NINTEDANIB SANDOZ

Patient Information Leaflet

Nintedanib Sandoz 100 mg Soft Capsules

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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Nintedanib Sandoz is and what it is used for

Nintedanib Sandoz 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 lung tissue over time 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. This medicine helps reduce further development of scarring and lung stiffening.

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype
In addition to IPF, there are other conditions in which lung tissue over time 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. This medicine 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 to the blood and their breathing capacity. Nintedanib Sandoz helps reduce further development of scarring and lung stiffening.

2. What you should 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 increased amount of protein in your urine has been detected,
• you have or have had bleeding problems,
• you are taking blood-thinning medicines (for example warfarin, phenprocoumon or heparin) to prevent blood clots,
• you are taking pirfenidone, which may increase the risk of developing diarrhoea, nausea, vomiting and liver problems,
• you have or have had heart problems (for example a heart attack),
• you have recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with this medicine 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,
• you have high blood pressure,
• the pressure in the blood vessels of your lungs is too high (pulmonary hypertension),
• you have or have had an aneurysm (a bulging and weakening of a blood vessel wall) 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 Sandoz.

Tell your doctor immediately while taking this medicine if:

• you develop diarrhoea. It is important to treat diarrhoea early (see section 4);
• you experience vomiting or feel unwell (nausea);
• you have 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 could be symptoms of serious liver problems;
• you have severe stomach pain, fever, chills, feel unwell, vomiting, or abdominal stiffness or swelling, as these could be symptoms of a hole in the wall of the intestine (“gastrointestinal perforation”). Also inform your doctor if you have previously had peptic ulcers or diverticular disease, or if you are taking anti-inflammatory medicines (NSAIDs) (used to relieve pain and treat swelling) or steroids (used for inflammation and allergies) at the same time, as this may increase this risk;
• you experience a combination of severe pain or cramps in your stomach, red blood in your stools or diarrhoea, as these could be symptoms of intestinal inflammation 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, particularly on the left side of your body, pain in your neck, jaw, shoulder or arm, rapid heartbeat, shortness of breath, nausea, or vomiting, as these may be symptoms of a heart attack;
• you have significant bleeding;
• bruises, bleeding, fever, fatigue and confusion occur. 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 disturbances such as weakness in one arm or leg, with or without high blood pressure. These may be symptoms of a brain condition called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents
Nintedanib Sandoz must not be taken by 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 without a prescription.
Nintedanib Sandoz 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 affects 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 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, think you may be pregnant or are planning to become pregnant, or if you 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 baby and cause birth defects.
Before starting treatment with this medicine, you must have a pregnancy test to confirm that you are not pregnant. Speak to your doctor.

Contraception

• Women of childbearing potential must use a highly effective method of contraception to prevent pregnancy when starting Nintedanib Sandoz, during treatment with Nintedanib Sandoz, and for at least 3 months after stopping treatment.
• Talk to your doctor about which contraceptive methods are most suitable for you.
• Vomiting and/or diarrhoea or other gastrointestinal problems may affect the absorption of oral hormonal contraceptives, such as the pill, and may reduce their effectiveness. Therefore, if you experience these symptoms, speak to your doctor about using an alternative, more appropriate contraceptive method.
• Inform your doctor or pharmacist immediately if you become pregnant or suspect you may be pregnant while taking this medicine.

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

Driving and using machines
This medicine has a minor influence on the ability to drive and use machines. If you do not feel well, you must not drive or operate machinery.

3. How to take Nintedanib Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Take the capsules twice daily, approximately 12 hours apart and at approximately 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, either 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 daily (for a total daily dose of 200 mg).
Do not take a higher dose than the recommended dose of 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 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 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 set 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 duration prescribed by your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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 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 affect more than 1 in 10 people)

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

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

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

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

• Pancreatitis
• Inflammation of the large intestine (colitis)
• Severe liver problems
• Low platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Jaundice, i.e. yellowing of the skin and whites of the eyes due to high 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
• Enlargement 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, seizures, or other neurological disturbances 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 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 function tests

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

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

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

• 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
• Enlargement 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, seizures, or other neurological disturbances 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 function tests

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

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

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

• Inflammation of the large intestine (colitis)
• Severe 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
• Enlargement 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, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome)

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 Sandoz

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.
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 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 any medicine 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 Sandoz contains

• The active substance is nintedanib. Each soft capsule contains nintedanib esilate equivalent to 100 mg of nintedanib.
• The other components are:
  • Capsule contents: medium-chain saturated triglycerides, solid semisynthetic 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 peach-coloured, opaque, oblong gelatin capsules measuring 13.5 to 17.5 mm in length, containing a yellow viscous suspension, printed with “NT 100” in red ink.
This medicinal product is available in a cardboard box containing 30x1 or 60x1 soft capsules in unit-dose divisible blisters made of OPA/Al/PVC-Aluminium.
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 Sciences 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 European Economic Area countries under the
following names:
Austria Nintedanib Sandoz 100 mg – Weichkapseln
Denmark Nintedanib Sandoz
Estonia Nintedanib Sandoz
Finland Nintedanib Sandoz 100 mg pehmeät kapselit
France NINTEDANIB SANDOZ 100 mg, capsule molles
Greece Nintedanib/Sandoz
Iceland Nintedanib Sandoz
Italy Nintedanib Sandoz
Latvia Nintedanib Sandoz 100 mg mīkstās kapsulas
Lithuania Nintedanib Sandoz 100 mg minkštosios kapsulės
Norway Nintedanib Sandoz
Netherlands Nintedanib Sandoz 100 mg, zachte capsules
Poland Nintedanib Sandoz
Portugal Nintedanib Sandoz 100 mg cápsulas moles
Czech Republic Nintedanib Sandoz
Spain Nintedanib Sandoz 100 mg cápsulas blandas EFG
Sweden Nintedanib Sandoz
Hungary Nintedanib Sandoz 100 mg lágy kapszula

Patient information leaflet

Nintedanib Sandoz 150 mg soft capsules

Generic medicine
Please read this entire leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Nintedanib Sandoz is and what it is used for

Nintedanib Sandoz 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 lung tissue over time becomes thickened, stiff, and scarred. As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream, making deep breathing difficult. This medicine helps reduce further development of scarring and lung stiffening.

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype
In addition to IPF, there are other conditions in which lung tissue over time becomes thickened, 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. This medicine 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 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, 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 Sandoz helps reduce further development of scarring and lung stiffening.

2. What you should 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 in your urine has been detected;
• you have or have had bleeding problems;
• you are taking blood-thinning medicines (e.g. warfarin, phenprocoumon or heparin) to prevent blood clots;
• you are taking pirfenidone, which may increase the risk of developing diarrhoea, nausea, vomiting and liver problems;
• you have or have had heart problems (e.g. a heart attack);
• you have recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with this medicine 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;
• you have high blood pressure;
• you have or have had high blood pressure in the blood vessels of the lungs (pulmonary hypertension);
• you have or have had an aneurysm (a weakened and bulging blood vessel wall) 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 Sandoz.

Tell your doctor immediately while taking this medicine if:

• you develop diarrhoea. It is important to treat diarrhoea early (see section 4);
• you experience vomiting or nausea;
• 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 abdomen, bleeding or bruising more easily than usual, or a feeling of fatigue. These may be symptoms of serious liver problems;
• 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 intestinal wall ("gastrointestinal perforation"). Inform your doctor also if you have previously suffered from peptic ulcers or diverticular disease, or if you are taking concomitant anti-inflammatory medicines (NSAIDs) (used to relieve pain and reduce 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 the stools or diarrhoea, as these may be symptoms of intestinal inflammation due to inadequate blood supply;
• you notice 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);
• 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;
• you experience significant bleeding;
• you develop bruising, bleeding, fever, fatigue and confusion. These may 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 disturbances such as weakness in one 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 must not be used in 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 without a prescription.
Nintedanib Sandoz may interact with certain medicines. The following medicines are some examples of those 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 affects the immune system (cyclosporine).

