Enstilar

Enstilar, 50 micrograms/0.5 mg/g, cutaneous foam
Calcipotriol + Betamethasone
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet contents:

1. What Enstilar is and what it is 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 Enstilar is and what it is used for

Enstilar is used to treat plaque psoriasis (Psoriasis vulgaris).
Psoriasis is caused by abnormally rapid skin cell growth. This leads to redness, scaling, and thickening of the skin.
Enstilar contains calcipotriol and betamethasone. Calcipotriol helps restore normal skin cell growth rate, while betamethasone has an anti-inflammatory effect.

2. Important information before using Enstilar

When not to use Enstilar

• if the patient is allergic to calcipotriol, betamethasone, or any of the other ingredients of the medicine (listed in section 6),
• if the patient has disorders of calcium levels in the blood (consult a doctor),
• if the patient has other forms of psoriasis, such as erythrodermic psoriasis or pustular psoriasis (inform the doctor).

Because Enstilar contains a potent corticosteroid, it should not be used in the following skin conditions:

• viral skin infections (e.g. herpes simplex or chickenpox),
• fungal skin infections (e.g. athlete’s foot or tinea corporis),
• bacterial skin infections,
• parasitic infections (e.g. scabies),
• tuberculosis,
• perioral dermatitis (red rash around the mouth),
• thin skin, fragile blood vessels, or striae (stretch marks),
• ichthyosis (dry, scaly skin resembling fish scales),
• acne,
• rosacea (intense redness or flushing of the facial skin),
• skin ulcers or damaged skin.

Warnings and precautions
Before starting treatment with Enstilar, discuss with your doctor or pharmacist if:

• the patient has diabetes, as corticosteroid-containing medicines may affect blood sugar levels,
• the patient is using other medicines containing corticosteroids, because adverse effects may occur,
• the patient has guttate (or papular) psoriasis.

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

• the patient has used this medicine for a long time and plans to stop treatment (because there is a risk that psoriasis may worsen or flare up after abrupt discontinuation of a steroid-containing medicine),
• a skin infection develops, as treatment may need to be stopped,
• changes in blood calcium levels occur (see section 4),
• blurred vision or other visual disturbances occur.

Precautions

• avoid using the medicine under bandages or dressings, as this increases absorption of the steroid,
• avoid using more than 15 g per day. This means that a 60 g container of Enstilar should last for at least 4 days. 15 g of medicine is dispensed when the piston is fully pressed for approximately 1 minute. Squeezing for 2 seconds delivers 0.5 g of Enstilar. As a guide, 0.5 g of foam covers an area of skin approximately equal to the size of an adult hand.
• avoid applying the medicine to more than 30% of the body surface,
• avoid applying to large areas of damaged skin, mucous membranes, or skin folds (e.g. groin, armpits, under the breasts), as this increases steroid absorption,
• avoid use on the face and genital organs (genital area), as these areas are particularly sensitive to steroids,
• avoid excessive sun exposure, use of sunbeds, or other forms of phototherapy, as the skin may be more 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 medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor, pharmacist, or nurse before using this medicine.
If the doctor approves breastfeeding, take care not to apply Enstilar to the breast area. See “Instructions for proper use”.
Driving and using machines
This medicine is not expected to have any effect on the ability to drive or operate machinery.
Enstilar contains butylhydroxytoluene (E321)
Enstilar contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. See “Instructions for proper use”.

3. How to use Enstilar

Enstilar must always be used exactly as directed by the doctor. If in doubt, consult your doctor or pharmacist.
Method of administration: topical application to the skin.
Before using, read the package leaflet carefully, even if Enstilar has been used previously.
Enstilar is intended for direct application to psoriatic skin lesions (sprayed onto the skin).

Instructions for correct use
Application to the body skin

1. Shake the container for several seconds before use.

2. Apply the foam holding the container at least 3 cm from the skin, directly onto the psoriatic areas.

3. The foam can be dispensed with the container in various positions, except horizontally.

4. Gently massage the foam into the affected areas.

5. After applying the foam, replace the cap on the container to prevent accidental dispensing.

6. After applying Enstilar, wash hands thoroughly (unless the foam was applied to lesions on the hands). This helps prevent accidental transfer of the foam to other areas (especially face, mouth, and eyes). To achieve optimal effect, washing the body immediately after application of Enstilar is not recommended. The medicine should be left on the skin overnight or during the day.

Application to the hairy scalp

1. Comb the hair to remove any loose skin scales.
2. Shake the container for several seconds before use.

3. Dispense the foam directly into the palm of the hand, holding the container at least 3 cm away. The foam may be dispensed with the container in any position except horizontal.

4. Take the foam with a finger and apply it directly to the affected areas. Avoid applying to the hair during application. Gently rub the foam into the scalp. After application, replace the cap on the container to prevent accidental dispensing when not in use.

5. After applying Enstilar, wash hands thoroughly. This helps prevent accidental transfer of the foam to other areas (especially face, mouth, and eyes). To achieve optimal effect, washing the hair immediately after application of Enstilar is not recommended. The medicine should be left on the scalp overnight or during the day.

The following instructions may be helpful when washing hair:

1. Apply a mild, non-medicated shampoo to dry hair, focusing on areas where the foam was applied.

2. Removing Enstilar will be easier if the shampoo is applied to dry hair, as water may reduce the cleansing effect of the shampoo.
3. Massage the shampoo into dry hair/scalp. Leave the shampoo on the scalp for several minutes before rinsing.
4. Rinse thoroughly with water.
5. Repeat normal hair washing if necessary.

Additional information on correct use:

• Apply the medicine only to skin affected by psoriasis; do not apply to unaffected skin.
• If the medicine gets into the eyes, mouth, genital area, or breasts during breastfeeding, wash or rinse these areas thoroughly.
• Do not be concerned if a small amount of foam accidentally spreads to healthy skin near the psoriatic lesion, but excessive amounts should be wiped off.
• Do not cover treated areas with bandages, occlusive dressings, or wraps.
• To achieve optimal effect, avoid showering or bathing immediately after applying the foam.
• After applying the foam, avoid contact with textiles that are easily stained by oily substances (e.g. silk).

Duration of treatment
Apply the foam once daily. It may be more convenient to use the foam in the evening.
The usual treatment period is 4 weeks, but the doctor may decide on a different duration.
If psoriatic lesions have cleared or nearly cleared, the doctor may recommend using Enstilar twice weekly. Apply Enstilar twice weekly on two non-consecutive days (e.g. Wednesday and Saturday) to previously affected areas. Between applications, there should be a 2–3 day break without Enstilar.
If symptoms recur, resume daily application of Enstilar as described above and consult your doctor to review the treatment plan.

Use of more than the recommended dose of Enstilar
Important: One 60 g container of Enstilar should last at least 4 days (see section 2: "Warnings and precautions"). When using other medicines containing calcipotriol, the total daily amount of calcipotriol, including that in Enstilar, must not exceed 15 g per day. If a higher than recommended daily dose is used, contact your doctor. Excessive use of Enstilar in high doses may cause disturbances in blood calcium levels, which usually resolve after stopping treatment. Long-term, high-dose use of Enstilar may also cause adrenal gland dysfunction (adrenal glands are organs located next to the kidneys that produce hormones). See section 4.

Missed dose of Enstilar
Do not use a double dose to make up for a missed dose.

Stopping Enstilar
Stop using Enstilar as directed by your doctor. Gradual discontinuation may be necessary, especially if the medicine has been used for a long time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Enstilar can cause adverse reactions, although not everyone will experience them.

Adverse reactions observed after using Enstilar:

Uncommon (may affect up to 1 in 100 people)

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

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

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

Enstilar contains betamethasone (a potent steroid) and calcipotriol. Therefore, the following adverse reactions may occur, particularly after prolonged use of Enstilar, use under occlusive dressings, in skin folds (such as groin, underarms, under breasts) or application over large areas of skin:

• allergic reactions with swelling of the face or other body parts such as hands or feet; swelling of the lips and/or throat and breathing difficulties may also occur;
• calcium levels in blood or urine may increase to such an extent that symptoms of hypercalcaemia appear: frequent urination, constipation, muscle weakness and confusion; after discontinuation of this medicine, calcium levels return to normal;
• adrenal gland dysfunction, with symptoms such as fatigue, depression and anxiety;
• blurred vision, difficulty seeing at night and light sensitivity (may be symptoms of cataract);
• eye pain, redness of the eyes or blurred vision (may be symptoms of increased intraocular pressure);
• infections (due to suppression of the immune system);
• pustular psoriasis (red area with yellowish pustules);
• fluctuations in blood glucose levels may occur. If any of the above symptoms occur, contact your doctor immediately.

Less severe adverse reactions caused by calcipotriol and betamethasone:

• skin thinning,
• striae (stretch marks),
• visible blood vessels under the skin,
• changes in hair growth rate,
• red rash around the mouth (perioral dermatitis),
• worsening of psoriasis,
• skin sensitivity to light causing a rash,
• itchy rash (eczema),
• yellowing of hair may occur when the medicine is applied to the scalp in patients with white or grey hair.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Aleje Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Enstilar

Warning: Extremely 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 empty near an open flame or other source of ignition.
Keep away from sparks, open flames and other sources of ignition. Do not smoke nearby.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after the word EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Shelf-life after first opening the container: 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 in this medicine are:
calcipotriol and betamethasone.
Each gram of foam contains 50 micrograms of calcipotriol (as calcipotriol monohydrate) and
0.5 mg of betamethasone (as betamethasone dipropionate).
Other ingredients are:
white soft paraffin
stearyl poly(oxypropylene) 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 topical use.
When dispensed, it forms a white or almost white foam.
The container is an aluminium can internally coated with a polyamide-imide lacquer, fitted with a valve and a dosing pump (PP/Polyacetal) with a protective cap made of PP.
The container holds 60 g of foam, not including the amount of propellant.
Pack sizes: 60 g, 2 x 60 g.
Not all pack sizes may be available on the market.

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

For 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
Poland
Tel +48 22 244 18 40

This medicine is authorised in the European Economic Area countries 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