Prospect: information for the patient

Klisyri 10 mg/g cream

tirbanibulina

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Klisyri and what it is used for

2. What you need to know before starting to use Klisyri

3. How to use Klisyri

4. Possible adverse effects

5. Storage of Klisyri

6. Contents of the pack and additional information

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

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 to use Klisyri

•Do not use Klisyri until the area to be treated has healed from any previous medication, procedure, or surgical treatment. Do not apply Klisyri to open wounds or torn skin.

•Wash your hands if you touch the area where the cream has been applied.

•Do not allow Klisyri to come into contact with your eyes. In case of accidental contact with your eyes, rinse them with plenty of water, seek medical attention as soon as possible, and bring this leaflet with you.

•Do not apply the cream to internal body areas, inside the nostrils, in the ear canal, or on the lips. In case of accidental contact of the cream with any of these areas, wash it off by rinsing 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.

•Inform your doctor if you have problems with your immune system.

•Be aware of the appearance of new red and scaly patches, open sores, and verrucous or raised lesions around the treatment area. If you notice any of them, consult your doctor immediately.

•After using Klisyri, avoid engaging in activities that may cause excessive sweating, as well as exposure to sunlight as much as possible (including sunlamps and tanning booths). When outdoors, wear protective clothing and a hat.

•Do not cover the treated area with bandages after using Klisyri.

•Do not apply more cream than your doctor has recommended.

•Do not apply the cream more than once a day.

•Do not allow pets or other people to touch the treated area for about 8 hours after the cream has been applied. If the treated area is touched, the other person's or pet's contact area should be washed.

•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 administer this medicine to children and adolescents under 18 years old because they do not develop actinic keratosis.

Other medicines and Klisyri

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

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

Pregnancy, breastfeeding, and fertility

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

Klisyri should not be used during pregnancy.

Driving and operating machines

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

Klisyri contains propylene glycol

Propylene glycol may cause skin irritation.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medication is indicated for treating a maximum area of 25 cm2in a single five-day treatment cycle. If the treated area does not show complete clearing approximately eight weeks after starting the treatment cycle or new lesions appear on 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 five consecutive days. A pack contains enough ointment to cover the treatment area. Do not save the opened pack for use 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 neutral soap and water and gently dry it.

3.Open a new pack each time you are going to apply this medication.

4.Open the pack 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, uniform layer of ointment over the entire affected area (figure 3).

7.Wash your hands with water and soap immediately after applying the ointment (figure4).

8.Do not wash or touch the treated area for eight hours. Once this period has elapsed, you can wash the treated area with neutral soap and water.

9.Do not cover the treated area with bandages 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 neutral soap and water. Consult your doctor or pharmacist if you experience intense skin reactions.

If you forgot to use Klisyri

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

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

After using this medication, you may experience adverse effects in the area of the skin where the ointment is applied. These adverse effects may worsen up to 8 days after the start of treatment and, in general, disappear between 2 and 3 weeks after it has been completed.Consult your doctor if these adverse effects worsen.

Most Frequent Adverse Effects in the Treated Area:

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

•Redness (erythema)

•Skin peeling (exfoliation)

•Crusts (crust formation)

•Swelling

•Loss of the top layer of skin (erosion, ulcer)

Other Possible Adverse Effects in the Treated Area:

Frequent(may affect up to 1 in 10 people)

•Pain (tenderness, itching, or burning sensation)

•Itching (pruritus)

•Blisters (vesicles, pustules)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not refrigerate or freeze.

Do not use this medication after the expiration date that appears on the box and label after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will helpto protectthe environment.

Composition of Klisyri

-The active ingredient 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 components are propylene glycol and 40-55 monoester of glycerol.

Appearance of the product and contents of the packaging

Each sachet of Klisyri contains 250 mg of white or off-white ointment. Each box contains 5 sachets of polyethylene/aluminum foil.

Holder of the marketing authorization

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

Responsible for manufacturing

Almirall Hermal GmbH Scholtzstrasse 3

21465 Reinbek

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet: 07/2021

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.