Nintedanib Intas: detailed information

Patient Information Leaflet

Nintedanib Intas 100 mg Soft Capsules

nintedanib
Generic Medicine
Please read all of this leaflet carefully before taking 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 give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Nintedanib Intas is and what it is used for
What you need to know before taking Nintedanib Intas
How to take Nintedanib Intas
Possible side effects
How to store Nintedanib Intas
Contents of the pack and other information

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

Nintedanib Intas contains the active substance 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, over time, lung tissue becomes thick, stiff, and scarred. As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream, making deep breathing difficult. Nintedanib Intas helps reduce further scarring and stiffening of the lungs.

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype
In addition to IPF, there are other conditions in which, over time, lung tissue becomes thick, stiff, and scarred (pulmonary fibrosis) and continues to worsen (progressive phenotype). Examples of these conditions include hypersensitivity pneumonitis, autoimmune ILDs (e.g., ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. Nintedanib Intas helps reduce further development of scarring and lung stiffening.

Interstitial lung disease associated with systemic sclerosis (SSc-ILD)
Systemic sclerosis (SSc), or scleroderma, is a rare chronic autoimmune disease affecting connective tissue in 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, this is referred to as interstitial lung disease (ILD), and the condition is known as SSc-ILD. Lung fibrosis reduces the lungs' ability to transfer oxygen into the blood and impairs breathing capacity. Nintedanib Intas helps reduce further progression of scarring and stiffening of the lungs.

2. What you need to know before taking Nintedanib Intas

Do not take Nintedanib Intas

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

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

if you have or have previously had liver problems,
if you have or have previously had kidney problems or if you have been found to have an increased amount of protein in your urine,
if you have or have previously had bleeding problems,
if you are taking medicines that thin the blood (for example warfarin, phenprocoumon or heparin) to prevent blood clots,
if you are taking pirfenidone, which may increase the risk of developing diarrhoea, nausea, vomiting and liver problems,
if you have or have previously had heart problems (for example a heart attack),
if you have recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Intas will usually be stopped for a certain period in case of surgery. Your doctor will decide when you can resume treatment with this medicine,
if you have high blood pressure,
if the pressure in the blood vessels of the lungs is too high (pulmonary hypertension),
if you have or have previously had an aneurysm (a bulge 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 carry out blood tests, for example to check liver function. Your doctor will discuss the test results with you and decide whether you can receive Nintedanib Intas.
Inform your doctor immediately while taking this medicine

if you develop diarrhoea. It is essential to treat diarrhoea early (see section 4);
if you experience vomiting or feeling unwell (nausea);
if you have unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown-coloured urine (tea-coloured), pain in the upper right part of the 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 abdominal stiffness or swelling, as these may be symptoms of a hole in the wall of the intestine (“gastrointestinal perforation”). Inform your doctor also if you have previously suffered from peptic ulcers or diverticular disease or if you are taking concomitant treatment with anti-inflammatory medicines (NSAIDs) (used to relieve pain and treat swelling) or steroids (used for inflammation and allergies), as this may increase this risk;
if you experience a combination of severe stomach pain or cramps, red blood in the stools 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 the chest, particularly on the left side of the body, pain in the 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 bruising, bleeding, fever, fatigue and confusion occur. These could be signs of damage to blood vessels known as thrombotic microangiopathy (TMA).

Children and adolescents
Nintedanib Intas must not be taken by children and adolescents under 18 years of age.
Other medicines and Nintedanib Intas
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicines without a prescription.
Nintedanib Intas may interact with some medicines. The following medicines are some examples of medicines that may increase nintedanib levels 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 modifies the immune system (cyclosporine)

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

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 you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn child and cause birth defects.
Before starting treatment with Nintedanib Intas, you must have a pregnancy test to confirm that 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 Nintedanib Intas, during treatment with Nintedanib Intas, and for at least 3 months after stopping treatment.
Discuss with your doctor the most appropriate contraceptive methods for your situation.
Vomiting and/or diarrhoea or other gastrointestinal disorders may affect the absorption of oral hormonal contraceptives, such as the pill, and may reduce their effectiveness. Therefore, if you experience these conditions, consult your doctor to consider a more appropriate alternative contraceptive method.
Inform your doctor or pharmacist immediately if you become pregnant or suspect you are pregnant during treatment with Nintedanib Intas.

Breastfeeding
Do not breastfeed while taking Nintedanib Intas, as there is a possible risk of harm to breastfed infants.
Driving and using machines
Nintedanib Intas has a minor influence on the ability to drive and use machines. If you do not feel well, you must not drive or use machines.
Nintedanib Intas contains soya lecithin
If you are allergic to soy or peanuts, do not take this medicine. Although soya lecithin contains very small amounts of soya protein (the substance that causes allergic reactions), a risk of an allergic reaction to Nintedanib Intas cannot be excluded.

3. How to take Nintedanib Intas

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the capsules twice daily, 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, either 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 daily (for a total daily dose of 200 mg). Do not take a higher dose than recommended, which is two capsules of Nintedanib Intas 100 mg per day.
If you do not tolerate the recommended dose of two capsules of Nintedanib Intas 100 mg per day (see possible side effects in section 4), your doctor may advise you to discontinue treatment with this medicine. Do not reduce the dose or stop treatment without first consulting your doctor.

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

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

If you stop taking Nintedanib Intas
Do not stop treatment with Nintedanib Intas without first consulting your doctor. It is important to take this medicine every day for the entire duration prescribed by your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You should be particularly careful if you experience the following side effects during treatment with
Nintedanib Intas:
Diarrhoea (very common, may occur in more than 1 in 10 patients):
Diarrhoea can lead to 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 occur in more than 1 in 10 patients)

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

Common side effects (may occur in fewer than 1 in 10 patients)

Vomiting
Loss of appetite
Weight loss
Bleeding
Rash
Headache (cephalalgia)

Uncommon side effects (may occur in fewer than 1 in 100 patients)

Pancreatitis
Inflammation of the large intestine (colitis)
Serious 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 levels of bilirubin
Itching (pruritus)
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
Widening and weakening of a blood vessel wall or a tear in the blood vessel wall (aneurysms and arterial dissections)

Other chronic fibrosing interstitial lung diseases (ILD) with progressive phenotype
Very common side effects (may occur in more than 1 in 10 patients)

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

Common side effects (may occur in fewer than 1 in 10 patients)

Weight loss
High blood pressure (hypertension)
Bleeding
Serious liver problems
Rash
Headache (cephalalgia)

Uncommon side effects (may occur in fewer than 1 in 100 patients)

Pancreatitis
Inflammation of the large intestine (colitis)
Low platelet count (thrombocytopenia)
Jaundice, i.e. yellowing of the skin and whites of the eyes due to high levels of bilirubin
Itching (pruritus)
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
Widening and weakening of a blood vessel wall or a tear in the blood vessel wall (aneurysms and arterial dissections)

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Very common side effects (may occur in more than 1 in 10 patients)

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

Common side effects (may occur in fewer than 1 in 10 patients)

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

Uncommon side effects (may occur in fewer than 1 in 100 patients)

Inflammation of the large intestine (colitis)
Serious liver problems
Kidney failure
Low platelet count (thrombocytopenia)
Rash
Itching (pruritus)

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 levels of bilirubin
Widening and weakening of a blood vessel wall or a tear in the blood vessel wall (aneurysms and arterial dissections)
Hair loss (alopecia)
Increased amount of protein in the urine (proteinuria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Intas

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

6. Package contents and other information

What Nintedanib Intas contains

The active substance is nintedanib. Each capsule contains 100 mg of nintedanib (as esilate).
The other components are:
Capsule contents: Medium-chain saturated triglycerides, lauroyl macrogol glycerides, soya lecithin (E322) (see section 2)
Capsule shell: Gelatin, glycerol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172)
Printing ink: Shellac, black iron oxide (E172), ammonium hydroxide, propylene glycol (E1520)

Description of the appearance of Nintedanib Intas and contents of the pack
Nintedanib Intas 100 mg capsules are soft, opaque, peach-coloured gelatin capsules, oblong in shape, printed with "JF1" in black ink, containing a suspension ranging in colour from bright greenish-yellow to pale yellow.
Nintedanib Intas 100 mg soft capsule packs are available in the following configurations:

Aluminium/aluminium blisters containing 30 and 60 soft capsules
Perforated aluminium/aluminium unit dose blisters containing 30x1 and 60x1 soft capsules

Not all pack sizes may be marketed.

Marketing Authorization Holder
Intas Third Party Sales 2005, S.L.
World Trade Center Building
Moll de Barcelona s/n
Edificio Este, 6th floor
08039 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 Intas 100 mg mjuka kapslar
Spain: Nintedanib Intas 100 mg cápsulas blandas EFG
Germany: Nintedanib Heumann 100 mg Weichkapseln
Italy: Nintedanib Intas
France: Nintedanib Intas 100 mg capsules molles

Package leaflet: information for the patient

Nintedanib Intas 150 mg soft capsules

nintedanib
Generic Medicine
Please read this leaflet carefully before taking 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Nintedanib Intas is and what it is used for
What you need to know before taking Nintedanib Intas
How to take Nintedanib Intas
Possible side effects
How to store Nintedanib Intas
Contents of the pack and other information

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

Nintedanib Intas contains the active substance 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 systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults.

Idiopathic pulmonary fibrosis (IPF)
IPF is a condition in which lung tissue becomes thick, stiff, and scarred over time. As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream, making deep breathing difficult. Nintedanib Intas helps reduce further scarring and stiffening of the lungs.

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype
In addition to IPF, there are other conditions in which lung tissue becomes thick, stiff, and scarred (pulmonary fibrosis) and continues to worsen (progressive phenotype). Examples of these conditions include hypersensitivity pneumonitis, autoimmune ILDs (e.g. ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. Nintedanib Intas helps reduce further development of scarring and stiffening of the lungs.

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Systemic sclerosis (SSc), or scleroderma, is a rare chronic autoimmune disease affecting connective tissue in 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, this is referred to as interstitial lung disease (ILD), and the condition is known as SSc-ILD. Lung fibrosis reduces the lungs' ability to transfer oxygen into the blood and impairs breathing capacity. Nintedanib Intas helps reduce further progression of scarring and stiffening of the lungs.

8. What you should know before taking Nintedanib Intas

Do not take Nintedanib Intas

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

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

if you have or have previously had liver problems,
if you have or have previously had kidney problems or if an increase in the amount of protein in your urine has been detected,
if you have or have previously had bleeding problems,
if you are taking blood-thinning medicines (e.g. warfarin, phenprocoumon, or heparin) to prevent blood clots,
if you are taking pirfenidone, which may increase the risk of developing diarrhoea, nausea, vomiting, and liver problems,
if you have or have previously had heart problems (e.g. a heart attack),
if you have recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Intas will usually be stopped for a certain period around the time 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 your lungs is too high (pulmonary hypertension),
if you have or have previously had an aneurysm (a bulge and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.

Based on this information, your doctor may perform blood tests, for example, to monitor liver function. Your doctor will discuss the test results with you and decide whether you can take Nintedanib Intas.
Inform your doctor immediately while taking this medicine

if you develop diarrhoea. It is essential to treat diarrhoea early (see section 4);
if you experience vomiting or feel sick (nausea);
if you develop unexplained symptoms such as yellowing of the skin or the whites of the eyes (jaundice), dark or brown-coloured urine (like tea), pain in the upper right part of the stomach area (abdomen), bleeding or bruising more easily than usual, or feel tired. These may be signs of serious liver problems;
if you have severe stomach pain, fever, chills, feeling unwell, vomiting, or abdominal stiffness or swelling, as these may be symptoms of a hole in the wall of the intestine (“gastrointestinal perforation”). Inform your doctor also if you have previously had peptic ulcers or diverticular disease, or if you are taking concomitant anti-inflammatory medicines (NSAIDs) (used to relieve pain and treat swelling) or steroids (used for inflammation and allergies), as this may increase this risk;
if you experience a combination of severe stomach pain or cramps, red blood in the stools, 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 the chest, particularly on the left side of the body, pain in the neck, jaw, shoulder, or arm, rapid heartbeat, shortness of breath, nausea, or vomiting, as these may be symptoms of a heart attack;
if you have significant bleeding;
if bruising, bleeding, fever, fatigue, and confusion occur. These could be signs of damage to blood vessels known as thrombotic microangiopathy (TMA).

Children and adolescents
Nintedanib Intas must not be taken by children and adolescents under 18 years of age.
Other medicines and Nintedanib Intas
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines and medicines without a prescription.
Nintedanib Intas may interact with certain medicines. The following medicines are some examples of medicines that may increase nintedanib levels 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 modifies the immune system (cyclosporine)

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

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 you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn child and cause birth defects.
Before starting treatment with Nintedanib Intas, you must have a pregnancy test to confirm you are not pregnant. Talk to your doctor.
Contraception

Women of childbearing potential must use a highly effective method of contraception to prevent pregnancy when starting treatment with Nintedanib Intas, during treatment with Nintedanib Intas, and for at least 3 months after stopping treatment.
Discuss with your doctor the most suitable contraceptive methods for your individual case.
Vomiting and/or diarrhoea or other gastrointestinal disorders may affect the absorption of oral hormonal contraceptives, such as the pill, and may reduce their effectiveness. Therefore, if you experience these symptoms, consult your doctor to consider a more appropriate alternative contraceptive method.
Inform your doctor or pharmacist immediately if you become pregnant or suspect you may be pregnant during treatment with Nintedanib Intas.

