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Calcipotriol Ointment 50micrograms/G

PACKAGE LEAFLET: INFORMATION FOR THE USER    SZ00000LT000

CALCIPOTRIOL OINTMENT 50 MICROGRAMS/G

Calcipotriol    A SANDOZ


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.


What is in this leaflet:

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

2.    What you need to know before you use Calcipotriol Ointment

50 micrograms/g

3.    How to use Calcipotriol Ointment 50 micrograms/g

4.    Possible side effects

5.    How to store Calcipotriol Ointment 50 micrograms/g

6.    Contents of the pack and other information


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


Calcipotriol Ointment 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 ointment helps bring the rate at which your skin cells are produced back to normal.


2. WHAT YOU NEED TO KNOW BEFORE YOU USE CALCIPOTRIOL OINTMENT 50 MICROGRAMS/G


Do not use Calcipotriol Ointment

50 micrograms/g:

•    if you are allergic to calcipotriol or to any of the other ingredients of this medicine (listed in section 6).

•    if you have severe liver or kidney impairment.

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

•    if you concomitantly use treatment with other medicinal product which increase your calcium level.

Warnings and precautions

Talk to your doctor or pharmacist

before using Calcipotriol Ointment

50 micrograms/g:

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

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

•the ointment may cause irritation of the skin. Wash your hands after you have applied the ointment. Wash it off if it spreads too far on your normal skin.

•    if you use more than 60 ml of Calcipotriol Ointment 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).

•    if you are exposed to sunlight when using this ointment. Any use of it with artificial UV light therapy (including sunbeds) should be discussed with your doctor first.

•    if you know you have a type of psoriasis called generalised pustular psoriasis or erythrodermic exfoliative psoriasis. Ask your doctor if you are unsure.

Do not apply it on your face.


Do not cover the treated area with waterproof wrap.

You should avoid excessive exposure to sunlight when using this ointment.

Other medicines and Calcipotriol Ointment 50 micrograms/g

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

If you are using this ointment with other treatments for psoriasis (e.g. topical corticosteroids), your doctor will tell you when to use it.

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Calcipotriol Ointment 50 micrograms/g should not be used during pregnancy unless clearly necessary. It is not known if calcipotriol is excreted in breast milk. Your doctor will decide whether you can be given Calcipotriol Ointment 50 micrograms/g during pregnancy and breast-feeding. Short-term use on small surfaces is not expected to lead to effects on the breastfed child. In all other cases, breast-feeding is not recommended during treatment with calcipotriol.

Driving and using machines

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

Calcipotriol Ointment 50 micrograms/g contains propylene glycol, which may cause skin irritation.


3. HOW TO USE CALCIPOTRIOL OINTMENT 50 MICROGRAMS/G


Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage:

For adults:

You should not apply more than 100 grams of this ointment in one week. If you apply it together with cream or solution containing calcipotriol, the total weekly amount of calcipotriol should not be more than 5 mg (for example 40 ml scalp solution plus 60 g of cream or ointment).

Method and route of administration: Calcipotriol Ointment 50 micrograms/g is intended for use on the skin (cutaneous use).

Wash your hands before you apply this ointment. Remove the cap and check that the seal is not broken before you


first use this ointment. If you have a 30 gram or 120 gram tube, you will need to break the seal by using the point in the back of the cap. Squeeze the ointment onto your finger or onto a patch of psoriasis. Apply ointment as a thin layer to affected areas of your skin. Rub it in gently to cover the affected area. Do not apply this ointment on your face (please see also Section 4).

Wash your hands after you have applied this ointment, unless you are using the ointment to treat psoriasis on your hands. Try not to transfer the ointment 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 ointment.

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Frequency of administration:

As monotherapy:

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

As combination therapy:

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

Duration of treatment:

You may notice an improvement after you have been using the ointment for about two weeks. The scaling or flaking usually goes away first. This will make your patches of psoriasis feel flatter. It will take longer for the redness of the skin to improve. The maximum effect is usually achieved after 4-8 weeks.

Children and adolescents

Calcipotriol Ointment 50 micrograms/g is not recommended for children and adolescents (under 18 years), because there is not enough experience with the


use of this ointment in these patients.

If you use more Calcipotriol Ointment 50 micrograms/g than you should

If you have applied more ointment than you should (more than 100 grams in a week), you should consult your doctor. Such usage may lead to high blood calcium levels, which may cause e.g. nausea, loss of appetite, constipation, vomiting, muscle weakness, lack of energy, tiredness and loss of consciousness.

If you forget to use Calcipotriol Ointment 50 micrograms/g

If you forget to use this ointment at the right time, apply it as soon as you remember. Then go on as before. Do not apply more ointment than usual to make up for a forgotten dose.

If you stop using Calcipotriol Ointment 50 micrograms/g

Always consult your doctor if you are thinking about stopping the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


4. POSSIBLE SIDE EFFECTS


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

Like all medicines, this ointment can cause allergic reaction in some patients (less than 1 in 10,000 people). Signs of allergy include hives, swelling of the face, eyelids, hands, feet or throat. If you get any of these symptoms after using this ointment, you should stop using the ointment and contact your doctor immediately.

Side effects could occur in approximately 25% of patients treated with Calcipotriol Ointment 50 micrograms/g.

These reactions are usually mild.

The most frequently reported are various transient skin reactions.

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

•    skin irritation.

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

•    itching

•    burning and stinging sensation

•    dry skin

•    redness

•    rash.


Uncommon side effects (may affect up to 1 in 100 people):

•    contact dermatitis

•    eczema

•    aggravated psoriasis.

Very rare side effects (may affect up to 1 in 10,000 people):

•    hypersensitivity reactions

•    hypercalcaemia, hypercalciuria

•    itchy raised rash (hives)

•    temporary changes in your skin colour

•    temporary increased sensitivity to sunlight

•    facial and perioral dermatitis.

If you accidentally get the ointment on your face, it can cause redness or irritation on your face or around your mouth.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme (Website: 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 OINTMENT 50 MICROGRAMS/G


Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.

3 months after you opened the tube for the first time you should not use the contents anymore.


Do not store above 25°C.

Do not refrigerate or freeze. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.


6. CONTENTS OF THE PACK AND OTHER INFORMATION


What Calcipotriol Ointment 50 micrograms/g contains:

The active substance is calcipotriol.

One gram of ointment contains 0.05 mg (is equal to 50 micrograms) of calcipotriol.

The other ingredients are: macrogol stearyl ether, disodium edetate, disodium phosphate dihydrate, alpha-tocopheryl acetate, propylene glycol (E490), light liquid paraffin, purified water and white soft paraffin.

What Calcipotriol Ointment 50 micrograms/g looks like and contents of the pack:

Your ointment has a white to off-white appearance.

The ointment comes in tubes of 30 grams, 60 grams, 100 grams and 120 grams.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.


Manufacturers

Salutas Pharma GmbH, Betriebsstatte Osterweddingen, Lange Gohren 3, 39171 Sulzetal, OT Osterweddingen, Germany

or

Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia.

This leaflet was last revised in 08/2014.


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