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CALCIPOTRIOL 50MCG/ML SCALP SOLUTION

Active substance(s): CALCIPOTRIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dovonex® Scalp Solution
(calcipotriol)

Your medicine is available using the name Dovonex Scalp Solution
but will be referred to as Dovonex throughout the leaflet.

Please read all of this leaflet carefully before
you start using this medicine.








Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects become serious, or you notice any
side effects not listed in this leaflet please tell your doctor or
pharmacist.

In this leaflet:

1.
2.
3.
4.
5.
6.

What Dovonex is and what it is used for
Before you use Dovonex
How to use Dovonex
Possible side effects
How to store Dovonex
Further information.

1. What Dovonex is and what it is used for
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.
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 works by reducing the amount of cells your skin makes.
This means your skin symptoms will reduce too.
These diagrams explain how your skin may improve when you use
this medicine.
(Visual 1)
Your skin before treatment.

(Visual 2)
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.

Dovonex is used to treat:


Scalp psoriasis (psoriasis on your head).

2. Before you use Dovonex
Do not use Dovonex







If you are allergic (hypersensitive) to calcipotriol or any of
the other ingredients in your medicine. You can find a list of
these ingredients in section 6 of this leaflet.
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 kidney problems.
If you have severe liver problems.

Take special care with Dovonex

Before you use Dovonex tell your doctor:

If you are already having ultraviolet (UV) light treatment.
You must discuss with your doctor about having light
treatment and using Dovonex at the same time.

If you know you have a type of psoriasis called generalised
pustular psoriasis. Ask your doctor if you are unsure.

If you know you have a type of psoriasis called
erythrodermic exfoliative psoriasis. Ask your doctor if you
are unsure.
Do not use Dovonex on your face.
Your doctor may tell you to limit your exposure to natural or
artificial sunlight while you are using this medicine.
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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have
recently taken any other medicines. This includes any medicines
which you have bought without a prescription.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before using
Dovonex:

If you are pregnant, or think you are pregnant.

If you are breast-feeding.
Tell your doctor if you become pregnant while using this medicine.

Driving and using machines

Usually your medicine may have very little effect on your ability to
drive or use machines. Check with your doctor if you feel any side
effect that may stop you from driving or using machines.

(Visual 3)
The redness of the skin will start to clear up
next. It may clear up in the centre first.
Page 1 of 2

Important information about some of the
ingredients of Dovonex
Dovonex contains:

Propylene glycol. It may irritate your skin.

Please ask your doctor if you are worried about any of the
ingredients in this medicine.

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

How to put on Dovonex

This medicine is only for using on your head (scalp).
Never put it on your face as it may cause irritation. Do not
swallow it. Do not put it inside your body.
Do not mix Dovonex with any other medicines.
Always wash your hands before using Dovonex.
Use your medicine when your hair is dry. Part your hair before
you use your medicine. This will help your medicine reach down to
the skin on your head.
Tilt your head back to stop any medicine running on to your face
or in your eyes.
Put the nozzle of the bottle close to your head. You can squeeze
your medicine on to your head directly where the rash is. One or
two drops will cover a small patch about the size of a postage
stamp. Rub it in gently.
Let your medicine dry naturally. It will not take long. Never dry it
with a hairdryer or near a fire. Leave your medicine on until you
next wash your hair. This will help it to work better.
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 medicine on your normal
skin, but wash it off if it spreads too far.
If you accidentally get any medicine in your eye, wash it out with
water straight away. Then bathe your eye with an eyewash if
possible. If your eye is sore, go to your doctor.
Keep your medicine away from your glasses or any plastic.

How much Dovonex to use

Your doctor will tell you how much Dovonex to use.
You should use this medicine twice each 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:.

Using only this medicine
Do not use more than 60 millilitres (ml) each week.


Using this medicine with other creams or ointments
Please check with your doctor or pharmacist if you are using
other medicines, and you are not sure what they contain.
Remember: your medicine contains the active ingredient
called calcipotriol. You may use it with other creams or
ointments that also contain calcipotriol.
You must use these medicines carefully together so you do
not have too much in a week.
Either:
Do not use more than 60 millilitres (ml) of Dovonex and 30
grams of calcipotriol cream or ointment each week.
or:
Do not use more than 30 millilitres (ml) of Dovonex and 60
grams of calcipotriol cream or ointment each week.

Children:

This medicine is not recommended for use in children.

If you use more Dovonex than you should

Tell your doctor straight away. You may get too much calcium in
your blood. Please read section 4 of this leaflet so you can spot
any signs that this may be happening to you.

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.

Other possible side effects:

The possible side effects described in the following section of this
leaflet are usually mild.

Very common side effects (probably affect more
than 1 in 10 people)


Skin irritation

Common side effects (probably affect up to 1 in 10
people)







Rash
Burning or stinging feeling.
Dry skin
Itching skin
Redness
Itchy rash and skin inflammation in the area where the
medicine is used.

Uncommon side effects (probably affect less than 1
in 100 people)



Worsening of your psoriasis
Red, itchy, scaly rash. Blisters may form. These may weep
or become crusty (eczema).

