DOVOBET GEL

Active substance: CALCIPOTRIOL MONOHYDRATE

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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

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

Leaflet Flat Size = 180 x 429

1. What Dovobet is and want 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).

Warning 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
• you have serious liver or kidney disease.

DATE:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1 - waymade - 22/04/14

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).

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 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.

DATE:

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.

DATE OF PROOF:

22/04/14

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.

TVT CHECKED

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.

Important information about some of the ingredients of Dovobet
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 Dovobet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dovobet Gel

06464/3017F

PRODUCT:

CODE:

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

Waymade
CUSTOMER:

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 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.

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.

000-0000F

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.

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.

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

PROOF HISTORY:
v.1 - waymade - 22/04/14

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 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 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.

DATE:

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.

DT

22/04/14

ARTWORKER:

DATE OF PROOF:

DATE:

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.

TVT CHECKED

04-1957
PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

Less serious side effects
The following less serious side effects have been reported for Dovobet
Common side effects (affect less than 1 in 10 people)
• Itching.

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.

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

06464/3017F

Dovobet Gel
PRODUCT:

CODE:

Waymade
CUSTOMER:






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 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. Contents of the pack and other 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-11 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.) 22.04.2014
DOVOBET is a registered trademark of LEO Pharma A/S
For further information about psoriasis, you can contact:
The Psoriasis Association.
mail@psoriasis-association.org.uk

WARNING!

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).

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.

27mm

WARNING!

If you have used more Dovobet than you should
Contact your doctor if you have used more than 15 grams in one day.

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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