Nintedanib Accord Pharma

Package leaflet: information for the patient

Nintedanib Accordpharma 100 mg soft capsules

Nintedanib
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 Nintedanib Accordpharma is and what it is used for

Nintedanib Accordpharma capsules contain the active substance nintedanib. Nintedanib inhibits the activity
of a group of proteins involved in the development of new blood vessels that supply cancer cells with nutrients and oxygen. By inhibiting 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) to treat a type of lung cancer called non-small cell lung cancer (NSCLC). This medicine is indicated for adult patients who have a certain type of NSCLC (“adenocarcinoma”) and who have already received another cancer treatment, but in whom the tumour 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, 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, particularly recent lung bleeding
• if you have or have had kidney problems or if increased levels of protein have been detected in your urine
• if you are taking medicines that thin the blood (for example, warfarin, phenprocoumon, heparin, or acetylsalicylic acid) to prevent blood clots. Treatment with Nintedanib Accordpharma may increase the risk of bleeding
• if you have recently undergone or are about to undergo surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Accordpharma will usually be stopped before 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 (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 and to determine how long it takes for your blood to clot. Your
doctor will discuss the test results with you and decide whether you can receive Nintedanib
Accordpharma.
Inform your doctor immediately while taking this medicine

• if you have diarrhea. It is important to treat diarrhea at the first sign (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 the eyes (jaundice), dark or brown-colored urine (like tea), pain in the upper right part of the stomach area (abdomen), bleeding or bruising more easily than usual, or feeling tired. These could be signs of serious liver problems
• if you have fever, chills, rapid breathing, or rapid heartbeat. These could be signs of infection or blood infection (sepsis) (see section 4)
• if you have severe pain in the stomach area, fever, chills, feeling unwell, vomiting, or abdominal stiffness or swelling, as these could be symptoms of a hole in the intestinal wall (“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 the stool, diarrhea or constipation, nausea and vomiting, as these could be symptoms of intestinal inflammation due to reduced blood supply (“ischemic colitis”)
• if you have pain, swelling, redness, or warmth in a limb, or chest pain and difficulty breathing, as these could be symptoms of a blood clot in a vein
• if you have significant bleeding
• if you feel pressure or pain in the chest, especially on the left side of the body, pain in the neck, jaw, shoulder, or arm, if you have a rapid heartbeat, shortness of breath, nausea, or vomiting, as these could be symptoms of a heart attack
• if 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 could be symptoms of a brain condition called reversible posterior encephalopathy syndrome (PRES)
• if one or more of the 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), and therefore must not be used in children and adolescents under 18 years of age.
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 over-the-counter medicines.
This medicine may interact with certain medicines. The following medicines may increase levels of nintedanib, the active substance in 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 may decrease 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 used to treat depression)

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn child or cause birth defects.
Contraception

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

Breastfeeding
It is not known whether this medicine passes into breast milk and whether it could harm a breastfed infant. Therefore, breastfeeding is not recommended 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 have a slight influence on the ability to drive and use machines.
If you do not feel well, you should not drive or operate machinery.
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 exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Do not take Nintedanib Accordpharma on the same day as chemotherapy treatment with
docetaxel.
Swallow the capsules whole with water; do not chew them. It is recommended to take the capsules with
food, either during a meal or immediately before or after. Do not open or crush the
capsule (see section 5).
The recommended dose is four capsules per day (i.e. a total of 400 mg of nintedanib per day).
Do not take a higher dose.
This daily dose should be divided into two doses of two capsules taken approximately 12 hours apart, for
example two capsules in the morning and two capsules in the evening. These two doses should 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 per day due to adverse 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.
Your doctor may reduce the recommended dose to 300 mg per 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 per day (two 100 mg
capsules). In this case, your doctor will prescribe capsules of the appropriate strength.
In both cases, you must take one capsule of the correct strength twice daily, approximately
12 hours apart and at approximately the same time each day, with food (e.g. in the morning and evening).
If your doctor has stopped chemotherapy with docetaxel, you should continue taking Nintedanib
Accordpharma twice daily.
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 the missed dose. Take the next dose of
Nintedanib Accordpharma at the next scheduled time, as prescribed, 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 duration prescribed by your doctor. If you do
not take this medicine as prescribed, this cancer treatment may not work properly.
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 will experience 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 lead to 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, for example with loperamide, as soon as possible after consulting your doctor.
• Febrile neutropenia and sepsis (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 ) which are important for the body's response to infections caused by bacteria or fungi. As a consequence of neutropenia, fever ( febrile neutropenia ) and blood infection ( sepsis ) may occur. If you have fever, chills, rapid breathing or rapid heartbeat, inform 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 fingers and toes ( peripheral neuropathy )
• Feeling unwell ( nausea )
• Vomiting
• Stomach (abdominal) pain
• Bleeding
• Decrease in the 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 liver enzyme levels (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
• Decrease in white blood cell count accompanied by fever ( febrile neutropenia )
• Blood clots in veins ( venous thromboembolism ), especially in the legs (symptoms include pain, redness, swelling and warmth in one limb), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, contact a doctor immediately)
• High blood pressure ( hypertension )
• Loss of fluids ( dehydration )
• Abscesses
• Low platelet count ( thrombocytopenia )
• Jaundice ( hyperbilirubinemia )
• Increased liver enzyme levels (gamma-glutamyl transferase) in the blood, detected by blood tests
• Weight loss
• Itching ( pruritus )
• Headache ( cephalalgia )
• Increased amount of protein in the urine ( proteinuria )