Side effects where the number of people affected is
not known




Itchy raised rash (hives).
Temporary changes in your skin colour.
Temporary increased sensitivity to sunlight.

If any of the side effects become serious or you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

6. Further information
What Dovonex contains




Dovonex contains an ingredient called calcipotriol. Each ml
of the topical solution contains 50 micrograms calcipotriol.
This is the active ingredient which treats your psoriasis.
The other ingredients in the solution are hydroxypropyl
cellulose, isopropanol, levomenthol, sodium citrate,
propylene glycol and purified water. These are inactive
ingredients which do not treat the psoriasis and are only
included to make the solution.

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 in a white plastic bottle with a nozzle and blue screw
cap, containing a clear solution.
Dovonex is available in packs of 30ml and 60ml (2 x 30ml)
bottles.

Manufacturer

Dovonex is manufactured by: LEO Pharmaceutical Products,
Industriparken 55, Ballerup, Denmark.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0517

POM

Leaflet revision and issue date (Ref): 29.01.15
Dovonex® is a registered trademark owned by LEO Pharma A/S.

4. Possible 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.

Like all medicines, Dovonex can cause side effects, although not
everybody gets them.

By reporting side effects, you can help provide more information
on the safety of this medicine.

Psoriasis is not infectious so you do not need to worry about other
people catching it from you.

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:

5. How to store Dovonex

We still do not know what causes psoriasis but you can inherit it.
Other things can make psoriasis worse such as stress.





You have difficulty breathing
Your face including around your eyes swell
Your skin develops a severe rash.

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:








You need to pass water (urine) more often
You feel thirsty
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
You feel sick or have constipation.









Keep out of the sight and reach of children.
Do not store above 25°C. Keep the solution away from fire
or flames as it may set on fire.
Do not use the solution after the expiry date on the bottle.
The expiry date refers to the last day of that month.
If your doctor decides to stop your treatment, take any
leftover medicine back to the pharmacy.
If your medicine appears to be discoloured or shows any
other signs of deterioration, take it to your pharmacist who
will advise you.
Medicines should not be disposed of via household
wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures
will help to protect the environment.

Page 2 of 2

More about psoriasis

You can get psoriasis anywhere on your body.

For further information about psoriasis, you can contact:
The Psoriasis Association,
mail@psoriasis-association.org.uk
If you have any questions about your treatment, ask your doctor
or pharmacist.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Calcipotriol 50 micrograms/ml Scalp Solution
Your medicine is available using the name Calcipotriol
50 micrograms/ml Scalp Solution but will be referred to as
Calcipotriol throughout the leaflet.

Please read all of this leaflet carefully before
you start using this medicine.








Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects become serious, or you notice any
side effects not listed in this leaflet please tell your doctor or
pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Calcipotriol is and what it is used for
Before you use Calcipotriol
How to use Calcipotriol
Possible side effects
How to store Calcipotriol
Further information.

1. What Calcipotriol is and what it is used for
Calcipotriol 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.
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.
Calcipotriol works by reducing the amount of cells your skin
makes. This means your skin symptoms will reduce too.
These diagrams explain how your skin may improve when you use
this medicine.
(Visual 1)
Your skin before treatment.

(Visual 2)
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.

Calcipotriol is used to treat:


Scalp psoriasis (psoriasis on your head).

2. Before you use Calcipotriol
Do not use Calcipotriol







If you are allergic (hypersensitive) to calcipotriol or any of
the other ingredients in your medicine. You can find a list of
these ingredients in section 6 of this leaflet.
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 kidney problems.
If you have severe liver problems.

Take special care with Calcipotriol

Before you use Calcipotriol tell your doctor:

If you are already having ultraviolet (UV) light treatment.
You must discuss with your doctor about having light
treatment and using Calcipotriol at the same time.

If you know you have a type of psoriasis called generalised
pustular psoriasis. Ask your doctor if you are unsure.

If you know you have a type of psoriasis called
erythrodermic exfoliative psoriasis. Ask your doctor if you
are unsure.
Do not use Calcipotriol on your face.
Your doctor may tell you to limit your exposure to natural or
artificial sunlight while you are using this medicine.
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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have
recently taken any other medicines. This includes any medicines
which you have bought without a prescription.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before using
Calcipotriol:

If you are pregnant, or think you are pregnant.

If you are breast-feeding.
Tell your doctor if you become pregnant while using this medicine.

Driving and using machines

Usually your medicine may have very little effect on your ability to
drive or use machines. Check with your doctor if you feel any side
effect that may stop you from driving or using machines.

(Visual 3)
The redness of the skin will start to clear up
next. It may clear up in the centre first.
Page 1 of 2

Important information about some of the
ingredients of Calcipotriol
Calcipotriol contains:

Propylene glycol. It may irritate your skin.

Please ask your doctor if you are worried about any of the
ingredients in this medicine.

