KLISYRI 10 mg /G Maść

Treść ulotki

1. Klisyri 10 mg/g ointment
   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. How to store Klisyri
   6. Package contents and other information

Klisyri 10 mg/g ointment

Tirbanibulina
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, 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 is Klisyri and what is it used for

Klisyri contains the active ingredient tirbanibuline. It is used for the treatment of mild to moderate grade actinic keratosis in adults. Actinic keratosis is an area of skin that has developed in people who have been exposed to the sun excessively for a long time. Klisyri should only be used for flat actinic keratosis on the face and scalp.

2. What you need to know before you use Klisyri

Do not use Klisyri

• if you are allergic to tirbanibuline or 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 medicine, 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 have 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 attention 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 by rinsing with water.
• Do not swallow this medicine. Drink a large amount of water if you accidentally swallow this medicine, seek medical attention and keep this leaflet with you.
• Tell your doctor if you have problems with your immune system.
• Check for the presence of new scaly red spots, open sores and raised or warty growths around the treatment area. If you notice any of these, see your doctor immediately.
• After using Klisyri, avoid activities that can cause excessive sweating and avoid sun exposure as much as possible (including sunbeds and tanning beds). When outdoors, wear protective clothing and a hat.
• Do not cover the treated area with bandages after using Klisyri.
• Do not apply an amount of ointment greater than that 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 about 8 hours after applying the ointment. If contact occurs, the area that came into contact on the other person or pet must be washed.
• See 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 give this medicine to children and adolescents under the age of 18 years as they do not develop actinic keratosis.

Other medicines and Klisyri
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you have previously used Klisyri or other similar medicines, tell your doctor before starting treatment.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
Klisyri should not be used during pregnancy.

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

Klisyri contains propylene glycol
Propylene glycol can cause skin irritation.

3. How to use Klisyri

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
This medicine is intended to treat an area up to 25 cm for a single treatment cycle of
five days. If complete clearance does not appear to have been achieved in the treated area approximately
8 weeks after the start of the treatment cycle, or if new lesions develop, the doctor will need to
re-evaluate the treatment and consider other 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 keep the 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 fingertip (Figure 2).
• 6. Apply a thin layer of ointment evenly 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 about 8 hours. After this time, you can wash the treated area with mild soap and water.
• 9. Do not cover the treated area with bandages after applying Klisyri.
• 10. Repeat the previous steps for 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 forget a dose, apply the ointment as soon as you remember and then continue with the normal
schedule. Do not apply the ointment more than once a day.
If you have any questions about using 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 on the skin where you apply
the ointment. These side effects may worsen up to 8 days after starting treatment
and generally disappear within 2-3 weeks after completing treatment. Contact your doctor if
these side effects become severe.

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

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

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

• pain (sensitivity to touch, pins and needles sensation or burning)
• itching
• blisters (vesicles, pustules)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system
as described 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 which is stated on the outer packaging and on the label
after Exp. The expiry date refers to the last day of that month.
For single use only. Do not reuse the sachets once opened.
Do not dispose of any medicine in 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 ingredient is tirbanibuline. Each sachet contains 2.5 mg of tirbanibuline in 250 mg of ointment. Each gram of ointment contains 10 mg of tirbanibuline.
• The other ingredients are propylene glycol and glycerol monostearate 40-55.

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

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 on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien/
Luxembourg/Luxemburg
Almirall N.V.
Tél/Tel: +32 (0)2 771 86 37

Ísland
Vistor hf.
Sími: +354 535 70 00

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

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

Danmark/ Norge/ Suomi/Finland/ Sverige
Almirall ApS
Tlf/ Puh/Tel: +45 70 25 75 75

Nederland
Almirall B.V.
Tel: +31 (0) 30 711 15 10

Deutschland
Almirall Hermal GmbH
Tel.: +49 (0)40 72704-0

Österreich
Almirall GmbH
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, http://www.ema.europa.eu/ .