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100% GB 059889-XX
Subject Date Date
INS 175 x 280 mm 11/02/20
Colour Sign. Sign.
Black RBE

Preparation Place of production

345
Strength
Packsize Dovobet® ointment Ireland
Comments:
Page 1 of 2 Font size: 9 pt Pharmacode 345 Mock-up for reg. purpose

175 mm
IIE007-01 - 175 x 280 mm

Package leaflet: Information for the user

175 x 280mm

Insert
100%
Dovobet 50 micrograms/g + 0.5 mg/g ointment
®
calcipotriol/betamethasone
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 only. 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: Other medicines and Dovobet

1. What Dovobet® is and what it is used for Tell your doctor or pharmacist if you are taking, have recently taken

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11/06/2018

IIE007-01
2. What you need to know before you use Dovobet® or might take any other medicines.

345
3. How to use Dovobet® Pregnancy and breast-feeding
4. Possible side effects If you are pregnant or breast-feeding, think you may be pregnant or
5. How to store Dovobet® are planning to have a baby, ask your doctor for advice before using
6. Contents of the pack and other information this medicine. If your doctor has agreed that you can breast-feed,
1. WHAT DOVOBET® IS AND WHAT IT IS USED FOR take care and do not apply Dovobet to the breast area.
Dovobet ointment is used on the skin to treat plaque psoriasis Driving and using machines
(psoriasis vulgaris) in adults. Psoriasis is caused by your skin cells This medicine should not have any effect on your ability to drive or
being produced too quickly. This causes redness, scaling and use machines.

059889-XX

OMA

PSR
thickness of your skin. Dovobet ointment contains Butylhydroxytoluene (E321)
Dovobet ointment contains calcipotriol and betamethasone. Dovobet ointment contains butylhydroxytoluene (E321). This may
Calcipotriol helps to bring the rate of skin cell growth back to normal cause local skin reactions (e.g. contact dermatitis), or irritation to the
eyes and mucous membranes.

Used for:
and betamethasone acts to reduce inflammation.

Isathalmic®, Verutex®, Verutex® B

Fucibet®, Fucithalmic®, Isathal®,
Fucidin®, Fucidin® H, Fucicort®,
Taclonex®, Psorcutan®, Token®,
Dovonex®, Daivobet®, Dovobet®
Calcipotriene. Conoptal®, Daivonex®,
3. HOW TO USE DOVOBET®
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOVOBET® Always use Dovobet exactly as your doctor has told you. Check with
Do not use Dovobet your doctor or pharmacist if you are not sure.
• If you are allergic (hypersensitive) to calcipotriol, betamethasone How to put on Dovobet: Cutaneous use.
or any of the other ingredients of this medicine (listed in section 6)
• If you have problems with calcium levels in the body (ask your doctor) Instruction for proper use
• If you have certain types of psoriasis: these are erythrodermic, • Use only on your psoriasis and do not use on skin which does not
exfoliative and pustular (ask your doctor). have psoriasis
• Remove the cap and check that the seal in the tube is not broken
As Dovobet contains a strong steroid do NOT use on skin affected by before you first use the ointment
• skin infections caused by viruses (e.g. cold sores or chicken pox) • To break the seal, use the point in the back of the cap
• skin infections caused by a fungus (e.g. athlete’s foot or ringworm) • Squeeze the ointment onto a clean finger
• skin infections caused by bacteria • Rub gently into your skin to cover the affected area of psoriasis
280 mm

• skin infections caused by parasites (e.g. scabies) until most of the ointment has disappeared into the skin
• tuberculosis (TB) • Do not bandage, tightly cover or wrap the treated skin area
• perioral dermatitis (red rash around the mouth) • Wash your hands well after using Dovobet (unless you are using
• thin skin, easily damaged veins, stretch marks the ointment to treat your hands). This will avoid accidentally
• ichthyosis (dry skin with fish-like scales) spreading the ointment to other parts of your body (especially the
• acne (pimples) face, scalp, mouth and eyes)
• rosacea (severe flushing or redness of the skin on the face) • Do not worry if some ointment accidentally gets on normal skin
• ulcers or broken skin.

