NINTEDANIB 100 mg Soft Capsules

Зміст інструкції

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

Nintedanib Accordpharma 100 mg soft capsules
Nintedanib
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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Nintedanib Accordpharma capsules contain the active substance nintedanib. Nintedanib blocks the activity
of a group of proteins that are involved in the development of new blood vessels that cancer cells need to
receive nutrients and oxygen. By blocking the activity of these proteins, nintedanib
may help to stop the growth and spread of cancer.
This medicine is used in combination with another cancer medicine (docetaxel), for
treating lung cancer called non-small cell lung cancer (NSCLC). This
medicine is indicated for adult patients who have an NSCLC of a certain type (“ adenocarcinoma”)
and who have already received another medicine for the treatment of this cancer, but in whom the tumor has
started to grow again.

2. What you need to know before taking Nintedanib Accordpharma

Do not take Nintedanib Accordpharma

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

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine

• if you have or have had liver problems, if you have or have had bleeding problems, in particular recent bleeding in the lungs
• if you have or have had kidney problems or if an increase in the amount of protein has been detected in your urine
• if you are taking medicines that thin the blood (e.g. warfarin, phenprocoumon, heparin or acetylsalicylic acid) to prevent blood clots. Treatment with Nintedanib Accordpharma may lead to an increased risk of bleeding
• if you have recently had surgery or are going to have surgery soon. Nintedanib can affect wound healing. Therefore, treatment with Nintedanib Accordpharma will normally be stopped in case of surgery. Your doctor will decide when you can restart treatment with this medicine
• if you have cancer that has spread to the brain
• if you have high blood pressure
• if you have or have had an aneurysm (bulging and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Based on this information, your doctor may perform blood tests, for example to
check liver function and to determine how long it takes for your blood to clot. Your
doctor will discuss the results of the tests with you and decide if you can receive Nintedanib
Accordpharma.
Tell your doctor immediately while taking this medicine

• if you have diarrhea. It is important to treat diarrhea when the first signs appear (see section 4)
• if you vomit or feel unwell (nausea)
• if you experience unexplained symptoms such as yellowing of the skin or the whites of your eyes (jaundice), dark or brown urine (tea-colored), pain in the upper right area of the abdomen, bleeding or bruising more easily than usual, or feeling tired. These may be symptoms of serious liver problems
• if you have fever, chills, rapid breathing or heartbeat. These may be signs of infection or blood infection (sepsis) (see section 4)
• if you have severe pain in the abdomen, fever, chills, feeling unwell, vomiting or stiffness or swelling of the abdomen, as these may be symptoms of an opening in the wall of the intestine (“gastrointestinal perforation”)
• if you experience a combination of some or all of the following symptoms: sudden onset of severe abdominal pain or cramps, red blood in your stool, diarrhea or constipation, nausea and vomiting, as these may be symptoms of inflammation of the intestine due to reduced blood supply (“ischemic colitis”)
• if you have pain, swelling, redness or warmth in a limb or if you have chest pain and difficulty breathing, as these may be symptoms of a blood clot in a vein
• if you have significant bleeding
• if you feel pressure or pain in your chest, especially on the left side of your body, pain in your neck, jaw, shoulder or arm, if you have a rapid heartbeat, shortness of breath, nausea or vomiting, as these may be symptoms of a heart attack
• if you experience symptoms such as headache, changes in vision, confusion, seizures or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure. These may be symptoms of a brain condition called reversible posterior encephalopathy syndrome (PRES)
• if one or more side effects that may occur (see section 4) become severe

Children and adolescents
This medicine has not been studied in children or adolescents for the treatment of lung cancer (NSCLC), therefore it should not be taken by children and adolescents under the age of
18 years.

Other medicines and Nintedanib Accordpharma
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.
This medicine can interact with some medicines. The following medicines can increase the
levels of nintedanib, the active ingredient of Nintedanib Accordpharma, in the blood, potentially increasing
the risk of side effects (see section 4):

• ketoconazole (used to treat fungal infections)
• erythromycin (used to treat bacterial infections) The following medicines can decrease the levels of nintedanib in the blood, potentially reducing the effectiveness of Nintedanib Accordpharma:
• rifampicin (an antibiotic used to treat tuberculosis)
• carbamazepine, phenytoin (used to treat epilepsy)
• St John's wort (an herbal medicine for treating depression)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the baby or cause
birth defects.
Contraception

• Women of childbearing potential must use a highly effective method of contraception to avoid pregnancy when starting to take Nintedanib Accordpharma, during treatment with Nintedanib Accordpharma and for at least 3 months after stopping treatment.
• Talk to your doctor to assess the most suitable contraceptive methods for you.
• Vomiting and/or diarrhea 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 assess a more appropriate alternative contraceptive method.
• Tell your doctor or pharmacist immediately if you become pregnant or suspect you may be pregnant during treatment with Nintedanib Accordpharma.

