Nintedanib Eugia 100 mg soft capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Nintedanib Eugia 100 mg soft capsules EFG

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Nintedanib Eugia is and what it is used for
2. What you need to know before taking 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 Nintedanib Eugia is and what it is used for

Nintedanib Eugia contains the active substance nintedanib, a medicine that belongs to a class of drugs known as tyrosine kinase inhibitors. It is used to treat the following conditions:

Idiopathic pulmonary fibrosis (IPF) in adults

IPF is a disease that causes thickening, hardening, and scarring of lung tissue over time. As a result, this scarring reduces the ability to transfer oxygen from the lungs into the bloodstream, making it difficult to breathe deeply. Nintedanib helps reduce the progression of further scarring and hardening of the lungs.

Other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype in adults

In addition to IPF, there are other disorders in which lung tissue becomes thickened, hardened, and scarred over time (pulmonary fibrosis) and continues to worsen (progressive phenotype). Examples of these disorders include hypersensitivity pneumonitis, autoimmune ILDs (such as ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. Nintedanib helps reduce the progression of new scarring and hardening of the lungs.

Clinically significant progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents aged 6 to 17 years

Pulmonary fibrosis may occur in patients with childhood interstitial lung disease. In this case, the lung tissue in children and adolescents becomes thickened, hardened, and scarred over time. Nintedanib helps reduce the progression of further scarring and hardening of the lungs.

Interstitial lung disease associated with systemic sclerosis (ILD-SSc) in adults, adolescents, and children aged 6 years and older

Systemic sclerosis (SSc), also known as scleroderma (and juvenile systemic sclerosis in children and adolescents), is a rare chronic autoimmune disease affecting connective tissue in many parts of the body. SSc causes fibrosis (scarring and hardening) of the skin and other internal organs, such as the lungs. When the lungs are affected by fibrosis, it is called interstitial lung disease (ILD), and thus the condition is referred to as ILD-SSc. Lung fibrosis reduces the ability to transfer oxygen into the bloodstream and impairs breathing capacity. Nintedanib helps reduce the progression of new scarring and hardening of the lungs.

2. What you need to know before taking Nintedanib Eugia

Do not take Nintedanib Eugia

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

Warnings and precautions

Talk to your doctor or pharmacist before taking nintedanib:

• If you have or have had liver problems.
• If you have or have had kidney problems, or if you have been found to have increased levels of protein in your urine.
• If you have or have had bleeding problems.
• If you are taking blood-thinning medicines (such as warfarin, phenprocoumon, or heparin) to prevent blood clots.
• If you are taking pirfenidone, as this may increase the risk of diarrhoea, nausea, vomiting, and liver problems.
• If you have or have had heart problems (for example, a heart attack).
• If you have recently undergone surgery. Nintedanib may affect how wounds heal. Therefore, treatment with nintedanib is usually paused for a period of time if you undergo surgery. Your doctor will decide when to restart treatment with this medicine.
• If you have high blood pressure.
• If you have abnormally high blood pressure in the blood vessels of the lungs (pulmonary hypertension).
• If you have or have had an aneurysm (a bulge and weakening of the blood vessel wall) or a tear in the wall of a blood vessel.

Based on this information, your doctor may carry out some blood tests, for example, to check your liver function. Your doctor will discuss the results of these tests with you to decide whether you can take nintedanib.

Tell your doctor immediately while you are taking this medicine:

• if you have diarrhoea. It is important to treat diarrhoea early (see section 4, “Possible side effects”).
• if you have vomiting or feel sick (nausea).
• if you have unexplained symptoms such as yellowing of the skin or the whites of the eyes (jaundice), dark or brown-coloured urine (tea-coloured), pain in the upper right side of the stomach area (abdomen), bleed or bruise more easily than normal, or feel tired. These could be signs of serious liver problems.
• if you have sudden severe stomach pain, fever, chills, dizziness, vomiting, or abdominal stiffness or swelling, as these could be symptoms of a hole in the wall of the intestines (“gastrointestinal perforation”). Also inform your doctor if you have previously had peptic ulcers or diverticular disease, or if you are being treated at the same time with anti-inflammatory medicines (NSAIDs) (used to relieve pain and swelling) or steroids (used for inflammation and allergies), as these may increase this risk.
• if you have a combination of severe or cramp-like stomach pain, red blood in the stools or diarrhoea, as these could be symptoms of intestinal inflammation due to insufficient blood supply.
• if you have pain, swelling, redness, or warmth in a limb, as these could be symptoms of a blood clot in one of your veins (a type of blood vessel).
• if you have pressure or pain in the chest, usually on the left side of the body, pain in the neck, jaw, shoulder, or arm, rapid heartbeat, difficulty breathing, nausea or vomiting, as these could be symptoms of a heart attack.
• if you have significant bleeding.
• if you experience bruising, bleeding, fever, fatigue, and confusion, as these may be signs of a blood vessel disorder known as thrombotic microangiopathy (TMA).
• if you experience symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure, which could be symptoms of a brain disorder called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents

Children under 6 years of age must not take this medicine.

Your doctor may carry out periodic dental examinations at least every 6 months until tooth development is complete and monitor your growth once a year (bone imaging study) while you are taking this medicine.

Other medicines and Nintedanib Eugia

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

Nintedanib may interact with other medicines. The following medicines may increase blood levels of nintedanib and therefore increase the risk of side effects (see section 4, “Possible side effects”):

• a medicine used to treat fungal infections (ketoconazole).
• a medicine used to treat bacterial infections (erythromycin).
• a medicine that affects your immune system (cyclosporine).

The following medicines are examples that may decrease blood levels of nintedanib and thereby reduce its effectiveness:

• an antibiotic used to treat tuberculosis (rifampicin).
• medicines used to treat seizures (carbamazepine, phenytoin).
• a herbal remedy used to treat depression (St. John’s wort).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take this medicine during pregnancy, as it may harm the unborn baby and cause birth defects.

A pregnancy test should be performed to make sure you are not pregnant before starting treatment with nintedanib. Consult your doctor.

Contraception

• Women who can become pregnant must use a highly effective method of contraception to prevent pregnancy when starting nintedanib, while taking nintedanib, and for at least 3 months after stopping treatment.
• Discuss with your doctor the most appropriate contraceptive methods for you.
• Vomiting and/or diarrhoea or other gastrointestinal disorders may affect the absorption of hormonal oral contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, if you experience any of these conditions, consult your doctor to consider a more appropriate alternative contraceptive method.
• Inform your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with nintedanib.

Breastfeeding

Do not breastfeed during treatment with nintedanib, as it may cause harm to the breastfed infant.

Driving and using machines

The effect of nintedanib on the ability to drive and use machines is minor. You should not drive or operate machinery if you feel dizzy.

Nintedanib Eugia contains soya lecithin

Do not use this medicine if you are allergic to peanut or soya (see section 2, “Do not take Nintedanib Eugia”).

3. How to take Nintedanib Eugia

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Take the capsules twice daily, approximately 12 hours apart and at approximately the same time each day; for example, one capsule in the morning and one capsule in the evening. This ensures that a constant level of nintedanib is maintained in your blood. Swallow the capsules whole with water, without chewing them. It is recommended to take the capsules with food, that is, during meals or immediately before or after meals. Do not open or break the capsule (see section 5, “Storage of Nintedanib Eugia”).

To make swallowing the capsules easier, you may take them with a small amount (one teaspoon) of soft food at room temperature or cold, such as apple sauce or chocolate pudding. Swallow the capsules immediately and do not chew them, to ensure they remain intact.

Adults

The recommended dose is one 100 mg capsule twice daily (a total of 200 mg per day).

Do not take more than the recommended dose of two 100 mg nintedanib capsules per day.

If you do not tolerate the recommended dose of two 100 mg nintedanib capsules per day (see possible adverse effects in section 4), your doctor may recommend that you stop taking this medicine. Do not reduce the dose or stop treatment on your own without first consulting your doctor.

Use in children and adolescents

The recommended dose depends on the patient's body weight.

Inform your doctor if at any time during treatment the patient's weight falls below 13.5 kg.

Inform your doctor if you have liver problems.

Your doctor will determine the correct dose. Your doctor may adjust the dose during the course of treatment.

If you do not tolerate the recommended daily dose of nintedanib capsules (see possible adverse effects in section 4), your doctor may reduce the daily dose of nintedanib.

Do not reduce the dose or interrupt treatment on your own without first consulting your doctor.

Weight-based dosing for nintedanib capsules in children and adolescents:

Weight range in kilograms (kg)	Dose of nintedanib in milligrams (mg)
13.5–22.9 kg	50 mg (two 25 mg capsules) twice daily
23.0–33.4 kg	75 mg (three 25 mg capsules) twice daily
33.5–57.4 kg	100 mg (one 100 mg capsule or four 25 mg capsules) twice daily
57.5 kg or more	150 mg (one 150 mg capsule or six 25 mg capsules) twice daily

If you take more Nintedanib Eugia than you should

Contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Nintedanib Eugia

Do not take two capsules together if you have forgotten to take your previous dose. You should take your next dose of nintedanib at the next scheduled time according to the prescribed regimen recommended by your doctor or pharmacist.

If you stop taking Nintedanib Eugia

Do not stop taking nintedanib without first consulting your doctor. It is important to take this medicine every day as long as your doctor prescribes it.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You should pay special attention if you experience the following adverse effects during treatment with nintedanib:

Diarrhoea (very common, may affect more than 1 in 10 people):

Diarrhoea may lead to dehydration: a loss of important body fluids and salts (electrolytes such as sodium or potassium). At the first signs of diarrhoea, drink plenty of fluids and contact your doctor immediately. Start an appropriate anti-diarrhoeal treatment as soon as possible, for example, by taking loperamide.

The following adverse effects have also been observed during treatment with this medicine.

Contact your doctor if you experience any type of adverse effect.

Idiopathic pulmonary fibrosis (IPF)

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

• Feeling sick (nausea).
• Pain in the lower part of the body (abdomen).
• Abnormal results in liver function tests.

Common adverse effects (may affect up to 1 in 10 people)

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

Uncommon adverse effects (may affect up to 1 in 100 people)

• Pancreatitis.
• Inflammation of the large intestine.
• Serious liver problems.
• Low platelet count (thrombocytopenia).
• High blood pressure (hypertension).
• Jaundice, i.e., yellowing of the skin and whites of the eyes due to high levels of bilirubin.
• Itching.
• Heart attack.
• Hair loss (alopecia).
• Increased amount of protein in the urine (proteinuria).

Frequency not known (cannot be estimated from available data)

• Kidney failure.
• Enlargement and weakening of a blood vessel wall or tear in the blood vessel wall (aneurysms and arterial dissections).
• Brain disorder with symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome).

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype

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

• Feeling sick (nausea).
• Vomiting.
• Loss of appetite.
• Pain in the lower part of the body (abdomen).
• Abnormal results in liver function tests.

Common adverse effects (may affect up to 1 in 10 people)

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

Uncommon adverse effects (may affect up to 1 in 100 people)

• Pancreatitis.
• Inflammation of the large intestine.
• Low platelet count (thrombocytopenia).
• Jaundice, i.e., yellowing of the skin and whites of the eyes due to high levels of bilirubin.
• Itching.
• Heart attack.
• Hair loss (alopecia).
• Increased amount of protein in the urine (proteinuria).

Frequency not known (cannot be estimated from available data)

• Kidney failure.
• Enlargement and weakening of a blood vessel wall or tear in the blood vessel wall (aneurysms and arterial dissections).
• Brain disorder with symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome).

Interstitial lung disease associated with systemic sclerosis (ILD-SSc)

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

• Feeling sick (nausea).
• Vomiting.
• Pain in the lower part of the body (abdomen).
• Abnormal results in liver function tests.

Common adverse effects (may affect up to 1 in 10 people)

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

Uncommon adverse effects (may affect up to 1 in 100 people)

• Inflammation of the large intestine.
• Serious liver problems.
• Kidney failure.
• Low platelet count (thrombocytopenia).
• Rash.
• Itching.

Frequency not known (cannot be estimated from available data)

• Heart attack.
• Pancreatitis.
• Jaundice, i.e., yellowing of the skin and whites of the eyes due to high levels of bilirubin.
• Enlargement and weakening of a blood vessel wall or tear in the blood vessel wall (aneurysms and arterial dissections).
• Hair loss (alopecia).
• Increased amount of protein in the urine (proteinuria).
• Brain disorder with symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome).

Fibrosing interstitial lung diseases (ILD) in children and adolescents

Adverse effects in children and adolescents were similar to those observed in adult patients.

Inform your doctor if you experience any type of adverse effect.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nintedanib Eugia

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

Do not use this medicine after the expiry date stated on the carton and on the blister, after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Keep in the original packaging to protect from moisture.

Do not use this medicine if you notice that the blister containing the capsules is open or if a capsule is damaged. If you come into contact with the capsule contents, wash your hands immediately with plenty of water (see section 3, "How to take Nintedanib Eugia").

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Nintedanib Eugia

• The active substance is nintedanib. Each soft capsule contains 100 mg of nintedanib (as esilate).
• The other components are:

Capsule contents: medium-chain triglycerides, solid semisynthetic glycerides, lecithin (soy).

Capsule shell: gelatin, glycerol (85%), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Printing ink: black iron oxide (E172), propylene glycol (E1520) and hypromellose 2910 (6 cp) (E464).

Nature and contents of the container

Soft capsules.

Peach-coloured, opaque, elongated soft gelatin capsules printed with “N100” in black ink, containing a bright yellow suspension.

Nintedanib Eugia soft capsules are available in blister packs containing 30, 60 or 120 soft capsules, and in perforated unit dose blister packs containing 60×1 soft capsules.

Only certain 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

Manufacturer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Or

Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

Or

Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Nintedanib PUREN 100 mg Weichkapseln

Belgium: Nintedanib Eugia 100 mg zachte capsules / capsules molles / Weichkapseln

Spain: Nintedanib Eugia 100 mg cápsulas blandas EFG

France: NINTEDANIB ARROW 100 mg, capsule molle

Italy: Nintedanib Aurobindo

Netherlands: Nintedanib Eugia 100 mg, zachte capsules

Poland: Nintedanib Eugia

Portugal: Nintedanib Eugia

Date of the most recent review of this leaflet: September 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).