Klisyri

Package leaflet: Information for the patient

Klisyri 10 mg/g ointment

Tirbanibulin
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Klisyri is and what it is used for

Klisyri contains the active substance tirbanibulin. It is used to treat mild actinic keratosis in adults. Actinic keratosis is a rough skin area that develops in people who have been exposed to excessive sunlight for prolonged periods. Klisyri should only be used for flat actinic keratosis on the face and scalp.

2. What you need to know before using Klisyri

Do not use Klisyri

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

Warnings and precautions
Talk to your doctor or pharmacist before using 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 damaged skin.
• Wash your hands if you happen to touch the area where you applied the ointment.
• Be careful not to transfer Klisyri into your eyes. If it accidentally comes into contact with your eyes, rinse them thoroughly with plenty of water and seek medical assistance as soon as possible, bringing this leaflet with you.
• Do not apply the ointment internally, inside the nostrils, inside the ears, or on the lips. If the ointment accidentally comes into contact with any of these areas, wash it off immediately with water.
• Do not swallow this medicine. Drink a large amount of water if you accidentally swallow this medicine, seek medical help, and keep this leaflet with you.
• Inform your doctor if you have problems with your immune system.
• Monitor for the appearance of new red, scaly patches, open sores, or raised, warty growths around the treated area. If you notice any of these, contact your doctor immediately.
• After using Klisyri, avoid activities that may cause excessive sweating and avoid exposure to sunlight (including sunlamps and tanning beds) as much as possible. When outdoors, wear protective clothing and a hat.
• Do not cover the treated area with bandages after using Klisyri.
• Do not apply more ointment than the amount recommended by your doctor.
• Do not apply the ointment more than once a day.
• Do not allow other people or pets to touch the treated area for approximately 8 hours after application of the ointment. In case of contact, the affected area on the person or pet should be washed.
• Contact your doctor if you develop skin reactions to this medicine in the treated area that become severe (see section 4).

Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as they do not develop actinic keratosis.

Other medicines and Klisyri
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
If you have previously used Klisyri or other similar medicines, inform your doctor before starting treatment.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Klisyri must not be used during pregnancy.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

Klisyri contains propylene glycol
This medicine contains 222.5 mg of propylene glycol per sachet, equivalent to 890 mg/g.

3. How to use Klisyri

Use this medicinal product exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This medicinal product is intended to treat an area of up to 25 cm² per single five-day treatment cycle. If complete clearance does not appear to have been achieved in the treated area approximately 8 weeks after starting treatment, or if new lesions develop, your doctor should reassess the treatment and consider alternative options.
Apply a thin layer of Klisyri to the affected area of the face or scalp once daily for 5 consecutive days. One sachet contains enough ointment to cover the treatment area. Do not store an opened sachet for use on another day, even if some ointment remains.

Instructions for use:

1. Wash your hands with soap and water before applying the ointment.
2. Wash the affected area with mild soap and water, and gently dry it.
3. Open a new sachet each time you apply this medicine.
4. Open the sachet along the perforations (Figure 1).
5. Squeeze the ointment onto the tip of your finger (Figure 2).
6. Apply a thin, even layer of ointment uniformly over the entire affected area (Figure 3).
7. Wash your hands with soap and water immediately after applying the ointment (Figure 4).
8. Do not wash or touch the treated area for approximately 8 hours. After this time has passed, you may wash the treated area with mild soap and water.
9. Do not cover the treated area with bandages after applying Klisyri.
10. Repeat the above steps each day of treatment, around the same time of day.

If you use more Klisyri than you should
Wash the treated area with mild soap and water. Contact your doctor or pharmacist if you experience severe skin reactions.
If you forget to use Klisyri
If you miss a dose, apply the ointment as soon as you remember, and then continue with your normal schedule. Do not apply the ointment more than once a day.
If you have any questions about the use of this medicine, consult 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 on the skin where you applied the ointment. These side effects may worsen for up to 8 days after starting treatment and usually disappear within 2–3 weeks after completion of treatment. Contact your doctor if these side effects become severe.

Side effects occurring more frequently at the treated area:
Very common (may affect more than 1 in 10 people)

• redness (erythema)
• skin peeling (desquamation)
• crusting (formation of crusts)
• swelling
• loss of the superficial skin layer (erosion, ulcer)

Other possible side effects at the treated area:
Common (may affect up to 1 in 10 people)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 stated on the outer carton and label after Exp. The expiry date refers to the last day of that month.
For single use only. Do not reuse sachets once opened.
Do not dispose of any medicine via 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

What Klisyri contains

• 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 components are propylene glycol (E1520) and glycerol monostearate 40-55.

Description of the appearance of Klisyri and contents of the pack
Each Klisyri sachet contains 250 mg of white to off-white ointment.
Each pack contains 5 polyethylene/aluminium foil sachets.

Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain

Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 3
21465 Reinbek
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien/Ísland/Luxembourg/Luxemburg
Vistor hf.
Almirall N.V.
Sími: +354 535 70 00
Tél/Tel: +32 (0)2 771 86 37

България/ Eesti/ Ελλάδα/ España/ Hrvatska/Italia/Κύπρος/ Latvija/ Lietuva/ Magyarország/Malta/ România/ Slovenija
Almirall SpA
Teл./ Tel/ Τηλ: +39 02 346181
Almirall, S.A.
Tel.: +34 93 291 30 00

Česká republika/Slovenská republika
Almirall s.r.o
Tel: +420 739 686 638

Danmark/Norge/Suomi/Finland/Sverige/Nederland
Almirall ApS
Almirall B.V.
Tlf/Puh/Tel: +45 70 25 75 75
Tel: +31 (0)30 711 15 10

Deutschland/Österreich
Almirall Hermal GmbH
Almirall GmbH
Tel.: +49 (0)40 72704-0
Tel.: +43 (0)1/595 39 60

France
Almirall SAS
Tél.: +33(0)1 46 46 19 20

Polska
Almirall Sp.z o.o.
Tel.: +48 22 330 02 57

Ireland
Almirall, S.A.
Tel: +353 1800 849322

Portugal
Almirall - Produtos Farmacêuticos, Lda.
Tel.: +351 21 415 57 50

More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu/.