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DOVOBET GEL

Active substance: CALCIPOTRIOL

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In this leaflet:
1. What Dovobet is and what it is used for
2. Before you use Dovobet
3. How to use Dovobet
4. Possible side effects
5. How to store Dovobet
6. Further information

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

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
• 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:
• 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).

DATE:

PROOF HISTORY:
v.3 - waymade - 04/08/13
CUSTOMER
APPROVED:

Dovobet contains calcipotriol and betamethasone. Calcipotriol helps to bring the rate of skin cell growth back
to normal and betamethasone acts to reduce inflammation.

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 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 a bathing cap, 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 breast) 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.

DATE:
04/08/13
DATE OF PROOF:

DT
ARTWORKER:

PRE-PRESS NO.:

04-1957

Q.A.
APPROVED:

Children
Dovobet is not recommended for the use in children below the age of 18 years.
Taking other medicines
Please tell your doctor or pharmacist 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
Dovobet contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis)
or irritation to the eyes and mucous membranes.
Dovobet also contains hydrogenated castor oil which may cause severe allergic reactions and/or skin
reactions.

Waymade

Dovobet Gel

06464/3017B

CUSTOMER:

PRODUCT:

CODE:

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.
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 gel
• 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
• For treatment of the scalp usually an amount between 1 g and 4 g per day is sufficient (4 g
corresponds to one teaspoon)
• Washing your hair before application of Dovobet is not necessary
• 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.
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.

WARNING!

This medicine is known as Dovobet Gel but will be referred to as Dovobet throughout this leaflet.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

WARNING!

27mm

Dovobet® Gel
(calcipotriol/betamethasone dipropionate)
Patient information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000B

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.

DATE:
04/08/13
DATE OF PROOF:

DATE:

DT

CODE:

06464/3017B

04-1957

ARTWORKER:

Waymade

Dovobet Gel
PRODUCT:

CUSTOMER:

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 (affect less than 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, or use under occlusion. 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 your 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 taking 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
taking 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 bone pain, constipation,
poor appetite, nausea and vomiting.
This can be serious, and you should contact your doctor immediately.
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

PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.3 - waymade - 04/08/13

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Approximately 1 in 12 people may experience side effects, but most of these are reactions at the site where
the gel has been applied.

Common side effects (affect less than 1 in 10 people):
• Itching.
Uncommon (affect less than 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.
Less serious side effects caused by using betamethasone for a long time include the following, and 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)
• Small white spots (colloid milia)
• Depigmentation (lightening of skin colour).
Less serious side effects known to be caused by calcipotriol include the following
• Sensitivity of the skin to light resulting in a rash
• Eczema. If you notice the above or any other changes in your health while taking this medicine, tell
your doctor. If any of the side effects get 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
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.

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. Further information
What Dovobet contains
The active substances are: calcipotriol and betamethasone. Each 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-15 stearyl ether, hydrogenated castor oil, butylhydroxytoluene (E321) and
all-rac-α-tocopherol
What Dovobet looks like and the contents of the pack
Dovobet Gel is an almost clear, colourless to slightly off-white gel.
Dovobet Gel is available as bottles of 60g and 120g (2 x 60g).
POM

PL No: 06464/3017 Dovobet Gel

This product is manufactured by LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S), Industriparken
55, DK-2750 Ballerup, Denmark and/or, LEO Laboratories Ltd, Cashel Road, Dublin 12, Ireland and procured
from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet revision and issue date (Ref.) 03.09.2013
DOVOBET is a registered trademark of LEO Pharma A/S

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

WARNING!

If you forget to use Dovobet
Do not use a double dose to make up for forgotten individual doses.

WARNING!

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 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).

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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.

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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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