NINTEDANIB 100 mg Soft Capsules

Зміст інструкції

1. Nintedanib Eignapharma 100 mg soft capsules
   1. What is Nintedanib Eignapharma and what it is used for
   2. What you need to know before taking Nintedanib Eignapharma
   3. How to take Nintedanib Eignapharma
   4. Possible side effects
   5. How to store Nintedanib Eignapharma
   6. Package Contents and Other Information
2. Nintedanib Eignapharma 150 mg soft capsules
   1. What is Nintedanib Eignapharma and what it is used for
   2. What you need to know before taking Nintedanib Eignapharma
   3. How to take Nintedanib Eignapharma
   4. Possible side effects
   5. How to store Nintedanib Eignapharma
   6. Package contents and other information

Nintedanib Eignapharma 100 mg soft capsules

nintedanib

Equivalent Medicine

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet. 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Nintedanib Eignapharma contains the active ingredient nintedanib, a medicine belonging to the class of
tyrosine kinase inhibitors, and is used for the treatment of idiopathic pulmonary fibrosis (IPF), other
chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype and interstitial lung
disease associated with systemic sclerosis (SSc-ILD) in adults.
Idiopathic pulmonary fibrosis (IPF)
IPF is a condition in which the tissue of the lungs becomes thick, stiff and
scarred over time. As a result, the scars reduce the ability to transfer oxygen from the lungs to the
bloodstream, making deep breathing difficult. Nintedanib Eignapharma helps to
reduce further scarring and stiffness of the lungs.
Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype
In addition to IPF, there are other conditions in which the tissue of the lungs becomes thick,
rigid and scarred (pulmonary fibrosis) over time and continues to worsen (progressive phenotype). Examples of
these conditions are hypersensitivity pneumonitis, autoimmune ILDs (e.g. ILD associated with rheumatoid
arthritis), nonspecific idiopathic interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia and other ILDs. Nintedanib Eignapharma helps to reduce the further appearance of scarring and
stiffening of the lungs.
Interstitial lung disease associated with systemic sclerosis (SSc-ILD)
Systemic sclerosis (SSc), or scleroderma, is a rare chronic autoimmune disease that affects the connective
tissue of various parts of the body. SSc causes fibrosis (scarring and stiffening) of the skin and
other internal organs such as the lungs. When the lungs are affected by fibrosis, it is referred to as interstitial lung
disease (ILD) and the pathology is called SSc-ILD. Fibrosis in the lungs reduces the ability of
them to transfer oxygen to the blood and respiratory capacity. Nintedanib Eignapharma helps to
further reduce the appearance of scarring and stiffening 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, to peanuts or soy, or to any of the other ingredients of this medicine (listed in section 6). See also "Nintedanib Eignapharma also contains soy lecithin" below.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nintedanib Eignapharma,

• if you have, or have had in the past, liver problems,
• if you have, or have had in the past, kidney problems or if an increase in the amount of protein in your urine has been detected,
• if you have, or have had in the past, bleeding problems,
• if you are taking medicines that thin the blood (such as warfarin, phenprocoumon or heparin) to prevent blood clots,
• if you are taking pirfenidone, which can lead to an increased risk of developing diarrhoea, nausea, vomiting and liver problems,
• if you have, or have had in the past, heart problems (such as a heart attack),
• if you have recently had surgery. Nintedanib can affect wound healing. Therefore, treatment with Nintedanib Eignapharma will normally be stopped for a certain period in case of surgery. Your doctor will decide when you can start treatment with this medicine again,
• if you have high blood pressure,
• if the pressure in the blood vessels in your lungs is excessively high (pulmonary hypertension),
• if you have or have had an aneurysm (bulging 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 blood tests, for example to check the
function of your liver. Your doctor will discuss the results of the tests with you and decide if you can receive
Nintedanib Eignapharma.
Tell your doctor immediately while taking this medicine

• if you develop diarrhoea. It is essential to treat diarrhoea early (see section 4);
• if you develop vomiting or feeling unwell (nausea);
• if you experience unexplained symptoms such as yellowing of the skin or the white of your eyes (jaundice), dark or brown urine (tea-coloured), pain in the upper right part of your abdomen, bleeding or bruising more easily than usual or feeling tired. These may be symptoms of serious liver problems;
• if you have severe stomach pain, fever, chills, feeling unwell, vomiting or stiffness or swelling of the abdomen, as these may be symptoms of an opening in the wall of the intestine (“gastrointestinal perforation”). Tell your doctor even if you have suffered from peptic ulcers or diverticular disease in the past or if you are being treated at the same time with anti-inflammatory drugs (NSAIDs) (used to relieve pain and treat swelling) or steroids (used for inflammation and allergies), because this may increase this risk;
• if you experience a combination of severe stomach pain or cramps, red blood in your stool or diarrhoea, as these may be symptoms of intestinal inflammation due to inadequate blood supply;
• if you have pain, swelling, redness or warmth in a limb, as these may be symptoms of a blood clot in a vein (a type of blood vessel);
• if you feel pressure or pain in your chest, especially on the left side of your body, pain in your neck, jaw, shoulder or arm, rapid heartbeat, shortness of breath, nausea, vomiting, as these may be symptoms of a heart attack;
• if you have significant bleeding;
• if bruises, bleeding, fever, fatigue and confusion appear. These could be signs of damage to blood vessels known as thrombotic microangiopathy (TMA).

Children and adolescents
Nintedanib Eignapharma must not be given to children and adolescents under 18 years of age.

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 you bought without a prescription.
Nintedanib Eignapharma can interact with some medicines. The following medicines are some examples of
medicines that can increase the levels of nintedanib in the blood, potentially increasing 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 alters the immune system (cyclosporine)

The following medicines are some examples of medicines that can decrease the levels of nintedanib
in the blood, potentially reducing the effectiveness of Nintedanib Eignapharma:

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist
for advice before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the baby and cause birth defects.
Before starting treatment with Nintedanib Eignapharma, you must have a pregnancy test to make sure you are
not pregnant. Talk to your doctor.
Contraception

• Women of childbearing potential must use a highly effective method of contraception to avoid pregnancy when starting to take Nintedanib Eignapharma, during the taking of Nintedanib Eignapharma and for at least 3 months after stopping treatment.
• Discuss the most suitable methods of contraception with your doctor.
• Vomiting and/or diarrhoea or other gastrointestinal disorders can affect the absorption of oral hormonal contraceptives, such as the pill, and can reduce their effectiveness. Therefore, if you experience these disorders, talk to your doctor to evaluate a more appropriate alternative method of contraception.
• Tell your doctor or pharmacist immediately if you become pregnant or suspect you are pregnant during treatment with Nintedanib Eignapharma.

Breastfeeding
Do not breastfeed while taking Nintedanib Eignapharma, as there is a potential risk of harm to breastfed
babies.

Driving and using machines
Nintedanib Eignapharma slightly affects the ability to drive and operate machines. If you do not feel well,
you should not drive or operate machines.

Nintedanib Eignapharma contains soy lecithin
If you are allergic to soy or peanuts, do not take this medicine. Although soy lecithin contains very small
amounts of soy protein (the substance that causes allergic reactions), the risk of an allergic reaction from
Nintedanib Eignapharma cannot be excluded.

3. How to take Nintedanib Eignapharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Take the capsules twice a day, approximately 12 hours apart and at similar times each day, for example one
capsule in the morning and one capsule in the evening. This ensures that a constant amount of
nintedanib is maintained in the bloodstream. Swallow the capsules whole with water and do not chew them. It is recommended to
take the capsules with food, i.e. during a meal or immediately before or after. Do not open or
crush the capsule (see section 5).

Adults
The recommended dose is one 100 mg capsule twice a day (for a total of 200 mg per day). Do not
take a dose higher than the recommended dose, which is 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 suggest that you stop treatment with
this medicine. Do not reduce the dose or stop treatment without first consulting your doctor.

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 at the same time if you have forgotten to take the previous dose. Take the
next dose of Nintedanib Eignapharma as scheduled, at the next scheduled time, and
as recommended by your doctor or pharmacist.

If you stop taking Nintedanib Eignapharma
Do not stop treatment with Nintedanib Eignapharma without first consulting your doctor. It is important
to take this medicine every day for the entire period indicated by your doctor.
If you have any questions about the use of this medicine, 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 pay particular attention if you experience the following side effects during treatment with
Nintedanib Eignapharma:

Diarrhoea(very common, may affect more than 1 in 10 people):
Diarrhoea can cause dehydration: loss of fluids and important salts (electrolytes, such as sodium or potassium)
from the body. At the first signs of diarrhoea, drink plenty of fluids and see your doctor immediately. Start
appropriate treatment for diarrhoea as soon as possible, for example with loperamide.

During treatment with this medicine, the following side effects have also been observed.
See your doctor if you experience any side effect.
Idiopathic pulmonary fibrosis (IPF)

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

• Feeling unwell (nausea)
• Pain in the lower part of the body (abdomen)
• Abnormal liver tests

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

• Vomiting
• Loss of appetite
• Weight loss
• Bleeding
• Skin rash
• Headache

Uncommon side 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, that is, a yellowing of the skin and the white of the eyes due to high levels of bilirubin
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Not known (frequency cannot be estimated from available data)

• Kidney failure
• Dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)

Other chronic progressive fibrosing interstitial lung diseases (ILD)

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

• Feeling unwell (nausea)
• Vomiting
• Loss of appetite
• Pain in the lower part of the body (abdomen)
• Abnormal liver tests

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

• Weight loss
• High blood pressure (hypertension)
• Bleeding
• Serious liver problems
• Skin rash
• Headache

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

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

Not known (frequency cannot be estimated from available data)

• Kidney failure
• Dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)

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

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

• Feeling unwell (nausea)
• Vomiting
• Pain in the lower part of the body (abdomen)
• Abnormal liver tests

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)

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

Not known (frequency cannot be estimated from available data)

• Heart attack
• Pancreatitis
• Jaundice, that is, a yellowing of the skin and the white of the eyes due to high levels of bilirubin
• Dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nintedanib Eignapharma

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 pack and on the blister. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice that the blister containing the capsules is open or if 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).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Nintedanib Eignapharma Contains

• The active ingredient is nintedanib. Each capsule contains 100 mg of nintedanib (as hexilate).
• The other ingredients are: Capsule content: Medium-chain saturated triglycerides, lauroyl macrogolglycerides, soybean lecithin (E322) (see section 2) Capsule: Gelatin, glycerol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) Printing ink: Shellac, black iron oxide (E172), ammonium hydroxide, propylene glycol (E1520)

Description of the Appearance of Nintedanib Eignapharma and Package Contents
Nintedanib Eignapharma 100 mg capsules are peach-colored, opaque, oblong soft gelatin capsules,
with "JF1" imprinted in black ink, containing a suspension ranging in color from bright yellow-green to
pale yellow.
Nintedanib Eignapharma 100 mg soft capsules are available in packs of:

• aluminium/aluminium blister packs with 30 and 60 soft capsules
• perforated aluminium aluminium blisters for unit doses with 30x1 and 60x1 soft capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eignapharma S.L.
Av. Ernest Lluch 32
Tower tcm2 6th floor
Tecnocampus
08302, Mataró,
Barcelona
Spain

Manufacturer
LABORATORI FUNDACIÓ DAU
Pol. Ind. Consorci Zona Franca,
c/ C, 12-14, Barcelona-08040
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Sweden Nintedanib Eignapharma 100 mg soft capsules
Spain Nintedanib Eignapharma 100 mg EFG soft capsules
Germany Nintedanib Eignapharma 100 mg soft capsules
Italy Nintedanib Eignapharma
France Nintedanib Eignapharma 100 mg soft capsules

Nintedanib Eignapharma 150 mg soft capsules

nintedanib

Equivalent Medicinal Product

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

• Keep this leaflet. 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 7. What Nintedanib Eignapharma is and what it is used for
• 8. What you need to know before you take Nintedanib Eignapharma
• 9. How to take Nintedanib Eignapharma
• 10. Possible side effects
• 11. How to store Nintedanib Eignapharma
• 12. Contents of the pack and other information

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

Nintedanib Eignapharma contains the active ingredient nintedanib, a medicine belonging to the class of
tyrosine kinase inhibitors, and is used for the treatment of idiopathic pulmonary fibrosis (IPF), other
chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype and interstitial lung
disease associated with systemic sclerosis (SSc-ILD) in adults.
Idiopathic pulmonary fibrosis (IPF)
IPF is a condition in which the tissue of the lungs becomes thickened, stiff and
scarred over time. As a result, the scars reduce the ability to transfer oxygen from the lungs to the
bloodstream, making it difficult to breathe deeply. Nintedanib Eignapharma helps to
reduce further scarring and stiffness of the lungs.
Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype
In addition to IPF, there are other conditions in which the tissue of the lungs becomes thickened,
stiff and scarred (pulmonary fibrosis) over time and continues to worsen (progressive phenotype). Examples of
these conditions are hypersensitivity pneumonitis, autoimmune ILDs (e.g. ILD associated with rheumatoid
arthritis), nonspecific idiopathic interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia and other ILDs. Nintedanib Eignapharma helps to reduce the further appearance of scarring and
stiffening of the lungs.
Interstitial lung disease associated with systemic sclerosis (SSc-ILD)
Systemic sclerosis (SSc), or scleroderma, is a rare chronic autoimmune disease that affects the connective
tissue of various parts of the body. SSc causes fibrosis (scarring and stiffening) of the skin and
other internal organs such as the lungs. When the lungs are affected by fibrosis, it is referred to as
interstitial lung disease (ILD) and the pathology is called SSc-ILD. Fibrosis in the lungs reduces the ability of
the lungs to transfer oxygen to the blood and the breathing capacity. Nintedanib Eignapharma helps to
further reduce the appearance of scarring and stiffening of the lungs.

8. What you need to know before taking Nintedanib Eignapharma

Do not take Nintedanib Eignapharma

• if you are pregnant,
• if you are allergic to nintedanib, to peanuts or soy, or to any of the other ingredients of this medicine (listed in section 6). See also "Nintedanib Eignapharma also contains soy lecithin" below.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nintedanib Eignapharma,

• if you have, or have had in the past, liver problems,
• if you have, or have had in the past, kidney problems or if an increase in the amount of protein in your urine has been detected,
• if you have, or have had in the past, bleeding problems,
• if you are taking medicines that thin the blood (such as warfarin, phenprocoumon or heparin) to prevent blood clots,
• if you are taking pirfenidone, which may lead to an increased risk of developing diarrhoea, nausea, vomiting and liver problems,
• if you have, or have had in the past, heart problems (such as a heart attack),
• if you have recently had surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Eignapharma will usually be stopped for a certain period in case of surgery. Your doctor will decide when you can start treatment with this medicine again,
• if you have high blood pressure,
• if the pressure in the blood vessels in your lungs is excessively high (pulmonary hypertension),
• if you have or have had an aneurysm (bulging 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 blood tests, for example to check the
liver function. The doctor will discuss the results of the tests with you and decide if you can receive
Nintedanib Eignapharma.
Tell your doctor immediately while taking this medicine

• if you develop diarrhoea. It is essential to treat diarrhoea early (see section 4);
• if you develop vomiting or feeling unwell (nausea);
• if you experience unexplained symptoms such as yellowing of the skin or the white of the eyes (jaundice), dark or brown coloured urine (tea coloured), pain in the upper right part of your abdomen, bleeding or bruising more easily than usual or feeling tired. These may be symptoms of serious liver problems;
• if you have severe stomach pain, fever, chills, feeling unwell, vomiting or stiffness or swelling of the abdomen, as these may be symptoms of an opening in the wall of the intestine (“gastrointestinal perforation”). Tell your doctor also if you have suffered from peptic ulcers or diverticular disease in the past or if you are being treated at the same time with anti-inflammatory drugs (NSAIDs) (used to relieve pain and treat swelling) or steroids (used for inflammation and allergies), because this may increase this risk;
• if you experience a combination of severe stomach pain or cramps, red blood in your stool or diarrhoea, as these may be symptoms of intestinal inflammation due to inadequate blood supply;
• if you have pain, swelling, redness or warmth in a limb, as these may be symptoms of a blood clot in a vein (a type of blood vessel);
• if you feel pressure or pain in your chest, especially on the left side of your body, pain in your neck, jaw, shoulder or arm, fast heartbeat, shortness of breath, nausea, vomiting, as these may be symptoms of a heart attack;
• if you have significant bleeding;
• if bruises, bleeding, fever, fatigue and confusion appear. These could be signs of damage to the blood vessels known as thrombotic microangiopathy (TMA).

Children and adolescents
Nintedanib Eignapharma must not be taken by children and adolescents under the age of 18 years.

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 you bought without a prescription.
Nintedanib Eignapharma can interact with some medicines. The following medicines are some
examples of medicines that can increase the levels of nintedanib in the blood, potentially increasing 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 alters the immune system (cyclosporine)

The following medicines are some examples of medicines that can decrease the levels of nintedanib
in the blood, potentially reducing the effectiveness of Nintedanib Eignapharma:

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the baby and cause birth defects.
Before starting treatment with Nintedanib Eignapharma, you must have a pregnancy test to
make sure you are not pregnant. Talk to your doctor.
Contraception

• Women of childbearing potential must use a highly effective method of contraception to avoid pregnancy when starting to take Nintedanib Eignapharma, during the treatment with Nintedanib Eignapharma and for at least 3 months after stopping treatment.
• Discuss the most suitable contraceptive methods with your doctor.
• Vomiting and/or diarrhoea or other gastrointestinal problems can affect the absorption of oral hormonal contraceptives, such as the pill, and can reduce their effectiveness. Therefore, if you experience these problems, talk to your doctor to evaluate a more appropriate alternative contraceptive method.
• Tell your doctor or pharmacist immediately if you become pregnant or suspect you may be pregnant while taking Nintedanib Eignapharma.

Breastfeeding
Do not breastfeed while taking Nintedanib Eignapharma, as there is a potential risk
of harm to breastfed babies.

Driving and using machines
Nintedanib Eignapharma slightly impairs the ability to drive and operate machines. If you do not
feel well, do not drive or operate machines.

Nintedanib Eignapharma contains soy lecithin
If you are allergic to soy or peanuts, do not take this medicine. Although soy lecithin contains
very small amounts of soy protein (the substance that causes allergic reactions), the risk of an allergic
reaction from Nintedanib Eignapharma cannot be excluded.

9. How to take Nintedanib Eignapharma

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your
doctor or pharmacist.
Take the capsules twice a day, approximately 12 hours apart and at similar times each day, for example one
capsule in the morning and one capsule in the evening. This ensures that a constant amount of
nintedanib is maintained in the bloodstream. Swallow the capsules whole with water and do not chew them. It is
recommended to take the capsules with food, i.e. during a meal or immediately before or after. Do not open or
crush the capsule (see section 5).

Adults
The recommended dose is one 150 mg capsule twice a day (for a total of 300 mg per day). Do not
take a dose higher than the recommended dose, which is 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 the
possible side effects in section 4), your doctor may reduce the daily dose of Nintedanib
Eignapharma. Do not reduce the dose or stop treatment without first consulting your doctor.
Your doctor may reduce the recommended dose to 100 mg twice a day (for a total of 200 mg per day).
In this case, your doctor will prescribe treatment with Nintedanib Eignapharma 100 mg capsules. Do not
take more than the recommended dose of two Nintedanib Eignapharma 100 mg capsules per day if your
dose has been reduced to 200 mg per day.

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 at the same time if you have forgotten to take the previous dose. Take the
next dose of Nintedanib Eignapharma as scheduled, at the next scheduled time, and
as recommended by your doctor or pharmacist.

If you stop taking Nintedanib Eignapharma
Do not stop treatment with Nintedanib Eignapharma without first consulting your doctor. It is important
to take this medicine every day for the entire period indicated by your doctor.
If you have any questions about using this medicine, ask your doctor or pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should pay particular attention if you experience the following side effects during treatment with
Nintedanib Eignapharma:

Diarrhoea(very common, may affect more than 1 in 10 people):
Diarrhoea can cause dehydration: loss of fluids and important salts (electrolytes, such as sodium or potassium)
from the body. At the first signs of diarrhoea, drink plenty of fluids and see your doctor immediately. Start
appropriate treatment for diarrhoea as soon as possible, for example with loperamide.

During treatment with this medicine, the following side effects have also been observed.
See your doctor if you experience any side effect.
Idiopathic pulmonary fibrosis (IPF)

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

• Feeling unwell (nausea)
• Pain in the lower part of the body (abdomen)
• Abnormal liver tests

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

• Vomiting
• Loss of appetite
• Weight loss
• Bleeding
• Skin rash
• Headache

Uncommon side 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, that is, a yellowing of the skin and the white part of the eyes due to high levels of bilirubin
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Not known (frequency cannot be estimated from the available data)

• Kidney failure
• Dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)

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

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

• Feeling unwell (nausea)
• Vomiting
• Loss of appetite
• Pain in the lower part of the body (abdomen)
• Abnormal liver tests

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

• Weight loss
• High blood pressure (hypertension)
• Bleeding
• Serious liver problems
• Skin rash
• Headache

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

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

Not known (frequency cannot be estimated from the available data)

• Kidney failure
• Dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)

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

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

• Feeling unwell (nausea)
• Vomiting
• Pain in the lower part of the body (abdomen)
• Abnormal liver tests

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)

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

Not known (frequency cannot be estimated from the available data)

• Heart attack
• Pancreatitis
• Jaundice, that is, a yellowing of the skin and the white part of the eyes due to high levels of bilirubin
• Dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Reporting of side effects
If you get 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 through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety of this medicine.

11. How to store Nintedanib Eignapharma

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 pack and blister. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice that the blister containing the capsules is open or if a capsule is broken.
If you come into contact with the capsule contents, wash your hands immediately with plenty of water
(see section 3).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

12. Package contents and other information

What Nintedanib Eignapharma contains

• The active ingredient is nintedanib. Each capsule contains 150 mg of nintedanib (as hexilate).
• The other ingredients are: Capsule content: Medium-chain saturated triglycerides, lauroyl macrogolglycerides, soybean lecithin (E322) (see section 2) Capsule: Gelatin, glycerol, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172) Printing ink: Shellac, iron oxide black (E172), ammonium hydroxide, propylene glycol (E1520)

Description of the appearance of Nintedanib Eignapharma and package contents
Nintedanib Eignapharma 150 mg capsules are soft gelatin capsules, opaque, oblong, colored brown, with "JF2" imprinted in black ink, containing a suspension ranging in color from bright yellow-green to pale yellow.
Available pack sizes of Nintedanib Eignapharma 150 mg soft capsules contain:

• aluminium/aluminium blister packs with 30 and 60 soft capsules
• perforated aluminium aluminium blisters for unit doses with 30x1 and 60x1 soft capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eignapharma S.L.
Av. Ernest Lluch 32
Tower tcm2 6th floor
Tecnocampus
08302, Mataró,
Barcelona
Spain

Manufacturer
LABORATORI FUNDACIÓ DAU
Pol. Ind. Consorci Zona Franca,
c/ C, 12-14, Barcelona-08040
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Sweden Nintedanib Eignapharma 150 mg soft capsules
Spain Nintedanib Eignapharma 150 mg cápsulas blandas EFG
Germany Nintedanib Eignapharma 150 mg Weichkapseln
Italy Nintedanib Eignapharma
France Nintedanib Eignapharma 150 mg capsules molles