KLISYRI 10 mg/g OINTMENT

Introduction

Package Leaflet: Information for the Patient

Klisyri 10 mg/g Ointment

Tirbanibulin

This medicine is subject to additional monitoring, which will allow for quicker identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Klisyri and what is it used for

Klisyri contains the active substance tirbanibulin. It is used for the treatment of mild actinic keratosis in adults. Actinic keratosis is a rough area of skin that develops in people who have been exposed to a lot of sun over a long period of time. Klisyri should only be used for flat actinic keratosis of the face and scalp.

2. What you need to know before you use Klisyri

Do not use Klisyri

• if you are allergic to tirbanibulin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Klisyri.

• Do not use Klisyri until the area to be treated has healed from any previous medicine, procedure, or surgical treatment. Do not apply Klisyri to open wounds or broken skin.
• Wash your hands if you touch the area where the ointment has been applied.
• Do not let Klisyri come into contact with your eyes. In case of accidental contact with the eyes, rinse them with plenty of water, seek medical attention as soon as possible, and bring this leaflet with you.
• Do not apply the ointment to internal areas of the body, inside the nostrils, inside the ear, or on the lips. In case of accidental contact of the ointment with any of these areas, wash the area with water.
• Do not ingest this medicine. In case of accidental ingestion of this medicine, drink plenty of water, seek medical attention, and bring this leaflet with you.
• Tell your doctor if you have problems with your immune system.
• Be aware of the appearance of new red and scaly patches, open sores, and warty or raised lesions around the treatment area. If you notice any of these, consult your doctor immediately.
• After using Klisyri, avoid activities that may cause excessive sweating, as well as exposure to sunlight as much as possible (including sunlamps and tanning beds). When outdoors, use protective clothing and a hat.
• Do not cover the treated area with a bandage after using Klisyri.
• Do not apply more ointment than your doctor has recommended.
• Do not apply the ointment more than once a day.
• Do not let pets or other people touch the treated area for about 8 hours after the ointment has been applied. If you touch the treated area, wash the contact area of the other person or pet.
• Contact your doctor if you experience skin reactions to this medicine in the treated area that worsen (see section 4).

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age because they do not develop actinic keratosis.

Other medicines and Klisyri

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

If you have used Klisyri or similar medicines before, tell your doctor before starting treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Klisyri should not be used during pregnancy.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines.

Klisyri contains propylene glycol

Propylene glycol may cause skin irritation.

3. How to use Klisyri

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

This medicine is indicated to treat a maximum area of 25 cm2 in a single 5-day treatment cycle. If the treated area does not show complete clearance approximately 8 weeks after starting the treatment cycle or new lesions have appeared in it, your doctor should reconsider continuing this treatment and consider other therapeutic options.

Apply a thin layer of Klisyri to the affected area of the face or scalp once a day for 5 consecutive days. One sachet contains enough ointment to cover the treatment area. Do not store the opened sachet for use on another day, even if there is still ointment left.

Application instructions:

1. Wash your hands with water and soap before applying the ointment.
2. Wash the affected area with water and mild soap and gently dry it.
3. Open a new sachet each time you are going to apply this medicine.
4. Open the sachet along the perforated line (figure 1).
5. Apply a small amount of ointment to the tip of your finger (figure 2).
6. Spread a thin layer of ointment evenly over the entire affected area (figure 3).
7. Wash your hands with water and soap immediately after applying the ointment (figure 4).
8. Do not wash or touch the treated area for about 8 hours. After this period, you can wash the treated area with water and mild soap.
9. Do not cover the treated area with a bandage after applying Klisyri.
10. Repeat the above steps each day of treatment at approximately the same time.

If you use more Klisyri than you should

Wash the treated area with water and mild soap. Consult your doctor or pharmacist if you have severe skin reactions.

If you forget to use Klisyri

If you forget a dose, apply the ointment as soon as you remember and then continue with your usual treatment schedule. Do not apply the ointment more than once a day.

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

4. Possible side effects

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

After using this medicine, you may experience side effects in the skin area where the ointment is applied. These side effects may worsen up to 8 days after starting treatment and usually disappear within 2 to 3 weeks after finishing treatment. Consult your doctor if these side effects worsen.

Most common side effects in the treated area:

Very common(may affect more than 1 in 10 people)

• redness (erythema)
• skin peeling (exfoliation)
• crusts (crusting)
• swelling
• loss of the top layer of the skin (erosion, ulcer)

Other possible side effects in the treated area:

Common(may affect up to 1 in 10 people)

• pain (tenderness, stinging, or burning sensation)
• itching (pruritus)
• blisters (vesicles, pustules)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Klisyri

Keep this medicine out of the sight and reach of children.

Do not refrigerate or freeze.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date is the last day of the month stated.

For single use only. Do not reuse the sachets once opened.

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

Composition of Klisyri

• The active substance is tirbanibulin. Each sachet contains 2.5 mg of tirbanibulin in 250 mg of ointment. Each gram of ointment contains 10 mg of tirbanibulin.
• The other ingredients are propylene glycol and glycerol monostearate 40-55.

Appearance of the product and pack contents

Each sachet of Klisyri contains 250 mg of white or almost white ointment. Each carton contains 5 sachets of polyethylene/aluminum foil.

Marketing authorisation holder

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

Manufacturer

Almirall Hermal GmbH Scholtzstrasse 3

21465 Reinbek

Germany

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: 07/2021

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.