NINTEDANIB 100 mg Soft Capsule

Зміст інструкції

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

Nintedanib Accord 100 mg soft capsules
nintedanib

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 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

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

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

Nintedanib Accord contains the active ingredient nintedanib, a medicine belonging to the class of so-called tyrosine kinase inhibitors, and is used for the treatment of the following diseases:
Idiopathic pulmonary fibrosis (IPF) in adults
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 Accord
helps to reduce further scarring and stiffness of the lungs.
Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype in adults
In addition to IPF, there are other conditions in which the tissue of the lungs becomes thickened, stiff and scarred over time (pulmonary fibrosis) and continues to worsen (progressive phenotype).
Examples of these conditions are hypersensitivity pneumonitis, autoimmune ILD (e.g. ILD
associated with rheumatoid arthritis), nonspecific idiopathic interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia and other ILD. Nintedanib Accord helps to reduce
further scarring and stiffening of the lungs.
Progressive fibrosing interstitial lung diseases (ILD) clinically significant in children and adolescents aged 6 to 17 years
In children with pediatric interstitial lung disease (chILD), pulmonary fibrosis can occur. When this happens, the lung tissue of children and adolescents becomes thickened, stiff and scarred over time. Nintedanib Accord promotes the reduction of further
scarring and stiffening of the lungs.
Interstitial lung disease associated with systemic sclerosis (SSc-ILD) in adults, children and adolescents aged 6 years and older
Systemic sclerosis (SSc), or scleroderma (and juvenile systemic sclerosis in children and adolescents), 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 breathing capacity. Nintedanib Accord promotes the reduction further
scarring and stiffening of the lungs.

2. What you need to know before taking Nintedanib Accord

Do not take Nintedanib Accord

• 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).

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

• if you have, or have had, liver problems,
• if you have, or have had, kidney problems or if an increase in the amount of protein in your urine has been detected,
• if you have, or have had, 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, heart problems (such as a heart attack),
• if you have recently had surgery. Nintedanib may have an impact on wound healing. Therefore, treatment with Nintedanib Accord will normally be interrupted for a certain period in case of surgery. Your doctor will decide when you can restart treatment with this medicine,
• 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
liver function. Your doctor will discuss the results of the tests with you and decide if you can receive
nintedanib Accord.
Tell your doctor immediately while taking this medicine

• if you develop diarrhoea. It is essential to treat diarrhoea early (see section 4, “Possible side effects”);
• if you develop vomiting or 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 an arm or leg, 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);
• 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. These may be symptoms of a brain condition called reversible posterior encephalopathy syndrome (PRES).

Children and adolescents
Nintedanib Accord should not be taken by children under the age of 6 years.
Your doctor may subject you to regular dental check-ups at least once every 6 months, until
full dental development, and monitor your growth annually (bone imaging examinations) while
taking this medicine.

Other medicines and Nintedanib Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including herbal medicines and medicines available without a prescription.
Nintedanib Accord 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, “Possible side effects”):

• a medicine used to treat fungal infections (ketoconazole)
• a medicine used to treat bacterial infections (erythromycin)
• a medicine that modifies 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 Accord:

• 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 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 Accord, you must perform 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 Accord, during the intake of nintedanib Accord 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 problems can affect the absorption of oral hormonal contraceptives, such as the pill, and may 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 Accord.

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

Driving and using machines
Nintedanib Accord slightly alters the ability to drive and use machines. If you do not feel
well, you should not drive or use machines.

Nintedanib Accord contains lecithin
If you are allergic to soy or peanuts, do not take this medicine (see section 2, under “Do not
take Nintedanib Accord”).

3. How to take Nintedanib Accord

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 paragraph 5, below “How to store Nintedanib Accord”).
To make swallowing easier, you can take the capsules with a small amount (one teaspoon) of soft food,
such as applesauce or chocolate pudding, cold or at room temperature. 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 (for a total of 200 mg per day).
Do not take more than the recommended dose of two Nintedanib Accord 100 mg capsules per day.
If you do not tolerate the recommended dose of two Nintedanib Accord 100 mg capsules per day (see
possible side effects in paragraph 4), your doctor may advise you to stop taking the
medicine. Do not reduce the dose or stop treatment on your own without first consulting your doctor.

