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CALCIPOTRIOL CREAM 50 MICROGRAMS/G

Active substance(s): CALCIPOTRIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CALCIPOTRIOL CREAM 50 MICROGRAMS/G
Calcipotriol

In this leaflet:

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
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

1

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

2

BEFORE YOU USE CALCIPOTRIOL CREAM 50 MICROGRAMS/G

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.

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.

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.

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).

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.

Do not apply it on your face.

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).

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

3

SZ00000LT000

HOW TO USE CALCIPOTRIOL CREAM 50 MICROGRAMS/G

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

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

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.

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.

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.

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

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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Artwork Proof Box
Ref: V007: Register for use in children
Proof no.
004.2

Date prepared:
17/04/2014

Colours:
Black
Black 20%
Dimensions: 148 x 297 mm

Font size:
7.5pt
Fonts:
Helvetica

Duration of treatment:
You may notice an improvement after you have been
using the cream 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.

your doctor. Such usage may lead to high blood
calcium level, 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 Cream 50
micrograms/g:
If you forget to use the cream at the right time, use it
as soon as you remember. Then go on as before.
Do not apply more cream than usual to make up for
a forgotten dose.

Children and adolescents
Calcipotriol Cream 50 micrograms/g is not
recommended for children and adolescents (under
18 years), because there is not enough experience
with the use of this cream in these patients.

If you use more Calcipotriol Cream 50
micrograms/g than you should:
If you have applied more cream than you should
(more than 100 grams in a week), you should consult

If you want to stop using Calcipotriol Cream 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.

Like all medicines, Calcipotriol Cream 50
micrograms/g can cause side effects, although not
everybody gets them.

Uncommon side effects (affecting more than 1 in
1000 and less than 1 in 100 people) are: contact
dermatitis, eczema and aggravated psoriasis.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this cream 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 cream, you
should stop using the cream and contact your doctor
immediately.
Side effects occur in approximately 25% of patients.
The most frequently reported are various transient
skin reactions.

Common side effects (affecting more than 1 in 100
and less than 1 in 10 people) are: itching, skin
irritation, burning and stinging sensation, dry skin,
redness and rash.

5

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

If any of the side effects gets serious, lasts for a long
time or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

HOW TO STORE CALCIPOTRIOL CREAM 50 MICROGRAMS/G

Keep out of the reach and sight of children.

Do not use Calcipotriol Cream 50 micrograms/g
after the expiry date which is stated on the tube and
carton after EXP. The expiry date refers to the last
day of that month.

6

Very rare side effects (affecting less than 1 in 10,000
people) are: high level of calcium in blood and urine,
short lived changes in skin colour, transient
increased sensitivity of the skin to light.

FURTHER INFORMATION

What Calcipotriol Cream 50 micrograms/g
contains
The active substance is calcipotriol. One gram of
cream contains 0.05 mg (is equal to 50 micrograms)
of calcipotriol.
The other ingredients are: disodium edetate,
disodium phosphate dihydrate, sodium dihydrogen
phosphate dihydrate, chloroallylmethenamine
chloride, glycerol, macrogol cetostearyl ether,
cetostearyl alcohol, light liquid paraffin, white soft
paraffin and purified water.

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 freeze.

Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
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, Betriebsstätte
Osterweddingen, Lange Göhren 3, 39171 Sülzetal,
OT Osterweddingen, Germany.

What Calcipotriol Cream 50 micrograms/g looks
like and contents of the pack
Your cream has a white appearance.
The cream comes in tubes of 30 grams, 60 grams,
100 grams and 120 grams.
This leaflet was last revised in 04/2014.

000000
SZ00000LT000

Artwork Proof Box
Ref: V007: Register for use in children
Proof no.
004.2

Date prepared:
17/04/2014

Colours:
Black
Black 20%
Dimensions: 148 x 297 mm

Font size:
7.5pt
Fonts:
Helvetica

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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.

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