PACKAGE LEAFLET: INFORMATION FOR THE USER

DOVONEX® 0.005% SCALP SOLUTION

(calcipotriol)

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.

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.

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.

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 generalized 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.

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 60millilitres (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 60millilitres (ml) of Dovonex Scalp Solution and 30grams of calcipotriol cream or ointment each week. or:

Do not use more than 30millilitres (ml) of Dovonex Scalp Solution and 60grams 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.

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 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 take your tablets after the expiry date which is stated on the bottle after ‘Exp'. The expiry date refers to the last day of that month.

Remember if your doctor tells you to stop taking this solution, return any unused solution to your pharmacist for safe disposal. Only keep this solution if your doctor tells you to.

If your solution become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

6. Further information

What Dovonex contains

•    The active ingredient is calcipotriol.

•    Dovonex Scalp Solution contains 50micrograms of calcipotriol in each millilitre of the solution.

•    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 0.005% 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, 55 Industriparken, 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® 0.005% SCALP SOLUTION PL No: 18799/0973

Leaflet date: 22.05.2015

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.

Dovonex is a registered trademark of Leo Pharma.