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CALCIPOTRIOL/BETAMETHASONE SANDOZ 50 MICROGRAMS PER G / 500 MICROGRAMS PER G OINTMENT

Active substance(s): BETAMETHASONE DIPROPIONATE / CALCIPOTRIOL MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ13401LT01A

Calcipotriol/Betamethasone 50 micrograms per g /
500 micrograms per g ointment
calcipotriol/betamethasone

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/Betamethasone is and
what it is used for
2. What you need to know before you use
Calcipotriol/Betamethasone
3. How to use Calcipotriol/Betamethasone
4. Possible side effects
5. How to store Calcipotriol/Betamethasone
6. Contents of the pack and other information

1

What Calcipotriol/
Betamethasone is and what it
is used for

Calcipotriol/Betamethasone ointment is used
on the skin to treat plaque psoriasis (psoriasis
vulgaris) in adults. Psoriasis is caused by your
skin cells being produced too quickly. This causes
redness, scaling and thickness of your skin.
Calcipotriol/Betamethasone ointment contains
calcipotriol and betamethasone.
Calcipotriol helps to bring the rate of skin cell
growth back to normal and betamethasone acts to
reduce inflammation.

2

What you need to know
before you use Calcipotriol/
Betamethasone

Do not use Calcipotriol/Betamethasone
• If you are allergic (hypersensitive) to
calcipotriol, betamethasone or any of the other
ingredients of Calcipotriol/Betamethasone
(listed in section 6)
• If you have problems with calcium levels in the
body (ask your doctor)
• If you have certain types of psoriasis: these are
erythrodermic, exfoliative and pustular (ask
your doctor).
As Calcipotriol/Betamethasone contains a strong
steroid do NOT use on skin affected by
• skin infections caused by viruses (e.g. cold sores
or chicken pox)
• skin infections caused by a fungus (e.g. athlete’s
foot or ringworm)
• skin infections caused by bacteria
• skin infections caused by parasites
(e.g. scabies)
• tuberculosis (TB)
• perioral dermatitis (red rash around the mouth)
• thin skin, easily damaged veins, stretch marks
• ichthyosis (dry skin with fish-like scales)
• acne (pimples)
• rosacea (severe flushing or redness of the skin
on the face)
• ulcers or broken skin
Warnings and precautions
Talk to your doctor or pharmacist before using
Calcipotriol/Betamethasone if:
• you are using other medicines that contain
corticosteroids, as you may get side effects
• you have used this medicine for a long time and
plan to stop (as there is a risk your psoriasis will
get worse or ‘flare up’ when steroids are
stopped suddenly)
• you have diabetes mellitus (diabetes), as your
blood sugar/glucose level may be affected by
the steroid
• your skin becomes infected, as you may need to
stop your treatment
• you have a certain type of psoriasis called
guttate psoriasis
Special precautions
• Avoid use on more than 30% of your body or
using more than 15 grams per day
• Avoid using under bandages or dressings as it
increases the absorption of the steroid
• Avoid use on large areas of damaged skin, on
mucous membranes or in skin folds (groin,
armpits, under breasts) as it increases the
absorption of the steroid
• Avoid use on the face or genitals (sex organs)
as they are very sensitive to steroids
• Avoid excessive sunbathing, excessive use of
solarium and other forms of light treatment.
Children
Calcipotriol/Betamethasone is not recommended
for the use in children below the age of 18 years.
Other medicines and Calcipotriol/
Betamethasone
Please tell your doctor, pharmacist or nurse if
you are taking or have recently taken any other
medicines, including medicines obtained without a
prescription.
Pregnancy, breast-feeding and fertility
Do not use Calcipotriol/Betamethasone if you
are pregnant (or might be pregnant) or if you are
breast-feeding, unless you have agreed it with

your doctor first. If your doctor has agreed that
you can breast-feed, take care and do not apply
Calcipotriol/Betamethasone to the breast area.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
This medicine should not have any effect on your
ability to drive or use machines.

to use Calcipotriol/
3 How
Betamethasone
Always use Calcipotriol/Betamethasone exactly
as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
How to put on Calcipotriol/Betamethasone:
Cutaneous use.
Instruction for proper use
• Use only on your psoriasis and do not use on
skin which does not have psoriasis
• Remove the cap and check that the seal in the
tube is not broken before you first use the
ointment
• To break the seal, use the point in the back of
the cap
• Squeeze the ointment onto a clean finger
• Rub gently into your skin to cover the affected
area of psoriasis until most of the ointment has
disappeared into the skin
• Do not bandage, tightly cover or wrap the
treated skin area
• Wash your hands well after using Calcipotriol/
Betamethasone (unless you are using the
ointment to treat your hands). This will avoid
accidentally spreading the ointment to other
parts of your body (especially the face, scalp,
mouth and eyes)
• Do not worry if some ointment accidentally gets
on normal skin near your psoriasis, but wipe it
off if it spreads too far
• In order to achieve optimal effect, it is
recommended not to take a shower or bath
immediately after application of Calcipotriol/
Betamethasone ointment
• After applying the ointment avoid contact with
textiles which are easily stained by grease
(e.g. silk).
Duration of treatment
• Use the ointment once a day. It may be more
convenient to use the ointment in the evening
• The normal initial treatment period is 4 weeks
but your doctor may decide on a different
treatment period
• Your doctor may decide on repeated treatment
• Do not use more than 15 grams in one day.
If you use other calcipotriol containing medicines,
the total amount of calcipotriol medicines must not
exceed 15 grams per day and the area treated
should not exceed 30% of the total body surface.
What should I expect when I use
Calcipotriol/Betamethasone?
Most patients see obvious results after 2 weeks,
even if the psoriasis is not yet cleared at that point.
If you have used more Calcipotriol/
Betamethasone than you should
Contact your doctor if you have used more than
15 grams in one day.
Excessive use of Calcipotriol/Betamethasone
may cause a problem with calcium in your blood,
which usually normalises when discontinuing
treatment.
Your doctor may need to carry out blood tests
to check that using too much ointment has not
caused a problem with calcium in your blood.
Excessive prolonged use can also cause your
adrenal glands to stop working properly
(these are found near the kidneys and produce
hormones).
If you forget to use Calcipotriol/
Betamethasone
Do not take a double dose to make up for
forgotten individual doses.
If you stop using Calcipotriol/
Betamethasone
The use of Calcipotriol/Betamethasone should be
stopped as indicated by your doctor.
It may be necessary for you to stop this medicine
gradually, especially if you have used it for a long
time.
If you have any further questions about the use of
this medicine, ask your doctor or pharmacist.
Continued on next page >>

