Nintedanib Eugia

Leaflet accompanying the packaging: information for the user

Nintedanib Eugia, 100 mg, soft capsules

Nintedanib Eugia, 150 mg, soft capsules

Nintedanib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Nintedanib Eugia and what is it used for
• 2. Important information before taking Nintedanib Eugia
• 3. How to take Nintedanib Eugia
• 4. Possible side effects
• 5. How to store Nintedanib Eugia
• 6. Package contents and other information

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

Nintedanib Eugia contains the active substance nintedanib, a medicine belonging to a group of so-called tyrosine kinase inhibitors, and is used to treat idiopathic pulmonary fibrosis (IPF), other chronic progressive interstitial lung diseases (ILDs) with a progressive phenotype, and systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults.
Idiopathic pulmonary fibrosis (IPF)
IPF is a disease in which the lung tissue gradually becomes thicker, stiff, and scarred. As a result, scarring reduces the ability to transport oxygen from the lungs to the bloodstream, and deep breathing becomes difficult. Nintedanib Eugia reduces further scarring and stiffness of the lungs.
Other chronic progressive interstitial lung diseases (ILD) with a progressive phenotype
Besides IPF, there are other conditions in which the lung tissue becomes thicker, stiff, and scarred (lung fibrosis) and worsens over time (progressive phenotype). Examples of these conditions 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 other internal organs, such as the lungs. The presence of fibrosis in the lungs is called interstitial lung disease (ILD) and is 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. Important information before taking Nintedanib Eugia

When not to take Nintedanib Eugia

Warnings and precautions

Before starting to take Nintedanib Eugia, the patient should discuss it with their doctor or pharmacist if they:

• have or have had liver problems,
• have or have had kidney problems or have been found to have a high level of protein in their urine,
• have or have had bleeding problems,
• are taking medicines to prevent blood clots (such as warfarin, phenprocoumon, or heparin),
• are taking pirfenidone, as this may increase the risk of diarrhea, vomiting, and liver problems,
• have or have had 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 the patient is to undergo surgery. The doctor will decide when to restart treatment with this medicine.
• have high blood pressure,
• have high blood pressure in the blood vessels of the lungs (pulmonary hypertension),
• 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.

Given this information, the doctor may perform blood tests, for example, to check liver function. The doctor will discuss the results of these tests with the patient and decide whether the patient can take Nintedanib Eugia.
The patient should immediately inform their doctor if, while taking this medicine, they:

• experience diarrhea. It is essential to treat diarrhea early (see section 4);
• vomit or feel nauseous;
• experience unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown (tea-colored) urine, pain in the upper right part of the abdomen, more frequent than usual bleeding or bruising, or feeling tired. These may be signs of severe liver problems;
• experience severe stomach pain, fever, chills, nausea, vomiting, or a hard stomach or bloating, as these may be signs of a hole in the wall of the intestine (gastrointestinal perforation). The patient should also inform their doctor if they have had stomach ulcers or diverticulitis in the past or 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;

and

• experience severe abdominal pain or cramps, red blood in their stool, or diarrhea, as these may be signs of inflammation of the intestine due to insufficient blood supply;
• experience pain, swelling, redness, and increased temperature of a limb, as these may be signs of a blood clot in one of the veins (a type of blood vessel);
• experience a feeling of pressure in their chest or pain, 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;
• experience severe bleeding;
• experience discoloration, bleeding, fever, fatigue, and confusion. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA).
• experience 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).

Children and adolescents

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

Nintedanib Eugia and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including herbal products and medicines that can be bought without a prescription.
Nintedanib Eugia may interact with certain other medicines. The following medicines may increase the level of nintedanib in the blood and thus increase the risk of side effects (see section 4):

• a medicine used to treat fungal infections (ketoconazole)
• a medicine used to treat bacterial infections (erythromycin)
• a medicine that affects the immune system (cyclosporin)

The following medicines are examples of medicines that may decrease the level of nintedanib in the blood and thus decrease the effectiveness of Nintedanib Eugia:

• an antibiotic used to treat tuberculosis (rifampicin)
• medicines used to treat epilepsy (carbamazepine, phenytoin)
• a herbal medicine used to treat depression (St. John's Wort)

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn baby and cause birth defects.
Before starting treatment with Nintedanib Eugia in a female patient, a pregnancy test must be performed to ensure that she is not pregnant. The patient should discuss this with their doctor.
Contraception

• Women who may become pregnant must use highly effective contraception to prevent pregnancy while starting to take Nintedanib Eugia, during treatment with Nintedanib Eugia, and for at least 3 months after stopping treatment.
• The patient should discuss the best methods of contraception with their doctor.
• Vomiting and/or diarrhea or other stomach and intestinal disorders may affect the absorption of oral hormonal contraceptives, such as birth control pills, and may reduce their effectiveness. In such cases, the patient should discuss the use of an alternative, more suitable method of contraception with their doctor.
• If the patient becomes pregnant or thinks they may be pregnant while taking Nintedanib Eugia, they should immediately inform their doctor or pharmacist.

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

Driving and using machines

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

Nintedanib Eugia contains soy lecithin

If the patient is allergic to soy or peanuts, they should not take this medicine (see section 2).

• 2.

3. How to take Nintedanib Eugia

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The patient should take the capsules twice a day, approximately every 12 hours, at the same time each day, for example, one capsule in the morning and one capsule in the evening. This will ensure that a constant amount of nintedanib is maintained in the patient's bloodstream. The capsules should be swallowed whole with water; do not chew the capsules. It is recommended to take the capsules with food, e.g., during or immediately before or after a meal. The capsules should not be opened or crushed (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 the patient does not tolerate the recommended dose of two 100 mg Nintedanib Eugia capsules per day (see possible side effects in section 4), the doctor may advise them to stop taking this medicine. Do not reduce the dose or stop treatment without consulting the doctor first.

Taking a higher dose of Nintedanib Eugia than recommended

Contact a doctor or pharmacist immediately.

Missing a dose of Nintedanib Eugia

Do not take two capsules at the same time if a dose is missed. Take the next 100 mg dose of Nintedanib Eugia as planned at the usual time prescribed by the 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 the patient does not tolerate the recommended dose of two 150 mg Nintedanib Eugia capsules per day (see possible side effects in section 4), the doctor may reduce the daily dose of Nintedanib Eugia. Do not reduce the dose or stop treatment without consulting the doctor first.
The doctor may reduce the recommended dose to two 100 mg doses per day (a total of 200 mg per day). In this case, the 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 the daily dose has been reduced to 200 mg per day.

Taking a higher dose of Nintedanib Eugia than recommended

Contact a doctor or pharmacist immediately.

Missing a dose of Nintedanib Eugia

Do not take two capsules at the same time if a dose is missed. Take the next 150 mg dose of Nintedanib Eugia as planned at the usual time prescribed by the doctor or pharmacist.

Stopping treatment with Nintedanib Eugia

Do not stop taking Nintedanib Eugia without consulting the doctor first. It is essential to take the medicine regularly, every day, for as long as the doctor prescribes.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Other side effects observed during treatment with this medicine.

If the patient experiences any side effects, they should tell their doctor.
Idiopathic pulmonary fibrosis (IPF)
Very common side effects (may affect more than 1 in 10 people)

• Nausea
• Abdominal pain
• Abnormal liver function test results

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

• 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, i.e., yellowing of the skin and whites of the eyes due to high bilirubin levels
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased protein levels in the urine (proteinuria)

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

• Kidney failure
• Aneurysm or dissection of a blood vessel
• A brain disease characterized by 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 progressive interstitial lung diseases (ILD) with a progressive phenotype
Very common side effects (may affect more than 1 in 10 people)

• Nausea
• Vomiting
• Loss of appetite
• Abdominal pain
• Abnormal liver function test results

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

• 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, i.e., yellowing of the skin and whites of the eyes due to high bilirubin levels
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased protein levels in the urine (proteinuria)

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

• Kidney failure
• Aneurysm or dissection of a blood vessel
• A brain disease characterized by 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
• Vomiting
• Abdominal pain
• Abnormal liver function test results

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

• 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
• Kidney failure
• Low platelet count (thrombocytopenia)
• Rash
• Itching

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

• Heart attack
• Pancreatitis
• Jaundice, i.e., 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)
• A brain disease characterized by 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 side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather 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 stated on the carton and blister after EXP.
The expiry date refers to the last day of the month stated.
Do not store above 25°C. Store in the original package to protect from moisture.
Do not use this medicine if the blister containing the capsules is open or if the capsule is damaged. In case of contact with the contents of the capsule, wash hands immediately with plenty of water (see section 3).
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents 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, hard 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).

• The active substance is nintedanib. Each capsule contains 150 mg of nintedanib (as nintedanib esylate).
• The other ingredients are: Capsule contents: medium-chain triglycerides, hard 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 are peach-colored, opaque, elongated, soft gelatin capsules with black print "N100", containing a light yellow suspension.
Nintedanib Eugia 150 mg, soft capsules:
Nintedanib Eugia 150 mg are brown, opaque, elongated, soft gelatin capsules with black print "N150", containing a light yellow suspension.
Nintedanib Eugia 100 mg, 150 mg, soft capsules
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 authorization holder and manufacturer/importer

Marketing authorization holder:

Eugia Pharma (Malta) Limited
Vault 14, level 2
Valletta Waterfront
Floriana, FRN 1914
Malta
e-mail: [email protected]

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 authorized 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