Skip to Content

CALCIPOTRIOL OINTMENT 0.005%

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

(Calcipotriol)
Patient Information Leaflet

27mm

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, Dovonex Ointment/Calcipotriol Ointment 0.005% will be called Dovonex.
In this leaflet:
1. What Dovonex is and what it is used for
2. Before you use Dovonex
3. How to use Dovonex

4. Possible side effects
5. How to store Dovonex
6. 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.

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.
Your skin before treatment.

Patch of
psoriasis
Normal
skin

PROOF HISTORY:
v.2 - waymade - 25/03/14

Leaflet Flat Size = 180 x 429

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

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.

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.

Patch
flatter

The redness of the skin will start to clear up next. It may clear up in the centre first.

WARNING!

DOVONEX OINTMENT/CALCIPOTRIOL OINTMENT 0.005%

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.

000-0000F

25/03/14

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.

REPORTING OF SIDE EFFECTS

You must tell your doctor or pharmacist if you are taking any of the following medicines:
• Any other medicines to treat psoriasis.

UK PIL DATED OCTOBER 2013

6464/0514F

TVTCHECKED

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.

DATE OF PROOF:

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.

CODE:

DT

DATE:

Your doctor may tell you to limit your exposure to natural or artificial sunlight while you are using this medicine.

ARTWORKER:
Dovonex ointment

PRODUCT:

CUSTOMER:

Waymade

PRE-PRESS NO.:

04-1957

Q.A.
APPROVED:

Do not use Dovonex on your face.

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.
If your doctor has agreed that you can breast-feed, do not apply Dovonex to the breast area.
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.
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 skin or the skin of a child. Do not swallow it. Do not put it inside your body.
Never put this medicine on your face or the face of your child as it may cause irritation.
Do not mix Dovonex with any other medicines.
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 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.

WARNING!

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.

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.

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.

DATE:

CUSTOMER
APPROVED:

Dovonex is used to treat:
• Plaque psoriasis (psoriasis vulgaris).

27mm

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:
The dose will depend on how bad the psoriasis is. Your doctor will prescribe the dose that is right for your child.

• 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:
Always refer to your doctor for advice.
If you use more Dovonex than you should
Tell your doctor straight away.

PROOF HISTORY:
v.2 - waymade - 25/03/14

Leaflet Flat Size = 180 x 429

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

• Children over 12 years old:
Use the medicine twice each day.
Do not use more than 75 grams each week.

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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dovonex can cause side effects, although not everybody gets them.

WARNING!

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

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.

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.

DT

25/03/14

ARTWORKER:

DATE OF PROOF:

DATE:

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).
TVTCHECKED

04-1957
PRE-PRESS NO.:

Q.A.
APPROVED:

Very common side effects (probably affect more than 1 in 10 people)
• Skin irritation.

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.

6464/0514F
CODE:

REPORTING OF SIDE EFFECTS

Dovonex ointment
PRODUCT:

UK PIL DATED OCTOBER 2013

Waymade
CUSTOMER:

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
• Do not use after the expiry date printed on the carton or metal tube.
• Dovonex ointment/Calcipotriol ointment 0.005% should be not be stored above 25°C.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop using the ointment, please take it back to the pharmacist for safe disposal. Only keep the ointment
if your doctor tells you to.
• 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. Further information
Your medicine is called Dovonex ointment/Calcipotriol ointment 0.005%. Each gram of ointment contains 50 micrograms of the
active ingredient, calcipotriol in a white, smooth ointment.
Dovonex ointment/Calcipotriol ointment 0.005% also contains the following inactive ingredients: disodium edetate, sodium
phosphate dihydrate, DL-α tocopherol, liquid paraffin, polyoxyethylene stearylether, propylene glycol, white soft paraffin, and
purified water.
Dovonex ointment/Calcipotriol ointment 0.005% is available as packs containing 1 x 30 gram tubes or 2 x 30gram tubes of
ointment.
POM

PL No: 6464/0514

This product is manufactured by Leo Pharmaceutical Products, Ballerup, Denmark 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.) 24.3.2014
Dovonex is a registered trademark of Leo Pharmaceutical Products Ltd

WARNING!

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

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.

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.

DATE:

CUSTOMER
APPROVED:

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.

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.

Hide