ENSTILAR 50 micrograms/g + 0.5 mg/g CUTANEOUS FOAM

Introduction

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.

Contents of the pack

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

1. What is Enstilar and what is it used for

Enstilar is used on the skin to treat psoriasis vulgaris in adults. The cause of psoriasis is the excessively rapid production of your skin cells. This causes redness, scaling, and thickening of your skin.

Enstilar contains calcipotriol and betamethasone. Calcipotriol helps to normalize the rate of growth of your skin cells and betamethasone reduces inflammation.

2. What you need to know before you use 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 the levels of calcium in your blood (consult your doctor)
• if you suffer from certain types of psoriasis called: erythrodermic psoriasis or pustular psoriasis (consult your doctor if you are unsure).

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

• skin infections caused by viruses (e.g., herpes or chickenpox)
• skin infections caused by fungi (e.g., athlete's foot or ringworm)
• skin infections caused by bacteria
• skin infections caused by parasites (e.g., scabies)
• tuberculosis
• perioral dermatitis (red rash around the mouth)
• thin skin, fragile veins, stretch marks
• ichthyosis (dry skin with scales)
• acne (pimples)
• rosacea (intense redness or flushing of the skin on the face)
• ulcers and wounds.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Enstilar if:

• you have diabetes mellitus (diabetes), as your blood sugar levels may be affected by the steroid
• you are using other medicines that contain steroids, as you may suffer from side effects
• you suffer from a type of psoriasis called guttate psoriasis.

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

• you have used this medicine for a long time and plan to stop using it (as there is a risk that your psoriasis may worsen or 'flare' when the steroids are stopped suddenly)
• a skin infection appears, as it may be necessary to interrupt treatment
• your blood calcium levels change (see section 4 for more information)
• you experience blurred vision or other visual disturbances.

Special precautions:

• avoid using dressings or bandages as this increases the absorption of the steroid
• avoid using more than 15 grams per day. This means that a 60-gram can of Enstilar should last at least 4 days. 15 grams are dispensed if the actuator is pressed fully for about 1 minute. A 2-second spray provides approximately 0.5 grams of Enstilar. As a guide, 0.5 grams of foam should cover a skin area corresponding to the surface of an adult's hand
• avoid using it on more than 30% of your body
• avoid using it on large areas of damaged skin, mucous membranes, or skin folds (e.g., groin, armpits, under the breasts) as this increases the absorption of the steroid
• avoid using it on the face or genitals (sex organs) as these areas are very sensitive to steroids.

Children and adolescents

This medicine is not recommended for use in children or adolescents under 18 years of age.

Using Enstilar with other medicines

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

If your doctor agrees that you can breastfeed, be careful and do not apply Enstilar to the breast area. See "Instructions for proper use".

Driving and using machines

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

Enstilar contains butylhydroxytoluene (E321)

It may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation. See "Instructions for proper use".

3. How to use Enstilar

Follow the instructions for administration of this medicine exactly as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist.

Enstilar is for cutaneous use (on the skin).

Before using, read the patient information, even if you have used the medicine before.

Enstilar is designed for direct application (spraying) onto your affected psoriasis skin.

Instructions for proper use

Use on body

1. After applying the foam, put the cap back on the can to avoid accidental spraying when not in use.
2. Wash your hands well after using Enstilar (unless you are using the foam to treat your hands). This will prevent accidental contact of the foam with other parts of your body (especially face, mouth, and eyes). To achieve an optimal effect, it is recommended not to wash the body immediately after applying Enstilar.

Leave the foam on the skin for the night or during the day.

Use on scalp

1. Brush your hair to remove loose scales.

Additional information for proper use:

• use it only on your psoriasis and do not use it on skin that does not have psoriasis
• wash or rinse well if, by accident, you have applied foam to your eyes, mouth, genitals, or breasts if you are breastfeeding
• do not worry if you accidentally apply a little foam to healthy skin near your psoriasis, but clean it if it has spread too much
• do not put a dressing or cover or wrap the treated skin area
• to achieve an optimal effect, it is recommended not to shower or bathe immediately after applying the foam
• after applying the foam, avoid contact with fabrics that may be easily stained by grease (e.g., silk).

Treatment duration

• apply the foam once a day. It may be more convenient to apply the foam at night.
• the normal treatment period is 4 weeks, but your doctor may decide on a different treatment period.

It is possible that your doctor will instruct you to use Enstilar twice a week once your psoriasis has healed or is almost healed. Enstilar should be applied twice a week for two non-consecutive days (e.g., Wednesday and Saturday) to all previously affected areas. Between applications, there should be 2 to 3 days without Enstilar treatment.

If symptoms recur, you should use Enstilar once a day as indicated above and contact your doctor to review your treatment.

If you use more Enstilar than you should

Important:A 60-gram can of Enstilar should last at least 4 days (see section 2 "Special precautions"). If you are using other medicines that contain calcipotriol, the total amount of medicines containing calcipotriol, including Enstilar, should not exceed 15 grams per day. Consult your doctor if you have used a higher dose than recommended.

Excessive use of this medicine may cause a problem with the calcium in your blood, which usually normalizes when treatment is stopped.

Prolonged and excessive use may also cause your adrenal glands to stop working properly (the adrenal glands are located near the kidneys and produce hormones).

See section 4 for more information.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Enstilar

Do not apply a double dose to make up for forgotten doses.

If you stop treatment with Enstilar

The use of Enstilar should be stopped as indicated by your doctor. It may be necessary to stop using this medicine gradually, especially if you have been using it for a long time.

If you have any other 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 seen with Enstilar:

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

• allergic reaction. Symptoms can include skin rash and swelling of the skin, face, or mouth
• worsening or 'rebound' of your psoriasis after stopping treatment
• increased level of calcium in your blood
• skin irritation which can include itching, pain, burning, and stinging and/or redness of the skin
• redness, pain, or inflammation of the hair root (folliculitis)
• loss of skin pigmentation (depigmentation).

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

• Blurred vision
• Redness of the skin where the product is applied

This medicine contains betamethasone (a potent steroid) and calcipotriol. You may therefore suffer from the following side effects. These side effects are more likely to occur if Enstilar is used for a long time, when the area is covered, when used in skin folds (e.g., groin, armpits, or under the breasts), or when used on large areas of skin:

• allergic reactions with swelling of the face or other parts of the body such as hands or feet. Swelling of the mouth/throat and breathing problems may also occur
• the levels of calcium in your blood or urine may increase to such an extent that you may experience symptoms. The symptoms are frequent urination, constipation, muscle weakness, and confusion. When treatment is stopped, calcium levels return to normal
• your adrenal glands may stop working properly. The symptoms are tiredness, depression, and anxiety
• blurred vision, decreased night vision, sensitivity to light (this could be a symptom of cataracts)
• eye pain, red eye, blurred vision, or decreased vision (this could be a symptom of increased pressure inside the eye)
• infections (because your immune system is weakened)
• pustular psoriasis (a red area of psoriasis with yellowish pustules)
• you may experience fluctuations in blood sugar levels.

If you experience any of the side effects mentioned, inform your doctor immediately.

The less serious side effects caused by calcipotriol or betamethasone include

• thinning of the skin
• stretch marks
• the blood vessels under the skin may become more visible
• changes in hair growth
• red rash around the mouth (perioral dermatitis)
• worsening of your psoriasis
• skin sensitivity to light leading to a skin rash
• skin rash with itching (eczema)
• when used on the scalp, white or gray hair may temporarily change to a yellowish color at the application site.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Enstilar

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 can after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

The can should be discarded 6 months after the first opening.

Medicines should not be disposed of via wastewater or household waste. Return the can and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the can and any unused medicine. This will help protect the environment.

6. Container contents and additional information

Composition of Enstilar

The active ingredients are:

Calcipotriol and betamethasone.

One 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

Polyoxypropylene stearyl ether

All-rac-α-tocopherol

White petrolatum

Butylhydroxytoluene (E321)

Butane

Dimethyl ether

Appearance of Enstilar and container contents

Enstilar is a cutaneous foam.

After spraying, a white or off-white foam is formed, with a non-expansive appearance that collapses gradually after spraying.

Aluminum container with an internal polyamide-imide lacquer, equipped with a pump and continuous valve.

The container contains 60 g of foam, excluding the amount corresponding to the propellants.

Container sizes: 60 g, 2 containers of 60 g.

Only some container sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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

This medicinal product is authorized in the Member States of the European Economic Area and in 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, Slovakia, Spain, Sweden, United Kingdom (Northern Ireland)

Enstilum: Belgium, Luxembourg, Romania, Slovenia

Date of last revision of this leaflet: July 2022.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.