Comments:
near your psoriasis, but wipe it off if it spreads too far

PackRat approved
1 column and 2 columns
Warnings and precautions • In order to achieve optimal effect, it is recommended not to take a
Talk to your doctor/nurse/pharmacist before and during use of shower or bath immediately after application of Dovobet ointment
Dovobet if • After applying the ointment avoid contact with textiles which are
• you are using other medicines that contain corticosteroids, as you easily stained by grease (e.g. silk).
may get side effects Duration of treatment
• you have used this medicine for a long time and plan to stop • Use the ointment once a day. It may be more convenient to use the
(as there is a risk your psoriasis will get worse or ‘flare up’ when ointment in the evening
steroids are stopped suddenly) • The normal initial treatment period is 4 weeks but your doctor may
• you have diabetes mellitus (diabetes), as your blood sugar/glucose decide on a different treatment period
level may be affected by the steroid • Your doctor may decide on repeated treatment
• your skin becomes infected, as you may need to stop your treatment • Do not use more than 15 grams in one day.
• you have a certain type of psoriasis called guttate psoriasis If you use other calcipotriol containing medicines, the total amount
• you experience blurred vision or other visual disturbances. of calcipotriol medicines must not exceed 15 grams per day and the
Special precautions area treated should not exceed 30% of the total body surface.
• Avoid use on more than 30% of your body or using more than What should I expect when I use Dovobet?
15 grams per day Most patients see obvious results after 2 weeks, even if the psoriasis
• Avoid using under bandages or dressings as it increases the is not yet cleared at that point.
absorption of the steroid If you use more Dovobet than you should
• Avoid use on large areas of damaged skin, on mucous membranes Contact your doctor if you have used more than 15 grams in one day.
Revision info:

or in skin folds (groin, armpits, under breasts) as it increases the Excessive use of Dovobet may cause a problem with calcium in your
changed reference from INS005 to IIE005-01
IIE007-01 - 03/06/2018 - OMA - Updated for CI project (CAPA 173674),
INS007-00 - 22/09/2017 DVR - Moved details about itemnumber

absorption of the steroid blood, which usually normalises when discontinuing treatment.
• Avoid use on the face or genitals (sex organs) as they are very Your doctor may need to carry out blood tests to check that using too
sensitive to steroids much ointment has not caused a problem with calcium in your blood.
• Avoid excessive sunbathing, excessive use of solarium and other Excessive prolonged use can also cause your adrenal glands to stop
forms of light treatment. working properly (these are found near the kidneys and produce
hormones).
Do not smoke or go near naked flames - risk of severe burns.
Fabric (clothing, bedding, dressings etc) that has been in contact If you forget to use Dovobet
Do not take a double dose to make up for a forgotten dose.
with this product burns more easily and is a serious fire hazard.
Washing clothing and bedding may reduce product build-up but not If you stop using Dovobet
totally remove it. The use of Dovobet should be stopped as indicated by your doctor.
It may be necessary for you to stop this medicine gradually,
Children especially if you have used it for a long time.
Dovobet is not recommended for the use in children below the age If you have any further questions on the use of this medicine, ask
of 18 years. your doctor or pharmacist.

2. JUG
13/03/20
SOP_000647, SOP_000962, SOP_000647, SOP_000962
SOP_003993 and and SOP_008676
SOP_008676
 Scale Get-up Material No Sent by e-mail▲
100% GB 059889-XX
Subject Date Date
INS 175 x 280 mm 11/02/20
Colour Sign. Sign.
Black RBE

Preparation Place of production

Strength
Packsize Dovobet® ointment Ireland
Comments:
Page 2 of 2 Font size: 9 pt Pharmacode 345 Mock-up for reg. purpose

175 mm
IIE007-01 - 175 x 280 mm

4. POSSIBLE SIDE EFFECTS Less serious side effects caused by using betamethasone, especially

175 x 280mm

Insert
100%
Like all medicines, this medicine can cause side effects, although for a long time, include the following. You should tell your doctor or
not everybody gets them. nurse as soon as possible if you notice any of them.
• Thinning of the skin
Serious side effects • Appearance of surface blood vessels or stretch marks
Tell your doctor/nurse immediately or as soon as possible if any of • Changes in hair growth
the following happens. You may have to stop your treatment. • Red rash around the mouth (perioral dermatitis)
The following serious side effects have been reported for Dovobet: • Skin rash with inflammation or swelling (allergic contact dermatitis)
Uncommon (may affect up to 1 in 100 people) • Golden coloured gel-filled bumps (colloid milia)
• Worsening of your psoriasis. If your psoriasis gets worse, tell your • Lightening of skin colour (depigmentation)
doctor as soon as possible. • Inflammation or swelling of the hair root (folliculitis).
Rare (may affect up to 1 in 1,000 people) Less serious side effects known to be caused by calcipotriol include
• Pustular psoriasis may occur (a red area with yellowish pustules the following
usually on the hands or feet). If you notice this, stop using Dovobet • Dry skin

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IIE007-01
and tell your doctor as soon as possible. • Sensitivity of the skin to light resulting in a rash
Some serious side effects are known to be caused by • Eczema

345
betamethasone (a strong steroid), one of the ingredients in Dovobet. • Itching
You should tell your doctor as soon as possible if any of the serious • Skin irritation
side effects occur. These side effects are more likely to happen after • Burning and stinging sensation
long-term use, use in skin folds (e.g. groin, armpits or under breasts), • Redness of the skin due to widening of the small blood vessels
use under occlusion or use on large areas of skin. (erythema)
The side effects include the following: • Rash
• Your adrenal glands may stop working properly. Signs are • Rash with inflammation of the skin (dermatitis)
• Worsening of psoriasis.

