ENSTILAR 50 MICROGRAMS/G + 0.5 MG/G Cutaneous foam

Зміст інструкції

1. Enstilar 50 micrograms/g + 0.5 mg/g cutaneous foam
   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. How to store Enstilar
   6. Package Contents and Other Information

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

calcipotriol/betamethasone

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Enstilar and what is it used for

Enstilar is used on the skin to treat plaque psoriasis in adults. Psoriasis is caused by skin cells that reproduce too quickly. This causes 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 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 calcium levels in your body (ask your doctor)
• if you have other types of psoriasis called: erythrodermic psoriasis or pustular psoriasis (if you are unsure, ask your doctor).

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

• skin infections caused by viruses (such as cold sores or chickenpox)
• skin infections caused by fungi (such as athlete's foot or ringworm)
• skin infections caused by bacteria
• skin infections caused by parasites (such as scabies)
• tuberculosis (TB)
• perioral dermatitis (red rash around the mouth)
• thin skin, easily damaged veins, stretch marks
• ichthyosis (dry skin with fish-like scales)
• acne (pimples)
• rosacea (severe 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 that contain steroids, as side 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 treatment with steroids is stopped suddenly there is a risk that the psoriasis will worsen or flare up)
• the skin lesions tend to become infected, you may need to stop treatment
• the calcium levels in your blood change (see section 4 for more information)
• you experience blurred vision or other visual disturbances.

Special precautions:

• avoid using bandages or dressings that may increase the absorption of the steroid
• avoid using more than 15 g of medicine per day. This means that a 60 g pack of Enstilar should last at least 4 days. A dose of 15 g is delivered if the actuator is pressed fully for about 1 minute. One actuation of 2 seconds delivers approximately 0.5 g of Enstilar. Indicatively, an amount of 0.5 g of foam should cover an area of skin corresponding to approximately the surface of an adult's hand.
• avoid applying the medicine to more than 30% of the body
• avoid use on large areas of damaged skin, on mucous membranes or in skin folds (for example groin, armpits or under the breasts), as this increases the absorption of the steroid
• avoid applying the medicine to the skin of the face or genitals (sex organs), as they are very sensitive to steroids

Children and adolescents
The use of Enstilar is not recommended in children under 18 years of age.

Other medicines and Enstilar
Tell 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, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If your doctor has established that you can breastfeed, make sure you do not apply Enstilar to the breast area. See “Instructions for correct use”.

Driving and using machines
This medicine should not affect your 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 correct use”.

3. How to use Enstilar

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or pharmacist.
Enstilar is for cutaneous (on the skin) use.
Enstilar is indicated for direct (delivery) application to the 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 holding the container at least 3 cm away from the skin and deliver the foam directly onto the affected area.

• 3. The foam can be delivered holding the

container oriented in any way, except
horizontally.

• 4. Gently rub the foam onto each area of

affected skin.

• 5. After applying the foam, put the cap on the container to avoid accidental deliveries when not in use.
• 6. Wash your hands thoroughly after using Enstilar (unless you are using the foam to treat your hands). This will avoid accidental contact of the foam with other parts of the body (especially the face, mouth and eyes). In order to achieve an 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.

Application to the scalp

• 1. Comb your hair to remove any scales that may be present.

• 2. Shake the container for a few seconds before use.

• 3. Hold the container at least 3 cm away.

Deliver the foam directly onto the palm of your
hand. The foam can be delivered holding the
container in any orientation, except
horizontally.

• 4. Collect the foam on your finger and apply it

directly onto the affected areas. Reduce to
the minimum the application on the hair to make
washing easier. Gently rub the foam
onto the scalp. After applying the foam,
put the cap on the container to prevent
accidental delivery when not in use.

• 5. Wash your hands thoroughly after using Enstilar. This will avoid spreading the foam accidentally to other parts of the body (especially face, mouth and eyes). In order to achieve an 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.

Whenyouwashyourhair,thefollowinginstructionsmaybehelpful:

• 1. Apply a mild, non-medicated shampoo to

dryhair, focusing on the areas where
the foam has been applied.
It is easier to remove Enstilar when the shampoo
is applied to dry hair, as water
dilutes the detergent effect of the shampoo.

• 2. Massage the shampoo into dryhair/scalp.Leave the shampoo on the scalp for a couple of minutes before washing.

• 3. Rinse thoroughly with water.
• 4. Repeat your normal shampoo if necessary.

Further information for correct use:

• use Enstilar only on psoriasis and do not use it on skin not affected by psoriasis
• wash or rinse thoroughly if, accidentally, you have applied the foam to your eyes, mouth, genitals or breast if you are breastfeeding
• do not be alarmed if a small part of the 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 an optimal effect, it is recommended not to bathe or shower immediately after applying the foam
• after applying the foam, avoid contact with fabrics that could easily stain with grease (e.g. silk).

Duration of treatment:

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

The doctor may prescribe you to use Enstilar twice a week once the psoriasis has healed or
almost healed. Enstilar must be applied twice a week for two non-consecutive days (e.g.
Wednesday and Saturday) on areas previously affected by psoriasis. There should be
2-3 days without treatment with Enstilar between applications.
If the symptoms reappear, you must use Enstilar once a day as described above and contact
your doctor to review the treatment.

If you use more Enstilar than you should
Important: A 60 g container of Enstilar should last at least 4 days (see section 2
“Special precautions”). If you use other medicines containing calcipotriol, the total amount of medicines
containing calcipotriol, including Enstilar, must not exceed 15 g per day. Contact your doctor if you
have used a dose higher than that recommended.
Excessive use of Enstilar can cause problems with calcium levels in the blood, which usually
normalize after stopping treatment.
Prolonged excessive use can also cause improper functioning 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
The use of Enstilar must be stopped as indicated by your doctor. It may be necessary
to stop using the medicine gradually, especially after using it for a long time.
If you have any doubts about using 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 observed 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 flare-up of psoriasis after treatment has been stopped
• increased levels of calcium in the blood
• skin irritation which may include itching, pain, burning and stinging and/or redness of the skin
• redness, pain or swelling at the hair root (folliculitis)
• skin discolouration (depigmentation).

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

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

Enstilar 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 long period of time, if used with a bandage or in skin folds (e.g.
groin, armpits or under the breasts), or if used on 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 difficulty breathing may also occur
• the levels of calcium in the blood or urine may increase so much that symptoms appear. The signs 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 signs are fatigue, depression, anxiety
• blurred vision, difficulty seeing at night, sensitivity to light (this can be a sign of cataracts)
• eye pain, redness of the eyes, decreased vision or blurred vision (this could be a sign of increased pressure inside the eyes)
• infections (because your immune system is weakened)
• 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 serious side effects due to the use of calcipotriol or betamethasone include:

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the 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

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 package and the container after
“Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
The container must be discarded 6 months after first opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

Warning: Extremely flammable. Pressurized container: may explode
if heated.
Protect from sunlight. Do not expose to temperatures exceeding 50°C. Do not
puncture 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.

What Enstilar contains
The active ingredients 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 ingredients are:
Liquid paraffin
Stearyl polypropylene glycol ether
All-rac-α-tocopherol
White soft paraffin
Butylated hydroxytoluene (E321)
Butane
Dimethyl ether

Description of Enstilar and package contents
Enstilar is a cutaneous foam.
After dispensing, a foam of colour from white to off-white is formed. The foam has
the appearance of a non-expanding foam that gradually collapses after dispensing.

Container made of aluminum internally coated with a polyamide-imide lacquer, equipped with a
continuous valve and a dispenser.
The container contains 60 g of foam, excluding the amount of propellant.
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
Dublin12
Ireland
Colep Laupheim GmbH & Co. KG
Fockestraße 12
DE-88471 Laupheim
Germany
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

Distributor for Italy:
LEO Pharma S.p.A.
Via Elio Vittorini 129
00144 Roma

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) under the following denominations:
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.