The following medicines are some examples of those that may decrease nintedanib levels 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, think you may be pregnant or are planning to become pregnant, or if you 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 this medicine, 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 treatment with Nintedanib Sandoz, during treatment with Nintedanib Sandoz, and for at least 3 months after stopping treatment.
• Talk to your doctor about which contraceptive methods are most suitable for you.
• Vomiting and/or diarrhoea or other gastrointestinal problems may affect the absorption of oral hormonal contraceptives, such as the pill, and may reduce their effectiveness. Therefore, if you experience these symptoms, talk to your doctor about using an alternative, more appropriate contraceptive method.
• Inform your doctor or pharmacist immediately if you become pregnant or suspect you are pregnant during treatment with this medicine.

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

Driving and using machines
This medicine 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.

3. How to take Nintedanib Sandoz

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 about 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, either 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 daily (for a total daily dose of 300 mg).
Do not take a higher dose than the recommended dose of 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 daily (for a total daily dose of 200 mg).
In this case, your doctor will prescribe treatment with Nintedanib Sandoz 100 mg capsules.
Do not take a higher dose than the recommended dose of 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 set 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 duration prescribed by your doctor.
If you have any questions about how to use 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 must 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 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 affect more than 1 in 10 people)

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

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

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

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

• Pancreatitis
• Inflammation of the large intestine (colitis)
• Severe liver problems
• Low platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Jaundice, i.e. yellowing of the skin and whites of the eyes due to high 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
• Enlargement and weakening of a blood vessel wall or a tear in the blood vessel wall (aneurysms and arterial dissections)
• Brain condition with symptoms such as headache, vision changes, confusion, seizures, or other neurological disturbances 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 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 test results

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

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

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

• 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
• Enlargement and weakening of a blood vessel wall or a tear in the blood vessel wall (aneurysms and arterial dissections)
• Brain condition with symptoms such as headache, vision changes, confusion, seizures, or other neurological disturbances 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 test results

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

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

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

• Inflammation of the large intestine (colitis)
• Severe 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
• Enlargement 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)
• Brain condition with symptoms such as headache, vision changes, confusion, seizures, or other neurological disturbances 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, 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 Sandoz

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 pack. 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 capsule contents, wash your hands immediately with plenty of water (see section 3).
Do not dispose of any medicine via 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 substance is nintedanib. Each soft capsule contains nintedanib esilate equivalent to 150 mg of nintedanib.
• The other components are:
  • Capsule contents: medium-chain saturated triglycerides, solid semisynthetic glycerides, and polyglyceryl-3 dioleate (E 475)
  • Capsule shell: gelatin (E 441), glycerol (85%) (E 422), titanium dioxide (E 171), iron oxide red (E 172), and iron oxide yellow (E 172)
  • Printing ink: shellac (E 904), iron oxide black (E 172), and propylene glycol (E 1520).

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

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

Manufacturers
Pharmadox Healthcare Limited,
KW20A Kordin Industrial Park,
Paola PLA 3000
Malta
Adalvo Limited
Malta Life Sciences 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 authorized in the European Economic Area countries under the
following names:
Austria Nintedanib Sandoz 150 mg – Weichkapseln
Denmark Nintedanib Sandoz
Estonia Nintedanib Sandoz
Finland Nintedanib Sandoz 150 mg pehmeät kapselit
France NINTEDANIB SANDOZ 150 mg, capsule molles
Greece Nintedanib/Sandoz
Iceland Nintedanib Sandoz
Italy Nintedanib Sandoz
Latvia Nintedanib Sandoz 150 mg mīkstās kapsulas
Lithuania Nintedanib Sandoz 150 mg minkštosios kapsulės
Norway Nintedanib Sandoz
Netherlands Nintedanib Sandoz 150 mg, zachte capsules
Poland Nintedanib Sandoz
Portugal Nintedanib Sandoz 150 mg cápsulas moles
Czech Republic Nintedanib Sandoz
Spain Nintedanib Sandoz 150 mg cápsulas blandas EFG
Sweden Nintedanib Sandoz
Hungary Nintedanib Sandoz 150 mg lágy kapszula