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CALCIPOTRIOL OINTMENT 50MICROGRAMS/G

Active substance(s): CALCIPOTRIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CALCIPOTRIOL OINTMENT 50 MICROGRAMS/G
Calcipotriol

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.

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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.

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.

Do not cover the treated area with
waterproof wrap.

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

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.

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.

Manufacturers
Salutas Pharma GmbH, Betriebsstätte
Osterweddingen, Lange Göhren 3,
39171 Sülzetal, OT Osterweddingen,
Germany
or

Lek Pharmaceuticals d.d., Verovškova
57, 1526 Ljubljana, Slovenia.
This leaflet was last revised in
08/2014.

The ointment comes in tubes of
30 grams, 60 grams, 100 grams and
120 grams.
Not all pack sizes may be marketed.

draft: 44060730, 44060731,
44060732
laetus code: 000
mat.no.: 00000000

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

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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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