059889-XX

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tiredness, depression and anxiety.
• Cataracts (signs are cloudy and foggy vision, difficulty seeing at Reporting of side effects
night and sensitivity to light) or an increase in pressure inside the If you get any side effects, talk to your doctor, pharmacist or nurse.
eye (signs are eye pain, red eye, decreased or cloudy vision) This includes any possible side effects not listed in this leaflet. You

Used for:
• Infections (because your immune system which fights infections can also report side effects directly via the Yellow Card Scheme at:

Isathalmic®, Verutex®, Verutex® B

Fucibet®, Fucithalmic®, Isathal®,
Fucidin®, Fucidin® H, Fucicort®,
Taclonex®, Psorcutan®, Token®,
Dovonex®, Daivobet®, Dovobet®
Calcipotriene. Conoptal®, Daivonex®,
may be suppressed or weakened) www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in
• Pustular psoriasis (a red area with yellowish pustules usually on the Google Play or Apple App Store.
the hands or feet). If you notice this, stop using Dovobet and tell By reporting side effects you can help provide more information on
your doctor as soon as possible. the safety of this medicine.
• Impact on the metabolic control of diabetes mellitus (if you have
diabetes you may experience fluctuations in the blood glucose levels). 5. HOW TO STORE DOVOBET®
• Keep this medicine out of the sight and reach of children
Serious side effects known to be caused by calcipotriol • Do not use this medicine after the expiry date, which is stated on the
• Allergic reactions with deep swelling of the face or other parts of label after EXP. The expiry date refers to the last day of that month
the body such as the hands or feet. Swelling of the mouth/throat • Do not store the product above 25°C
and trouble breathing may occur. If you have an allergic reaction, • The tube should be discarded 1 year after first opening. Write the
stop using Dovobet, tell your doctor immediately or go to the date you first opened the tube in the space provided on the carton.
280 mm

casualty department at your nearest hospital.

• Treatment with this ointment may cause the level of calcium in Do not throw away any medicines via wastewater or household
your blood or urine to increase (usually when too much ointment waste. Ask your pharmacist how to throw away medicines you no
has been used). Signs of increased calcium in blood are excessive longer use. These measures will help protect the environment.
secretion of urine, constipation, muscle weakness, confusion and 6. CONTENTS OF THE PACK AND OTHER INFORMATION
coma. This can be serious and you should contact your doctor What Dovobet contains
immediately. However, when the treatment is stopped, the levels The active substances are:

Comments:
return to normal. Calcipotriol and betamethasone.

PackRat approved
1 column and 2 columns
Less serious side effects One gram of ointment contains 50 micrograms of calcipotriol
The following less serious side effects have been reported for Dovobet. (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Common side effects (may affect up to 1 in 10 people) The other ingredients are:
• Itching • liquid paraffin
• Skin exfoliation. • all-rac-α-tocopherol
• polyoxypropylene stearyl ether
Uncommon (may affect up to 1 in 100 people) • white soft paraffin
• Skin pain or irritation • butylhydroxytoluene (E321).
• Rash with inflammation of the skin (dermatitis)
• Redness of the skin due to widening of the small blood vessels What Dovobet looks like and contents of the pack
(erythema) Dovobet ointment is an off-white to yellow coloured ointment filled in
• Inflammation or swelling of the hair root (folliculitis) aluminium/epoxyphenol tubes with polyethylene screw cap.
• Changes in skin colour in the area you have used the ointment Pack sizes: 15, 30, 60, 100 and 120 g.
• Rash Not all pack sizes may be marketed.
• Burning sensation Marketing Authorisation Holder and Manufacturer
• Infection of the skin The Marketing Authorisation holder is:
• Thinning of the skin LEO Pharma A/S
• Appearance of red or purple discolouration on the skin Industriparken 55, DK-2750 Ballerup, Denmark
(purpura or ecchymosis). The manufacturer is:
Revision info:

Rare (may affect up to 1 in 1,000 people) LEO Laboratories Ltd.

changed reference from INS005 to IIE005-01
IIE007-01 - 03/06/2018 - OMA - Updated for CI project (CAPA 173674),
INS007-00 - 22/09/2017 DVR - Moved details about itemnumber

• Bacterial or fungal infection of hair follicle (furuncle) Cashel Road, Dublin 12, Ireland.
• Allergic reactions
This leaflet was last revised in March 2020.
• Hypercalcaemia
• Stretch marks
• Sensitivity of the skin to light resulting in a rash
For information in large print, Braille or
• Acne (pimples) audio/CD, telephone +44 (0)1844 347333
• Dry skin
Detailed information on this medicine is available on the website of
• Rebound effect: A worsening of symptoms/psoriasis after ended the Medicines and Healthcare Products Regulatory Agency,
treatment. www.mhra.gov.uk
Frequency not known (frequency cannot be estimated from
the available data)
• Blurred vision.
LEO