ANZUPGO 20 mg /G Krem

Treść ulotki

1. Anzupgo 20 mg/g cream
   1. What is Anzupgo and what is it used for
   2. What you need to know before using Anzupgo
   3. How to use Anzupgo
   4. Possible side effects
   5. How to store Anzupgo
   6. Contents of the pack and other information

Anzupgo 20 mg/g cream

delgocitinib

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 medicine. 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, 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, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Anzupgo and what is it used for

Anzupgo contains the active substance delgocitinib. It belongs to a group of medicines called
Janus kinase inhibitors.
Anzupgo is used in the treatment of adults with moderate to severe chronic hand eczema.
It is used when treatment with topical corticosteroid-based creams does not work sufficiently or cannot be used.
Anzupgo targets several proteins (enzymes) in the body called Janus kinases. It works
by blocking the activity of four specific Janus kinase enzymes, helping to reduce inflammation and
immune responses that cause hand eczema. By reducing these processes, Anzupgo can
help improve skin condition and reduce itching and pain. This, in turn, can
increase the ability to perform daily activities and improve quality of life.

2. What you need to know before using 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 using Anzupgo.

Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age, because it has not been
studied in this age group.

Other medicines and Anzupgo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Using Anzupgo at the same time as other medicines on the skin affected by eczema is
not recommended, because this use has not been studied.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before using this medicine.
The effects of this medicine on pregnant women are unknown; for this reason, it is
preferable to avoid using Anzupgo if you are pregnant or suspect you may be pregnant.
It is not known whether delgocitinib passes into human breast milk, but this medicine is absorbed in
minimal amounts into the body. Therefore, no risks are expected for the baby and Anzupgo can be
used during breastfeeding.
However, if you are breastfeeding, you should be careful to ensure that this medicine does not
come into contact with the nipple or any other area where the baby may ingest it during
breastfeeding.
If you are caring for a baby, you should also avoid contact of your hands with the baby's skin immediately
after applying Anzupgo. This precaution is to limit any unnecessary exposure of the baby to this
medicine. If the cream is accidentally transferred to the
baby's skin, the cream can be removed.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate
machines.

Anzupgo contains benzyl alcohol, butylhydroxyanisole and cetostearyl alcohol
This medicine contains 10 mg of benzyl alcohol (E 1519) per gram. Benzyl alcohol can
cause allergic reactions or mild local irritation.
Butylhydroxyanisole (E 320) may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

3. How to use Anzupgo

Use this medicine following the instructions of your doctor, pharmacist or
nurse exactly. If you have any doubts, ask your doctor, pharmacist or nurse.
Anzupgo is only for external use. Avoid contact with eyes, mouth or nose. If the cream comes into
contact with any of these areas, remove it completely and/or wash the cream away with water.

Before first use

• 1. Unscrew the cap.
• 2. Remove the seal on the top of the tube. Screw the cap back on.

Dosage 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 hands and wrists. Make sure the skin is clean and dry.

Twice a day
If the medicine is applied by another person, they should wash their hands after application.

How long to use Anzupgo

• Use Anzupgo until the skin is free or almost free from lesions, or as directed by your doctor.
• If the signs or symptoms of chronic hand eczema recur, you can resume treatment with Anzupgo as directed by your doctor.
• Tell your doctor if you do not notice any improvement after 12 weeks of treatment with Anzupgo.

If you use more Anzupgo than you should
If you have applied too much Anzupgo, remove 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 then
continue with the normal application schedule. Do not apply the cream more than twice a day.
If you have any questions about using 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.
With Anzupgo the following side effects have been reported:

Common(may affect up to 1 in 10 people)

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

Reporting of side effects
If you get any side effect, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system as indicated in Annex V. By reporting side effects you can help
to provide more information on the safety of this medicine.

5. How to store 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 the box after
“EXP”. The expiry date refers to the last day of that month.
Do not freeze.
The tube must be discarded 1 year after first opening.
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. Contents of the pack and other information

What Anzupgo contains

• The active ingredient is delgocitinib. One gram of cream contains 20 mg of delgocitinib.
• The other ingredients are benzyl alcohol (E 1519), butylated hydroxyanisole (E 320), cetostearyl alcohol, citric acid monohydrate (E 330), disodium edetate, hydrochloric acid (E 507) (for pH adjustment), liquid paraffin, macrogol cetostearyl ether and purified water (see section 2 “Anzupgo contains benzyl alcohol, butylated hydroxyanisole and cetostearyl alcohol”).

Description of the appearance of Anzupgo and contents of the pack
Anzupgo is a cream ranging in colour from white to slightly brown.
Anzupgo is supplied in tubes containing 15 or 60 grams of cream. Each box 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
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
LEO Pharma N.V./S.A
Tél/Tel: +32 3 740 7868

Lietuva
LEO Pharma A/S
Tel: +45 44 94 58 88

България
LEO Pharma A/S
Teл.: +45 44 94 58 88

Luxembourg/Luxemburg
LEO Pharma N.V./S.A
Tél/Tel: +32 3 740 7868

Česká republika
LEO Pharma s.r.o
Tel: +420 734 575 982

Magyarország
LEO Pharma A/S
Tel.: +45 44 94 58 88

Danmark
LEO Pharma AB
Tlf.: +45 70 22 49 11

Malta
LEO Pharma A/S
Tel: +45 44 94 58 88

Deutschland
LEO Pharma GmbH
Tel: +49 6102 2010

Nederland
LEO Pharma B.V.
Tel: +31 205104141

Eesti
LEO Pharma A/S
Tel: +45 44 94 58 88

Norge
LEO Pharma AS
Tlf: +47 22514900

Ελλάδα
LEO Pharmaceutical Hellas S.A.
Τηλ: +30 212 222 5000

Österreich
LEO Pharma GmbH
Tel: +43 1 503 6979

España
Laboratorios LEO Pharma, S.A.
Tel: +34 93 221 3366

Polska
LEO Pharma Sp. z o.o.
Tel.: +48 22 244 18 40

France
Laboratoires LEO
Tél: +33 1 3014 4000

Portugal
LEO Farmacêuticos Lda.
Tel: +351 21 711 0760

Hrvatska
LEO Pharma A/S
Tel: +45 44 94 58 88

România
LEO Pharma A/S
Tel: +45 44 94 58 88

Ireland
LEO Laboratories Ltd
Tel: +353 (0) 1 490 8924

Slovenija
LEO Pharma A/S
Tel: +45 44 94 58 88

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
LEO Pharma s.r.o.
Tel: +420 734 575 982

Italia
LEO Pharma S.p.A.
Tel: +39 06 52625500

Suomi/Finland
LEO Pharma Oy
Puh/Tel: +358 20 721 8440

Κύπρος
The Star Medicines Importers Co. Ltd.
Τηλ: +357 2537 1056

Sverige
LEO Pharma AB
Tel: +46 40 3522 00

United Kingdom (Northern Ireland)
LEO Laboratories Ltd
Tel: +44 (0) 1844 347333
More detailed information on this medicine is available on the website of the European Medicines Agency, https://www.ema.europa.eu .

Latvija
LEO Pharma A/S
Tel: +45 44 94 58 88