Breastfeeding
It is not known whether the medicine passes into breast milk and whether it may harm a breastfed baby.
Therefore, it is recommended not to breastfeed during treatment with
Nintedanib Accordpharma.

Fertility
The effect of this medicine on human fertility has not been studied.

Driving and using machines
Nintedanib Accordpharma may slightly impair the ability to drive and operate machines.
If you feel unwell, do not drive or operate machines.

Nintedanib Accordpharma contains soy
The capsules contain soy lecithin. If you are allergic to peanuts or soy, do not use this
medicine.

3. How to take Nintedanib Accordpharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Do not take Nintedanib Accordpharma on the same day as chemotherapy treatment with docetaxel.
Swallow the capsules whole with water and do not chew them. It is recommended to take the capsules with food, i.e. during a meal or immediately before or after. Do not open or crush the capsule (see section 5).
The recommended dose is four capsules a day (i.e. a total of 400 mg of nintedanib a day).
Do not take a higher dose.
This daily dose must be divided into two doses of two capsules approximately 12 hours apart, for example two capsules in the morning and two capsules in the evening. These two doses must be taken at approximately the same time each day. Following these instructions ensures that a constant amount of nintedanib is maintained in the body.

Dose reduction
If you do not tolerate the recommended dose of 400 mg a day due to undesirable effects (see section 4), your doctor may reduce the daily dose of Nintedanib Accordpharma. Do not reduce the dose or stop treatment without first consulting your doctor.
The doctor may reduce the recommended dose to 300 mg a day (two 150 mg capsules). In this case, your doctor will prescribe treatment with Nintedanib Accordpharma 150 mg soft capsules.
If necessary, your doctor may further reduce the daily dose to 200 mg a day (two 100 mg capsules). In this case, your doctor will prescribe the capsules of the correct dosage.
In both cases, you must take one capsule of the correct dosage twice a day, approximately 12 hours apart and at approximately the same time, with food (for example in the morning and in the evening).
If your doctor has stopped chemotherapy with docetaxel, you must continue to take Nintedanib Accordpharma twice a day.

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

If you forget to take Nintedanib Accordpharma
Do not take a double dose to make up for a missed dose. Take the next dose of Nintedanib Accordpharma at the next scheduled time, as programmed, and at the dose recommended by your doctor or pharmacist.

If you stop taking Nintedanib Accordpharma
Do not stop treatment with Nintedanib Accordpharma without first consulting your doctor. It is important to take this medicine every day for the entire period indicated by your doctor. If you do not take this medicine as prescribed by your doctor, this cancer treatment may not work properly.
If you have any doubts 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 Accordpharma:

• Diarrhoea(very common, may affect more than 1 in 10 people)Diarrhoea can cause 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, for example with loperamide, as soon as possible after consulting your doctor.
• Febrile neutropeniaandsepsis(common, may affect up to 1 in 10 people)Treatment with Nintedanib Accordpharma can cause a reduction in the number of a type of white blood cells (neutropenia) that are important for the body's reaction to infections caused by bacteria or fungi. As a consequence of neutropenia, fever (febrile neutropenia) and blood infection (sepsis) can occur. If you have a fever, chills, rapid breathing or heartbeat, tell your doctor immediately. During treatment with Nintedanib Accordpharma, your doctor will regularly monitor your blood cells and examine you regularly to rule out signs of infection, such as inflammation, fever or fatigue. The following side effects have been observed during treatment with this medicine:

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

• Diarrhoea - see above
• Sensation of pain, numbness and/or tingling in the fingers of the hands and feet (peripheral neuropathy)
• Feeling unwell (nausea)
• Vomiting
• Stomach pain (abdomen)
• Bleeding
• Decreased number of white blood cells (neutropenia)
• Inflammation of the mucous membranes lining the digestive tract, including sores and ulcers in the mouth (mucositis, including stomatitis)
• Skin rash
• Reduced appetite
• Electrolyte imbalance
• Increased levels of liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline blood phosphatase) in the blood, detected by blood tests
• Hair loss (alopecia)

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

• Blood infection (sepsis) - see above
• Decreased number of white blood cells accompanied by fever (febrile neutropenia)
• Blood clots in the veins (venous thromboembolism), especially in the legs (symptoms include pain, redness, swelling and warmth in a limb) which can move through the blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, see a doctor immediately)
• High blood pressure (hypertension)
• Loss of fluids (dehydration)
• Abscesses
• Low platelet count (thrombocytopenia)
• Jaundice (hyperbilirubinemia)
• Increased levels of liver enzymes (gamma-glutamyltransferase) in the blood, detected by blood tests
• Weight loss
• Itching
• Headache (cephalalgia)
• Increased amount of protein in the urine (proteinuria)

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

• Formation of openings in the wall of the intestine (gastrointestinal perforation)
• Severe liver problems
• Inflammation of the pancreas (pancreatitis)
• Myocardial infarction
• Kidney failure

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

• Inflammation of the large intestine
• Dilation and weakening of the wall of a blood vessel or tearing of 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).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the address: 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 Accordpharma

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

6. Package contents and other information

What Nintedanib Accordpharma contains
The active ingredient is nintedanib. Each soft capsule contains 100 mg of nintedanib (as hexilate).
The excipients are:

Capsule content: Medium-chain triglycerides, lauroyl macrogol glycerides, 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 Accordpharma and package contents
Nintedanib Accordpharma 100 mg soft capsules are soft gelatin capsules of oblong
shape, opaque, peach-colored, approximately 16 mm, with "JF1" printed in black ink,
containing a suspension ranging in color from bright yellowish-green to light yellow.
Nintedanib Accordpharma 100 mg soft capsules are available in packs containing:

• aluminium-aluminium blisters, available in packs of 60 and 120 soft capsules (multipack containing 2 cartons of 60 soft capsules each).
• aluminium-aluminium blisters, available in cross-perforated unit blisters of 60 x 1 and 120 x 1 soft capsules (multipack containing 2 cartons of 60 soft capsules each). Not all packs of Nintedanib Accordpharma 100 mg soft capsules may be marketed.

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

Manufacturer
Accord Healthcare Polska Sp.z.o.o. Magazyn Importera
ul. Lutomierska 50,
Pabianice, 95-200,
Poland
Accord Healthcare B.V.
Winthontlaan 200,
Utrecht, 3526 KV,
Netherlands
Pharmadox Healthcare
Limited Kw20a Kordin Industrial Park,
Paola, PLA 3000,
Malta
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Tanagra Viotia, 3200,
Greece

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:

Nintedanib Accordpharma 150 mg soft capsules

Nintedanib

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

Contents of this leaflet

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

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

Nintedanib Accordpharma capsules contain the active ingredient nintedanib. Nintedanib blocks the activity
of a group of proteins that are involved in the development of new blood vessels that cancer cells need to
receive nutrients and oxygen. By blocking the activity of these proteins, nintedanib
may help to stop the growth and spread of cancer.
This medicine is used in combination with another cancer medicine (docetaxel), for
treating lung cancer called non-small cell lung cancer (NSCLC). This
medicine is indicated for adult patients who have a NSCLC of a certain type (“ adenocarcinoma”)
and who have already received another medicine for the treatment of this cancer, but in whom the tumor has
started to grow again.

2. What you need to know before taking Nintedanib Accordpharma

Do not take Nintedanib Accordpharma

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

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine

• if you have or have had liver problems, if you have or have had bleeding problems, in particular recent bleeding in the lungs
• if you have or have had kidney problems or if an increase in the amount of protein has been detected in your urine
• if you are taking medicines that thin the blood (e.g. warfarin, phenprocoumon, heparin or acetylsalicylic acid) to prevent blood clots. Treatment with Nintedanib Accordpharma may lead to an increased risk of bleeding
• if you have recently had surgery or are about to have surgery. Nintedanib can affect wound healing. Therefore, treatment with Nintedanib Accordpharma will normally be stopped in case of surgery. Your doctor will decide when you can resume treatment with this medicine
• if you have cancer that has spread to the brain
• if you have high blood pressure
• if you have or have had an aneurysm (bulging and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Based on this information, your doctor may perform blood tests, for example to
check liver function and to determine how long it takes for your blood to clot. The
doctor will discuss the test results with you and decide if you can receive Nintedanib
Accordpharma.
Tell your doctor immediately while taking this medicine