Use in children and adolescents
The recommended dose depends on the patient's weight.
Tell your doctor if at any time during treatment the patient's weight is less than 13.5
kg.
Tell your doctor if you have liver problems.
The doctor will determine the correct dose. The doctor may adjust the dose during treatment.
If you do not tolerate the recommended dose of Nintedanib capsules per day (see possible side
effects in paragraph 4), the doctor may reduce the daily dose of Nintedanib.
Do not reduce the dose or stop treatment on your own initiative without first consulting your doctor.
Dosage based on the weight of Nintedanib capsules in children and adolescents:
*Nintedanib Accord is only available in soft capsules of 100 mg and 150 mg. Therefore, it is not possible
to administer Nintedanib Accord to pediatric patients who require a dose less than 100 mg.
If an alternative dose is required, other products containing nintedanib that offer this option must be used.

If you take more Nintedanib Accord than you should
Contact your doctor or pharmacist immediately.

If you forget to take Nintedanib Accord
Do not take two capsules at the same time if you have forgotten to take the previous dose. Take
the next dose of Nintedanib Accord as scheduled, at the next scheduled time, and
as recommended by your doctor or pharmacist.

If you stop taking Nintedanib Accord
Do not stop taking Nintedanib Accord 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.

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 Accord:

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 contact your doctor immediately. Start
appropriate treatment for diarrhoea as soon as possible, for example with loperamide.

The following side effects have also been observed during treatment with this medicine.
Contact your doctor if you experience any side effect.
Idiopathic pulmonary fibrosis (IPF)

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

• 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
• Widening and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)
• A condition of the brain 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 (reversible posterior encephalopathy syndrome)

Other chronic fibrosing 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
• 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
• Widening and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)
• A condition of the brain 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 (reversible posterior encephalopathy syndrome)

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)

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

• 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
• Widening 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) A condition of the brain 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 (reversible posterior encephalopathy syndrome)

Fibrosing interstitial lung diseases (ILD) in children and adolescents
Side effects in children and adolescents are similar to side effects in adult patients.
Contact your doctor if you experience any side effect.

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 listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store nintedanib Accord

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 after Scad. and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage precautions.
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 paragraph, “How to take Nintedanib Accord”).
Do not dispose of any medicine in waste water 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 Accord Contains

• The active ingredient is nintedanib. Each soft capsule contains nintedanib esilate equivalent to 100 mg of nintedanib.
• The other ingredients are: Capsule content: Medium-chain triglycerides, lauric macrogolglycerides, lecithin (E322) (see section 2, under “Do not take Nintedanib Accord”). Capsule: Gelatin, glycerol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) Ink: Shellac, black iron oxide (E172), ammonium hydroxide and propylene glycol (E1520)

Description of Nintedanib Accord and Package Contents
Nintedanib Accord 100 mg capsules are soft gelatin capsules approximately 16 mm in size, peach-colored,
opaque, oblong in shape, with “JF1” imprinted in black ink, containing a suspension ranging in color
from bright yellow-green to pale yellow.
Nintedanib Accord 100 mg capsules are available in packs containing:

• Aluminum/aluminum blisters are available in packs of 30, 60 and 120 soft capsules (multipack containing 2 packs of 60 soft capsules each).
• Aluminum/aluminum blisters are available in perforated blisters divisible for unit dose of 30 x 1, 60 x 1 and 120 x 1 soft capsules (multipack containing 2 packs of 60 soft capsules each).

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de
Barcelona, s/n
Edifici Est, 6 Planta
08039 Barcelona
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul.Lutomierska 50,
95-200, Pabianice, Poland
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht, Netherlands
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT /
NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Τηλ: +30 210 74 88 821
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu

Nintedanib Accord 150 mg soft capsules

nintedanib

Read this leaflet carefully before you start taking 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 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 Accord is and what it is used for
• 2. What you need to know before you take Nintedanib Accord
• 3. How to take Nintedanib Accord
• 4. Possible side effects
• 5. How to store Nintedanib Accord
• 6. Contents of the pack and other information

