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DOVOBET 50 MICROGRAM/G + 0.5MG/G OINTMENT

Active substance(s): BETAMETHASONE / CALCIPOTRIOL / BETAMETHASONE / CALCIPOTRIOL / BETAMETHASONE / CALCIPOTRIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dovobet® Ointment
(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. 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 Ointment 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 ointment 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.
Dovobet ointment 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.

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
ointment
Dovobet ointment contains butylhydroxytoluene (E321). This 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.
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.
If your ointment become discoloured or show any signs of
deterioration, you should seek the advice of your pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What is in Dovobet® ointment?
One gram of ointment contains 50micrograms of calcipotrol (as
monohydrate) and 0.5mg of betamethasone (as dipropionate) as an
active substance.
The other ingredients are:
• liquid paraffin
• polyoxypropylene-15-stearyl ether
• α-tocopherol
• white soft paraffin
• butylated hydroxytoluene (E321)
What Dovobet® looks like and contents of the pack
The ointment is off-white to yellow.
The ointment is available in tubes of 30 grams.
Manufactured by: LEO Laboratories Ltd. Cashel Road, Dublin 12,
Ireland.
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® 50microgram/g + 0.5mg/g ointment
PL: 18799/2006
POM
For further information about this product, contact the local
representative of the Marketing Authorisation Holder:
LEO Laboratories Limited, Princes Risborough, Bucks
HP27 9RR, UK.
Tel: (01844) 347333
e-mail: medical-info.uk@leo-pharma.com
For further information about your psoriasis, you can contact:
The Psoriasis Association
mail@psoriasis.demon.co.uk
Leaflet date: 01.04.2014

Dovobet is a registered Trade Mark of Leo.

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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