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DOVONEX PSORIASIS 50 MICROGRAM PER G OINTMENT

Active substance(s): CALCIPOTRIOL ANHYDROUS / CALCIPOTRIOL ANHYDROUS

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GB

Subject

Date

INS 175 x 560 mm *)

*) Dette format går kun til 60 g - 120 g

Date

15/02/17

Colour

Sign.

Black % 70, 60, 50 ,40, 30, 20, 15
Preparation
Strength
Packsize
Comments:

Sign.

EBD
Place of production

Ireland

Dovonex® ointment - OTC Layout
Page 1 of 2 Font size: Heading: 10 point, section: 9 point, linespacing: 3,2 mm

Pharmacode XXX Mock-up for reg. purpose

175 mm

Package leaflet: Information for the patient

Dovonex® Psoriasis 50 microgram/g ointment
calcipotriol

1. What Dovonex® Psoriasis is and what it is used for
Dovonex Psoriasis contains the active substance
calcipotriol. This medicine belongs to a group of
medicines called anti-psoriatics. It is a type of vitamin D.
Vitamin D controls how the cells in your skin grow.

560 mm

This medicine is used in adults to treat:
Mild or moderate plaque psoriasis (psoriasis vulgaris)
which has been previously diagnosed by a doctor.
Psoriasis is mild or moderate when it affects an area of
skin no bigger than the skin surface on one of your arms.
If the cells in your skin grow too much you may get
psoriasis. Psoriasis is a condition where your skin
develops raised red patches and silver coloured scaly
patches. The scaly patches are dead cells that would
normally fall off your skin without you noticing.
Dovonex Psoriasis works by reducing the amount of
cells your skin makes. This means your skin symptoms
will reduce too.
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These diagrams explain how your skin may improve
when you use this medicine.
Your skin before
treatment.

Patch of
psoriasis
Normal
skin

Patch
flatter

After about two weeks
you may see a change in
your skin. The scaly or
flaky patches usually
clear up first. They will
feel smoother.
The redness of the skin
will start to clear up next.
It may clear up in the
centre first.

2. What you need to know before you use
Dovonex® Psoriasis
Do not use this medicine:
• If you are allergic to calcipotriol or any of the other
ingredients of this medicine (listed in section 6)
• If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby
• If you have been told by a doctor that you have high or
low levels of a substance called calcium in your body.
Warnings and precautions
You should see your doctor once a year for a routine
check of your psoriasis.
Talk to your doctor before using this medicine:
• If your psoriasis is much worse or different to when
your doctor last saw it
• If you have specific types of psoriasis covering large
areas of the body (guttate or erythrodermic/exfoliative)
or psoriasis with pus-filled bumps (pustular). Ask your
doctor if you are unsure
• If your joints swell or are painful or if you have
problems with your nails
• If you have liver or kidney problems
• If you are already having ultraviolet (UV) light treatment.
Stop using this medicine and talk to your doctor:
• If your psoriasis becomes worse at any time, or is no
better after using the medicine every day for 4 weeks
• If you need to use more than 60 grams (1 tube) of
ointment per week.

You must see your doctor if you feel that your psoriasis
has not cleared up by up to 50% after using this
medicine for 12 weeks.
Excess calcium in the blood
This medicine can cause increases in calcium levels in
the body so it is important that you do not use more than
the recommended dose. You should apply Dovonex
Psoriasis once a day and you must not use more than
60 grams (1 tube) of ointment per week.
Signs of an increased blood calcium level can include:
• Passing water (urine) more frequently or in greater
quantities than usual
• Increased thirst
• Dry or metallic taste in the mouth
• Stomach upsets (including pain, feeling sick, nausea,
vomiting and constipation)
• Feeling weak or having pains in the muscles or bones
• Tiredness and confusion.
If you get any of these symptoms, stop using this
medicine and tell your doctor straight away.
You are not likely to get too much calcium in your blood if
you use this medicine as outlined in this leaflet or as your
pharmacist has told you.

SOP_000647, SOP_000962
and SOP_008676

Do not use this medicine:
• on your face, as it may irritate the skin on your face or
accidentally get in your eyes
• on your scalp, as in this area psoriasis is difficult to
treat and special treatments may be needed
• on your genitals or in skin folds such as armpits or
under the breasts, as you may be more likely to get
skin side effects in these areas.
Do not cover your skin with any dressings or bandages
when you have applied this medicine.
You should avoid sunbathing or using sunbeds while you
are using this medicine as it may enhance harmful
effects of the sun.
Children and adolescents
Do not use this medicine on children and adolescents
aged less than 18 years old as supervision by a doctor is
needed in these age groups. Dovonex Psoriasis is only
suitable for use in adults over 18 years old.
Other medicines and Dovonex Psoriasis
Tell your pharmacist if you are taking or have recently
taken or might take any other medicines. This includes
any medicines which you have bought without a
prescription or herbal medicines.
You should not use any other psoriasis treatment other
than a moisturiser (emollient) while you are using this
medicine.
Do not take calcium supplements or any other medicines
that contain calcium while using this medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, do not use this
medicine and talk to your doctor.
Driving and using machines
This medicine should not have any effect on your ability
to drive or use machines. Check with your pharmacist if
you develop any side effects that may interfere with your
ability to drive, operate machinery or take part in any
other activity where they may put you or others at risk.
Important information about some of the ingredients of
Dovonex Psoriasis
This medicine contains:
• Propylene glycol. This is a skin moisturiser. It may
irritate your skin.
Please ask your pharmacist if you are worried about any
of the ingredients in this medicine.

3. How to use Dovonex® Psoriasis
Always use this medicine exactly as described in this
leaflet. You should check with your pharmacist if you are
not sure.
How to apply Dovonex Psoriasis
This medicine is only for use on your skin. Do not
swallow it. Do not put it inside your body. You should
only use the ointment to treat a total area of skin no
bigger than the skin surface on one of your arms
(around 10% of your body surface area).
Do not use this medicine:
• on your face, as it may irritate the skin on your face or
accidentally get in your eyes
• on your scalp, as in this area psoriasis is difficult to
treat and special treatments may be needed
• on your genitals or in skin folds such as armpits or
under the breasts, as you may be more likely to get
skin side effects in these areas.
Remove the cap. Check the seal is not broken before you
first use the ointment. You will need to break the seal by
using the point in the back of the cap.
Always wash your hands before using this medicine.

You can use Dovonex Psoriasis for up to 12 weeks.
If you feel your psoriasis has improved a lot or has
completely cleared up, you may stop using this medicine
at any time within 12 weeks. You may start to use this
medicine again if your psoriasis comes back after
clearing up.

SOP_000647, SOP_000962,
SOP_003993 and
SOP_008676

6. Contents of the pack and other information

OMA

5. How to store Dovonex® Psoriasis

Apply the ointment to the skin which has the psoriasis.
You can squeeze your medicine on to your skin directly,
or you can squeeze it on to your finger first if you wish,
to measure how much ointment to use. Squeeze the
ointment along your finger from the tip to the first joint as
shown in the diagram. This is called a fingertip unit.
As a guide, around 6 fingertip units
will sufficiently cover an area equal
in size to one entire arm (not
including your hand). If you need to
use a little more or a little less do not
worry. Then rub it in gently to cover
the psoriasis.
Always wash your hands after using Dovonex Psoriasis,
unless you are treating your hands. This will stop any
medicine accidentally spreading to other parts of your
body. Do not worry if you accidentally get any ointment
on your normal skin, but wash it off if it spreads too far.
Do not cover your skin with any dressings or bandages
when you have applied this medicine.
Do not shower or bath immediately after applying the
ointment.
You should avoid sunbathing or using sunbeds while you
are using this medicine as it may enhance harmful
effects of the sun.
You should try to keep your skin well moisturised,
particularly after a bath or shower. If you use a moisturiser,
wait for it to soak in before you use your medicine.

22/05/17

4. Possible side effects

2.

3. How to use Dovonex® Psoriasis

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2. What you need to know before you use
Dovonex® Psoriasis

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
Always use this medicine exactly as described in this
leaflet or as your pharmacist has told you.
•Keep this leaflet. You may need to read it again.
•Ask your pharmacist if you need more information or
advice.
•If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
•In this leaflet Dovonex® Psoriasis 50 microgram/g
ointment will be called Dovonex Psoriasis.
•You must talk to your doctor if you do not see any
improvement in your psoriasis after 4 weeks.

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What is in this leaflet
1. What Dovonex® Psoriasis is and what it is used for

Get-up

Matrial No

100%

000000-AA

GB

Subject

Sent by e-mail



Scale

Date

INS 175 x 560 mm

Date

15/02/17

Colour

Sign.

Preparation
Strength
Packsize
Comments:

Sign.

EBD

Black % 70, 60, 50 ,40, 30, 20, 15

Place of production

Ireland

Dovonex® ointment - OTC Layout
Page 1 of 2 Font size: Heading: 10 point, section: 9 point, linespacing: 3,2 mm

Pharmacode XXX Mock-up for reg. purpose

175 mm

How much Dovonex Psoriasis to use
Adults:
Apply Dovonex Psoriasis to the affected area once daily.
You can use this medicine for up to 12 weeks.
Do not use more than 60 grams (1 tube) each week.
If your psoriasis becomes worse at any time or it is no
better after using the medicine every day for 4 weeks,
stop using this medicine and see your doctor.
You must see your doctor if you feel that your psoriasis
has not improved by up to 50% after using this medicine
for 12 weeks.
If you use more Dovonex Psoriasis than you should
Tell your doctor or pharmacist straight away and take
this leaflet with you. If you use more of this medicine
than you should, you may get too much calcium in your
blood and your doctor may need to do a blood test to
check for this. Your doctor may tell you to stop using this
medicine until your calcium level goes back to normal.
If you forget to use Dovonex Psoriasis
If you forget to use your medicine, use it as soon as you
remember. Then continue to use your medicine at the
usual time.

5. How to store Dovonex® Psoriasis
• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date on the
tube and carton (EXP). The expiry date is the last day of
that month.
• The tube should be discarded 6 months after first
opening. Write the date you first opened the tube in the
space provided on the carton.
• Do not store above 25°C.
Medicines should not be thrown away in waste water or
in household waste. Please ask your pharmacist how to
throw away any medicine you do not need anymore.
If you do this you will help protect the environment.

6. Contents of the pack and other information
What Dovonex Psoriasis contains
• The active substance is calcipotriol. Dovonex Psoriasis
contains 50 micrograms of calcipotriol in each gram of
ointment.
• The other ingredients are disodium edetate, disodium
phosphate dihydrate, all-rac-α-tocopherol, liquid
paraffin, macrogol-(2)-stearyl ether, propylene glycol,
purified water and white soft paraffin.

Do not use a double dose to make up for a forgotten dose.
If you have any further questions about using this
medicine, please ask your pharmacist.

4. Possible side effects
Like all medicines, Dovonex Psoriasis can cause side
effects, although not everybody gets them.
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Important side effects to look out for:
You must get urgent medical help if you have any of the
following symptoms. You may be having an allergic
reaction:
• You have difficulty breathing
• Your face, including around your eyes, swells
• Your skin develops a severe rash, particularly if the
skin is blistering or bleeding.
You should stop using this medicine and tell your doctor
straight away if you spot any of the following signs
which may be due to too much calcium in your blood or
urine:
• You need to pass water (urine) more often
• You feel thirsty or have lost your appetite
• You have a dry mouth or a metallic taste in your mouth
• You feel weak or have pain in your muscles or bones
• You feel sick or have pain in your stomach (including
nausea, vomiting and constipation)
• You feel tired, fatigued and confused.
Other possible side effects:
Common side effects (may affect up to 1 in 10 people)
• Worsening of your psoriasis
• Skin inflammation
• Redness of the skin
• Flaking skin
• Burning or stinging feeling
• Skin irritation
• Itching skin
• Pain in the area where the medicine is used.
Uncommon side effects (may affect up to 1 in 100 people)
• Infection in a hair follicle
• Rash, including red, itchy, scaly rash. Blisters may form.
These may weep or become crusty
• Dry skin
• Changes in skin colour where the medicine is used.
Rare side effects (may affect up to 1 in 1000 people)
• Allergic reaction
• Too much calcium in the blood
• Increased sensitivity to sunlight
• Skin swelling or puffiness
• Itchy raised rash (hives)
• Skin conditions where there are oily glands. For
example; on the face, centre of chest, or conditions
such as dandruff
• Too much calcium in the urine.

You can find important information about some of the
ingredients in your medicine near the end of section 2
of this leaflet.
What Dovonex Psoriasis looks like and contents of the
pack
This medicine is an off-white to yellowish-white
translucent ointment.
It comes in aluminium tubes of 60 grams.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LEO Laboratories Limited,
Hurley, Berkshire SL6 6RJ, UK.
Manufacturer:
LEO Laboratories Limited, Dublin 12, Ireland.
This leaflet was last revised in May 2017.
®

Registered Trade Mark

FURTHER HELPFUL INFORMATION
People with psoriasis should see their doctor once a
year for a regular check-up of their skin, their treatment
and their general health. This is because psoriasis can
affect other parts of the body as well as the skin. This is
more likely if psoriasis is severe.
Moisturisers (emollients) are useful in treating psoriasis.
Moisturisers can reduce skin dryness and itching. They
can also reduce skin scaling and soften hard cracked
areas, which may help treatments such as Dovonex
Psoriasis to get into the skin.
You should use moisturisers instead of soap when
washing or having a bath. Feel free to moisturise
generously as often as you like, since this will help your
skin symptoms.
It is a good idea to use a moisturiser before you treat
your psoriasis, but allow about 30 minutes between
moisturising and using Dovonex Psoriasis.
Please remember to keep Dovonex Psoriasis out of the
reach of pets. If you suspect that your pet has eaten
Dovonex Psoriasis or chewed the tube, please contact
your vet as soon as possible as it may be harmful to your
pet.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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.

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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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