Medication Guide App

DOVOBET OINTMENT

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

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ARIAL BOLD
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CRESTOR 6464/2069 2070

Leaflet Flat Size = 180 x 429

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).

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.

DATE:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1 - waymade - 19/11/13

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).

Children
Dovobet is not recommended for the use in children below the age of 18 years.
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.

TVT CHECKED

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.
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.
UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

6464/2117F

DATE OF PROOF:

19/11/13

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.

CODE:

DT
ARTWORKER:

CUSTOMER: Waymade
PRODUCT:
Dovobet ointment

PRE-PRESS NO.:

04-1957

Q.A.
APPROVED:

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.

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.

WARNING!

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 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.

This medicine is known by the above name but will usually be referred to as Dovobet in this leaflet.

WARNING!

27mm

DOVOBET® OINTMENT
(calcipotriol/betamethasone)
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

4. Possible side effects
Like all medicines, Dovobet can cause side effects, although not everybody gets them.

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.

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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.

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.

PROOF HISTORY:
v.1 - waymade - 19/11/13

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.

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.

DATE:

CUSTOMER
APPROVED:

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.

19/11/13
DATE OF PROOF:

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

CODE:

6464/2117F

TVT CHECKED

DT
ARTWORKER:

DATE:

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.

CUSTOMER: Waymade
PRODUCT:
Dovobet ointment

PRE-PRESS NO.:

04-1957

Q.A.
APPROVED:

Not known frequency
• Rebound effect: A worsening of symptoms/psoriasis after ended treatment.








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 the ointment becomes discoloured or shows any other signs of deterioration, you should consult your pharmacist who
will advise you what to do.

6. Contents of the pack and other information
What is in Dovobet ointment?
Each gram of ointment contains: 50 micrograms of CALCIPOTRIOL (as hydrate) and 500 micrograms of BETAMETHASONE (as
dipropionate).
The other ingredients are:
liquid paraffin, polyoxypropylene-15-stearyl ether, α-tocopherol, white soft paraffin.
What Dovobet looks like and contents of the pack
Dovobet ointment is available as packs containing 60 gram tubes of ointment.
Dovobet ointment is a white, translucent ointment.
POM

PL No: 6464/2117

This product is manufactured by Leo Laboratories Limited, Cashel Road, Dublin 12, Ireland and is 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.) 19.11.2013
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!

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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 take a double dose to make up for forgotten individual doses.

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.

27mm

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).

Expand view ⇕

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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