Nintedanib Eugia

Package Leaflet: Information for the User

Nintedanib Eugia, 100 mg, soft capsules

Nintedanib Eugia, 150 mg, soft capsules

Nintedanib

Read all of this leaflet carefully before 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.

Contents of the pack and other information

• 1. What is Nintedanib Eugia and what is it used for
• 2. Before you take Nintedanib Eugia
• 3. How to take Nintedanib Eugia
• 4. Possible side effects
• 5. How to store Nintedanib Eugia
• 6. Contents of the pack and other information

1. What is Nintedanib Eugia and what is it used for

Nintedanib Eugia contains the active substance nintedanib, which belongs to a group of medicines called tyrosine kinase inhibitors, and is used to treat idiopathic pulmonary fibrosis (IPF), other chronic and progressive fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults. Idiopathic pulmonary fibrosis (IPF) is a disease in which the lung tissue gradually becomes thicker, stiffer, and scarred. As a result, scarring reduces the ability to transport oxygen from the lungs into the bloodstream, and deep breathing becomes difficult. Nintedanib Eugia reduces further scarring and stiffness of the lungs. Other chronic and progressive fibrosing interstitial lung diseases (ILDs) with a progressive phenotype Besides IPF, there are other diseases in which the lung tissue becomes thicker, stiffer, and scarred (lung fibrosis) over time and worsens continuously (progressive phenotype). Examples of these diseases include allergic alveolitis, autoimmune ILD (e.g., ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassified idiopathic interstitial pneumonia, and other ILDs. Nintedanib Eugia helps reduce further scarring and stiffness of the lungs. Systemic sclerosis-associated interstitial lung disease (SSc-ILD) Systemic sclerosis (also known as scleroderma) is a rare chronic autoimmune disease that affects the connective tissue in many parts of the body. Systemic sclerosis (SSc) causes scarring (fibrosis and stiffness) of the skin and internal organs, such as the lungs. The presence of fibrosis in the lungs is called interstitial lung disease (ILD) and is therefore referred to as SSc-ILD. Lung fibrosis reduces the ability to supply oxygen to the bloodstream, making breathing difficult. Nintedanib Eugia helps reduce further scarring and stiffness of the lungs.

2. Before you take Nintedanib Eugia

When not to take Nintedanib Eugia

• If you are pregnant,
• If you are allergic to nintedanib, peanuts, or soy or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Nintedanib Eugia, tell your doctor or pharmacist if you have or have had liver problems, kidney problems, or high levels of protein in your urine, bleeding problems, are taking blood thinners (such as warfarin, phenprocoumon, or heparin) to prevent blood clotting, are taking pirfenidone, as this may increase the risk of diarrhea, vomiting, and liver problems, have heart problems (e.g., heart attack), have recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Eugia is usually stopped for a while if you are going to have surgery. Your doctor will decide when to restart treatment with this medicine, if you have high blood pressure, if you have high blood pressure in the blood vessels of the lungs (pulmonary hypertension), if you have had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Your doctor may perform blood tests, for example to check liver function. Your doctor will discuss the results of these tests with you and decide whether you can take Nintedanib Eugia. If you experience any of the following while taking this medicine, tell your doctor immediately: diarrhea, vomiting or nausea, unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or tea-colored urine, pain in the upper right abdomen, more frequent than usual bleeding or bruising, or feeling tired. These may be signs of serious liver problems, severe stomach pain, fever, chills, nausea, vomiting, or a hard or swollen abdomen, as these may be signs of a hole in the wall of the intestine (gastrointestinal perforation). You should also tell your doctor if you have had stomach ulcers or diverticulitis in the past or if you are taking non-steroidal anti-inflammatory drugs (NSAIDs) (used to treat pain and swelling) or steroids (used to treat inflammation and allergies), as these factors increase the risk;

severe abdominal pain or cramps, blood in the stool, or diarrhea, as these may be signs of inflammation of the intestine due to poor blood supply, pain, swelling, redness, and increased temperature of a limb, as these may be signs of a blood clot in a vein (a type of blood vessel), chest pain or discomfort, typically on the left side of the body, pain in the neck, jaw, arm, or hand, rapid heartbeat, shortness of breath, nausea, vomiting, as these may be signs of a heart attack, severe bleeding, discoloration, bleeding, fever, fatigue, and confusion. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA), symptoms such as headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arms or legs, with high blood pressure or without high blood pressure. These may be signs of a brain disease called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents

Children and adolescents under 18 years of age should not take Nintedanib Eugia.

Nintedanib Eugia and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including herbal products and medicines that can be obtained without a prescription. Nintedanib Eugia may interact with certain other medicines. The following medicines may increase the levels of nintedanib in the blood and thus increase the risk of side effects (see section 4): ketoconazole (used to treat fungal infections), erythromycin (used to treat bacterial infections), cyclosporin (used to affect the immune system). The following medicines are examples of medicines that may decrease the levels of nintedanib in the blood and thus decrease the effectiveness of Nintedanib Eugia: rifampicin (an antibiotic used to treat tuberculosis), carbamazepine, phenytoin (used to treat epilepsy), St. John's Wort (a herbal medicine used to treat depression).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Do not take this medicine during pregnancy, as it may harm the unborn child and cause birth defects. Before starting treatment with Nintedanib Eugia, a pregnancy test must be performed to ensure that you are not pregnant. You should discuss this with your doctor. Contraception Women who may become pregnant must use highly effective contraception to prevent pregnancy while taking Nintedanib Eugia, throughout the entire treatment period with Nintedanib Eugia, and for at least 3 months after stopping treatment. You should discuss the best methods of contraception with your doctor. Vomiting and/or diarrhea or other gastrointestinal disorders may affect the absorption of oral hormonal contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, in the event of such disorders, you should discuss the use of an alternative, more suitable method of contraception with your doctor. If you become pregnant or think you may be pregnant while taking Nintedanib Eugia, you should tell your doctor or pharmacist immediately.

Breastfeeding Do not breastfeed while taking Nintedanib Eugia, as it may harm the breastfed child.

Driving and using machines

Nintedanib Eugia may have a minor influence on the ability to drive and use machines. If you feel nauseous, you should not drive or operate machinery.

Nintedanib Eugia contains soy lecithin

If you are allergic to soy or peanuts, do not take this medicine (see section 2).

3. How to take Nintedanib Eugia

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Take the capsules twice a day, approximately 12 hours apart, at the same time every day, for example, one capsule in the morning and one capsule in the evening. This will help keep a steady level of nintedanib in your blood. Swallow the capsules whole with water; do not chew the capsules. It is recommended to take the capsules with food, for example, during or immediately before or after a meal. Do not open or crush the capsules (see section 5). For the 100 mg dose: Adults The recommended dose is one 100 mg capsule twice a day (a total of 200 mg per day). Do not take more than the recommended dose of two 100 mg Nintedanib Eugia capsules per day. If you cannot tolerate the recommended dose of two 100 mg Nintedanib Eugia capsules per day (see possible side effects in section 4), your doctor may advise you to stop taking this medicine. Do not reduce the dose or stop treatment without first consulting your doctor.

Taking a higher dose of Nintedanib Eugia than recommended

Contact your doctor or pharmacist immediately.

Missing a dose of Nintedanib Eugia

Do not take two capsules at the same time if you miss a dose. Take the next 100 mg dose of Nintedanib Eugia as planned at the usual time recommended by your doctor or pharmacist. For the 150 mg dose: Adults The recommended dose is one 150 mg capsule twice a day (a total of 300 mg per day). Do not take more than the recommended dose of two 150 mg Nintedanib Eugia capsules per day. If you cannot tolerate the recommended dose of two 150 mg Nintedanib Eugia capsules per day (see possible side effects in section 4), your doctor may reduce your daily dose of Nintedanib Eugia. Do not reduce the dose or stop treatment without first consulting your doctor. Your doctor may reduce the recommended dose to two 100 mg doses per day (a total of 200 mg per day). In this case, your doctor will prescribe 100 mg Nintedanib Eugia capsules for treatment. Do not take more than the recommended dose of two 100 mg Nintedanib Eugia capsules per day if your daily dose has been reduced to 200 mg per day.

Taking a higher dose of Nintedanib Eugia than recommended

Contact your doctor or pharmacist immediately.

Missing a dose of Nintedanib Eugia

Do not take two capsules at the same time if you miss a dose. Take the next 150 mg dose of Nintedanib Eugia as planned at the usual time recommended by your doctor or pharmacist.

Stopping treatment with Nintedanib Eugia

Do not stop taking Nintedanib Eugia without first consulting your doctor. It is important to take this medicine regularly and continuously for as long as your doctor recommends. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should be aware of the following side effects while taking Nintedanib Eugia. Diarrhea (very common, may affect more than 1 in 10 people) Diarrhea can lead to dehydration: loss of water and important substances (electrolytes, such as sodium or potassium) from the body. If you experience the first symptoms of diarrhea, drink plenty of fluids and contact your doctor immediately. You should start appropriate anti-diarrheal treatment as soon as possible, for example with loperamide.

Other side effects that have been reported with this medicine.

If you experience any side effects, talk to your doctor. Idiopathic pulmonary fibrosis (IPF) Very common side effects (may affect more than 1 in 10 people) Nausea (nausea) Abdominal pain (abdominal pain) Abnormal liver function test results

• Vomiting
• Loss of appetite
• Weight loss
• Bleeding
• Rash
• Headache

Uncommon side effects (may affect up to 1 in 100 people) Pancreatitis Colitis Severe liver problems Low platelet count (thrombocytopenia) High blood pressure (hypertension) Jaundice, yellowing of the skin and whites of the eyes due to high bilirubin levels Itching Myocardial infarction Hair loss (alopecia) Increased protein levels in the urine (proteinuria)

• Renal failure
• Aneurysm or dissection of a blood vessel
• Brain disease with symptoms such as headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arms or legs, with high blood pressure or without high blood pressure (posterior reversible encephalopathy syndrome, PRES)

Other chronic and progressive fibrosing interstitial lung diseases (ILDs) with a progressive phenotype Very common side effects (may affect more than 1 in 10 people) Nausea (nausea) Vomiting Loss of appetite Abdominal pain (abdominal pain) Abnormal liver function test results

• Weight loss
• High blood pressure (hypertension)
• Bleeding
• Severe liver problems
• Rash
• Headache

Uncommon side effects (may affect up to 1 in 100 people) Pancreatitis Colitis Low platelet count (thrombocytopenia) Jaundice, yellowing of the skin and whites of the eyes due to high bilirubin levels Itching Myocardial infarction Hair loss (alopecia) Increased protein levels in the urine (proteinuria)

• Renal failure
• Aneurysm or dissection of a blood vessel
• Brain disease with symptoms such as headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arms or legs, with high blood pressure or without high blood pressure (posterior reversible encephalopathy syndrome, PRES)

Systemic sclerosis-associated interstitial lung disease (SSc-ILD) Very common side effects (may affect more than 1 in 10 people) Nausea (nausea) Vomiting Abdominal pain (abdominal pain) Abnormal liver function test results

• Bleeding
• High blood pressure (hypertension)
• Loss of appetite
• Weight loss
• Headache

Uncommon side effects (may affect up to 1 in 100 people) Colitis Severe liver problems Renal failure Low platelet count (thrombocytopenia) Rash Itching

• Myocardial infarction
• Pancreatitis
• Jaundice, yellowing of the skin and whites of the eyes due to high bilirubin levels
• Aneurysm or dissection of a blood vessel
• Hair loss (alopecia)
• Increased protein levels in the urine (proteinuria)
• Brain disease with symptoms such as headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arms or legs, with high blood pressure or without high blood pressure (posterior reversible encephalopathy syndrome, PRES)

Reporting of side effects

If you experience 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 the "Contact" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nintedanib Eugia

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 carton and blister after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original package to protect from moisture. Do not use this medicine if you notice that the blister containing the capsules is open or that the capsule is broken. In case of contact with the contents of the capsule, wash your hands immediately with plenty of water (see section 3). 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 other information

What Nintedanib Eugia contains

• The active substance is nintedanib. Each capsule contains 100 mg of nintedanib (as nintedanib esylate).
• The other ingredients are: Capsule contents: medium-chain triglycerides, solid fat, soybean lecithin. Capsule shell: gelatin, glycerol (85%), titanium dioxide, yellow iron oxide (E 172), red iron oxide (E 172). Black ink:black iron oxide (E 172), propylene glycol (E 1520), hypromellose 2910 (6 cP) (E 464).

Black ink:black iron oxide (E 172), propylene glycol (E 1520), hypromellose 2910 (6 cP) (E 464).

• The active substance is nintedanib. Each capsule contains 150 mg of nintedanib (as nintedanib esylate).
• The other ingredients are: Capsule contents: medium-chain triglycerides, solid fat, soybean lecithin. Capsule shell: gelatin, glycerol (85%), titanium dioxide, yellow iron oxide (E 172), red iron oxide (E 172). Black ink:black iron oxide (E 172), propylene glycol (E 1520), hypromellose 2910 (6 cP) (E 464).

What Nintedanib Eugia looks like and contents of the pack

Soft capsules Nintedanib Eugia 100 mg, soft capsules: Nintedanib Eugia 100 mg capsules are peach-colored, opaque, elongated, soft gelatin capsules with black printing "N100", containing a light yellow suspension. Nintedanib Eugia 150 mg, soft capsules: Nintedanib Eugia 150 mg capsules are brown, opaque, elongated, soft gelatin capsules with black printing "N150", containing a light yellow suspension. Nintedanib Eugia 100 mg, 150 mg, soft capsules are available in blisters containing 30, 60, or 120 soft capsules and in perforated unit dose blisters containing 60 x 1 soft capsule, in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Eugia Pharma (Malta) Limited Vault 14, level 2 Valletta Waterfront Floriana, FRN 1914 Malta e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd. HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generis Farmacêutica, S.A. Rua João de Deus N 19, Venda Nova 2700-487 Amadora Portugal Arrow Génériques 26 Avenue Tony Garnier 69007 Lyon France

This medicine is authorised in the Member States of the European Economic Area under the following names:

Belgium:

Nintedanib Eugia 100 mg soft capsules / capsules molles / Weichkapseln Nintedanib Eugia 150 mg soft capsules / capsules molles / Weichkapseln

Portugal:

Nintedanib Eugia

France:

NINTEDANIB ARROW 100 mg, capsule molle NINTEDANIB ARROW 150 mg, capsule molle

Germany:

Nintedanib PUREN 100 mg Weichkapseln Nintedanib PUREN 150 mg Weichkapseln

Italy:

Nintedanib Aurobindo

Netherlands:

Nintedanib Eugia 100 mg, soft capsules Nintedanib Eugia 150 mg, soft capsules

Poland:

Nintedanib Eugia

Spain:

Nintedanib Eugia 100 mg cápsulas blandas EFG Nintedanib Eugia 150 mg cápsulas blandas EFG

Date of last revision of the leaflet: 06/2025