Breastfeeding
Do not breastfeed during treatment with Nintedanib Intas, as there may be a risk of harm to breastfed infants.
Driving and using machines
Nintedanib Intas may have a minor influence on the ability to drive and use machines. If you do not feel well, you should not drive or operate machinery.
Nintedanib Intas contains lecithin from soy
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 causing allergic reactions), a risk of an allergic reaction to Nintedanib Intas cannot be excluded.

9. How to take Nintedanib Intas

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take the capsules twice daily, 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, either 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 daily (for a total of 300 mg daily). Do not take a higher dose than the recommended dose of two Nintedanib Intas 150 mg capsules per day.
If you do not tolerate the recommended dose of two Nintedanib Intas 150 mg capsules per day (see possible
side effects in section 4), your doctor may reduce the daily dose of Nintedanib Intas. Do not reduce the dose or stop treatment without first consulting your doctor.
Your doctor may reduce the recommended dose to 100 mg twice daily (for a total of 200 mg daily).
In this case, your doctor will prescribe treatment with Nintedanib Intas 100 mg capsules. Do not take more
than the recommended dose of two Nintedanib Intas 100 mg capsules per day if your dose has been reduced to
200 mg daily.
If you take more Nintedanib Intas than you should
Contact your doctor or pharmacist immediately.
If you forget to take Nintedanib Intas
Do not take two capsules at the same time if you have missed a previous dose. Take the next dose of Nintedanib Intas as scheduled at the next planned time, as recommended by your doctor or pharmacist.
If you stop taking Nintedanib Intas
Do not stop treatment with Nintedanib Intas without first consulting your doctor. It is important to take
this medicine every day for the entire duration prescribed by your doctor.
If you have any questions about how to use this medicine, consult 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 Intas:
Diarrhoea (very common, may occur in more than 1 in 10 patients):
Diarrhoea may lead to 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 occur in more than 1 in 10 patients)

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

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

Vomiting
Loss of appetite
Weight loss
Bleeding
Rash
Headache (cephalalgia)

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

Pancreatitis
Inflammation of the large intestine
Serious 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 levels of bilirubin
Itching (pruritus)
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 progressive phenotype
Very common side effects (may occur in more than 1 in 10 patients)

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

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

Weight loss
High blood pressure (hypertension)
Bleeding
Serious liver problems
Rash
Headache (cephalalgia)

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

Pancreatitis
Inflammation of the large intestine
Low platelet count (thrombocytopenia)
Jaundice, i.e. yellowing of the skin and whites of the eyes due to high levels of bilirubin
Itching (pruritus)
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)

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Very common side effects (may occur in more than 1 in 10 patients)

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

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

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

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

Inflammation of the large intestine
Serious liver problems
Kidney failure
Low platelet count (thrombocytopenia)
Rash
Itching (pruritus)

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 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website 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 Intas

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. The expiry date refers to the last day of that month.
This medicine does not require any special 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 medicines via 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 Intas contains

The active substance is nintedanib. Each capsule contains 150 mg of nintedanib (as esilate).
The other components are:
Capsule contents: Medium-chain saturated triglycerides, macrogol lauroyl glycerides, soybean lecithin (E322) (see section 2)
Capsule shell: Gelatin, glycerol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172)
Printing ink: Shellac, black iron oxide (E172), ammonium hydroxide, propylene glycol (E1520)

Description of the appearance of Nintedanib Intas and contents of the pack
Nintedanib Intas 150 mg capsules are soft gelatin capsules, brown, opaque, oblong in shape, imprinted with "JF2" in black ink, containing a suspension ranging in colour from bright greenish-yellow to pale yellow.
Nintedanib Intas 150 mg soft capsules are available in the following pack sizes:

Aluminium/aluminium blisters containing 30 and 60 soft capsules
Perforated aluminium/aluminium unit dose blisters containing 30x1 and 60x1 soft capsules

Not all pack sizes may be marketed.

Marketing Authorization Holder
Intas Third Party Sales 2005, S.L.
World Trade Center Building
Calle Moll de Barcelona s/n
Edificio Este, 6th floor,
08039 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 European Economic Area Member States under the following names:
Sweden Nintedanib Intas 150 mg mjuka kapslar
Spain Nintedanib Intas 150 mg cápsulas blandas EFG
Germany Nintedanib Heumann 150 mg Weichkapseln
Italy Nintedanib Intas
France Nintedanib Intas 150 mg capsules molles