Dovonex Scalp Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOVONEX® SCALP SOLUTION
(calcipotriol)
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® Scalp Solution will sometimes be called Dovonex®._
Your skin before treatment.
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.
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 antipsoriatics. 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.
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.
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® Scalp Solution 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® Scalp Solution and 30 grams of calcipotriol cream or ointment each week. or:
Do not use more than 30 millilitres (ml) of Dovonex® Scalp Solution 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.
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.
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.
Other possible side effects:
The possible side effects described in the following section of this leaflet are usually mild.
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.
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®
Keep out of the sight and reach of children.
Do not store above 25°C.
CAUTION flammable - keep away from fire or flames.
Do not use the solution after the expiry date on the bottle.
As with any medicine, if your doctor tells you to stop using the solution, take any left over back to the pharmacist. Only keep it if your doctor tells you to.
If the solution becomes discoloured or shows any signs of deterioration, consult your pharmacist who will tell you what to do.
6. FURTHER INFORMATION What Dovonex® contains
• The active ingredient is calcipotriol.
Each 1ml of Scalp Solution contains 50micrograms of calcipotriol (as the hydrate).
• The other ingredients in the solution are hydroxypropyl cellulose, isopropanol, levomenthol, sodium citrate, propylene glycol and purified water.
What Dovonex® looks like and contents of the pack
Dovonex scalp solution comes in a white plastic bottle with a blue screw lid containing 30ml or 60ml of clear, slightly viscous solution.
Manufactured by: LEO Pharmaceutical Products, DK 2750, Ballerup, Denmark.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
Dovonex® Scalp Solution_
PL No: 18799/0952 IPOM
Leaflet date: 14.07.2014
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.demon.co.uk Registered charity number 257414.
Very common side effects (probably affect more than 1 in 10 people)
• Skin irritation
Common side effects (probably affect up to 1 in 10
If you have any questions about your treatment, ask your doctor or pharmacist.
Dovonex is a registered trademark of Leo Pharma.
people)
• Rash
• Burning or stinging feeling.
• Dry skin
• Itching skin
• Redness
• Itchy rash and skin inflammation in the area where the medicine is used.
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCIPOTRIOL 50micrograms/ml SCALP SOLUTION
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 Calcipotriol 50micrograms/ml Scalp Solution will sometimes be called Calcipotriol._
Your skin before treatment.
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.
In this leaflet:
1. What Calcipotriol is and what it is used for
2. Before you use Calcipotriol
3. How to use Calcipotriol
4. Possible side effects
5. How to store Calcipotriol
6. Further information
1. WHAT CALCIPOTRIOL IS AND WHAT IT IS USED FOR
Calcipotriol belongs to a group of medicines called antipsoriatics. 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.
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.
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.
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.
Do not use Calcipotriol on your face.
Keep your medicine away from your glasses or any plastic.
How much Calcipotriol to use
Your doctor will tell you how much Calcipotriol Scalp Solution 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 Scalp Solution and 30 grams of calcipotriol cream or ointment each week. or:
Do not use more than 30 millilitres (ml) of Calcipotriol Scalp Solution 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Calcipotriol 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.
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.
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.
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 CALCIPOTRIOL
Keep out of the sight and reach of children.
Do not store above 25°C.
CAUTION flammable - keep away from fire or flames.
Do not use the solution after the expiry date on the bottle.
As with any medicine, if your doctor tells you to stop using the solution, take any left over back to the pharmacist. Only keep it if your doctor tells you to.
If the solution becomes discoloured or shows any signs of deterioration, consult your pharmacist who will tell you what to do.
6. FURTHER INFORMATION What Calcipotriol contains
• The active ingredient is calcipotriol.
Each 1ml of Scalp Solution contains 50micrograms of calcipotriol (as the hydrate).
• The other ingredients in the solution are hydroxypropyl cellulose, isopropanol, levomenthol, sodium citrate, propylene glycol and purified water.
What Calcipotriol looks like and contents of the pack
Calcipotriol scalp solution comes in a white plastic bottle with a blue screw lid containing 30ml or 60ml of clear, slightly viscous solution.
Manufactured by: LEO Pharmaceutical Products, DK 2750, Ballerup, Denmark.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
Calcipotriol 50micrograms/ml ^ Scalp Solution PL No: 18799/0952 IPomI
Leaflet date: 14.07.2014
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.demon.co.uk Registered charity number 257414.
If you have any questions about your treatment, ask your doctor or pharmacist.