Enstilar

PATIENT INFORMATION LEAFLET: USER INFORMATION

Enstilar, 50 micrograms/0.5 mg/g, foam for cutaneous use
Calcipotriol+ Betamethasone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Enstilar and what is it used for
• 2. Important information before using 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 is Enstilar and what is it used for

Enstilar is used to treat plaque psoriasis (Psoriasis vulgaris).
Psoriasis is caused by the skin cells growing too quickly. This leads to redness,
scaling and thickening of the skin.
Enstilar contains calcipotriol and betamethasone. Calcipotriol helps to restore the normal rate
of skin cell growth, and betamethasone has anti-inflammatory effects.

2. Important information before using Enstilar

When not to 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 disturbances of calcium levels in the blood (you should consult your doctor),
• if you have other types of psoriasis, such as erythrodermic or pustular psoriasis (you should tell your doctor).

Because Enstilar contains a strong steroid, you must not use it:
for skin infections (e.g. cold sores or chicken pox),

• fungal skin infections (e.g. athlete's foot or ringworm),
• bacterial skin infections,
• parasitic infections (e.g. scabies),
• tuberculosis,
• perioral dermatitis (redness around the mouth),
• thin skin, fragile skin or skin atrophy,
• ichthyosis (dry skin with fish-like scales),
• acne (pimples),
• rosacea (redness and acne-like symptoms on the face),
• ulcers or damaged skin.

Warnings and precautions

Before starting treatment with Enstilar, you should discuss it with your doctor or pharmacist if:
you have diabetes, as steroid medicines may affect blood sugar levels,

• you are using other medicines that contain corticosteroids, as side effects can occur,
• you have guttate psoriasis.

You should talk to your doctor, pharmacist or nurse during treatment if:

• you have been using this medicine for a long time and plan to stop using it (as there is a risk that your psoriasis may get worse or flare up when the treatment is stopped),
• a skin infection develops, as treatment may need to be stopped,
• you experience a change in calcium levels in the blood (see section 4),
• you experience blurred vision or other vision disturbances.

Precautions

• avoid using the medicine under bandages or dressings, as this increases the absorption of the steroid,
• avoid using more than 15 g of the medicine per day. This means that a 60 g can of Enstilar should last for at least 4 days. 15 g of the medicine is delivered when the actuator is fully pressed for about 1 minute. Pressing for 2 seconds delivers 0.5 g of Enstilar. A guide is that 0.5 g of foam covers a skin surface area of approximately the size of the palm of an adult hand.
• avoid applying the medicine to more than 30% of the body surface,
• avoid applying the medicine to large areas of damaged skin, to mucous membranes or in skin folds (e.g. armpits, groin, under the breasts), as this increases the absorption of the steroid,
• avoid applying the medicine to the face and genital area, as these areas are sensitive to steroids,
• avoid excessive sunbathing, using sunlamps or other forms of light therapy, as the skin is sensitive to light.

Children and adolescents

Enstilar is not recommended for use in children under 18 years of age.

Other medicines and Enstilar

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before using this medicine.
If your doctor agrees that you can breastfeed, be careful not to apply Enstilar to the breast area. See "Instructions for proper use".

Driving and using machines

This medicine is not likely to affect your ability to drive or use machines.

Enstilar contains butylhydroxytoluene (E321)

Enstilar contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis) or eye and mucous membrane irritation. See "Instructions for proper use".

3. How to use Enstilar

Enstilar should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
How to use Enstilar: apply to the skin.
Before using, read the leaflet carefully, even if you have used Enstilar before.
Enstilar is for direct application to the skin affected by psoriasis (sprayed onto the skin).

Instructions for proper use

Application to body skin

• 1. Shake the can for a few seconds before

use.

• 2. Apply the foam holding the can at least 3

cm from the skin, directly onto the areas affected by psoriasis.

• 3. The foam can be sprayed with the can in various positions

except with the can in a horizontal position.