4 Possible side effects
Like all medicines, Calcipotriol/Betamethasone
can cause side effects, although not everybody
gets them.
Serious side effects
Tell your doctor/nurse immediately or as soon as
possible if any of the following happens. You may
have to stop your treatment.
The following serious side effects have been
reported for Calcipotriol/Betamethasone:
Uncommon (may affect up to 1 in 100 people)
• Worsening of your psoriasis. If your psoriasis
gets worse, tell your doctor as soon as possible.
Rare (may affect up to 1 in 1,000 people)
• Pustular psoriasis may occur (a red area
with yellowish pustules usually on the hands or
feet). If you notice this, stop using Calcipotriol/
Betamethasone and tell your doctor as soon as
possible.
Some serious side effects are known to be caused
by betamethasone (a strong steroid), one of the
ingredients in Calcipotriol/Betamethasone. You
should tell your doctor as soon as possible if any
of the serious side effects occur. These side effects
are more likely to happen after long-term use, use
in skin folds (e.g. groin, armpits or under breasts),
use under occlusion or use on large areas of skin.
The side effects include the following:
• Your adrenal glands may stop working
properly. Signs are tiredness, depression and
anxiety.
• Cataracts (signs are cloudy and foggy vision,
difficulty seeing at night and sensitivity to light)
or an increase in pressure inside the eye (signs
are eye pain, red eye, decreased or cloudy
vision).
• Infections (because your immune system which
fights infections may be suppressed or
weakened).
• Pustular psoriasis (a red area with yellowish
pustules usually on the hands or feet). If you
notice this, stop using Calcipotriol/
Betamethasone and tell your doctor as soon as
possible.
• Impact on the metabolic control of diabetes
mellitus (if you have diabetes you may
experience fluctuations in the blood glucose
levels).
Serious side effects known to be caused by
calcipotriol
• Allergic reactions with deep swelling of the
face or other parts of the body such as the
hands or feet. Swelling of the mouth/throat
and trouble breathing may occur. If you have
an allergic reaction, stop using
Calcipotriol/Betamethasone, tell your
doctor immediately or go to the
casualty department at your nearest
hospital.
• Treatment with this ointment may cause the
level of calcium in your blood or urine to
increase (usually when too much ointment has
been used). Signs of increased calcium in blood
are excessive secretion of urine, constipation,
muscle weakness, confusion and coma. This
can be serious and you should contact
your doctor immediately. However,
when the treatment is stopped, the levels return
to normal.
Less serious side effects
The following less serious side effects have been
reported for Calcipotriol/Betamethasone:
Common side effects (may affect up to 1 in
10 people)
• Itching
• Skin exfoliation
Uncommon (may affect up to 1 in 100 people)
• Skin pain or irritation
• Rash with inflammation of the skin (dermatitis)
• Redness of the skin due to widening of the small
blood vessels (erythema)
• Inflammation or swelling of the hair root
(folliculitis)
• Changes in skin colour in the area you have
used the ointment
• Rash
• Burning sensation
• Infection of the skin
• Thinning of the skin
• Appearance of red or purple discolouration on
the skin (purpura or ecchymosis).

• Thinning of the skin
• Appearance of surface blood vessels or stretch
marks
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Skin rash with inflammation or swelling (allergic
contact dermatitis)
• Golden coloured gel-filled bumps (colloid milia)
• Lightening of skin colour (depigmentation)
• Inflammation or swelling of the hair root
(folliculitis).
Less serious side effects known to be caused by
calcipotriol include the following
• Dry skin
• Sensitivity of the skin to light resulting in a rash
• Eczema
• Itching
• Skin irritation
• Burning and stinging sensation
• Redness of the skin due to widening of the small
blood vessels (erythema)
• Rash
• Rash with inflammation of the skin (dermatitis)
• Worsening of psoriasis
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
(www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on
the safety of this medicine

to store Calcipotriol/
5 How
Betamethasone
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 carton and tube after EXP.
The expiry date refers to the last day of that
month.
Do not store above 25°C.
The tube should be discarded 1 year after first
opening. Write the date you first opened the tube
in the space provided on the carton.
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 protect the environment.

of the pack and other
6 Contents
information
What Calcipotriol/Betamethasone
contains
• The active substances are: calcipotriol and
betamethasone.
One gram of ointment contains 50 micrograms
of calcipotriol (as monohydrate) and 0.5 mg of
betamethasone (as dipropionate).
• The other ingredients are: all-rac-α-tocopherol
(E307), oleyl alcohol, liquid paraffin, white soft
paraffin
What Calcipotriol/Betamethasone looks
like and the contents of the pack
Calcipotriol/Betamethasone is an off white
ointment. The ointment is filled in the container with
aluminium/epoxyphenol tubes with polyethylene
or polypropylene screw caps.
Pack sizes: Tubes containing 15 g, 30 g, 60 g
and 120 g of ointment.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, UK
Manufacturer
Lek Pharmaceuticals d.d
Verovskova ulica 57,
1526 Ljubljana,
Slovenia
This leaflet was last revised in 12/2015.

Rare (may affect up to 1 in 1,000 people)
• Bacterial or fungal infection of hair follicle
(Furuncle)
• Allergic reactions
• Hypercalcaemia
• Stretch marks
• Sensitivity of the skin to light resulting in a rash
• Acne (pimples)
• Dry skin
• Rebound effect: A worsening of symptoms/
psoriasis after ending treatment.
Less serious side effects caused by using
betamethasone, especially for a long time, include
the following. You should tell your doctor or nurse
as soon as possible if you notice any of them.

46172812
SZ13401LT01A

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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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