3. How to use Calcipotriol
Always use Calcipotriol exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

How to put on Calcipotriol

This medicine is only for using on your head (scalp).
Never put it on your face as it may cause irritation. Do not
swallow it. Do not put it inside your body.
Do not mix Calcipotriol with any other medicines.
Always wash your hands before using Calcipotriol.
Use your medicine when your hair is dry. Part your hair before
you use your medicine. This will help your medicine reach down to
the skin on your head.
Tilt your head back to stop any medicine running on to your face
or in your eyes.
Put the nozzle of the bottle close to your head. You can squeeze
your medicine on to your head directly where the rash is. One or
two drops will cover a small patch about the size of a postage
stamp. Rub it in gently.
Let your medicine dry naturally. It will not take long. Never dry it
with a hairdryer or near a fire. Leave your medicine on until you
next wash your hair. This will help it to work better.
Always wash your hands after using Calcipotriol. This will stop any
medicine accidentally spreading to other parts of your body. Do
not worry if you accidentally get any medicine on your normal
skin, but wash it off if it spreads too far.
If you accidentally get any medicine in your eye, wash it out with
water straight away. Then bathe your eye with an eyewash if
possible. If your eye is sore, go to your doctor.
Keep your medicine away from your glasses or any plastic.

How much Calcipotriol to use

Your doctor will tell you how much Calcipotriol to use.
You should use this medicine twice each 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:.

Using only this medicine
Do not use more than 60 millilitres (ml) each week.


Using this medicine with other creams or ointments
Please check with your doctor or pharmacist if you are using
other medicines, and you are not sure what they contain.
Remember: your medicine contains the active ingredient
called calcipotriol. You may use it with other creams or
ointments that also contain calcipotriol.
You must use these medicines carefully together so you do
not have too much in a week.
Either:
Do not use more than 60 millilitres (ml) of Calcipotriol and
30 grams of calcipotriol cream or ointment each week.
or:
Do not use more than 30 millilitres (ml) of Calcipotriol and
60 grams of calcipotriol cream or ointment each week.

Children:

This medicine is not recommended for use in children.

If you use more Calcipotriol than you should

Tell your doctor straight away. You may get too much calcium in
your blood. Please read section 4 of this leaflet so you can spot
any signs that this may be happening to you.

If you forget to use Calcipotriol

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.

Other possible side effects:

The possible side effects described in the following section of this
leaflet are usually mild.

Very common side effects (probably affect more
than 1 in 10 people)


Skin irritation

Common side effects (probably affect up to 1 in 10
people)







Rash
Burning or stinging feeling.
Dry skin
Itching skin
Redness
Itchy rash and skin inflammation in the area where the
medicine is used.

Uncommon side effects (probably affect less than 1
in 100 people)



Worsening of your psoriasis
Red, itchy, scaly rash. Blisters may form. These may weep
or become crusty (eczema).

Side effects where the number of people affected is
not known




Itchy raised rash (hives).
Temporary changes in your skin colour.
Temporary increased sensitivity to sunlight.

If any of the side effects become serious or you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

4. Possible 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.

Like all medicines, Calcipotriol can cause side effects, although not
everybody gets them.

By reporting side effects, you can help provide more information
on the safety of this medicine.

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:

5. How to store Calcipotriol





You have difficulty breathing
Your face including around your eyes swell
Your skin develops a severe rash.

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:








You need to pass water (urine) more often
You feel thirsty
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
You feel sick or have constipation.









Keep out of the sight and reach of children.
Do not store above 25°C. Keep the solution away from fire
or flames as it may set on fire.
Do not use the solution after the expiry date on the bottle.
The expiry date refers to the last day of that month.
If your doctor decides to stop your treatment, take any
leftover medicine back to the pharmacy.
If your medicine appears to be discoloured or shows any
other signs of deterioration, take it to your pharmacist who
will advise you.
Medicines should not be disposed of via household
wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures
will help to protect the environment.

Page 2 of 2

6. Further information
What Calcipotriol contains




Calcipotriol contains an ingredient called calcipotriol. Each ml
of the topical solution contains 50 micrograms calcipotriol.
This is the active ingredient which treats your psoriasis.
The other ingredients in the solution are hydroxypropyl
cellulose, isopropanol, levomenthol, sodium citrate,
propylene glycol and purified water. These are inactive
ingredients which do not treat the psoriasis and are only
included to make the solution.

You can find important information about some of the ingredients
in your medicine near the end of section 2 of this leaflet.

What Calcipotriol looks like and contents of the
pack

Calcipotriol is in a white plastic bottle with a nozzle and blue screw
cap, containing a clear solution.
Calcipotriol is available in packs of 30ml and 60ml (2 x 30ml)
bottles.

Manufacturer

Calcipotriol is manufactured by: LEO Pharmaceutical Products,
Industriparken 55, Ballerup, Denmark.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0517

POM

Leaflet revision and issue date (Ref): 29.01.15

More about psoriasis

You can get psoriasis anywhere on your body.
Psoriasis is not infectious so you do not need to worry about other
people catching it from you.
We still do not know what causes psoriasis but you can inherit it.
Other things can make psoriasis worse such as stress.
For further information about psoriasis, you can contact:
The Psoriasis Association,
mail@psoriasis-association.org.uk
If you have any questions about your treatment, ask your doctor
or pharmacist.

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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