• if you have diarrhea. Treatment of diarrhea is important when the first signs appear (see section 4)
• if you vomit or feel unwell (nausea)
• if you experience unexplained symptoms such as yellowing of the skin or the whites of your eyes (jaundice), dark or brown urine (tea-colored), pain in the upper right part of your abdomen, bleeding or bruising more easily than usual, or feeling tired. These may be symptoms of serious liver problems
• if you have fever, chills, rapid breathing or heartbeat. These may be signs of infection or blood infection (sepsis) (see section 4)
• if you have severe abdominal 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”)
• if you experience a combination of some or all of the following symptoms: sudden severe abdominal pain or cramps, red blood in your stool, diarrhea or constipation, nausea and vomiting, as these may be symptoms of inflammation of the intestine due to reduced blood supply (“ischemic colitis”)
• if you have pain, swelling, redness or warmth in a limb or if you have chest pain and difficulty breathing, as these may be symptoms of a blood clot in a vein
• if you have significant bleeding
• if you feel pressure or pain in your chest, especially on the left side of your body, neck pain, jaw pain, shoulder or arm pain, if you have a rapid heartbeat, shortness of breath, nausea or vomiting, as these may be symptoms of a heart attack
• if you experience symptoms such as headache, changes in vision, confusion, seizures, or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure. These may be symptoms of a brain condition called reversible posterior encephalopathy syndrome (PRES)
• if one or more side effects that may occur (see section 4) become serious

Children and adolescents
This medicine has not been studied in children or adolescents for the treatment of lung cancer (NSCLC), therefore it should not be taken by children and adolescents under the age of
18 years.

Other medicines and Nintedanib Accordpharma
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.
This medicine can interact with some medicines. The following medicines can increase the
levels of nintedanib, the active ingredient of Nintedanib Accordpharma, in the blood, potentially increasing
the risk of side effects (see section 4):

• ketoconazole (used to treat fungal infections)
• erythromycin (used to treat bacterial infections) The following medicines can decrease the levels of nintedanib in the blood, potentially reducing the effectiveness of Nintedanib Accordpharma:
• rifampicin (an antibiotic used to treat tuberculosis)
• carbamazepine, phenytoin (used to treat epilepsy)
• St John's wort (a herbal medicine for treating depression)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the baby or cause
birth defects.
Contraception

• Women of childbearing potential must use a highly effective method of contraception to avoid pregnancy when starting to take Nintedanib Accordpharma ,during treatment with Nintedanib Accordpharma 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 diarrhea 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 may be pregnant during treatment with Nintedanib Accordpharma.

Breastfeeding
It is not known whether the medicine passes into breast milk and whether it can harm a breastfed baby. Therefore, it is recommended not to breastfeed during treatment with
Nintedanib Accordpharma.

Fertility
The effect of this medicine on human fertility has not been studied.

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

Nintedanib Accordpharma contains soy
The capsules contain soy lecithin. If you are allergic to peanuts or soy, do not use this
medicine.

3. How to take Nintedanib Accordpharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any
doubts, ask your doctor or pharmacist.
Do not take Nintedanib Accordpharma on the same day as chemotherapy treatment with
docetaxel.
Swallow the capsules whole with water and do not chew them. It is recommended to take the capsule with
food, that is during a meal or immediately before or after. Do not open or crush the
capsule (see section 5).
The recommended dose is two capsules a day (i.e., a total of 300 mg of nintedanib per day).
Do not take a higher dose.
This daily dose must be divided into two doses of one capsule approximately 12 hours apart, for
example one capsule in the morning and one capsule in the evening. The two doses must be taken at
approximately the same time each day. Following these instructions ensures that a constant amount
of nintedanib is maintained in the body.

Dose reduction
If you do not tolerate the recommended dose of 300 mg per day due to undesirable effects (see
section 4), your doctor may reduce the recommended daily dose of Nintedanib Accordpharma to
200 mg per day (two 100 mg capsules). In this case, your doctor will prescribe treatment with
Nintedanib Accordpharma 100 mg soft capsules.
You must take one capsule of this strength twice a day, approximately 12 hours apart and
at approximately the same time, with food (for example in the morning and in the evening).
Do not reduce the dose or stop treatment without first consulting your doctor.
If your doctor has stopped chemotherapy with docetaxel, you must continue to take Nintedanib
Accordpharma twice a day.

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

If you forget to take Nintedanib Accordpharma
Do not take a double dose to make up for a missed dose. Take the next dose of
Nintedanib Accordpharma at the next scheduled time, as programmed, and at the dose
recommended by your doctor or pharmacist.

If you stop taking Nintedanib Accordpharma
Do not stop treatment with Nintedanib Accordpharma without first consulting your doctor. It is
important to take this medicine every day for the entire period indicated by your doctor. If you do not
take this medicine as prescribed by your doctor, this cancer treatment may not
work properly.
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 be particularly careful if you experience the following side effects during treatment with
Nintedanib Accordpharma:

• Diarrhea(very common, may affect more than 1 in 10 people)Diarrhea can cause loss of fluids and important salts (electrolytes, such as sodium or potassium) from the body. At the first signs of diarrhea, drink plenty of fluids and see your doctor immediately. Start appropriate treatment for diarrhea, for example with loperamide, as soon as possible after consulting your doctor.
• Febrile neutropeniaandsepsis(common, may affect up to 1 in 10 people)Treatment with Nintedanib Accordpharma can cause a reduction in the number of a type of white blood cells (neutropenia) that are important for the body's reaction to infections caused by bacteria or fungi. As a consequence of neutropenia, fever (febrile neutropenia) and blood infection (sepsis) may occur. If you have a fever, chills, rapid breathing or heartbeat, tell your doctor immediately. During treatment with Nintedanib Accordpharma, your doctor will regularly monitor your blood cells and examine you regularly to rule out signs of infection, such as inflammation, fever or fatigue. The following side effects have been observed during treatment with this medicine:

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

• Diarrhea - see above
• Sensation of pain, numbness and/or tingling in the fingers of the hands and feet (peripheral neuropathy)
• Feeling unwell (nausea)
• Vomiting
• Stomach pain (abdomen)
• Bleeding
• Decreased number of white blood cells (neutropenia)
• Inflammation of the mucous membranes lining the digestive tract, including sores and ulcers in the mouth (mucositis, including stomatitis)
• Skin rash
• Reduced appetite
• Electrolyte imbalance
• Increased levels of liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) in the blood, detected by blood tests
• Hair loss (alopecia)

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

• Blood infection (sepsis) - see above
• Decreased number of white blood cells accompanied by fever (febrile neutropenia)
• Blood clots in the veins (venous thromboembolism), especially in the legs (symptoms include pain, redness, swelling and warmth in a limb) which can move through the blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, see a doctor immediately)
• High blood pressure (hypertension)
• Loss of fluids (dehydration)
• Abscesses
• Low platelet count (thrombocytopenia)
• Jaundice (hyperbilirubinemia)
• Increased levels of liver enzymes (gamma-glutamyltransferase) in the blood, detected by blood tests
• Weight loss
• Itching
• Headache (cephalalgia)
• Increased amount of protein in the urine (proteinuria)

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

• Formation of openings in the wall of the intestine (gastrointestinal perforation)
• Serious liver problems
• Inflammation of the pancreas (pancreatitis)
• Myocardial infarction
• Kidney failure

Not known (frequency cannot be estimated from available data)

• Inflammation of the large intestine
• Dilation and weakening of the wall of a blood vessel or rupture of the wall of a blood vessel (aneurysms and arterial dissections)
• Condition of the brain with 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 (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 Accordpharma

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

6. Package contents and other information

What Nintedanib Accordpharma contains
The active ingredient is nintedanib. Each soft capsule contains 150 mg of nintedanib (as hexilate).
The excipients are:

Capsule content: Medium chain triglycerides, lauroyl macrogol glycerides, lecithin (E322)
(see section 2)

Capsule shell:Gelatin, glycerol, titanium dioxide (E171), iron oxide red
(E172), iron oxide yellow (E172)

Printing ink:Shellac, iron oxide black (E172), ammonium hydroxide, propylene glycol (E1520)

Description of the appearance of Nintedanib Accordpharma and package contents
Nintedanib Accordpharma 150 mg soft capsules are oblong, opaque, soft gelatin capsules, of brown color, approximately 18 mm in size, with "JF2" imprinted in black ink, containing a suspension ranging in color from bright greenish-yellow to light yellow.
One pack contains 60 capsules (6 aluminium blisters of 10 capsules each).

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

Manufacturer
Accord Healthcare Polska Sp.z.o.o. Magazyn Importera
ul. Lutomierska 50,
Pabianice, 95-200,
Poland
Accord Healthcare B.V.
Winthontlaan 200,
Utrecht, 3526 KV,
Netherlands
Pharmadox Healthcare
Limited Kw20a Kordin Industrial Park,
Paola, PLA 3000,
Malta
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Tanagra Viotia, 3200,
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations: