Skip to Content

DOVONEX OINTMENT

Active substance: CALCIPOTRIOL

View full screen / Print PDF » Download PDF ⇩
Transcript
Please return to:
LEO Pharma A/S
Internal Market Access

Subject

Item No.

GB

Rev. No.

Date

Colour

Date

Date

Sign.

Sign.

01/10/14
Sign.

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

Sent by e-mail

YY

026596

INS 175 x 560 mm

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



Scale

61

ARTWORK

LOF
Supplier / Place of production

Dovonex® ointment

Ireland

Comments:

Page 1 of 2 Font size: Heading: 10 point, section: 9 point, linespacing: 3,35 mm

Pharmacode 61

Mock-up for reg purpose

175 mm

Package leaflet: Information for the user

Dovonex® Ointment
calcipotriol
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.
• In this leaflet Dovonex® Ointment will be called Dovonex®.

These diagrams explain how your skin may improve
when you use this medicine.
Patch of
psoriasis
Normal
skin

026596-YY

000000-00

Patch
flatter

Remove the cap. Check the seal is not broken
before you first use the ointment. If you have a
240 gram tube, remove the foil seal on the tube.
* If you have a 15 gram, 30 gram, 60 gram, 100
gram or 120 gram tube, you will need to break the
seal by using the point in the back of the cap.*
Always wash your hands before using Dovonex®.
Put your medicine on the skin which has the
psoriasis. You can squeeze your medicine on to
your skin directly. You can squeeze it on to your
finger first if you wish. Put your medicine on thickly.
Then rub it in gently to cover the psoriasis.

Your skin before
treatment.

Always wash your hands after using Dovonex®.
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.

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.

Unless you are using the ointment to treat your
hands, always wash your hands after using
Dovonex®.

The redness of the skin
will start to clear up next.
It may clear up in the
centre first.
Dovonex® is used to treat:
• Plaque psoriasis (psoriasis vulgaris).

2. What you need to know before you use
Dovonex®
Do not use Dovonex®
• If you are allergic (hypersensitive) to calcipotriol or
any of the other ingredients of this medicine (listed
in section 6).
If you have been told by a doctor that you have
high or low levels of a substance called calcium in
your body (calcium metabolism disorders).
• If you have severe liver problems
• If you have severe kidney problems
• Do not use on your face
• Do not use on children under 6 years old
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before using
Dovonex®
• If you are already having ultraviolet (UV) light
treatment.
• If you have guttate, erythrodermic, exfoliative or
pustular psoriasis. Ask your doctor if you are unsure
Excess calcium in the blood (hypercalcaemia)
This medicine can cause increases in calcium levels
in the body so it is important that you do not exceed
the recommended dose (See section 4).
Raised calcium levels can produce
• Increased amounts of urine (passing water more
frequently or in greater quantities than usual)
and/or increased thirst
• Dry or metallic taste in the mouth
• Stomach upsets (including pain, nausea, vomiting
and constipation)
• Weak muscles and/or pain in the bones
• Tiredness, fatigue and confusion
If you get any of these tell you doctor straight away.
You may get too much calcium in your blood when
you use this medicine. Please read section 4 of this
leaflet so that you can spot any signs this may be
happening to you. Your doctor may need to change
your dose.
You are not likely to get too much calcium in your
blood if you use the dose prescribed for you. You
can find the dose that you should use in section 3 of
this leaflet. You are more likely to get too much
calcium in your blood if you use more than the
recommended dose each week.
Do not use Dovonex® on your face as it may irritate
the skin on your face or accidentally get in your eyes.
Be careful when using Dovonex® in skin folds such
as armpits or under the breasts. You may be more
likely to get skin side effects in these areas.
Your doctor may tell you to limit your exposure to
natural or artificial sunlight, e.g. sunbathing and sun
beds, while you are using this medicine.
Children
Do not use this medicine on children under 6 years
old.
Other medicines and Dovonex®
Tell your doctor or 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.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine. If your doctor has agreed that you can
breast-feed, do not apply Dovonex® to the breast
area.
Driving and using machines
This medicine should not have any effect on your
ability to drive or use machines. Check with your
doctor if you develop any 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®
Dovonex® contains:
• Propylene glycol. This is a skin moisturiser. It may
irritate your skin.
Please ask your doctor if you are worried about any
of the ingredients in this medicine.

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.
How much Dovonex® to use
Your doctor will tell you how much Dovonex® to
use, or give to your child.
For the best results you should use Dovonex® twice
each day. If you are an adult, your doctor may
suggest you use the medicine once a day. If you use
it twice a day, use it in the morning and in the
evening. To remind you to use your medicine it may
help to use it when you do another regular action,
such as brushing your teeth.
Adults:
Your dose will depend on how bad your psoriasis
is. Your doctor will prescribe the dose that is right
for you.
Use the medicine once or twice each day. Follow
the advice of your doctor.
Do not use more than 100 grams each week.
Children and adolescents:
The dose will depend on how bad the psoriasis is.
Your doctor will prescribe the dose that is right for
your child.
• Children over 12 years old:
Use the medicine twice each day.
Do not use more than 75 grams each week.
• Children between 6 and 12 years old:
Use the medicine twice each day.
Do not use more than 50 grams each week.
• Children under 6 years old:
Do not use on children under 6 years of age
If you use more Dovonex® than you should
Tell your doctor straight away.
You may get too much calcium in your blood.
Please read sections 2 and 4 of this leaflet so you
can spot any signs that this may be happening to
you. Your doctor may tell you to stop taking your
medicine until the amount of calcium in your blood
goes back to normal.
If you forget to use Dovonex®
If you forget to use your medicine, use it as soon as
you remember. Then next use your medicine at the
usual time.
If you have any further questions about taking this
medicine, please ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Dovonex® can cause side effects,
although not everybody gets them.
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 swell
• Your skin develops a severe rash, particularly if
the skin is blistering or bleeding
You should 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 have a headache or pain in your stomach
• You feel sick or have constipation
Other possible side effects:
The possible side effects in the following section of
this leaflet are usually mild.
Common side effects (may affect up to 1 in 10
people)
• Skin irritation
• Worsening of your psoriasis
• Dermatitis
• Redness
• Flaking skin
• Burning or stinging feeling
• Itchy rash and skin inflammation in the area where
the medicine is used
• Itching skin
• Pain in the area where the medicine is used

Item-number:
See details below.

02/10/14

Do not mix Dovonex® with any other medicines.

000000-00

560 mm

Dovonex® works by reducing the amount of cells
your skin makes. This means your skin symptoms
will reduce too.

Never put this medicine on your face or the face of
your child as it may cause irritation.

LOF

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.

How to put on Dovonex®
This medicine is only for using on your skin or the
skin of a child. Do not swallow it. Do not put it
inside your body.

026596-YY

200 mm

Dovonex® contains the active substance calcipotriol.
Dovonex® 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.

Always use Dovonex® exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.

6.

1. What Dovonex® is and what it is used for

3. How to use Dovonex®

360 mm

What is in this leaflet:
1. What Dovonex® is and what it is used for
2. What you need to know before you use Dovonex®
3. How to use Dovonex®
4. Possible side effects
5. How to store Dovonex®
6. Contents of the pack and other information

Scale

Please return to:
LEO Pharma A/S
Internal Market Access

Subject

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

Item No.

100%

GB

Rev. No.

Sent by e-mail

YY

026596
Date

INS 175 x 560 mm



ARTWORK

Date

Date

Sign.

Sign.

01/10/14

Colour

Sign.

LOF

Black

Supplier / Place of production

Dovonex® ointment

Ireland

Comments:

Page 2 of 2

Font size: Heading: 10 point, section: 9 point, linespacing: 3,35 mm

Pharmacode 61

175 mm

Uncommon side effects (may affect up to 1 in
100 people)
• Folliculitis (infection in the hair follicle)
• Rash
• Red, itchy, scaly rash. Blisters may form. These
may weep or become crusty (eczema).
• Dry skin
• Changes in skin colour where the medicine is used
Rare side effects (may affect up to 1 in 1000 people)
• Hypersensitivity (allergic reaction)
• Hypercalcaemia (too much calcium in the blood)
• Temporary increased sensitivity to sunlight
• Skin swelling or puffiness (oedema)
• Itchy raised rash (hives)
• Seborrhoeic dermatitis (such as dandruff or cradle
cap)
• Hypercalciuria (too much calcium in the urine)
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.

5. How to store Dovonex®

560 mm

• Keep this medicine out of the sight and reach of
children.
• Do not use Dovonex® ointment 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® contains
• The active substance is calcipotriol.
Dovonex® ointment contains 50 micrograms of
calcipotriol in each gram of ointment.
• The other ingredients are disodium edetate,
disodium phosphate dihydrate, DL-α tocopherol,
liquid paraffin, macrogol (2) stearyl ether,
propylene glycol, purified water and white soft
paraffin.
You can find important information about some of
the ingredients in your medicine near the end of
section 2 of this leaflet.
What Dovonex® looks like and contents of the pack
Dovonex® is an off white to yellowish white
translucent ointment.
Dovonex® comes in aluminium tubes of 5 grams,
15 grams, 30 grams, 60 grams, 100 grams,
120 grams and 240 grams.
Not all pack sizes may be marketed.
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 September 2014.
®Registered

Trade Mark

LEO
026596-YY

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.

Hide