InfoCons Consumer Protection informs you – Jascayd – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Jascayd is and what it is used for

Jascayd contains the active substance nerandomilast.

It is a medicine called phosphodiesterase 4B inhibitor, which helps to regulate the activity of your immune system and to reduce tissue scarring.

Jascayd is used:

• to treat idiopathic pulmonary fibrosis (IPF) in adults;
• to treat progressive pulmonary fibrosis (PPF) in adults.

IPF and PPF are lung diseases in which the tissue in the lungs becomes thickened, stiff and scarred over time. The scarring makes it difficult for oxygen to pass from the lungs into the bloodstream, making it hard to breathe deeply. Jascayd helps to reduce further scarring and stiffening of the lungs, thereby making it easier for you to breathe.

⚠️ 2. What you need to know before you take Jascayd

Do not take Jascayd

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Jascayd:

• if you take nintedanib or pirfenidone as this can increase the risk of certain side effects;

41 • if you have stomach or gut problems;

• if you have, or had in the past, stomach or gut problems when taking nintedanib or pirfenidone;
• if you have mental health problems.

Talk to your doctor while taking Jascayd:

• if you get diarrhoea, feel sick (nausea) or lose your appetite;
• if you lose weight without meaning to.

Children and adolescents

Do not give this medicine to children or adolescents because it is not known if this medicine is safe and effective in this population.

Other medicines and Jascayd

Jascayd may affect the way other medicines work, and other medicines may affect how Jascayd works.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

This is especially important if you are taking pirfenidone (another medicine to treat IPF), as it can reduce how well Jascayd works.

Additionally, tell your doctor or pharmacist if you are taking any of the following medicines as they may reduce how well Jascayd works:

• carbamazepine: a medicine to treat epilepsy and certain nerve pain;
• St. John’s wort: a herbal medicine used to help with mild depression, symptoms of menopause, and certain mood -related conditions such as anxiety;
• rifampicin: an antibiotic medicine to treat tuberculosis and other bacterial infections;
• phenytoin: a medicine to treat epilepsy;
• bosentan: a medicine to treat pulmonary arterial hypertension;
• metamizole: a medicine to relieve pain and reduce fever.

Also tell your doctor if you take any of the medicines listed below. Your doctor may reduce your dose of Jascayd if you take any of these, as they may increase the levels of Jascayd in your blood:

• clarithromycin: an antibiotic medicine to treat bacterial infections;
• itraconazole: a medicine to treat fungal infections;
• ritonavir: a medicine to treat COVID -19 and HIV infections.

Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine may cause loss of pregnancy (miscarriage). You should use effective contraception during treatment with Jascayd. If you become pregnant while being treated with this medicine, tell your doctor straight away. You and your doctor will decide if the benefit of having the medicine is greater than the risk to your baby.

It is not known if this medicine passes into breastmilk. Do not breastfeed during treatment with Jascayd.

42 Driving and using machines This medicine is not expected to affect your ability to drive or to use machines.

Jascayd contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Jascayd contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium – free’.

💊 3. How to take Jascayd

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how much Jascayd to take and when to take it.

The recommended dose is 1 tablet of Jascayd 18 mg twice daily. Take the tablets approximately 12 hours apart.

Your doctor may decide to reduce your dose of Jascayd to 9 mg twice daily depending on:

• how well you tolerate Jascayd;
• any other medicines you are taking.

Taking this medicine

• Swallow the tablets whole with water.
• You can take the tablet with or without food.

If you cannot swallow Jascayd tablets whole:

• Fill a glass with about 100 mL of non -carbonated (still) water that is at room temperature. Do not use any other liquids.
• Drop the tablet into the water without crushing it.
• Stir regularly for approximately 15 to 20 minutes until the tablet has broken down into very small bits (it will not dissolve completely).
• Drink the Jascayd and water mixture within 2 hours of mixing.
• If you do not drink the mixture right away, stir the mixture again before drinking.
• Fill the glass with another 100 mL of water and drink it. This ensures you have taken the full dose.

If you take more Jascayd than you should

Contact your doctor or pharmacist immediately.

If you forget to take Jascayd

If you forget a dose, take your next dose at your regular time. Do not take the missed dose. Do not take more than 2 tablets of 18 mg Jascayd in 1 day.

43 If you stop taking Jascayd You should continue taking Jascayd until your doctor tells you to stop.

Do not stop taking Jascayd without talking to your doctor first.

If you have any further questions on the use of 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.

Talk to your doctor if you get any side effects.

Idiopathic pulmonary fibrosis (IPF)

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

• diarrhoea.

Common (may affect up to 1 in 10 people)

• decreased appetite;
• feeling sick (nausea);
• back pain;
• weight loss.

Progressive pulmonary fibrosis (PPF)

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

• diarrhoea.

Common (may affect up to 1 in 10 people)

• decreased appetite;
• feeling sick (nausea);
• back pain;
• weight loss.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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. How to store Jascayd

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 blister or bottle label and on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

44 This medicine does not require any special temperature storage conditions.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Jascayd contains

Jascayd 9 mg tablets

• The active substance is nerandomilast. Each tablet contains 9 mg nerandomilast.
• The other ingredients are:
• lactose monohydrate;
• microcrystalline cellulose;
• hydroxypropylcellulose;
• croscarmellose sodium;
• magnesium stearate;
• hypromellose 2910;
• talc;
• mannitol;
• macrogol 8000;
• iron oxide yellow (E172).

Jascayd 18 mg tablets

• The active substance is nerandomilast. Each tablet contains 18 mg nerandomilast.
• The other ingredients are:
• lactose monohydrate;
• microcrystalline cellulose;
• hydroxypropylcellulose;
• croscarmellose sodium;
• magnesium stearate;
• hypromellose 2910;
• talc;
• mannitol;
• macrogol 8000;
• iron oxide red (E172);
• iron oxide black (E172).

What Jascayd looks like and contents of the pack

Jascayd 9 mg film-coated tablets are light yellow, oval and biconvex. They have “F9” on one side and the Boehringer Ingelheim logo on the other side. The tablets are 9.5 mm long and 4.6 mm wide.

Jascayd 18 mg film-coated tablets are light red, oval and biconvex. They have “F18” on one side and the Boehringer Ingelheim logo on the other side. The tablets are 12 mm long and 5.9 mm wide.

Jascayd tablets are available in:

• PVC/aluminium perforated unit dose blisters.

The pack sizes are 10 × 1, 30 × 1 or 60 × 1 film-coated tablets.

• HDPE bottle with a child -resistant closure.

The pack sizes are 60 or 180 film-coated tablets.

Not all pack sizes may be marketed.

45 Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173 55216 Ingelheim am Rhein Germany Boehringer Ingelheim France 100-104 Avenue de France 75013 Paris France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Boehringer Ingelheim SComm Tél/Tel: +32 2 773 33 11 Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel: +370 5 2595942 България Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ

• клон България Тел.: +359 2 958 79 98 Luxembourg/Luxemburg Boehringer Ingelheim SComm Tél/Tel: +32 2 773 33 11 Česká republika Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111 Magyarország Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe Tel.: +36 1 299 89 00 Danmark Boehringer Ingelheim Danmark A/S Tlf.: +45 39 15 88 88 Malta Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620 Deutschland Boehringer Ingelheim Pharma GmbH & Co.

KG Tel: +49 (0) 800 77 90 900 Nederland Boehringer Ingelheim B.V.

Tel: +31 (0) 800 22 55 889 Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Tel: +372 612 8000 Norge Boehringer Ingelheim Danmark A/S NUF Tlf: +47 66 76 13 00 Ελλάδα Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.

Tηλ: +30 2 10 89 06 300 Österreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105 -7870 46 España Boehringer Ingelheim España, S.A.

Tel: +34 93 404 51 00 Polska Boehringer Ingelheim Sp. z o.o.

Tel.: +48 22 699 0 699 France Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33 Portugal Boehringer Ingelheim Portugal, Lda.

Tel: +351 21 313 53 00 Hrvatska Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600 România Boehringer Ingelheim RCV GmbH & Co KG Viena – Sucursala Bucureşti Tel: +40 21 302 28 00 Ireland Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620 Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podružnica Ljubljana Tel: +386 1 586 40 00 Ísland Vistor ehf.

Sími: +354 535 7000 Slovenská republika Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka Tel: +421 2 5810 1211 Italia Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1 Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102 800 Κύπρος Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.

Tηλ: +30 2 10 89 06 300 Sverige Boehringer Ingelheim AB Tel: +46 8 721 21 00 Latvija Boehringer Ingelheim RCV GmbH & Co KG Latvijas filiāle Tel: +371 67 240 011 This leaflet was last revised in.

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

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Jascayd (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/26/2040).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.