ANZUPGO 20 MG/G CREAM

Introduction

Package Leaflet: Information for the User

Anzupgo 20 mg/g Cream

Delgocitinib

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Anzupgo and what is it used for

Anzupgo contains the active substance delgocitinib. It belongs to a group of medicines known as Janus kinase inhibitors.

Anzupgo is used in adults to treat moderate to severe chronic hand eczema. It is used when topical corticosteroids do not work well enough or cannot be used.

Anzupgo targets different proteins (enzymes) in the body called Janus kinases. It blocks the activity of four specific Janus kinase enzymes, which helps to reduce inflammation and immune responses that cause hand eczema. By suppressing these processes, Anzupgo can help to improve the condition of the skin and reduce itching and pain. This can also increase the ability to perform daily activities and may improve quality of life.

2. What you need to know before you use Anzupgo

Do not use Anzupgo

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Anzupgo.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as it has not been studied in this age group.

Other medicines and Anzupgo

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

It is not recommended to use Anzupgo at the same time as other medicines on the affected skin, as this has not been studied.

Pregnancy and breastfeeding

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.

The effects of this medicine in pregnant women are not known; therefore, it is preferable to avoid the use of Anzupgo if you are pregnant or think you may be pregnant.

It is not known if delgocitinib passes into human breast milk, but the body only absorbs very small amounts of this medicine. Therefore, no risk to the baby is expected, and Anzupgo can be used during breastfeeding.

However, if you are breastfeeding, you should avoid getting this medicine directly on the nipple or any other area where the baby may ingest it during feeding.

If you are caring for a baby, you should also avoid touching the baby's skin with your hands immediately after applying Anzupgo. This is a precaution to limit any unnecessary exposure of the baby to this medicine. In case of accidental transfer of the cream to the baby's skin, the cream can be washed off the skin.

Driving and using machines

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

Anzupgo contains benzyl alcohol, butylhydroxyanisole, and cetearyl alcohol

This medicine contains 10 mg of benzyl alcohol (E 1519) in each gram. Benzyl alcohol may cause allergic reactions or moderate local irritation.

Butylhydroxyanisole (E 320) may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

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

3. How to use Anzupgo

Follow exactly the instructions of administration of this medicine given to you by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.

Anzupgo is for use on the skin only. Avoid contact with the eyes, mouth, or nose. If the cream comes into contact with any of these areas, wash it off and rinse with water.

Before the first use

1. Remove the cap.
2. Remove the seal from the top end of the tube. Replace the cap.

Dose and method of administration

• Avoid applying other products, such as creams or ointments, to the skin immediately before or after applying Anzupgo.
• Apply a thin layer of Anzupgo twice a day to the affected areas of the hands and wrists. Make sure your skin is clean and dry.

If another person applies this medicine to your skin, they should wash their hands after application.

Duration of treatment with Anzupgo

• You should use Anzupgo until the skin lesions have cleared or almost cleared, or as advised by your doctor.
• When advised by your doctor, you can restart using Anzupgo if the signs or symptoms of chronic hand eczema come back.
• If you do not see any improvement after 12 weeks of treatment with Anzupgo, you should talk to your doctor.

If you use more Anzupgo than you should

If you have applied too much Anzupgo, wipe off the excess.

If you forget to use Anzupgo

If you forget to apply the cream at the scheduled time, do so as soon as you remember and continue with your normal schedule. Do not apply the cream more than twice a day.

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

4. Possible side effects

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

The following side effects have been reported with Anzupgo:

Common(may affect up to 1 in 10 people)

• Reactions at the application site (i.e., pain, itching, redness, and tingling sensation)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anzupgo

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

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

Do not freeze.

The tube should be discarded 1 year after first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Anzupgo

• The active substance is delgocitinib. Each gram of cream contains 20 mg of delgocitinib.
• The other ingredients are benzyl alcohol (E 1519), butylhydroxyanisole (E 320), cetearyl alcohol, citric acid monohydrate (E 330), disodium edetate, hydrochloric acid (E 507) (for pH adjustment), liquid paraffin, cetearyl alcohol macrogol ether, and purified water (see section 2 "Anzupgo contains benzyl alcohol, butylhydroxyanisole, and cetearyl alcohol").

Appearance and packaging of the product

Anzupgo is a white to slightly brown cream.

Anzupgo is supplied in tubes containing 15 or 60 grams of cream, or in a multipack containing 3 tubes, 2 tubes of 15 g and 1 tube of 60 g. Each carton contains one tube. Not all pack sizes may be marketed.

Marketing authorisation holder

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Manufacturer

LEO Laboratories Ltd.

285 Cashel Road

Crumlin, Dublin 12

Ireland

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

Date of last revision of this leaflet:

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