NINTEDANIB EIGNAPHARMA 100 mg SOFT CAPSULES

Introduction

Package Leaflet:information for the patient

Nintedanib Eignapharma 100 mg soft capsules EFG

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 experience 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

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

5 Conservation of Nintedanib Eignapharma

1. Contents of the pack and other 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 drugs known as 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 occurrence 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 the 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), nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILD. Nintedanib reduces new scarring and new hardening of the lungs.

Fibrosing interstitial lung diseases (ILD) in children and adolescents from 6 to 17 years of age

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 occurrence 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 the 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, therefore, 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 new hardening of the lungs.

2. What you need to know before you take 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

Talk to your doctor or pharmacist before you start taking 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 your blood (such as warfarin, phenprocoumon, or heparin) to prevent blood clots,
• if you are taking pirfenidone, as this 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 you are 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 stomach area (abdomen), bleeding or bruising more easily than usual, or feeling tired. These could be symptoms of severe liver problems;
• if you have severe stomach pain, fever, chills, dizziness, vomiting, or stiffness or swelling of the abdomen, as these could be symptoms of having a hole in the wall of the intestines ("gastrointestinal perforation"). Also, tell your doctor if you have had stomach 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 these may increase this risk;
• if you have a combination of severe or colicky stomach 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 having 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.

It is possible that your doctor will 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 you are 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 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 fetus and cause birth defects.

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

Contraception

• Women who may become pregnant must use a highly effective method of contraception to prevent pregnancy when starting to take Nintedanib Eignapharma, while taking Nintedanib Eignapharma, and for at least 3 months after stopping treatment.
• Talk to 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, talk to 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 while taking Nintedanib Eignapharma, as it may harm the baby.

Driving and using machines

Nintedanib Eignapharma has a minor 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

Take the capsules twice a day, approximately 12 hours apart, 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 you maintain a constant level of nintedanib 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 100 mg capsule twice a day (a total of 200 mg per day).

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

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

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 taking Nintedanib Eignapharma

Do not stop taking Nintedanib Eignapharma without talking to your doctor first. It is essential to take this medicine every day while your doctor prescribes it.

If you have any further questions on the use of this product, 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

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

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

Frequency not known (cannot be estimated from available data)

• Kidney failure
• Increased and weakened blood vessel wall or tear in the blood vessel wall

blood vessel (aneurysms and arterial dissections)

• Cerebral disorder with 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 (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

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

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

Frequency not known (cannot be estimated from available data)

• Kidney failure
• Increased and weakened blood vessel wall or tear in the blood vessel wall

blood vessel (aneurysms and arterial dissections)

• Cerebral disorder with 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 (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

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

• Colitis

• Severe 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., yellow color in the skin and whites of the eyes due to high levels of bilirubin
• Increased and weakened blood vessel wall or tear in the blood vessel wall (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased protein in the urine (proteinuria)
• Cerebral disorder with 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 (posterior reversible encephalopathy syndrome)

Interstitial Lung Disease (ILD) in children and adolescents

The adverse effects in children and adolescents were similar to those 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 you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines 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 100 mg of nintedanib (as esylate).
• The other ingredients are:

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

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 and Package Contents of the Product

Nintedanib Eignapharma 100 mg soft gelatin capsules are peach-colored, opaque, oblong, with "JF1" printed in black ink, containing a bright yellow-green to pale yellow suspension.

There are two package sizes for Nintedanib Eignapharma 100 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