NINTEDANIB EIGNAPHARMA 150 mg SOFT CAPSULES

Introduction

Leaflet: information for the patient

Nintedanib Eignapharma 150 mg soft capsules EFG

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience side effects, contact your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Nintedanib Eignapharma and what is it used for
2. What you need to know before taking Nintedanib Eignapharma
3. How to take Nintedanib Eignapharma
4. Possible side effects

5 Conservation of Nintedanib Eignapharma

1. Contents of the pack and additional information

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

Nintedanib Eignapharma contains the active substance nintedanib, a medicine that belongs to the class of tyrosine kinase inhibitors, and is used to treat the following diseases:

Idiopathic pulmonary fibrosis (IPF) in adults

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

Other chronic fibrosing interstitial lung diseases (ILD) 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). Some examples of these disorders are hypersensitivity pneumonitis, autoimmune ILD (such as ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILD. Nintedanib reduces new scarring and hardening of the lungs.

Fibrosing interstitial lung diseases (ILD) in children and adolescents between 6 and 17 years old

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

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

Systemic sclerosis (SSc), also known as scleroderma (and juvenile systemic sclerosis in children and adolescents), is a rare chronic autoimmune disease that affects 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 the disease is called SSc-ILD. Fibrosis in the lungs reduces the ability to transfer oxygen to the bloodstream and reduces the ability to breathe. Nintedanib reduces new scarring and hardening of the lungs.

2. What you need to know before taking Nintedanib Eignapharma

Do not take Nintedanib Eignapharma

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nintedanib Eignapharma

• if you have or have had liver problems,
• if you have or have had kidney problems, or if you have been detected with an increase in the amount of protein in the urine,
• if you have or have had bleeding problems,
• if you are taking medicines to thin the blood (such as warfarin, phenprocoumon, or heparin) to prevent blood clots,
• if you are taking pirfenidone, as it may increase the risk of diarrhea, nausea, vomiting, and liver problems,
• if you have or have had heart problems (such as a heart attack), if you have recently undergone surgery. Nintedanib may affect the way wounds heal. Therefore, treatment with Nintedanib Eignapharma will usually be suspended for a while if you undergo surgery. Your doctor will decide when to resume 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 (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Based on this information, your doctor may perform some blood tests, for example, to check your liver function. Your doctor will discuss the results of these tests with you to decide if you can take Nintedanib Eignapharma.

Tell your doctor immediately while taking this medicine

• if you have diarrhea. It is essential to treat diarrhea early (see section 4, "Possible side effects");
• if you have vomiting or feel like vomiting (nausea);
• if you have symptoms without an apparent cause, such as yellowing of the skin or the whites of the eyes (jaundice), dark or brown urine (the color of tea), pain in the upper right side of the abdominal area, bleeding or bruising more easily than usual, or feeling tired. These could be symptoms of severe liver problems;
• if you have severe abdominal 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 had peptic ulcers or diverticular disease in the past or if you are being treated with anti-inflammatory medicines (NSAIDs) (used to relieve pain and swelling) or steroids (used against inflammation and allergies), as this may increase the risk;
• if you have a combination of severe or colicky abdominal pain, blood in the stool, or diarrhea, 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 a significant bleeding.
• if you experience bruising, bleeding, fever, fatigue, and confusion, as these may be a sign of a blood vessel injury known as thrombotic microangiopathy (TMA).
• if you experience symptoms such as headache, changes in vision, confusion, seizures, or other neurological disorders, 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 should not take Nintedanib.

Your doctor may perform regular dental examinations at least every 6 months until the completion of tooth development and monitor your growth once a year (bone imaging study) while taking this medicine.

Other medicines and Nintedanib Eignapharma

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

Nintedanib Eignapharma may interact with other medicines. The following medicines may increase the levels of nintedanib in the blood 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 the levels of nintedanib in the blood and, thus, reduce the efficacy of Nintedanib Eignapharma:

• an antibiotic used to treat tuberculosis (rifampicin)
• medicines used to treat seizures (carbamazepine, phenytoin)
• a herbal medicine 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 fetus and cause birth defects.

A pregnancy test should be performed to ensure you are not pregnant before starting treatment with Nintedanib Eignapharma. Consult your doctor.

Contraception

• Women who may become pregnant should use a highly effective contraceptive method to avoid pregnancy when starting to take Nintedanib Eignapharma, while taking Nintedanib Eignapharma, and for at least 3 months after stopping treatment.
• Consult your doctor about the most suitable contraceptive methods for you.
• Vomiting and/or diarrhea 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 situations, consult your doctor to assess an alternative contraceptive method more suitable for you.
• Tell your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with Nintedanib Eignapharma.

Breastfeeding

Do not breastfeed your baby during treatment with Nintedanib Eignapharma, as it may harm the baby.

Driving and using machines

Nintedanib Eignapharma has little influence on the ability to drive and use machines. Do not drive or use machines if you feel dizzy.

Nintedanib Eignapharma contains soy lecithin

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

3. How to take Nintedanib Eignapharma

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take the capsules twice a day, with approximately 12 hours between doses, and at about the same time each day; for example, one capsule in the morning and one capsule in the evening. This will ensure that a constant level of nintedanib is maintained in your blood. Swallow the capsules whole with water, without chewing them. It is recommended that you take the capsules with food, i.e., during meals or immediately before or after meals. Do not open or break the capsule (see section 5, "Conservation of Nintedanib").

To make it easier to swallow the capsules, you can take them with a small amount (a teaspoon) of a soft, cold, or room-temperature food, 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 150 mg capsule twice a day (a total of 300 mg per day).

Do not take more than the recommended dose of two Nintedanib Eignapharma 150 mg capsules per day.

If you do not tolerate the recommended dose of two Nintedanib Eignapharma 150 mg capsules per day (see possible side effects in section 4), your doctor may reduce your daily dose of Nintedanib Eignapharma. Do not reduce the dose or stop treatment without consulting your doctor first.

Your doctor may reduce the recommended dose to 100 mg twice a day (a total of 200 mg per day). In this case, your doctor will prescribe Nintedanib 100 mg capsules for your treatment. Do not take more than the recommended dose of two Nintedanib 100 mg capsules per day if your daily dose has been reduced to 200 mg per day.

Use in children and adolescents

The recommended dose depends on the patient's weight.

Tell your doctor if the patient's weight is less than 13.5 kg at any time during treatment.

Tell 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 side effects in section 4), your doctor may reduce the daily dose of Nintedanib.

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

Dosing based on weight for Nintedanib capsules in children and adolescents:

If you take more Nintedanib Eignapharma than you should

Contact your doctor or pharmacist immediately.

If you forget to take Nintedanib Eignapharma

Do not take two capsules together if you have missed your previous dose. You should take your next dose of Nintedanib Eignapharma according to the schedule established and recommended by your doctor or pharmacist.

If you stop treatment with Nintedanib Eignapharma

Do not stop taking Nintedanib Eignapharma without consulting your doctor first. It is essential to take this medicine every day while 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 all people suffer from them.

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

Diarrhea(very frequent, may affect more than 1 in 10 people):

Diarrhea can cause dehydration: a loss of fluids and important salts from the body (electrolytes, such as sodium or potassium). If you experience the first symptoms of diarrhea, drink plenty of fluids and consult your doctor immediately. Start appropriate antidiarrheal treatment as soon as possible, for example, by taking loperamide.

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

medicine.

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

Idiopathic Pulmonary Fibrosis (IPF)

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

• Nausea
• Pain in the lower half of the body (abdomen)
• Abnormal liver test results

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

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

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

• Pancreatitis
• Inflammation of the large intestine
• Severe liver problems
• Low platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Jaundice, i.e., yellow color in the skin and in the 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 the available data)

• Kidney failure
• Enlargement and weakening of the wall of a blood vessel or tearing of the wall of a blood

vessel (aneurysms and arterial dissections)

• Cerebral disorder with symptoms such as headache, changes in vision, confusion, convulsions or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

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

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

• Nausea
• Vomiting
• Loss of appetite
• Pain in the lower half of the body (abdomen)
• Abnormal liver test results

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

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

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

• Pancreatitis
• Inflammation of the large intestine
• Low platelet count (thrombocytopenia)
• Jaundice, i.e., yellow color in the skin and in the 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 the available data)

• Kidney failure
• Enlargement and weakening of the wall of a blood vessel or tearing of the wall of a blood

vessel (aneurysms and arterial dissections)

• Cerebral disorder with symptoms such as headache, changes in vision, confusion, convulsions or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

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

• Nausea
• Vomiting
• Pain in the lower half of the body (abdomen)
• Abnormal liver test results

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

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

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

• Inflammation of the large intestine

• Severe liver problems
• Kidney failure
• Low platelet count (thrombocytopenia)
• Rash
• Itching

Frequency not known (cannot be estimated from the available data)

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

Chronic Fibrosing Interstitial Lung Diseases (ILD) in Children and Adolescents

The adverse effects in children and adolescents were similar to the adverse effects in adult patients.

Report to your doctor if you experience any type of adverse effect.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Nintedanib Eignapharma

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

Do not use this medicine after the expiration date stated on the carton and blister. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not use this medicine if you notice that the blister containing the capsules is open or that a capsule is broken.

If you come into 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. Deposit the packaging and medicines that you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofNintedanib Eignapharma

• The active ingredient is nintedanib. Each capsule contains 150 mg of nintedanib (as esylate).
• The other ingredients are:

Capsule content: medium-chain triglycerides, lauroyl macrogolglycerides, soy lecithin (E322) (see section 2)

Outer capsule shell: gelatin, glycerol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172)

Printing ink: Shellac, black iron oxide (E172), ammonium hydroxide, and propylene glycol (E1520)

Appearance of the Product and Package Contents

Nintedanib Eignapharma 150 mg soft gelatin capsules are brown, opaque, oblong, with "JF2" printed in black ink, containing a bright yellow-green to pale yellow suspension.

There are two package sizes for Nintedanib Eignapharma 150 mg capsules:

• 30 and 60 soft capsules in aluminum/aluminum blisters
• 30 and 60 soft capsules in single-dose, cross-perforated aluminum/aluminum blisters

Only some package sizes may be marketed.

Marketing Authorization Holder

Eignapharma S.L.

Av. Ernest Lluch 32

Tecnocampus Torre TCM 2, 6th floor

08302, Mataró,

Barcelona

Spain

Manufacturer

Laboratori Fundació Dau

Calle Lletra C De La Zona Franca 12-14,

Polígono Industrial De La Zona Franca,

De Barcelona-08040

Spain

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

Date of the Last Revision of thisLeaflet: 07/2025

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