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ENSTILAR 50 MICROGRAMS/G + 0.5 MG/G CUTANEOUS FOAM

Active substance(s): BETAMETHASONE DIPROPIONATE / CALCIPOTRIOL MONOHYDRATE

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Please return to:
LEO Pharma A/S
Internal Market Access

Subject

100%

Item No.

GB+IE

Rev. No.

N/A

050522

21/03/16

Date

Date

Sign.

Sign.

19/02/16
Sign.

Black

RBE

9.

Sent by e-mail

Date

INS 287 x 420 mm
Colour

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up



ARTWORK

RBE
Supplier / Place of production

Enstilar® Foam

Colep

Comments:

Page 1 of 2

Point size: 9 pt

287 mm

Package leaflet: Information for the patient

Enstilar® 50 micrograms/g + 0.5 mg/g cutaneous foam
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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Enstilar® is and what it is used for
2. What you need to know before you use Enstilar®
3. How to use Enstilar®
4. Possible side effects
5. How to store Enstilar®
6. Contents of the pack and other information

1. What Enstilar® is and what it is used for

Children and adolescents
Enstilar is not recommended for the use in children below
the age of 18 years.
Other medicines and Enstilar
Tell your doctor, pharmacist or nurse if you are using, have
recently used, or might use any other medicines.

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

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 for
advice before using this medicine.
If your doctor has agreed that you can breast-feed, take care
and do not apply Enstilar to the breast area.
See ‘Instruction for proper use’.

2. What you need to know before you use Enstilar®

Driving and using machines
This medicine should not have any effect on your ability to
drive or use machines.

Do not use Enstilar:
• if you are allergic to calcipotriol, betamethasone or any of
the other ingredients of this medicine (listed in section 6)
• if you have problems with calcium levels in your blood
(ask your doctor)
• if you have certain types of psoriasis called: erythrodermic
psoriasis or pustular psoriasis (ask your doctor if you are
unsure).
As Enstilar contains a strong steroid, do NOT use Enstilar
on skin areas 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 and
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 and wounds.

3. How to use Enstilar®
Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Enstilar is for cutaneous use (on the skin).
Before use, read the patient information, even if you have
used Enstilar before.
Enstilar is designed for direct application (spray-on) to your
skin affected by psoriasis vulgaris.

Instruction for proper use
1. Shake the can for a few seconds before use.

2. Apply the foam by holding the can at least 3 cm from the
skin and spray directly onto each affected area.
min. 3 cm

Further information for proper use:
• use only on your psoriasis and do not use on skin which
does not have psoriasis
• wash or rinse well if, by accident, you have applied foam
to your eyes, mouth, sexual organs or breasts if you are
breast-feeding
• do not worry if some foam accidentally gets on normal
skin near your psoriasis, but wipe it off if it spreads too far
• do not bandage, tightly cover or wrap the treated skin area
• in order to achieve optimal effect, it is recommended not to
take a shower or bath immediately after spraying the foam
• after applying the foam, avoid contact with textiles which
are easily stained by grease (e.g. silk).
Duration of treatment
• apply the foam once daily. It may be more convenient to
use the foam in the evening.
• the normal treatment period is 4 weeks but your doctor
may decide on a different treatment period.

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If you have used more Enstilar than you should
Important: One 60 g can of Enstilar should last for at least
4 days (see section 2 'Special precautions'). If you use other
calcipotriol containing medicines, the total amount of
calcipotriol medicines, including Enstilar, must not exceed
15 grams per day. Contact your doctor if you have used
more than the recommended dose.
Excessive use of Enstilar may cause a problem with calcium
in your blood, which usually returns to normal when
treatment is discontinued.
Excessive prolonged use can also cause your adrenal
glands to stop working properly (the adrenal glands are
found near the kidneys and produce hormones).
See section 4 for further information.

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5. After applying the foam, put the cap back on the can to
prevent accidental spraying when not in use.
6. Wash your hands well after using Enstilar (unless you are
using the foam to treat your hands). This will avoid
accidentally spreading the foam to other parts of your
body (especially the face, mouth and eyes).

Talk to your doctor, pharmacist or nurse before using
Enstilar if:
• you have diabetes mellitus (diabetes), as your blood sugar
level may be affected by the steroid
• you are using other medicines that contain steroids, as
you may get side effects
• you have a certain type of psoriasis called guttate psoriasis.

Special precautions:
• avoid use under bandages or dressings as this increases
the absorption of the steroid
• avoid use of more than 15 grams per day. This means that
one 60 g can of Enstilar should last for at least 4 days.
15 g is dispensed if you fully depress the actuator for
approximately 1 minute. Spraying for 2 seconds provides
approximately 0.5 g of Enstilar. As a guide, 0.5 g of foam
should cover an area of skin roughly corresponding to the
surface area of an adult hand
• avoid use on more than 30% of your body
• avoid use on large areas of damaged skin, on mucous
membranes or in skin folds (groin, armpits, under breasts)
as this increases the absorption of the steroid
• avoid use on the face or on genitals (sexual organs) as
they are very sensitive to steroids
• avoid excessive sunbathing, excessive use of a solarium
and other forms of light treatment, as your skin is sensitive
to light.

4. Gently rub the foam into each affected skin area.

Enstilar contains butylhydroxytoluene (E321)
This may cause local skin reactions (e.g. contact dermatitis),
or irritation to the eyes and mucous membranes.
See ‘Instruction for proper use’.

Warnings and precautions

Talk to your doctor, pharmacist or nurse during treatment if:
• you have used this medicine for a long period of time and
plan to stop (as there is a risk your psoriasis will get worse
or ‘flare up’ when steroids are stopped suddenly)
• your skin becomes infected, as you may need to stop your
treatment
• the calcium level in your blood changes (see section 4 for
further information).

3. The foam can be sprayed holding the can in any
orientation except horizontally.

Scale

Please return to:
LEO Pharma A/S
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Subject

Item No.

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Colour

Rev. No.

Sent by e-mail

N/A

050522
Date

INS 287 x 420 mm

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Sign.

Black

Date

Date

Sign.

Sign.

19/02/16
RBE
Supplier / Place of production

Enstilar® Foam

Colep

Comments:

Page 2 of 2

287 mm

If you forget to use Enstilar
Do not use a double dose to make up for forgotten doses.
If you stop using Enstilar
The use of Enstilar 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, pharmacist or nurse.

4.Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Side effects that have been observed for Enstilar:
Uncommon side effects (may affect up to 1 in 100 people):
• allergic reaction. Symptoms may include skin rash and
swelling of the skin, face or mouth
• worsening or ‘flare up’ of your psoriasis after treatment
has stopped
• a rise in calcium levels in the blood
• skin irritation which might include itching, burning and
stinging and/or redness of the skin
• redness, pain or swelling of the hair roots of the skin
(folliculitis)
• loss of skin colour (depigmentation).

5.How to store Enstilar®
Caution: Extremely flammable aerosol. Pressurised
container: May burst if heated. Protect from sunlight. Do not
expose to temperatures exceeding 50°C. Do not pierce or
burn, even after use. Do not spray on an open flame or
other ignition source. Keep away from sparks, open flames
and other ignition sources. No smoking near the can.
Keep this medicine out of the sight and reach of children.
Do not use Enstilar after the expiry date, which is stated on
the carton and can after EXP. The expiry date refers to the
last day of that month.
Do not store above 30°C.
The can should be discarded 6 months after first opening.
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.

6.Contents of the pack and other information
What Enstilar contains
The active substances are:
Calcipotriol and betamethasone.
One gram of cutaneous foam contains 50 micrograms of
calcipotriol (as monohydrate) and 0.5 mg of betamethasone
(as dipropionate).

Enstilar contains betamethasone (a strong steroid) and
calcipotriol. You may therefore experience the following
side effects. These side effects are more likely to happen if
Enstilar is used for a long time, if used under dressings or in
skin folds (e.g. groin, armpits or under breasts), or if used
on large skin areas:
• allergic reactions with 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 also occur
• calcium levels in your blood or urine may increase so
much that you get symptoms. Signs are frequent
urination, constipation, muscle weakness, and confusion.
When the treatment is stopped, the calcium levels return
to normal
• your adrenal glands may stop working properly. Signs are
tiredness, depression, anxiety
• cloudy vision, difficulty seeing at night, sensitivity to light
(this could be a sign of cataracts)
• eye pain, red eye, decreased or cloudy vision (this could
be a sign of increased pressure inside the eye)
• infections (because your immune system is weakened)
• pustular psoriasis (a red area of psoriasis with yellowish
pustules (pimples))
• you may experience fluctuations in blood sugar levels.
If you experience any of the above side effects you should
contact your doctor immediately.

The excipients are:
Liquid paraffin
Polyoxypropylene stearyl ether
All-rac-α-tocopherol
White soft paraffin
Butylhydroxytoluene (E321)
Butane
Dimethyl ether.

Less serious side effects known to be caused by calcipotriol
or betamethasone include the following:
• thinning of the skin
• stretch marks
• blood vessels under your skin may become more
noticable
• changes in hair growth
• red rash around the mouth (perioral dermatitis)
• worsening of your psoriasis
• sensitivity of the skin to light resulting in a rash
• itchy skin rash (eczema)
• white or grey hair can transiently change to a yellowish
colour at the application site when used on the scalp.

Manufacturer
Colep Laupheim GmbH & Co. KG
Fockestraße 12
DE-88471 Laupheim
Germany

For Ireland, via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
For the United Kingdom, 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.

Pack sizes: 60 g, 2 x 60 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

This medicinal product is authorised in the Member States
of the EEA under the following names:
Enstilar: Austria, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta,
Netherlands, Norway, Poland, Portugal, Slovak Republic,
Spain, Sweden, United Kingdom
Enstilum: Belgium, Luxembourg, Romania, Slovenia
This leaflet was last revised in March 2016.
Detailed information on this medicine is available on the
website of the Health Products Regulatory Authority,
www.hpra.ie. and Medicines and Healthcare products
Regulatory Agency, www.mhra.gov.uk.

050522

No vision control until further notice! JUG 01.07.2014

420 mm

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
national reporting system.

What Enstilar looks like and contents of the pack
Enstilar is a cutaneous foam.
After spraying, a white to off-white foam is formed.
Aluminium can with a polyamide-imide inner lacquer,
equipped with a continuous valve and actuator.
The can contains 60 g of foam, not including the amount of
propellants.

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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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