (allergic contact dermatitis)
 Shiny brown gel-filled bumps (colloid milia)
 Lightening of skin colour (depigmentation).

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 has also been reported
 Eczema.
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 store the product above 25°C.
 Do not use after the expiry date stated on the label (EXP). This expiry
date refers to the last day of that month.
 The tube should be discarded 12 months after first opening. Write the
date you first opened the tube in the space provided on the carton.
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:
Each gram of ointment contains 50 micrograms of calcipotriol (as hydrate)
and 0.5 milligrams of betamethasone (as dipropionate)
The other ingredients are:
liquid paraffin, polyoxypropylene-15-stearyl ether, all-rac-α-tocopherol and
white soft paraffin.
What Dovobet looks like and contents of the pack
The ointment comes in a tube of 30 grams.
Dovobet is an off-white coloured ointment filled in aluminium/epoxyphenol
tubes with polyethylene screw caps.
PL 10383/1779

Dovobet Ointment

POM

Who makes and repackages your medicine?
Your medicine is manufactured by LEO Laboratories Ltd, 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: 10.06.2014
For further information about psoriasis, you can contact:
The Psoriasis Association.

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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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