In this leaflet:

1.    What Calcipotriol Cream 50 micrograms/g is and what it is used for

2.    Before you use Calcipotriol Cream 50 micrograms/g

3.    How to use Calcipotriol Cream 50 micrograms/g

4.    Possible side effects

5.    How to store Calcipotriol Cream 50 micrograms/g

6.    Further information

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, please 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1 WHAT CALCIPOTRIOL CREAM 50 MICROGRAMS/G IS AND WHAT IT IS USED FOR

Calcipotriol Cream 50 micrograms/g is used on the skin for local treatment of mild to moderately severe psoriasis (psoriasis vulgaris).

Psoriasis is when your skin cells are being produced too quickly. This causes scaling and redness. This cream helps bring the rate at which your skin cells are produced back to normal.

2 BEFORE YOU USE CALCIPOTRIOL CREAM 50 MICROGRAMS/G

Do not use Calcipotriol Cream 50 micrograms/g:

•    if you are allergic (hypersensitive) to calcipotriol or to any of the other ingredients (please see Section 6 for other ingredients)

•    if you have a problem with your calcium metabolism or if the level of calcium in your body is too high. This cream can increase calcium levels in the blood.

Take special care with Calcipotriol Cream 50 micrograms/g:

•    if patient is less than 18 years old, because there is not enough experience with the use of this cream in children and adolescents.

•    if you have severe kidney or liver impairment, because of limited experiences.

•    as the cream may cause irritation of the skin.

Wash your hands after you have applied the cream. Wash it off if it spreads too far on your normal skin.

•    if you use more than 100 grams of Calcipotriol Cream 50 micrograms/g in a week, as you may develop high blood calcium levels. This may cause e.g. weakness, nausea, loss of appetite and constipation (please see also Section 3).

Do not apply it on your face.

Do not apply it together with ointments, creams or lotions containing salicylic acid.

Do not cover the treated area with waterproof wrap.

You should avoid excessive exposure to sunlight when using this cream. Any use of it with artificial UV light therapy (including sunbeds) should be

discussed with your doctor first.

Using other medicines

If you are using this cream with other treatments for psoriasis, your doctor will tell you when to use it.

Do not apply a cream or ointment containing salicylic acid to the skin where this cream has to be applied, as it breaks down the active substance in this cream.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Avoid use in pregnancy since there is no information available. It is not known if calcipotriol is excreted in breast milk, so avoid use also during breast-feeding. Tell your doctor if you are pregnant or breast-feeding or if you become pregnant while you are using this cream.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No effect on ability to drive and use machines is to be expected.

Important information about some of the ingredients of Calcipotriol Cream 50 micrograms/g

This cream contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

3 HOW TO USE CALCIPOTRIOL CREAM 50 MICROGRAMS/G

Always apply this cream exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

Adults

Dosage:

You should not apply more than 100 grams of this cream in one week. If you apply it together with ointment or solution containing calcipotriol, the total weekly amount of calcipotriol should not be more than 5 mg.

Method and route of administration:

Calcipotriol Cream 50 micrograms/g is intended for use on the skin (cutaneous use).

Wash your hands before you use the cream.

Remove the cap and check that the seal is not broken before you first use the cream. Break the seal by using the point in the back of the cap. Squeeze the cream onto your finger or onto a patch of psoriasis. Apply cream as a thin layer to affected areas of your skin. Rub it in gently to cover the

affected area. Do not apply the cream on your face (please see also Section 4).

Wash your hands after you have applied the cream, unless you are using the cream to treat psoriasis on your hands. Try not to transfer the cream from the areas you have treated to other areas of your body, especially your face.

If you are using a moisturiser, you should put it on first and wait for it to soak in before applying this cream.

Frequency of administration:

As monotherapy:

For the best results you should apply this cream twice a day, once in the morning and once in the evening. Depending on the effect, your doctor may suggest you use the cream once a day.

As combination therapy:

If you are using this cream together with other treatments for psoriasis, your doctor will tell you how often and when to apply the cream.

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