Nintedanib accordpharma

Package leaflet: Information for the patient

Nintedanib Accordpharma, 100 mg, soft capsules
Nintedanibum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the 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 soft capsules contain the active substance nintedanib. Nintedanib inhibits
the activity of a group of proteins involved in the development of new blood vessels, which are
required by cancer cells to supply nutrients and oxygen. By inhibiting the activity of these proteins,
nintedanib may slow down the growth and spread of cancer cells.
This medicine is used in combination with another anticancer medicine (docetaxel) for the treatment of
lung cancer known as non-small cell lung cancer (NSCLC). It is intended for adult patients whose NSCLC is a specific type of cancer (‘adenocarcinoma’) and who have previously been treated with another anticancer therapy, but whose tumour has started to grow again.

2. Important information before taking Nintedanib Accordpharma

When not to take Nintedanib Accordpharma

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

Warnings and precautions
Before starting treatment with Nintedanib Accordpharma, discuss with your doctor or
pharmacist if:

• the patient has or has had liver problems, has or has had bleeding problems, especially recent pulmonary bleeding;
• the patient has or has had kidney problems or if proteinuria (increased protein in urine) has been detected;
• the patient is taking medicines that reduce blood clotting (such as warfarin, phenprocoumon, heparin, or acetylsalicylic acid (aspirin)) to prevent blood clots. Treatment with Nintedanib Accordpharma may increase the risk of bleeding;
• the patient has recently undergone surgery or is planning to undergo surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Accordpharma is usually interrupted if the patient undergoes surgery. Your doctor will decide when treatment should be resumed;
• the patient has cancer with brain metastases;
• if the patient has hypertension;
• if the patient has or has previously had an aneurysm (a bulge and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.

Based on this information, the doctor may perform blood tests, for example, to check liver function or to assess how quickly blood clots. The doctor will discuss the results of these tests with the patient and decide whether Nintedanib Accordpharma can be administered.
Contact your doctor immediately if, during treatment with this medicine:

• the patient develops diarrhoea. It is important to treat diarrhoea promptly as soon as the first symptoms appear (see section 4);
• the patient experiences vomiting or nausea;
• the patient develops unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown (tea-coloured) urine, pain in the upper right part of the abdomen, more frequent than usual bleeding or bruising, or feeling tired. These may be symptoms of serious liver problems;
• the patient develops fever, chills, rapid breathing, or rapid heartbeat. These may be symptoms of infection or blood infection (sepsis) (see section 4);
• the patient develops severe stomach pain, fever, chills, nausea, vomiting, or a hard or distended abdomen, as these may be symptoms of a perforation in the intestinal wall (gastrointestinal perforation);
• the patient experiences several or all of the following symptoms at the same time: sudden severe abdominal pain or cramps, presence of red blood in stool, diarrhoea or constipation, nausea and vomiting, as these may be symptoms of intestinal inflammation due to reduced blood flow (ischaemic colitis);
• the patient develops pain, swelling, redness, and increased temperature in a limb or if the patient experiences chest pain and difficulty breathing, as these may be symptoms of a blood clot in a vein (thrombosis);
• the patient experiences serious bleeding;
• the patient experiences pressure or pain in the chest, typically on the left side of the body, pain in the neck, jaw, arm, or hand, rapid heartbeat, shortness of breath, nausea, or vomiting, as these may be symptoms of a heart attack;
• any adverse reaction that may occur in the patient (see section 4) becomes severe.

Children and adolescents
This medicine has not been studied in children and adolescents for the treatment of non-small cell lung cancer (NSCLC), and therefore is not intended for use in children and adolescents under 18 years of age.
Nintedanib Accordpharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including herbal products and over-the-counter medicines.
This medicine may interact with certain other medicines. The following medicines may increase the blood concentration of nintedanib, the active substance in Nintedanib Accordpharma, and thereby increase the risk of adverse reactions (see section 4):

• ketoconazole (a medicine used to treat fungal infections);
• erythromycin (an antibiotic used to treat bacterial infections).
  The following medicines may decrease the blood concentration of nintedanib and thereby reduce the effectiveness of Nintedanib Accordpharma:
• rifampicin (an antibiotic used to treat tuberculosis);
• carbamazepine, phenytoin (medicines used to treat epileptic seizures);
• St. John's wort (an herbal product used to treat depression).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn child and cause congenital malformations.
Contraceptive methods

• Women of childbearing potential who are taking Nintedanib Accordpharma must use a highly effective method of contraception to prevent pregnancy, both during initiation of treatment, throughout the treatment period, and for at least 3 months after stopping treatment.
• Discuss with your doctor the most appropriate method of contraception.
• Vomiting and (or) diarrhoea or other gastrointestinal disorders may affect the absorption of oral hormonal contraceptives, such as contraceptive pills, and may reduce their effectiveness. Therefore, in case of such disorders, discuss with your doctor the use of an alternative, more suitable method of contraception.
• If the patient becomes pregnant or suspects she may be pregnant while being treated with Nintedanib Accordpharma, inform your doctor or pharmacist immediately.

Breastfeeding
It is not known whether the medicine passes into human breast milk and whether it may harm a breastfed infant.
Therefore, women should not breastfeed during treatment with Nintedanib Accordpharma.
Fertility
The effect of Nintedanib Accordpharma on fertility in humans has not been studied.
Driving and operating machinery
Nintedanib Accordpharma may have a minor influence on the ability to drive and operate machinery. If the patient experiences nausea, he or she should not drive or operate machinery.
Nintedanib Accordpharma contains soya lecithin
The capsules contain soya lecithin. Do not use if known hypersensitivity to peanuts or soya has been diagnosed.

3. How to take Nintedanib Accordpharma

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If in doubt,
ask your doctor or pharmacist.
Do not take Nintedanib Accordpharma on the same day the patient receives chemotherapy with docetaxel.
The capsules should be swallowed whole with water; do not chew them. It is recommended to take the capsules
with food, i.e. during a meal or immediately before or after a meal.
Do not open or crush the capsules (see section 5).
The recommended dose is four capsules per day (providing a total of 400 mg nintedanib per day). Do not
take a higher dose.
This daily dose should be divided into two doses of two capsules each, 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 times each day. Taking the medicine this way will ensure a constant level of
nintedanib in the patient's body.
Dose reduction
If the patient does not tolerate the recommended dose of 400 mg per day due to adverse reactions (see
section 4), the doctor may reduce the daily dose of Nintedanib Accordpharma. Do not reduce the dose or
discontinue treatment on your own without consulting your doctor first.
The doctor may reduce the recommended dose to 300 mg per day (two capsules of 150 mg). In this case,
the doctor will prescribe the patient Nintedanib Accordpharma, 150 mg, soft capsules for continued treatment.
If necessary, the doctor may further reduce the recommended dose to 200 mg per day (two capsules of 100 mg). In this case, the patient will receive a prescription from the doctor for capsules of the appropriate strength.
In both cases, one capsule of the appropriate strength should be taken twice daily, approximately 12 hours apart, with food (e.g. in the morning and evening), at approximately the same time each day.
If the doctor discontinues docetaxel chemotherapy, the patient should continue taking Nintedanib Accordpharma twice daily.
Taking more Nintedanib Accordpharma than recommended
Contact your doctor or pharmacist immediately.
Missing a dose of Nintedanib Accordpharma
Do not take a double dose to make up for a missed dose. Take the next dose of Nintedanib Accordpharma
according to the schedule, at the usual time and in the dose recommended by your doctor or pharmacist.
Stopping Nintedanib Accordpharma
Do not stop taking Nintedanib Accordpharma without first consulting your doctor.
It is important to take the medicine every day for as long as your doctor recommends. If the patient does not
take this medicine as directed by the doctor, cancer treatment may not be effective.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Particular attention should be paid to the following adverse reactions during treatment with
Nintedanib Accordpharma.

• Diarrhoea (very common, may occur in more than 1 in 10 people) Diarrhoea may lead to loss of water and important substances (electrolytes such as sodium or potassium) from the body. If the first symptoms of diarrhoea occur, drink plenty of fluids and contact your doctor immediately. Anti-diarrhoeal treatment, for example with loperamide, should be started as soon as possible, after consulting your doctor.
• Neutropenic fever and sepsis (common, may occur in up to 1 in 10 people) Treatment with Nintedanib Accordpharma may lead to a decrease in a certain type of white blood cells ( neutropenia ), which are very important for the body's defence against bacterial or fungal infections. As a result of neutropenia, fever ( neutropenic fever ) and blood infection ( sepsis ) may occur. If the patient develops fever, chills, rapid breathing or rapid heartbeat, the doctor should be informed immediately. During treatment with Nintedanib Accordpharma, the doctor will regularly check blood cell counts and monitor the patient for signs of infection, such as inflammation, fever or fatigue.

The following adverse reactions have been observed with this medicine:
Very common adverse reactions (may occur in more than 1 in 10 people)

• Diarrhoea – see above
• Pain, numbness and (or) tingling in fingers, hands and feet ( peripheral neuropathy )
• Nausea ( nausea )
• Vomiting
• Abdominal pain
• Bleeding
• Decreased number of white blood cells ( neutropenia )
• Inflammation of the mucous membranes of the gastrointestinal tract, including mouth ulcers and development of sores ( mucositis, including stomatitis )
• Rash
• Decreased appetite
• Electrolyte imbalance
• Increased liver enzyme activity (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase in blood) observed in blood tests
• Hair loss (alopecia)

Common adverse reactions (may occur in up to 1 in 10 people)

• Sepsis ( sepsis ) – see above
• Decreased number of white blood cells with fever ( neutropenic fever )
• Formation of blood clots in veins ( venous thromboembolic disease ), particularly in the legs (symptoms include pain, redness, swelling and increased warmth of the limb), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing (if any of these symptoms occur, seek medical help immediately).
• High blood pressure ( hypertension )
• Loss of fluids from the body ( dehydration )
• Abscesses
• Low platelet count ( thrombocytopenia )
• Jaundice ( hyperbilirubinemia )
• Increased activity of liver enzyme (gamma-glutamyl transferase) in blood, observed in blood test results
• Weight loss
• Itching
• Headache
• Increased protein in urine ( proteinuria )

Uncommon adverse reactions (may occur in up to 1 in 100 people)

• Formation of a hole in the intestinal wall ( gastrointestinal perforation )
• Severe liver function disorders
• Pancreatitis
• Myocardial infarction
• Renal failure

Unknown frequency (cannot be estimated from available data)

• Colitis
• Enlargement and weakening of the blood vessel wall or tearing of the blood vessel wall (aneurysms and arterial dissections)
• Brain disorder characterised by symptoms such as headache, visual disturbances, confusion, seizures or other neurological disturbances such as weakness in arms or legs, with or without high blood pressure (posterior reversible encephalopathy syndrome).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or nurse. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 pack. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use this medicine if the blister pack containing the capsules is open or if a capsule appears damaged or broken.
In case of contact with the capsule contents, wash hands immediately with plenty of water (see section 3).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Nintedanib Accordpharma contains

• The active substance is nintedanib. Each soft capsule contains nintedanib esilate in an amount equivalent to 100 mg of nintedanib.
• Other ingredients are:
  Capsule contents: medium-chain triglycerides, macrogol glycerides of lauric acid, 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 and propylene glycol (E1520)

What Nintedanib Accordpharma looks like and contents of the pack
Nintedanib Accord 100 mg capsules are soft gelatin capsules approximately 16 mm in length, peach-coloured, opaque, elongated in shape, printed with black ink with the code "JF1", containing a suspension ranging in colour from bright greenish-yellow to pale yellow.
Nintedanib Accord 100 mg capsules are available in boxes containing:

• Aluminium/aluminium foil blisters with 60 and 120 soft capsules (pack containing 2 boxes of 60 capsules each) in a cardboard box
• Aluminium/aluminium foil blisters, divided into single doses and perforated through, with 60 × 1 and 120 × 1 soft capsules (pack containing 2 boxes of 60 capsules each) in a cardboard box

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 22 577 28 00
Manufacturer
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht, Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, 32009, Greece
This medicinal product is authorised in the European Economic Area under the following names: