clascoterone: package leaflet

Winlevi contains the active substance clascoterone that belongs to a group of medicines known as ‘anti-acne preparations’.

Winlevi cream is a medicine used in adults and adolescents from 12 years of age and older to treat acne vulgaris. Acne vulgaris is a common skin condition that causes pimples, blackheads, and whiteheads that can affect the face, chest and back. In adolescents the use must be limited to the face only.

The active susbtance in Winlevi, clascoterone, blocks androgen receptors (a type of protein that binds to hormones called androgens). It also counteracts the effects of androgens in sebaceous glands (small glands in the skin that produce an oily substance called sebum) which improves acne vulgaris.

Do not use Winlevi
- if you are allergic to clascoterone or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant.

Warnings and precautions
*
Talk to your doctor before using Winlevi. Your doctor should start and supervise the treatment.
*
Winlevi is for external use only. It should only be applied to the skin.
*
Do not use more Winlevi than the prescribed dose.
*
Adolescents must apply the cream on the face only.

*
Winlevi can cause irritation (for example, dryness, redness, itching or a stinging/burning sensation). In most cases, this is of minimal or mild severity.
*
Use caution when applying to this medicine to sensitive areas of the skin, such as the neck. If a reaction in a sensitive area occurs, your doctor may instruct you to stop treatment. You may also apply emollients at least 2 hours before or after the application of Winlevi.
*
Do not apply Winlevi to cuts, abrasions, eczema or on sunburnt skin, or to areas affected by inflammatory skin conditions that may coexist with acne (such as, for example, redness (blushing) across your face or red rash around the mouth).
*
Do not use this medicine at the same time as photodynamic therapy. Your doctor may tell you to stop taking this medicine before starting photodynamic therapy.
*
Do not cover the affected area with additional dressings or bandages, as this increases the risk of experiencing side effects.
*
Avoid using this medicine on skin that has been exposed to other treatments, including cosmetic treatments (such as hair removal, chemical peels, dermabrasion or laser resurfacing), until the skin has recovered.
*
Wash your hands after applying the cream.
*
Avoid getting this medicine in your eyes, on your lips, mouth or corners of the nose, or on the mucous membranes on the inside of your nose and lips. If cream accidentally gets on these areas, rinse well with water.
*
Avoid using this medicine at the same time as other cutaneous acne medicines. Using more than one acne medicine at the same time may cause more irritation. If treatment with more than one acne medicine is required, these should be applied or taken with at least 2 hours before or after the application of Winlevi.
*
Avoid using skin products that may dry or irritate your skin.
*
You may experience adrenal suppression (reduced activity of the adrenal glands, which produce a stress hormone called cortisol) as an undesirable effect of Winlevi during treatment. If you use Winlevi over large areas of your skin for a long time or if you cover the area with a bandage or dressing, this can increase the risk of developing adrenal suppression. If you develop one or more of the following symptoms, which are otherwise unexplained and do not get better, this may indicate adrenal suppression, and you should contact your doctor right away:
* feeling tired,
* weight loss,
* decreased appetite,
* low blood pressure,
* feeling sick (nausea),
* diarrhoea,
* vomiting,
* belly (abdominal) pain,
* low blood glucose levels (hypoglycaemia),
Your doctor could consider to test your blood cortisol levels and refer you to endocrinologist evaluation in the presence of signs or symptoms suggestive of adrenal suppression.
*
Your doctor will monitor your condition and may stop or change the treatment if necessary.
Regular follow-up is important, especially during long-term use.

If you experience a reoccurrence (worsening) of acne in previously treated areas within days to weeks from treatment interruption, this may represent an exacerbation of acne due to the product (rebound).
Do not re-treat the area without consulting a doctor.

If you are not sure about any of the warnings and precautions, you should discuss with your doctor.

Children and adolescents
This medicine is only for use in adolescents 12 years and over. Do not give this medicine to children under 12 years because no benefit of the medicine was seen in this age group.

Other medicines and Winlevi
Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Winlevi may harm an unborn baby. If you're pregnant, do not use Winlevi. If you could become pregnant, you have to use effective contraception (birth control) while using Winlevi and for at least 10 days after stopping the treatment. You should talk to your doctor about which contraception method is right for you while you are taking Winlevi.

Your pregnancy status should be verified before starting the treatment.

It is not known if the active substance in Winlevi, clascoterone, or its by-products can be passed into breast milk. This means there may be a risk to the baby if you use Winlevi while breast-feeding. You should stop breast-feeding during treatment.

A patient card is provided with the Winlevi package to remind you of clascoterone risks in pregnancy.

Driving and using machines
Winlevi has no or negligible influence on the ability to drive and use machines.

Winlevi contains cetyl alcohol.
Cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Winlevi contains propylene glycol.
Propylene glycol may cause skin irritation. Because this medicine contains propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns).

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

A thin and even layer of the cream should be applied twice a day, once in the morning and once in the evening. Adolescents must apply the cream on the face only. Ensure that you wait at least 8 hours between each application.

Before applying this cream, gently wash and dry the affected skin area. Apply a thin, even layer of cream to the affected area, massaging gently. Two (2) fingertip units of cream (which correspond to about 1 g) will cover an area of about 28 x 22 cm (approximately 600 cm2) that corresponds to the average surface area of the face. A fingertip unit is the amount of cream squeezed out from a tube along the length of an adult’s index finger, from the first finger crease to the tip. One fingertip unit dose is about 0.5 g of cream.

The cream must be applied to the entire affected area, and not to the acne lesions only.

Avoid applying the cream to the eyes, eyelids, lips and nostrils. Wash your hands after applying the cream. Do not cover the affected area with additional dressings or bandages, as this increases the risk of experiencing side effects.

In adults Winlevi can be applied to the face, chest and/or back. The daily dose should not exceed 10 fingertip units (about 5 g).
In adolescents Winlevi must be applied to the face only. The daily dose should not exceed 4 fingertip units (about 2 g). No more than one 60 g a month (corresponding to one 60 g tube or two 30 g tubes) should be used.

Apply other skin medicines or cosmetic products, such as moisturisers or sunscreens, with a minimum gap of 2 hours before or after you use Winlevi.

Your doctor will tell you how long you will need to use Winlevi. After three months of treatment, your doctor may need to assess if or how much your acne has improved. After that, your doctor will reassess regularly (every three months) if you should continue treatment.
If you are an adolescent, your doctor may decide to schedule a visit earlier than three months.

If you use more Winlevi than you should
If you use Winlevi over large areas of your skin for a long time or if you cover the area with a bandage or dressing, this can increase the risk of developing side effects including adrenal suppression (see sections 2 and 4).

If you forget to use Winlevi
Wait for at least eight (8) hours between applications.
Do not apply a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In some cases, laboratory tests may show lower-than-normal levels of a stress hormone called cortisol.
This usually does not cause any symptoms and returns to normal within few weeks after stopping treatment.
There is a possibility that specific symptoms may develop such as: feeling tired, weight loss, decreased appetite, feeling sick (nausea), diarrhoea, vomiting, belly (abdominal) pain, low blood glucose levels (hypoglycemia).
See section 2 “Warnings and precautions” for information on what to do if you experience such symptoms.

Application site reactions such as redness, peeling, dryness, itching, stinging/burning of the skin, may be experienced with the use of Winlevi. See section 2 “Warnings and precautions” for information on what to do if you experience such symptoms.

Winlevi may cause the following side effects:

Common (may affect up to 1 in 10 people)
- Application site pain, dryness, redness, and excessive hair growth
- Lower-than-normal levels of a stress hormone called cortisol

Rare (may affect up to 1 in 1 000 people)
- Hypersensitivity (allergic reactions) at the site of application,
- Acne
- Itchy, blistered, dry and cracked skin (dermatitis contact)
- Headache
- Inflammation of hair follicles (folliculitis) at the site of application
- Sore throat (oropharyngeal pain)

Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.
By reporting side effects you can help provide more information on the safety of this medicine.

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 tube after EXP. The expiry date refers to the last day of that month.

Discard the unused product 1 month after first opening.

Store in a refrigerator (2 °C – 8 °C). Once opened: do not store above 25 °C. Do not freeze.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Winlevi contains
- The active substance is clascoterone.
- The other ingredients are cetyl alcohol, citric acid monohydrate (E330) (for pH-adjustment), glycerol monostearate 40-55 Type I, liquid paraffin, polysorbate 80, propylene glycol (E1520), purified water, disodium edetate, all-rac-α-tocopherol (E307). See section 2. Winlevi contains cetyl alcohol. Winlevi contains propylene glycol.

What Winlevi looks like and contents of the pack
Winlevi is a white to almost white cream.

Winlevi is available in tubes containing 10 g, 30 g or 60 g of cream. There is one tube per carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Cassiopea S.p.A.

Via C. Colombo, 1
Lainate, 20045
Milan
Italy

Manufacturer
Cosmo S.p.A.
Via C. Colombo, 1
Lainate, 20045
Milan
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BE, BG, CY, EE, HR, IE, LT, LU, LV, MT, SI
Cassiopea S.p.A.
Italy info@cassiopea.com

Magyarország
Mediner Kft.
Tel.: +36 52 535 708 info@mediner.hu
Česká republika
Glenmark Pharmaceuticals s.r.o.
Tel: + 420 227 629 511 recepce@glenmarkpharma.com

Italia
InfectoPharm S.r.l.
Tel: + 39 02 007066 1 info-ita@infectopharm.com

DK, FI, IS, NO, SE
Glenmark Pharmaceuticals Nordic AB
Sweden
Tlf./Puh/Tel/Sími: + 46 40 35 48 10 info@glenmarkpharma.se

Nederland
Glenmark Pharmaceuticals BV
Tel: + 31 (0)8003355533 nlinfo@glenmarkpharma.com
AT, DE
INFECTOPHARM Arzneimittel und Consilium
GmbH
Germany
Tel: + 49 6252 957000 kontakt@infectopharm.com

Polska
Glenmark Pharmaceuticals Sp. z o. o.
Tel.: + 48 22 35 12 500 poland.receptionist@glenmarkpharma.com

España
Glenmark Farmacéutica, S.L.U.
Tel: + 34 911 593 944 infospain@glenmarkpharma.com
Portugal
Laboratório Medinfar - Produtos Farmacêuticos
Tel: + 351 214 997 461 medinfar@medinfar.pt
France
Laboratoires Bailleul
Tél: + 33 (0)1 56 33 11 11 vigilance-reclamation@bailleul.com

România
IASIS PHARMACEUTICALS SRL
Tel.: +40 720 536008 iasis@iasispharma.ro

Ελλάδα
IASIS PHARMA
Τηλ: + 30 210 2311031 iasis@iasispharma.gr

Slovenská republika
Glenmark Pharmaceuticals SK, s.r.o.
Tel: + 421 2 20 255 041 info-sk@glenmarkpharma.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.