Enstilar

Package leaflet: Information for the patient

Enstilar 50 micrograms/g + 0.5 mg/g cutaneous foam

calcipotriol/betamethasone
Please 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Enstilar is and what it is used for
2. What you need to know 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 Enstilar is and what it is used for

Enstilar is used on the skin to treat mild to moderate plaque psoriasis in adults. Psoriasis is caused by
skin cells reproducing too quickly. This leads to redness, scaling, and
thickening of the skin.
Enstilar contains calcipotriol and betamethasone. Calcipotriol normalizes the growth of skin cells,
and betamethasone works by reducing inflammation.

2. What you need to know before using Enstilar

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 body (ask your doctor)
• if you have other types of psoriasis called: erythrodermic psoriasis or pustular psoriasis (if in doubt, consult your doctor).

Since Enstilar contains a potent steroid, DO NOT use it on skin affected by:

• viral skin infections (such as cold sores or chickenpox)
• fungal skin infections (such as athlete’s foot or ringworm)
• bacterial skin infections
• parasitic skin infections (such as scabies)
• tuberculosis (TB)
• perioral dermatitis (red skin rashes around the mouth)
• thin skin, fragile blood vessels, stretch marks
• ichthyosis (dry, scaly skin resembling fish scales)
• acne (pimples)
• rosacea (flushing or redness of the facial skin)
• skin ulcers and open wounds.

Warnings and precautions
Before using Enstilar, tell your doctor, pharmacist, or nurse if:

• you have diabetes mellitus (diabetes), as blood sugar levels may be affected by the steroid
• you are using other medicines containing steroids, as adverse effects may occur
• you have a certain type of psoriasis called guttate psoriasis.

Tell your doctor, pharmacist, or nurse if during treatment:

• you have used this medicine for a long time and decide to stop treatment (when steroid treatment is stopped suddenly, there is a risk that psoriasis may worsen or flare up)
• your skin lesions tend to become infected, as it may be necessary to discontinue treatment
• your blood calcium levels change (see section 4 for more information)
• you experience blurred vision or other visual disturbances.

Special precautions:

• avoid using occlusive dressings or bandages, as they may increase steroid absorption
• avoid using more than 15 g of medicine per day. This means that a 60 g container of Enstilar should last at least 4 days. A dose of 15 g is delivered by fully pressing the dispenser for approximately 1 minute. A 2-second spray delivers approximately 0.5 g of Enstilar. As a guide, 0.5 g of foam should cover an area of skin approximately equal to the surface of an adult hand.
• avoid applying the medicine to more than 30% of the body surface
• avoid use over large areas of damaged skin, mucous membranes, or skin folds (e.g., groin, armpits, or under the breasts), as this increases steroid absorption
• avoid applying the medicine to the facial skin or genital area (sex organs), as these areas are highly sensitive to steroids.

Children and adolescents
The use of Enstilar is not recommended in children under 18 years of age.
Other medicines and Enstilar
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If your doctor has determined that you may breastfeed, make sure not to apply Enstilar to the breast area. See "Instructions for correct use".
Driving and using machines
This medicine is unlikely to affect your ability to drive or operate machinery.
Enstilar contains butylated hydroxytoluene (E321)
Enstilar contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes. See "Instructions for correct use".

3. How to use Enstilar

Use this medicine exactly as directed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
Enstilar is for cutaneous use (on the skin).
Before use, read the package leaflet, even if you have used Enstilar before.
Enstilar is intended for direct application (administration) to skin affected by plaque psoriasis.

Instructions for correct use
Application to the body

1. Shake the container for a few seconds before use.

2. Apply the foam by holding the container at least 3 cm away from the skin and dispense the foam directly onto the affected area.
3. The foam can be dispensed with the container held in any position except horizontally.

4. Gently rub the foam into each affected area of skin.
5. After applying the foam, replace the cap on the container to prevent accidental dispensing when not in use.
6. Wash your hands thoroughly after using Enstilar (unless you are treating your hands with the foam). This will prevent accidental contact of the foam with other parts of the body (especially face, mouth, and eyes). To achieve optimal effect, it is recommended not to wash the body immediately after applying Enstilar. Leave the foam on the skin overnight or during the day.

Application to the scalp

1. Comb your hair to remove any loose scales.

2. Shake the container for a few seconds before use.
3. Hold the container at least 3 cm away. Dispense the foam directly into the palm of your hand. The foam can be dispensed with the container held in any orientation except horizontally.

4. Take the foam with your finger and apply it directly to the affected areas. Minimize application to the hair to make washing easier. Gently rub the foam into the scalp. After applying the foam, replace the cap on the container to prevent accidental dispensing when not in use.
5. Wash your hands thoroughly after using Enstilar. This will prevent accidental spreading of the foam to other parts of the body (especially face, mouth, and eyes). To achieve optimal effect, it is recommended not to wash your hair immediately after applying Enstilar. Leave the foam on the scalp overnight or during the day.

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

1. Apply a gentle, non-medicated shampoo to dry hair, focusing on the areas where the foam was applied. It is easier to remove Enstilar when shampoo is applied to dry hair, as water dilutes the cleansing effect of the shampoo.
2. Massage the shampoo into dry hair/scalp. Leave the shampoo on the scalp for a few minutes before washing.
3. Rinse thoroughly with water.
4. Repeat the regular shampoo if necessary.

Additional information for correct use:

• use Enstilar only on psoriatic lesions and do not apply it to unaffected skin
• wash or rinse thoroughly if, accidentally, the foam has been applied to the eyes, mouth, genital organs, or breast if breastfeeding
• do not be alarmed if a small amount of foam accidentally touches healthy skin around the psoriatic plaque, but clean the skin if the medicine spreads too far from the psoriatic area
• do not bandage, tightly wrap, or cover the treated skin area
• to achieve optimal effect, it is recommended not to bathe or shower immediately after applying the foam
• after applying the foam, avoid contact with fabrics that may be easily soiled by greasy residue (e.g., silk).

Duration of treatment:

• apply the foam once daily. It may be more convenient to apply the foam in the evening.
• the normal treatment period is 4 weeks, but your doctor may prescribe a different duration.

Your doctor may instruct you to use Enstilar twice a week once the psoriasis has cleared or nearly cleared. Enstilar should be applied twice a week on two non-consecutive days (e.g., Wednesday and Saturday) to areas previously affected by psoriasis. There should be 2–3 days without treatment between applications.
If symptoms reappear, use Enstilar once daily as described above and contact your doctor to review the treatment.

If you use more Enstilar than you should
Important: A 60 g Enstilar container should last at least 4 days (see section 2 “Special precautions”). If you are using other medicines containing calcipotriol, the total amount of calcipotriol-containing medicines, including Enstilar, must not exceed 15 g per day. Contact your doctor if you have used more than the recommended dose.
Excessive use of Enstilar may cause problems with calcium levels in the blood, which usually return to normal after stopping treatment.
Prolonged excessive use may also cause impaired function of the adrenal glands (the adrenal glands are located near the kidneys and produce hormones).
See section 4 for more information.

If you forget to use Enstilar
Do not use a double dose to make up for a missed dose.

If you stop using Enstilar
Treatment with Enstilar should be stopped as directed by your doctor. You may need to stop using the medicine gradually, especially after long-term use.
If you have any questions about using this medicine, consult 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 observed with Enstilar:

Uncommon side effects (may affect up to 1 in 100 people)

• allergic reaction. Symptoms may include rash and swelling of the skin, face or mouth
• worsening or recurrence of psoriasis after treatment has been stopped
• increased levels of calcium in the blood
• skin irritation which may include itching, pain, burning, stinging and/or redness of the skin
• redness, pain or swelling at the hair root (folliculitis)
• skin discoloration (depigmentation).

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

• Blurred vision.
• Redness of the skin at the site of application of the medicine.

Enstilar contains betamethasone (a potent steroid) and calcipotriol. Therefore, you may experience the following side effects. These side effects are more likely if Enstilar is used for a long time, if used under occlusive dressing, in skin folds (e.g. groin, armpits or under the breasts), or over large areas of skin:

• 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 breathing difficulties may also occur
• levels of calcium in the blood or urine may increase enough to cause symptoms. Signs include frequent urination, constipation, muscle weakness and confusion. When treatment is stopped, calcium levels return to normal
• your adrenal glands may stop functioning properly. Signs include fatigue, depression, anxiety
• blurred vision, difficulty seeing at night, light sensitivity (this may be a sign of cataract)
• eye pain, eye redness, decreased vision or blurred vision (this could be a sign of increased internal eye pressure)
• infections (due to weakened immune system)
• pustular psoriasis (a red area of psoriasis with yellowish pustules (boils))
• you may experience changes in blood sugar levels. If you experience any of these side effects, contact your doctor immediately.

Less severe side effects due to the use of calcipotriol or betamethasone include:

• thinning of the skin
• stretch marks
• blood vessels under the skin becoming more visible
• changes in hair growth
• red rashes around the mouth (perioral dermatitis)
• worsening of psoriasis
• skin sensitivity to light resulting in a skin rash
• itchy skin rash (eczema)
• when used on the scalp, white or grey hairs may temporarily turn yellowish at the application site.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enstilar

Warning: Extremely flammable. Pressurized 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 onto an open flame or other source of ignition. Keep away from sparks, open flames, or other sources of ignition. Do not smoke.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and container after "Exp". The expiry date refers to the last day of that month.
Do not store above 30°C.
The container must be discarded 6 months after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Enstilar contains
The active substances are:
Calcipotriol and betamethasone.
Each gram of cutaneous foam contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of
betamethasone (as dipropionate).
The other components are:
Liquid paraffin
Polyoxyl stearate ether
All-rac-α-tocopherol
White soft paraffin
Butylhydroxytoluene (E321)
Butane
Dimethyl ether

Description of the appearance of Enstilar and contents of the pack
Enstilar is a cutaneous foam.
After dispensing, a foam forms that ranges in colour from white to off-white. The foam appears as a non-expanding foam that gradually collapses after dispensing.

Aluminium container internally coated with a polyamide-imide lacquer, equipped with a continuous valve and a dispenser.
The container holds 60 g of foam, excluding the amount of propellants.
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
Colep Laupheim GmbH & Co. KG
Fockestraße 12
DE-88471 Laupheim
Germany
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

Concessionaire for sales in Italy:
LEO Pharma S.p.A.
Via Elio Vittorini 129
00144 Roma
Italy

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland)
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 (Northern Ireland).
Enstilum: Belgium, Luxembourg, Romania, Slovenia.