• 4. Gently massage the foam into the areas affected

by psoriasis.

• 5. After applying the foam, put the cap back on the can to avoid accidental spraying, when the medicine is not in use.
• 6. After using Enstilar, wash your hands thoroughly (unless the foam was applied to the hands). This will prevent accidental transfer of the foam to other areas (especially the face, mouth and eyes). For optimal effect, do not wash the body immediately after applying Enstilar. Leave the medicine on the skin for the whole night or day.

Application to scalp skin

• 1. Comb your hair to remove any loose skin scales
• 2. Shake the can for a few seconds before

use.

• 3. Spray the foam directly onto your hand holding

the can at least 3 cm away. The foam can be sprayed with the can in any position, except horizontal.

• 4. Take the foam on your finger and apply it

directly to the areas affected by psoriasis.
Avoid applying to hair during application.
Gently massage the foam into the scalp. After application, put the cap back on the can to prevent accidental spraying, when the medicine is not in use.

• 5. After using Enstilar, wash your hands thoroughly. This will prevent accidental transfer of the foam to other areas (especially the face, mouth and eyes). For optimal effect, do not wash your hair immediately after applying Enstilar. Leave the medicine on the scalp for the whole night or day.

When washing your hair, the following instructions may be helpful:

• 1. Apply a mild shampoo, without medicinal substances

to dry hair, focusing on the areas where the foam was applied.

• 2. Removing Enstilar will be easier if the shampoo is applied to dry hair, as water weakens the cleansing effect of the shampoo.

• 3. Massage the shampoo into dry hair/scalp. Leave the shampoo on the scalp for a few minutes before rinsing.
• 4. Rinse thoroughly with water.
• 5. Repeat your normal hair washing if necessary.

Other information about proper use:

• apply the medicine to skin affected by psoriasis, do not apply to unaffected skin,
• if the medicine gets into your eyes, mouth, genital area or breasts when breastfeeding, wash the area thoroughly with water or rinse,
• do not worry if some foam accidentally gets onto healthy skin near the psoriasis area, but wipe off any excess medicine,
• do not cover the treated area with bandages, tight dressings or tight clothing,
• for optimal effect, do not take a shower or bath immediately after applying Enstilar. Leave the medicine on the skin for the whole night or day,
• after applying the foam, avoid contact with fabrics that may stain easily due to the fat content (e.g. silk).

Treatment duration
the foam should be used once a day. It may be more convenient to use the foam in the evening.
the usual treatment period is 4 weeks, but after this time your doctor may decide on a different treatment period.
Your doctor may advise you to use Enstilar twice a week, if the psoriasis plaques have cleared or almost cleared. Enstilar should be applied twice a week for two non-consecutive days (e.g. Wednesday and Saturday) to the previously affected areas. There should be 2-3 days without treatment with Enstilar between applications.
If symptoms of psoriasis recur, Enstilar should be used once a day, as described above, and you should contact your doctor to discuss treatment.

Using more Enstilar than you should

Important:one 60 g can of Enstilar should be enough for at least 4 days (see section 2: "Warnings and precautions"). If you are using other medicines that contain calcipotriol, the total amount of calcipotriol, including the amount in Enstilar, must not be more than 15 g per day. If you use more Enstilar than you should, talk to your doctor. Using too much Enstilar can also cause changes in the levels of calcium in your blood, which usually go back to normal when treatment is stopped.
Long-term use of Enstilar in large amounts can also cause changes in the function of the adrenal glands (glands that produce hormones). See section 4.

Forgetting to use Enstilar

Do not use a double dose to make up for a forgotten dose.

Stopping use of Enstilar

Stop using Enstilar when your doctor tells you to. It may be necessary to stop treatment gradually, especially if you have been using Enstilar for a long time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Enstilar can cause side effects, although not everybody gets them.
Side effects that have been reported with Enstilar.
Uncommon (may affect up to 1 in 100 people)

• allergic reactions, which may include skin rash and swelling of the face or mouth,
• worsening of existing psoriasis or appearance of psoriasis symptoms after stopping treatment,
• increased levels of calcium in the blood,
• skin irritation, which may include itching, pain, stinging or burning and (or) redness of the skin,
• redness, pain or swelling of the hair root (folliculitis),
• discoloration (depigmentation).

Frequency not known (cannot be estimated from the available data)

• blurred vision,
• redness of the skin at the application site.

Enstilar contains betamethasone (a strong steroid) and calcipotriol. Because of this, the following side effects may occur, which are likely to happen after long-term use of Enstilar, use under a dressing, in skin folds (e.g. armpits, groin, under the breasts) or use on large areas of skin:

• allergic reactions with swelling of the face or other parts of the body such as hands or feet; may also include swelling of the mouth and (or) throat and difficulty breathing;
• levels of calcium in the blood or urine may increase to the point where symptoms of excess occur: frequent urination, constipation, muscle weakness and confusion; after stopping the treatment, calcium levels will return to normal;
• adrenal gland problems, symptoms of which include tiredness, depression and anxiety;
• blurred vision, difficulty seeing at night and increased sensitivity to light (may be symptoms of cataracts);
• eye pain, redness of the eyes or blurred vision (may be symptoms of increased pressure in the eye);
• infections (due to a weakened immune system);
• psoriatic erythroderma (red area with yellowish pustules);
• fluctuations in blood sugar levels may occur.

If you experience any of the above symptoms, contact your doctor immediately.

Less serious side effects caused by calcipotriol and betamethasone:

• skin thinning,
• stretch marks,
• visibility of blood vessels under the skin,
• change in hair growth rate,
• red rash around the mouth (perioral dermatitis),
• worsening of psoriasis,
• sensitivity of the skin to light, which may cause a rash,
• itchy rash (pruritus),
• yellowing of hair may occur when using the medicine on the scalp in patients with white or grey hair.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the national reporting system (listed below). By reporting side effects, you can help provide more information on the safety of this medicine.

• Department of Medicines Monitoring, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl You can also report side effects to the marketing authorisation holder.

5. How to store Enstilar

Warning:Highly flammable aerosol. Pressurised container: May burst if heated.
Protect from sunlight. Do not expose to temperatures above 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. Do not smoke near the product.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the can after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Shelf-life after first opening: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Enstilar contains

The active substances are:
calcipotriol and betamethasone.
One gram of foam contains 50 micrograms of calcipotriol (as calcipotriol monohydrate) and
0.5 mg of betamethasone (as betamethasone dipropionate).
The other ingredients are:
white soft paraffin
polyoxypropylene stearyl ether
liquid paraffin
all-rac-α-Tocopherol
butylhydroxytoluene
butane
dimethyl ether

What Enstilar looks like and contents of the pack

Enstilar is a foam for cutaneous use.
After spraying, a white or off-white foam is formed.
The aluminium can is internally coated with a polyamide-imide lacquer, with a valve and a metering device (PP/Polyacetal) with a protective cap made of PP.
The can contains 60 g of foam, not including the propellant.
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

Manufacturers

LEO Laboratories Ltd.
285 Cashel Road, Crumlin
Dublin 12
Ireland
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

To obtain further information on this medicine, contact the local representative of the marketing authorisation holder:

Leo Pharma Sp z o.o
ul. Marynarska 15
02-674 Warsaw
Tel + 48 22 244 18 40

This medicine is authorised in the Member States of the European Economic Area under the following names:

Enstilar:Austria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Spain, Netherlands, Iceland, Ireland, Lithuania, Latvia, Malta, Norway, Poland, Portugal,
Slovakia, Sweden, Hungary, Italy.
Enstilum:Belgium, Bulgaria, Luxembourg, Romania, Slovenia
Date of last revision of the leaflet: