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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

calcipotriol/betamethasone

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

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 adverse 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 moderate to severe plaque psoriasis in adults. Psoriasis is caused by an abnormally rapid production of skin cells. This leads to redness, scaling, and thickening of the skin.

Enstilar contains calcipotriol and betamethasone. Calcipotriol helps normalize the rate of skin cell growth, and betamethasone reduces 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 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 blood vessels, stretch marks
• ichthyosis (dry, scaly skin)
• acne (spots)
• rosacea (intense redness or flushing of the facial skin)
• ulcers and wounds.

Warnings and precautions

Talk to 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 containing steroids, as you may experience adverse effects
• you suffer from a type of psoriasis called guttate psoriasis.

Talk to your doctor, pharmacist, or nurse during treatment if:

• you have used this medicine for a long time and plan to stop using it (since there is a risk that your psoriasis may worsen or 'rebound' when steroids are suddenly discontinued)
• a skin infection develops, as treatment may need to be interrupted
• your blood calcium levels change (see section 4 for additional information)
• you experience blurred vision or other visual disturbances.

Special precautions:

• avoid using dressings or bandages, as they increase steroid absorption
• avoid using more than 15 grams per day. This means that a 60-g Enstilar container should last at least 4 days. 15 grams are dispensed by fully pressing the pump 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 corresponding to approximately the surface of an adult’s hand
• avoid use over more than 30% of your body surface
• avoid use on large areas of damaged skin, mucous membranes, or skin folds (groin, armpits, under the breasts), as this increases steroid absorption
• avoid use on the face or genitals (sexual organs), as these areas are highly sensitive to steroids.

Children and adolescents

Use of this medicine is not recommended in children and adolescents under 18 years of age.

Using Enstilar with other medicines

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

If your doctor approves breastfeeding, take care not to 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 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".

3. How to use Enstilar

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

If in doubt, consult your doctor or pharmacist.

Enstilar is for cutaneous use (on the skin).

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

Enstilar is designed for direct application (spraying) to your skin affected by psoriasis vulgaris.

Instructions for proper use

Use on body

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 help avoid accidental contact of the foam with other parts of your body (especially the face, mouth, and eyes). For optimal effect, it is recommended not to wash your body immediately after applying Enstilar.

Allow the foam to remain on the skin overnight or during the day.

Use on the scalp

1. Brush your hair to remove loose scales.

Additional information for proper use:

• use it only on areas affected by psoriasis and do not apply it to unaffected skin
• wash or rinse thoroughly if, accidentally, the foam has come into contact with your eyes, mouth, genital organs, or breasts while breastfeeding
• do not worry if a small amount of foam is accidentally applied to healthy skin near the psoriasis, but wipe it off if it has spread excessively
• do not cover, bandage, or wrap the treated skin area
• to achieve 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).

Duration of treatment

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

Your doctor may instruct you to use Enstilar twice a week once your psoriasis has cleared or nearly cleared. Enstilar should then be applied twice a week on two non-consecutive days (e.g., Wednesday and Saturday) to all areas previously affected by psoriasis. Between applications, there should be a gap of 2 to 3 days without Enstilar treatment.

If symptoms reappear, use Enstilar once daily as indicated above and contact your doctor to review your 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 medications containing calcipotriol, the total daily amount of calcipotriol-containing medicines, including Enstilar, must not exceed 15 grams. Consult your doctor if you have used more than the recommended dose.

Excessive use of this medicine may cause disturbances in blood calcium levels, which usually return to normal once treatment is stopped.

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

See section 4 for further information.

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

If you forget to use Enstilar

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

If you stop using Enstilar

Treatment with Enstilar should be discontinued as directed by your doctor. It may be necessary to gradually stop using this medicine, especially if it has been used for a long time.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects observed with Enstilar:

Uncommon adverse 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 stopping treatment
• increased level of calcium in your blood
• skin irritation which may include itching, pain, burning and stinging and/or redness of the skin
• redness, pain or inflammation at the hair root (folliculitis)
• loss of skin color (depigmentation).

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

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

This medicine contains betamethasone (a potent corticosteroid) and calcipotriol. Therefore, you may experience the following adverse effects. These adverse effects are more likely if Enstilar is used for a prolonged period, if the treated area is covered, if it is used in skin folds (e.g. groin, armpits or under the breasts), or if it is used over large skin areas:

• allergic reactions with swelling of the face or other body parts such as hands or feet. Swelling of the mouth/throat and breathing difficulties may also occur
• increased calcium levels in your blood or urine, which may lead to symptoms. Symptoms include frequent urination, constipation, muscle weakness and confusion. When treatment is stopped, calcium levels return to normal
• your adrenal glands may stop functioning properly. Symptoms include tiredness, 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 pressure inside the eye)
• infections (because your immune system is weakened)
• pustular psoriasis (an area of red psoriasis with yellowish pustules (blisters))
• you may experience fluctuations in blood sugar levels.

If you experience any of the adverse effects listed above, inform your doctor immediately.

Less severe adverse effects caused by calcipotriol or betamethasone include:

• thinning of the skin
• stretch marks
• 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
• itchy skin rash (eczema)
• when used on the scalp, white or grey hair may temporarily turn yellowish at the application site.

Reporting of adverse effects

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

5. Storage of Enstilar

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 is the last day of the month indicated.

Do not store above 30°C.

The container should be discarded 6 months after first opening.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enstilar

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).

The other components are:

Liquid paraffin

Polioxipropilén stearyl ether

All-rac-α-tocopherol

White vaseline

Butylhydroxytoluene (E321)

Butane

Dimethyl ether

Appearance of Enstilar and pack contents

Enstilar is a cutaneous foam.

Upon spraying, a white or off-white foam is formed, which appears non-expanding and gradually collapses after spraying.

Aluminium container with an internal polyamide-imide lacquer, fitted with a spray actuator and continuous valve.

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

Pack sizes: 60 g, 2 packs of 60 g.

Only certain pack sizes may be commercially available.

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

This medicinal product is authorised in European Economic Area (EEA) Member States 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 the most recent review of this leaflet: July 2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) http://www.aemps.gob.es/.