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

• Formation of holes in the wall of the intestine ( gastrointestinal perforation )
• Severe liver problems
• Inflammation of the pancreas ( pancreatitis )
• Myocardial infarction
• Renal 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 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 elevated 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 Accordpharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, packaging, and blisters. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that the blister containing the capsules is open or if a capsule is 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Nintedanib Accordpharma contains
The active substance is nintedanib. Each soft capsule contains 100 mg of nintedanib (as esilate).
The excipients are:
Capsule contents: Medium-chain triglycerides, lauroyl macrogol glyceride, 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 oblong, opaque, peach-colored soft gelatin capsules approximately 16 mm in size, printed with "JF1" in black ink, containing a bright greenish-yellow to light yellow suspension.

Nintedanib Accordpharma 100 mg soft capsules are available in packages containing:

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

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

Manufacturers
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,
The 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 authorized in the Member States of the European Economic Area under the following names:

Patient information leaflet

Nintedanib Accordpharma 150 mg soft capsules

Nintedanib
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Nintedanib Accordpharma is 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. Contents of the pack and other information

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

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

2. What you should know before taking Nintedanib Accordpharma

Do not take Nintedanib Accordpharma

• if you are allergic to nintedanib, 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, particularly recent lung bleeding
• if you have or have had kidney problems or if increased levels of protein have been detected in your urine
• if you are taking blood-thinning medicines (for example, warfarin, phenprocoumon, heparin, or acetylsalicylic acid) to prevent blood clots. Treatment with Nintedanib Accordpharma may increase the risk of bleeding
• if you have recently undergone or are about to undergo surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Accordpharma will usually be stopped before 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 (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 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 test results with you and decide whether you can receive Nintedanib
Accordpharma.
Tell your doctor immediately while taking this medicine

• if you have diarrhoea. It is important to treat diarrhoea at the first sign (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 the eyes (jaundice), dark or brown-coloured urine (tea-coloured), pain in the upper right part of the stomach area (abdomen), bleeding or bruising more easily than usual, or feeling tired. These could be symptoms of serious liver problems
• if you have fever, chills, rapid breathing, or rapid heartbeat. These could be signs of infection or blood infection (sepsis) (see section 4)
• if you have severe pain in the stomach area, fever, chills, feeling unwell, vomiting, or abdominal stiffness or swelling, as these could 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 onset of severe abdominal pain or cramps, red blood in the stool, diarrhoea or constipation, nausea and vomiting, as these could be symptoms of intestinal inflammation due to reduced blood supply (“ischaemic colitis”)
• if you have pain, swelling, redness, or warmth in a limb, or chest pain and difficulty breathing, as these could be symptoms of a blood clot in a vein
• if you have significant bleeding
• if you feel pressure or pain in the chest, particularly on the left side of the body, pain in the neck, jaw, shoulder, or arm, rapid heartbeat, shortness of breath, nausea or vomiting, as these could be symptoms of a heart attack
• if you experience symptoms such as headache, vision changes, confusion, seizures, or other neurological disturbances such as weakness in one arm or leg, with or without high blood pressure. These could be symptoms of a brain condition called posterior reversible encephalopathy syndrome (PRES)
• if one or more of the 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), and therefore must not be taken by children and adolescents under 18 years of age.
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 over-the-counter medicines.
This medicine may interact with certain medicines. The following medicines may increase levels of nintedanib, the active substance in 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 may decrease 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 used to treat depression)

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn child or cause birth defects.
Contraception

• Women of childbearing potential must use a highly effective method of contraception to prevent pregnancy when starting treatment with Nintedanib Accordpharma, during treatment with Nintedanib Accordpharma, and for at least 3 months after stopping treatment.
• Speak to your doctor to evaluate the most suitable contraceptive methods 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, consult your doctor to consider a more appropriate alternative contraceptive method.
• Inform your doctor or pharmacist immediately if you become pregnant or suspect pregnancy during treatment with Nintedanib Accordpharma.

Breastfeeding
It is not known whether this medicine passes into breast milk and whether it could harm a breastfed infant. Therefore, breastfeeding is not recommended 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 have a minor influence on the ability to drive and use machines.
If you do not feel well, you should not drive or use 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 exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Do not take Nintedanib Accordpharma on the same day as chemotherapy treatment with docetaxel.
Swallow the capsules whole with water; do not chew them. It is recommended to take the capsule with food, either during a meal or immediately before or after. Do not open or crush the capsule (see section 5).
The recommended dose is two capsules per day (i.e., a total of 300 mg of nintedanib per day). Do not take a higher dose.
This daily dose should be divided into two doses of one capsule each, taken approximately 12 hours apart; for example, one capsule in the morning and one capsule in the evening. The two doses should be taken at approximately the same time each day. Following these instructions ensures 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 side 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 your treatment with Nintedanib Accordpharma 100 mg soft capsules.
You must take one capsule of this dosage twice daily, approximately 12 hours apart and at approximately the same time each day, with food (e.g., in the morning and evening).
Do not reduce the dose or stop treatment without first consulting your doctor.
If your doctor has discontinued docetaxel chemotherapy, you must continue taking Nintedanib Accordpharma twice daily.

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 the missed dose. Take the next dose of Nintedanib Accordpharma at the next scheduled time, as planned, 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 duration prescribed by your doctor. If you do not take this medicine as prescribed, this cancer treatment may not work properly.
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 experiences 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 may lead to loss of fluids and important salts (electrolytes such as sodium or potassium) from the body. At the first sign of diarrhoea, drink plenty of fluids and contact your doctor immediately. Start appropriate treatment for diarrhoea, for example with loperamide, as soon as possible after consulting your doctor.
• Febrile neutropenia and sepsis (common, may affect up to 1 in 10 people) Treatment with Nintedanib Accordpharma may cause a reduction in the number of a type of white blood cells ( neutropenia ) that are important for the body's response to infections caused by bacteria or fungi. As a consequence of neutropenia, fever ( febrile neutropenia ) and blood infection ( sepsis ) may occur. If you experience fever, chills, rapid breathing or rapid heartbeat, inform your doctor immediately. During treatment with Nintedanib Accordpharma, your doctor will regularly monitor your blood cells and perform regular check-ups 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 fingers and toes ( peripheral neuropathy )
• Feeling unwell ( nausea )
• Vomiting
• Stomach (abdominal) pain
• Bleeding
• Decrease in the 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 )
• Rash
• Reduced appetite
• Electrolyte imbalance
• Increased liver enzyme levels (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
• Decrease in the 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 one limb), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (if you experience any of these symptoms, contact a doctor immediately)
• High blood pressure ( hypertension )
• Fluid loss ( dehydration )
• Abscesses
• Low platelet count ( thrombocytopenia )
• Jaundice ( hyperbilirubinemia )
• Increased liver enzyme levels (gamma-glutamyltransferase) in the blood, detected by blood tests
• Weight loss
• Itching ( pruritus )
• Headache ( cephalalgia )
• Increased amount of protein in the urine ( proteinuria )

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

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

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

• Inflammation of the large intestine
• Widening and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (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).

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 Accordpharma

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

6. Package contents and other information

What Nintedanib Accordpharma contains
The active substance is nintedanib. Each soft capsule contains 150 mg of nintedanib (as esilate).
The excipients are:
Capsule contents: 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 150 mg soft capsules are oblong, opaque, brown soft gelatin capsules approximately 18 mm in size, printed with "JF2" in black ink, containing a bright yellowish-green to light yellow suspension.
One pack contains 60 capsules (6 aluminium blisters with 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

Manufacturers
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,
The 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 European Economic Area Member States under the following names: