Package Insert: Information for the Patient

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

calcipotriol/betamethasone

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1.What Enstilar is and for what it is used

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

3.How to use Enstilar

4.Possible adverse effects

5.Storage of Enstilar

6.Contents of the package and additional information

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

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

Do not use Enstilar:

• if you are allergic to calcipotriol, betamethasone, or any of the other components of this medication (listed in section 6)
• if you have problems with calcium levels in your blood (consult your doctor)
• if you have certain types of psoriasis called erythrodermic or pustular psoriasis (consult your doctor if you are unsure)

Since Enstilar contains a potent steroid, DO NOT use Enstilar on the 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, striae
• ichthyosis (dry skin with scales)
• acne (pimples)
• rosacea (intense redness or flushing of 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 level may be affected by the steroid
• you are using other medications that contain steroids, as you may experience adverse effects
• you have a type of psoriasis called guttate psoriasis

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

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

Special precautions:

• avoid using bandages or gauze as it may increase the absorption of the steroid
• avoid using more than 15 grams per day. This means that a 60-gram Enstilar container should last at least 4 days. 15 grams are dispensed if you press the actuator fully for approximately 1 minute. A 2-second spray provides approximately 0.5 grams of Enstilar. As a guide, 0.5 grams of foam should cover an area of skin that corresponds to the surface area 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 (groins, armpits, under the breasts) as it may increase the absorption of the steroid
• avoid using it on the face or genitals (genital organs) as these areas are highly sensitive to steroids

Children and adolescents

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

Using Enstilar with other medications

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

If your doctor agrees that it is safe to breastfeed, be careful and do not apply Enstilar to the breast area. See 'Instructions for proper use'.

Driving and operating machinery

This medication does not affect your ability to drive or operate machinery.

Enstilar contains butylhydroxytoluene (E321)

It may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes. See 'Instructions for proper use'.

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

In case of doubt, consult your doctor or pharmacist.

Enstilar is for topical use (on the skin).

Before using, read the patient information, even if you have used the medication previously.

Enstilar is designed for direct application (spraying) on the affected skin of vulgaris psoriasis.

Instructions for proper use

Body use

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

Leave the foam on the skin overnight or during the day.

Head use

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 thoroughly if, by accident, you have applied foam to your eyes, mouth, genital organs, or breasts if 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 apply a bandage, cover, or wrap the treated skin area.
• To achieve optimal effect, it is recommended not to shower or bathe immediately after applying the foam.
• Avoid contact with fabrics that can easily stain with 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.

Your doctor may 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) on all previously affected areas by psoriasis. Between applications, there should be 2-3 days without Enstilar treatment.

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

Using more Enstilar than you should

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

Excessive use of this medicationmay cause a problem with your blood calcium levels, which usually normalize when the treatment is stopped.

Long-term and excessive use may also cause your adrenal glands to malfunction (adrenal glands are located near the kidneys and produce hormones).

See section 4 for additional information.

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

If you forget to use Enstilar

Do not apply a double dose to compensate for the missed doses.

If you interrupt Enstilar treatment

Enstilar treatment should be completed as indicated by your doctor. You may need to stop using this medication gradually, especially if you have been using it for a long time.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects observed with Enstilar:

Rare 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 'rebound' of your psoriasis after treatment completion
• Increased level of calcium in your blood
• Skin irritation that may include itching, pain, burning, and/or stinging and/or redness of the skin
• Redness, pain, or inflammation of the hair follicle (folliculitis)
• Pigmentation loss of the skin.

Unknown frequency (frequency that cannot be estimated from 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 experience the following side effects. These side effects are more likely to occur if Enstilar is used for a prolonged period, when the area is covered, when used in skin folds (e.g. elbows, axillae, or under the breasts), or when used on large areas of skin:

• Allergic reactions with facial swelling or other parts of the body such as hands or feet. Swelling of the mouth/throat and respiratory problems may also occur
• Your blood or urine calcium levels may increase to the point where you may experience symptoms. Symptoms are frequent urination, constipation, muscle weakness, and confusion. When treatment is stopped, calcium levels return to normal
• Your adrenal glands may not function properly. Symptoms are fatigue, depression, and anxiety
• Blurred vision, decreased night vision, light sensitivity (this could be a symptom of cataracts)
• Eye pain, red eye, blurred vision, or decreased vision (this could be a symptom of increased eye pressure)
• Infections (because your immune system is weakened)
• Pustular psoriasis (a red area of psoriasis with yellowish pustules (grains))
• You may experience fluctuations in blood sugar levels.

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

Less severe side effects caused by calcipotriol or betamethasone include::

• Thinning of the skin
• Striae
• The blood vessels under the skin may become more visible
• Changes in hair growth
• Red, itchy rash around the mouth (perioral dermatitis)
• Worsening of your psoriasis
• Sensitivity of the skin to light resulting in a skin rash
• Itchy skin rash (eczema)
• When used on the scalp, the white or gray hair may temporarily change to a yellowish color at the application site.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the container after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F.

The container must be disposed of after 6months of the first opening.

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and medicines that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Enstilar

The active principles are:

Calcipotriol and betamethasone.

One gram of cutaneous foam contains 50micrograms of calcipotriol (as monohydrate) and 0.5mg of betamethasone (as dipropionate).

Theother components are:

Liquid paraffin

Polyoxypropylene stearyl ether

All-rac-α-tocopherol

White vaseline

Butilhydroxytoluene (E321)

Butane

Dimethyl ether

Appearance of Enstilar and contents of the container

Enstilar is a cutaneous foam.

After spraying, a white or off-white, non-expansive foam is formed that collapsesgradually after spraying.

Aluminum container with an internal coating of polyamide-imide, provided with a pump and continuous valve.

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

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

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Responsible for manufacturing

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) with 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

Last review date 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 Medical Devices (AEMPS) http://www.aemps.gob.es/.