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

Nintedanib Accord contains the active ingredient nintedanib, a medicine belonging to the class of so-called
tyrosine kinase inhibitors, and is used for the treatment of the following diseases:
Idiopathic pulmonary fibrosis (IPF) in adults
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 deep
breathing difficult. Nintedanib Accord helps to reduce further scarring and stiffness of the lungs.
Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype in adults
In addition to IPF, there are other conditions in which the tissue of the lungs becomes thickened,
rigid and scarred (pulmonary fibrosis) and continues to worsen (progressive phenotype) over time. Examples
of these conditions are hypersensitivity pneumonitis, autoimmune ILD (e.g. ILD associated with
rheumatoid arthritis), nonspecific idiopathic interstitial pneumonia, idiopathic interstitial pneumonia not
otherwise classified and other ILD. Nintedanib Accord helps to reduce the further appearance of scarring and
stiffening of the lungs.
Progressive fibrosing interstitial lung diseases (ILD) that are clinically significant in children and
adolescents aged 6 years and older
In children with pediatric interstitial lung disease (chILD), pulmonary fibrosis may occur. When this
happens, the lung tissue of children and adolescents becomes thickened, stiff and scarred over time. Nintedanib
Accord promotes the reduction of the further appearance of scarring and stiffening of the lungs.
Interstitial lung disease (ILD) associated with systemic sclerosis (SSc-ILD) in adults, children and
adolescents aged 6 years and older
Systemic sclerosis (SSc), or scleroderma (and juvenile systemic sclerosis in children and adolescents), 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 their ability to transfer oxygen to the blood and breathing capacity. Nintedanib
Accord promotes the reduction of the appearance of scarring and stiffening of the lungs.

2. What you need to know before taking Nintedanib Accord

Do not take Nintedanib Accord

• 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).

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

• if you have, or have had, liver problems,
• if you have, or have had, kidney problems, or if an increase in the amount of protein has been detected in your urine,
• if you have, or have had, 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, heart problems (such as a heart attack),
• if you have recently had surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Accord will usually be stopped for a certain period in case of surgery. Your doctor will decide when you can restart treatment with this medicine,
• if you have high blood pressure,
• if the pressure in the blood vessels of the 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 Accord.
Tell your doctor immediately while taking this medicine

• if you develop diarrhoea. It is essential to treat diarrhoea early (see section 4, “Possible side effects”);
• if you develop vomiting or 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 stomach area (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 a hole 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, blood in your stools or diarrhoea, as these may be symptoms of inflammation of the intestine 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),
• 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.

These may be symptoms of a brain condition called reversible posterior encephalopathy syndrome (PRES).

Children and adolescents
Nintedanib Accord should not be taken by children under the age of 6 years.
Your doctor may subject you to regular dental check-ups at least every 6 months, until
complete development of the teeth, and monitor your growth annually (bone imaging examinations) while
taking this medicine.

Other medicines and Nintedanib Accord
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 Accord can interact with some medicines. The following medicines are some examples of
medicines that may increase the levels of nintedanib in the blood, potentially increasing 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 alters the immune system (cyclosporine)

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are 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 Accord, you must perform 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 Accord, during treatment with Nintedanib Accord 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 problems can affect the absorption of oral hormonal contraceptives, such as the pill, and may 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 while taking Nintedanib Accord.

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

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

Nintedanib Accord contains lecithin
If you are allergic to soy or peanuts, do not take this medicine (see section 2, under “Do not
take Nintedanib Accord”).

3. How to take Nintedanib Accord

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult 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 paragraph 5, below “How to store Nintedanib Accord”).
To make swallowing easier, you can take the capsules with a small amount (one teaspoon) of soft food,
such as applesauce or chocolate pudding, cold or at room temperature. Swallow the
capsules immediately and do not chew them, to ensure they remain intact.).

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

Use in children and adolescents
The recommended dose depends on the patient's weight.
Inform your doctor if at any time during treatment the patient's weight is less than 13.5
kg.
Inform your doctor if you have liver problems.
The doctor will determine the correct dose. The doctor may adjust the dose during the course of
treatment.
If you do not tolerate the recommended dose of Nintedanib capsules per day (see possible side
effects in paragraph 4), your doctor may reduce the daily dose of Nintedanib.
Do not reduce the dose or stop treatment on your own initiative without first consulting your doctor.
Dosage based on the weight of Nintedanib capsules in children and adolescents:

* - Nintedanib Accord is only available in soft capsules of 100 mg and 150 mg. Therefore, it is not possible
to administer Nintedanib Accord to pediatric patients who require a dose less than 100 mg.
If an alternative dose is required, other products containing nintedanib
that offer this option must be used.

If you take more Nintedanib Accord than you should
Contact your doctor or pharmacist immediately.

If you forget to take Nintedanib Accord
Do not take two capsules at the same time if you have forgotten to take the previous dose. Take the next dose
of Nintedanib Accord as scheduled, at the next scheduled time, and as recommended by
your doctor or pharmacist.

If you stop taking Nintedanib Accord
Do not stop treatment with Nintedanib Accord 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.

4. Possible side effects

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

Diarrhoea(very common, may occur in more than 1 in 10 patients):
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 consult your doctor immediately. Start
appropriate treatment for diarrhoea as soon as possible, for example with loperamide.

The following side effects have also been observed during treatment with this medicine.
Consult your doctor if you experience any side effect.
Idiopathic pulmonary fibrosis (IPF)

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

• Nausea
• Pain in the lower part of the body (abdomen)
• Abnormal liver tests

Common side effects (may occur in less than 1 in 10 people)

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

Uncommon side effects (may occur in less than 1 in 100 people)

• Pancreatitis
• Inflammation of the large intestine
• Serious liver problems
• Low platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Jaundice, i.e. a yellowing of the skin and 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)

Not known (frequency cannot be estimated based on 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)
• A condition of the brain 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 (reversible posterior encephalopathy syndrome)

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

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

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

Common side effects (may occur in less than 1 in 10 people)

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

Uncommon side effects (may occur in less than 1 in 100 people)

• Pancreatitis
• Inflammation of the large intestine
• Low platelet count (thrombocytopenia)
• Jaundice, i.e. a yellowing of the skin and 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)

Not known (frequency cannot be estimated based on 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)
• A condition of the brain 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 (reversible posterior encephalopathy syndrome)

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)

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

• Nausea
• Vomiting
• Pain in the lower part of the body (abdomen)
• Abnormal liver tests

Common side effects (may occur in less than 1 in 10 people)

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

Uncommon side effects (may occur in less than 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 based on available data)

• Heart attack
• Pancreatitis
• Jaundice, i.e. a yellowing of the skin and the whites 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)
• A condition of the brain 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 (reversible posterior encephalopathy syndrome)

Fibrosing interstitial lung diseases (ILD) in children and adolescents
Side effects in children and adolescents are similar to side effects in
adult patients.
Consult your doctor if you experience any side effect.

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 detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nintedanib Accord

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 after Scad. and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage precautions.
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 “How to take Nintedanib Accord”).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information What Nintedanib Accord contains

• The active ingredient is nintedanib. Each soft capsule contains nintedanib esilate equivalent to 150 mg of nintedanib.
• The other ingredients are: Capsule content: Medium-chain triglycerides, lauric macrogolglycerides, lecithin (E322) (see section 2 under “Do not take Nintedanib Accord”) Capsule: Gelatin, glycerol, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172) Ink: Shellac, iron oxide black (E172), ammonium hydroxide and propylene glycol (E1520)

Description of the appearance of Nintedanib Accord and package contents
Nintedanib Accord 150 mg capsules are soft gelatin capsules approximately 18 mm in size, brown in color,
opaque, oblong in shape, with “JF2” imprinted in black ink, containing a suspension ranging in color from
bright yellow-green to pale yellow.
Nintedanib Accord 150 mg capsules are available in packs containing:

• Aluminum/aluminum blisters are available in packs of 30 and 60 soft capsules.
• Aluminum/aluminum blisters are available in unit-dose divisible blisters of 30 x 1 and 60 x 1 soft capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n
Edifici Est, 6 Planta
08039 Barcelona
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul.Lutomierska 50,
95-200, Pabianice, Poland
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht, Netherlands
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
For further information on this medicinal product, contact the local representative of the marketing authorisation
holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO
/ PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Τηλ: +30 210 74 88 821
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu .