NINTEDANIB 100 mg Soft Capsule

Зміст інструкції

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

Nintedanib Sandoz 100 mg soft capsules

Generic medicine

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

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

Nintedanib Sandoz 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), of
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 it difficult to breathe deeply. This medicine helps
to reduce the further appearance of 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 the tissue of the lungs becomes
thick, stiff and scarred (pulmonary fibrosis) and continues to worsen (progressive phenotype) over time.
Examples of these conditions are hypersensitivity pneumonitis, autoimmune ILDs (e.g. ILD
associated with rheumatoid arthritis), nonspecific idiopathic interstitial pneumonia, idiopathic interstitial
pneumonia not classifiable and other ILDs. This medicine 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 condition is called SSc-ILD. Fibrosis in the lungs reduces the
ability of the lungs to transfer oxygen to the blood and breathing capacity. Nintedanib Sandoz
helps to reduce the further appearance of scarring and stiffening of the lungs.

2. What you need to know before taking Nintedanib Sandoz

Do not take Nintedanib Sandoz:

• if you are allergic to nintedanib or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant

Warnings and precautions
Talk to your doctor or pharmacist before taking Nintedanib Sandoz, if:

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

• you develop diarrhoea. It is important to treat diarrhoea early (see section 4);
• you develop vomiting or feeling unwell (nausea);
• 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 could be symptoms of serious liver problems;
• you have severe stomach pain, fever, chills, feeling unwell, vomiting or stiffness or swelling of the abdomen, as these could be symptoms of a hole 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), as this may increase this risk;
• you experience a combination of severe stomach pain or cramps, red blood in your stool, or diarrhoea, as these could be symptoms of inflammation of the intestine due to inadequate blood supply;
• you have pain, swelling, redness or warmth in a limb, as these could be symptoms of a blood clot in a vein (a type of blood vessel);
• 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;
• you have significant bleeding;
• bruising, bleeding, fever, fatigue and confusion appear. These could be signs of damage to blood vessels known as thrombotic microangiopathy (TMA);
• 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 Sandoz should not be given to children and adolescents under 18 years of age.

Other medicines and Nintedanib Sandoz
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 Sandoz 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 affects 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 Sandoz:

• 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 are pregnant, are planning to become pregnant 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 baby and cause
birth defects.
Before starting treatment with this medicine, you must perform a pregnancy test to make sure
you are not pregnant. Contact your doctor.
Contraception

• Women of childbearing potential must use a highly effective method of contraception to avoid pregnancy when starting to take Nintedanib Sandoz, during the taking of Nintedanib Sandoz and for at least 3 months after stopping treatment.
• Talk to your doctor to evaluate the most suitable contraceptive methods for you.
• 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 disorders, contact 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 this medicine.

Breastfeeding
Do not breastfeed during treatment with this medicine, as there is a possible risk
of harm to breastfed babies.

Driving and using machines
This medicine can slightly impair the ability to drive and operate machines. If you do not feel
well, do not drive or operate machines.

3. How to take Nintedanib Sandoz

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 roughly the same time 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, that is during a meal or immediately before or after. Do not open or crush the capsule to avoid accidental exposure to the capsule contents (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 Sandoz 100 mg capsules per day.
If you do not tolerate the recommended dose of two Nintedanib Sandoz 100 mg capsules per day (see possible side effects in section 4), your doctor may suggest that you discontinue treatment with this medicine. Do not reduce the dose or stop treatment without first consulting your doctor.

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

If you forget to take Nintedanib Sandoz
Do not take two capsules at the same time if you have forgotten to take the previous dose. Take the next 100 mg dose of Nintedanib Sandoz as scheduled at the next recommended time
by your doctor or pharmacist.

If you stop taking Nintedanib Sandoz
Do not stop treatment with Nintedanib Sandoz 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 Sandoz:

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 immediately contact your
doctor. 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.
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)

• 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, which is 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 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)
• 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 (ILDs) 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, which is 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 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)
• 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)

• 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, which is a yellowing of the skin and the whites 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)
• 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)

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 Sandoz

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.
Store in the original packaging to protect the medicine from moisture.
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 Sandoz contains

• The active ingredient is nintedanib. Each soft capsule contains nintedanib hexylate equivalent to 100 mg of nintedanib.
• The other ingredients are:
• Capsule content: medium-chain saturated triglycerides, solid semi-synthetic glycerides and polyglyceryl-3 dioleate (E 475)
• Capsule shell: gelatin (E441), glycerol (85%) (E 422), titanium dioxide (E 171), red iron oxide (E172) and yellow iron oxide (E172)
• Printing ink: shellac (E 904), carmine (E 120), propylene glycol (E 1520) and simethicone

Description of the appearance of Nintedanib Sandoz and package contents
Nintedanib Sandoz 100 mg soft capsules are opaque, oblong, peach-colored soft gelatin capsules,
measuring from 13.5 to 17.5 mm in length, containing a viscous yellow suspension and bearing
the imprint “NT 100” in red ink.
This medicinal product is available in a cardboard box containing 30x1 and 60x1 soft capsules in
unit-dose divisible OPA/Al/PVC-Aluminum blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milan
Italy

Manufacturer
Pharmadox Healthcare Limited,
KW20A Kordin Industrial Park,
Paola PLA 3000
Malta
Adalvo Limited
Malta Life Scienes Park, Building 1, Level 4,
Sir Temi Zammit Buildings
San Ġwann SĠN 3000
Malta
Qualimetrix S.A.
579 Mesogeion Avenue,
Agia Paraskevi,
Athens, 15343
Greece
Lek Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana,
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria Nintedanib Sandoz 100 mg – Soft capsules
Denmark Nintedanib Sandoz
Estonia Nintedanib Sandoz
Finland Nintedanib Sandoz 100 mg soft capsules
France NINTEDANIB SANDOZ 100 mg, soft capsules
Greece Nintedanib/Sandoz
Iceland Nintedanib Sandoz
Italy Nintedanib Sandoz
Latvia Nintedanib Sandoz 100 mg soft capsules
Lithuania Nintedanib Sandoz 100 mg soft capsules
Norway Nintedanib Sandoz
Netherlands Nintedanib Sandoz 100 mg, soft capsules
Poland Nintedanib Sandoz
Portugal Nintedanib Sandoz 100 mg soft capsules
Czech Republic Nintedanib Sandoz
Spain Nintedanib Sandoz 100 mg soft capsules EFG
Sweden Nintedanib Sandoz
Hungary Nintedanib Sandoz 100 mg soft capsule

Nintedanib Sandoz 150 mg soft capsules

Generic medicine

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

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

Nintedanib Sandoz 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), of
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. This medicine helps
to reduce the further appearance of 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 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 ILD (e.g. ILD
associated with rheumatoid arthritis), nonspecific idiopathic interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia and other ILDs. This medicine 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 respiratory capacity. Nintedanib Sandoz
helps to reduce the further appearance of scarring and stiffening of the lungs.

2. What you need to know before taking Nintedanib Sandoz

Do not take Nintedanib Sandoz:

• if you are allergic to nintedanib, or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nintedanib Sandoz, if:

• you have, or have had, liver problems
• you have, or have had, kidney problems or if an increase in the amount of protein has been detected in your urine,
• you have, or have had, bleeding problems,
• you are taking medicines that thin the blood (e.g. warfarin, phenprocoumon or heparin) to prevent blood clots,
• you are taking pirfenidone, which may lead to an increased risk of developing diarrhoea, nausea, vomiting and liver problems,
• you have, or have had, heart problems (e.g. a heart attack),
• you have recently had surgery. Nintedanib can affect wound healing. Therefore, treatment with this medicine will normally be interrupted for a certain period in case of surgery. Your doctor will decide when you can resume treatment with this medicine,
• you have high blood pressure,
• the pressure in the blood vessels of the lungs is excessively high (pulmonary hypertension),
• 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 Sandoz.
Tell your doctor immediately while taking this medicine if:

• you develop diarrhoea. It is important to treat diarrhoea early (see section 4);
• you develop vomiting or feeling unwell (nausea);
• 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 could be symptoms of serious liver problems;
• you have severe stomach pain, fever, chills, feeling unwell, vomiting or stiffness or swelling of the abdomen, as these could 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), as this may increase this risk;
• you experience a combination of severe stomach pain or cramps, red blood in your stools or diarrhoea, as these could be symptoms of inflammation of the intestine due to inadequate blood supply;
• pain, swelling, redness or warmth in an arm or leg, as these could be symptoms of a blood clot in a vein (a type of blood vessel);
• you feel pressure or pain in your chest, particularly on the left side of your body, neck pain, jaw pain, shoulder or arm pain, rapid heartbeat, shortness of breath, nausea, vomiting, as these could be symptoms of a heart attack;
• you have significant bleeding;
• bruising, bleeding, fever, fatigue and confusion appear. These could be signs of damage to blood vessels known as thrombotic microangiopathy (TMA);
• 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 Sandoz should not be given to children and adolescents under 18 years of age.

Other medicines and Nintedanib Sandoz
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 Sandoz 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 affects 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 Sandoz:

• an antibiotic used to treat tuberculosis (rifampicin)
• medicines used to treat epilepsy (carbamazepine, phenytoin)
• an herbal medicine used 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 this medicine, 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 Sandoz, during the intake of Nintedanib Sandoz and for at least 3 months after stopping treatment.
• Talk to your doctor to evaluate the most suitable contraceptive methods for you.
• 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 disorders, 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 are pregnant while taking this medicine.

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

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

3. How to take Nintedanib Sandoz

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 roughly the same time 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 to avoid accidental exposure to the capsule contents (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 Sandoz 150 mg capsules
per day.
If you do not tolerate the recommended dose of two Nintedanib Sandoz 150 mg capsules per day (see
possible side effects in section 4) your doctor may reduce the daily dose of Nintedanib
Sandoz. 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 Sandoz 100 mg capsules.
Do not take a dose higher than the recommended dose, which is two Nintedanib Sandoz 100 mg
capsules per day if your dose has been reduced to 200 mg per day.

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

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

If you stop taking Nintedanib Sandoz
Do not stop treatment with Nintedanib Sandoz 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 Sandoz:

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 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.
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)

• 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, 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)
• Brain condition 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 (ILDs) 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, 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)
• Brain condition 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)

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 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)
• Brain condition 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)

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 Sandoz

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.
Store in the original packaging to protect the medicine from moisture.
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 Sandoz contains

• The active ingredient is nintedanib. Each soft capsule contains nintedanib hexalate equivalent to 150 mg of nintedanib
• The other ingredients are:
• Capsule content: medium-chain saturated triglycerides, solid semi-synthetic glycerides and polyglyceryl-3 dioleate (E 475)
• Capsule shell: gelatin (E 441), glycerol (85%) (E 422), titanium dioxide (E 171), red iron oxide (E 172) and yellow iron oxide (E 172)
• Printing ink: shellac (E 904), black iron oxide (E 172) and propylene glycol (E 1520).

Description of the appearance of Nintedanib Sandoz and package contents
Nintedanib Sandoz 150 mg soft capsules are gelatin soft capsules, brown in colour, opaque,
oblong, measuring from 15 to 19 mm in length, containing a viscous yellow suspension and
bearing the inscription “NT 150” in black ink.
This medicinal product is available in a cardboard box containing 30x1 and 60x1 soft capsules in
unit-dose divisible OPA/Al/PVC-Aluminum blisters
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milano
Italy

Manufacturer
Pharmadox Healthcare Limited,
KW20A Kordin Industrial Park,
Paola PLA 3000
Malta
Adalvo Limited
Malta Life Scienes Park, Building 1, Level 4,
Sir Temi Zammit Buildings
San Ġwann SĠN 3000
Malta
Qualimetrix S.A.
579 Mesogeion Avenue,
Agia Paraskevi,
Athens, 15343
Greece
Lek Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana,
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria Nintedanib Sandoz 150 mg – Soft capsules
Denmark Nintedanib Sandoz
Estonia Nintedanib Sandoz
Finland Nintedanib Sandoz 150 mg soft capsules
France NINTEDANIB SANDOZ 150 mg, soft capsules
Greece Nintedanib/Sandoz
Iceland Nintedanib Sandoz
Italy Nintedanib Sandoz
Latvia Nintedanib Sandoz 150 mg soft capsules
Lithuania Nintedanib Sandoz 150 mg soft capsules
Norway Nintedanib Sandoz
Netherlands Nintedanib Sandoz 150 mg, soft capsules
Poland Nintedanib Sandoz
Portugal Nintedanib Sandoz 150 mg soft capsules
Czech Republic Nintedanib Sandoz
Spain Nintedanib Sandoz 150 mg soft capsules EFG
Sweden Nintedanib Sandoz
Hungary Nintedanib Sandoz 150 mg soft capsule