Winlevi 10 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Winlevi 10 mg/g cream

clascoterone

This medicine is subject to additional monitoring, which will allow for rapid detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read the entire leaflet carefully before you start using this medicine, as 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.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Winlevi is and what it is used for
2. What you need to know before using Winlevi
3. How to use Winlevi
4. Possible side effects
5. How to store Winlevi
6. Contents of the pack and other information

1. What Winlevi is and what it is used for

Winlevi contains the active substance clascoterone, which belongs to a group of medicines known as "anti-acne preparations".

Winlevi cream is a medicine used in adults and adolescents aged 12 years and older to treat acne vulgaris. Acne vulgaris is a common skin condition that causes pimples, blackheads, and whiteheads, which may affect the face, chest, and back. In adolescents, its use should be limited to the face.

The active substance 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), thereby improving acne vulgaris.

2. What you need to know before using Winlevi

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

• Consult your doctor before starting to use Winlevi. Your doctor must initiate 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 should apply the cream only to the face.
• Winlevi may cause irritation (for example, dryness, redness, itching, or stinging/burning sensation). In most cases, this is of minimal or mild severity.
• Be cautious when applying this medicine to sensitive areas of the skin, such as the neck. If a reaction occurs in a sensitive area, your doctor may advise you to stop treatment. You may also apply emollients at least 2 hours before or after applying Winlevi.
• Do not apply Winlevi to cuts, abrasions, eczema, sunburned skin, or areas affected by inflammatory skin conditions that may coexist with acne (such as facial redness (flushing) or a red rash around the mouth).
• Do not use this medicine with photodynamic therapy. Your doctor may advise you to stop taking this medicine before starting photodynamic therapy.
• Do not cover the treated area with other dressings or bandages, as this increases the risk of adverse effects.
• Avoid using this medicine on skin that has been exposed to other treatments, including cosmetic treatments (such as waxing, chemical peels, dermabrasion, or laser resurfacing), until the skin has fully recovered.
• Wash your hands after applying the cream.
• Avoid contact of this medicine with the eyes, lips, mouth, or corners of the nose, or with the mucous membranes inside the nose and lips. If the cream accidentally gets into these areas, rinse thoroughly with water.
• Avoid using this medicine at the same time as other topical acne medications. Using more than one acne medication simultaneously may cause increased irritation. If treatment with more than one acne medication is required, they should be applied or taken at least 2 hours before or after applying 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 adverse effect of Winlevi during treatment. The risk of adrenal suppression may increase if you use Winlevi over large areas of skin for prolonged periods or if you cover the treated area with a dressing or bandage. If you experience one or more of the following symptoms, which have no other explanation and do not improve, this may indicate adrenal suppression, and you should contact your doctor immediately:
  • feeling tired,
  • weight loss,
  • decreased appetite,
  • low blood pressure,
  • feeling unwell (nausea),
  • diarrhea,
  • vomiting,
  • abdominal pain,
  • low blood sugar (hypoglycemia).

Your doctor may consider measuring blood cortisol levels and refer you for endocrine evaluation if you develop signs or symptoms suggestive of adrenal suppression.

• Your doctor will monitor your condition and may interrupt or modify treatment if necessary. Regular follow-up is important, especially during long-term use.

If acne worsens (reappears) in previously treated areas within a few days or weeks after stopping treatment, this may be a medication-related acne flare (rebound). Do not re-treat the area without consulting a doctor.

If you are unsure about any of the warnings and precautions, you should discuss them with your doctor.

Children and adolescents

This medicine is intended for use only in adolescents aged 12 years and older. Do not administer this medicine to children under 12 years of age, as no benefit of the medicine has been demonstrated in this age group.

Other medicines and Winlevi

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

Pregnancy and breastfeeding

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

Winlevi may harm the fetus. If you are pregnant, do not use Winlevi. If you could become pregnant, you must use an effective method of contraception while using Winlevi and for at least 10 days after stopping treatment. You should discuss with your doctor the most appropriate contraceptive method for you while taking Winlevi.

Your pregnancy status should be checked before starting treatment.

It is unknown whether the active ingredient in Winlevi, clascoterone, or its metabolites are excreted in breast milk. This means there may be a risk to the infant if you use Winlevi during breastfeeding. Breastfeeding must be discontinued during treatment.

The Winlevi packaging contains a patient card reminding you of the risks of clascoterone during pregnancy.

Driving and using machines

The effect of Winlevi on the ability to drive and use machines is none or negligible.

Winlevi contains cetyl alcohol

Cetyl alcohol may cause local skin reactions (such as contact dermatitis).

Winlevi contains propylene glycol

Propylene glycol may cause skin irritation. This medicine contains propylene glycol; do not use on open wounds or large areas of damaged skin (such as burns) without first consulting your doctor or pharmacist.

3. How to use Winlevi

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

A thin and even layer of cream should be applied twice daily, once in the morning and once in the evening. Adolescents should apply the cream only to the face. Make sure to wait at least 8 hours between each application.

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

Fingertip unit

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

Avoid applying the cream to the eyes, eyelids, lips, and inside the nostrils. Wash your hands after applying the cream. Do not cover the treated area with dressings or bandages, as this may increase the risk of adverse effects.

In adults, Winlevi may be applied to the face, chest, or back. The daily dose must not exceed 10 fingertip units (about 5 g).

In adolescents, Winlevi should be applied only to the face. The daily dose must not exceed 4 fingertip units (about 2 g). No more than 60 g per month should be used (equivalent to one 60 g tube or two 30 g tubes).

Apply other topical medicines or cosmetic products, such as moisturizers or sunscreens, at least 2 hours before or after using Winlevi.

Your doctor will advise you on how long you should use Winlevi. After three months of treatment, your doctor may need to assess whether your acne has improved and to what extent. Thereafter, your doctor will periodically reassess (every three months) whether treatment should continue.

If you are an adolescent, your doctor may decide to schedule a visit before the three-month mark.

If you use more Winlevi than you should

If you use Winlevi over large areas of skin for prolonged periods or cover the area with a dressing or bandage, you may increase the risk of developing adverse effects, including adrenal suppression (see sections 2 and 4).

If you forget to use Winlevi

Wait at least eight (8) hours between applications.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 a few weeks after stopping treatment.

Specific symptoms may possibly occur, such as: feeling tired, weight loss, decreased appetite, feeling unwell (nausea), diarrhoea, vomiting, abdominal pain, or low blood glucose levels (hypoglycaemia).

See section 2 “Warnings and precautions” for information on what to do if you experience these symptoms.

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

Winlevi may cause the following adverse effects:

Frequent (may affect up to 1 in 10 people)

• Pain at the application site, 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 application site
• Acne
• Itching, blisters, dry and cracked skin (contact dermatitis)
• Headache
• Inflammation of the hair follicles (folliculitis) at the application site
• Sore throat (oropharyngeal pain)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Winlevi

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 on the tube after EXP. The expiry date is the last day of the month indicated.

Discard the unused product 1 month after first opening.

Store in a refrigerator (between 2 °C and 8 °C). After opening: do not store above 25 °C. Do not freeze.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Winlevi

• The active substance is clascoterone.
• The other components are cetyl alcohol, citric acid monohydrate (E330) (to adjust pH), 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.

Appearance of the medicinal product and contents of the container

Winlevi is a white or almost white cream.

Winlevi is available in tubes containing 10 g, 30 g or 60 g of cream. One tube is supplied per carton.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Cassiopea S.p.A.

Via C. Colombo, 1

Lainate, 20045

Milan

Italy

Manufacturer responsible for batch release

Cosmo S.p.A.

Via C. Colombo, 1

Lainate, 20045

Milan

Italy

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).