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

Active substance(s): BETAMETHASONE / BETAMETHASONE DIPROPIONATE / CALCIPOTRIOL / CALCIPOTRIOL ANHYDROUS

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500000/PL1a

Calcipotriol/Betamethasone 50 micrograms per g /
500 micrograms per g Ointment
(calcipotriol / betamethasone dipropionate)
Patient Information Leaflet
The name of your medicine is Calcipotriol/Betamethasone 50
micrograms per g / 500 micrograms per g Ointment but will be
referred to as Calcipotriol/Betamethasone throughout the rest
of this leaflet.
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.

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.
3. HOW TO USE CALCIPOTRIOL/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.

Children
Calcipotriol/Betamethasone is not recommended for the use
in children below the age of 18 years.

Continued overleaf

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).
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.
• 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 on this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. HOW TO STORE CALCIPOTRIOL/BETAMETHASONE
• Keep 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.
• If you notice any sign of discolouration or deterioration
of your medicine, please tell your pharmacist
immediately.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Calcipotriol/Betamethasone contains
• The active substances are: calcipotriol and
betamethasone.
One gram of ointment contains 50 micrograms of
calcipotriol (as monohydrate) and 500 micrograms of
betamethasone (as dipropionate).
• The other ingredients are: all-rac-α-tocopherol (E307),
oleyl alcohol, liquid light 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.
Tube containing 30 g of ointment.
Product Licence Holder
Procured from within the EU.
Product Licence Holder Ginova Ltd and repackager Ginova
UK Ltd, both of St James' House, 8 Overcliffe, Gravesend,
Kent, DA11 0HJ.
Manufacturer
Lek Pharmaceuticals d.d, Verovskova 57, 1526 Ljubljana,
Slovenia

Calcipotriol/Betamethsone 50 micrograms per g /
500 micrograms per g Ointment
POM

PL No: 18067/0519
th

This leaflet was last revised on 19 December 2017.
®

Sandoz is the registered trademark of Novartis AG.

To request a copy of this leaflet in
Braille, large print or audio please
call 01622 690172.

500000/PL1a

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