Nintedanib accordpharma

Package leaflet: Information for the patient

Nintedanib Accordpharma, 150 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 so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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 to supply cancer cells with 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 certain type of cancer (“adenocarcinoma”) and who have already 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, bleeding problems, or especially recent pulmonary haemorrhage;
• the patient has or has had kidney problems or if proteinuria (increased protein in urine) has been detected;
• the patient is taking medications 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 plans to undergo a surgical procedure. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Accordpharma is usually interrupted if the patient undergoes surgery. The doctor will decide when treatment with this medicine 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 weakened and enlarged blood vessel wall) or arterial dissection.

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 the doctor immediately if, during treatment with this medicine:

• the patient develops diarrhoea. It is important to treat diarrhoea promptly upon the first symptoms (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 tea-coloured urine, pain in the upper right part of the abdomen, more frequent bleeding or bruising, or a feeling of fatigue. These may be signs of severe liver disorders;
• the patient develops fever, chills, rapid breathing, or rapid heartbeat. These may be signs of infection or blood infection (sepsis) (see section 4);
• the patient experiences severe abdominal pain, fever, chills, nausea, vomiting, or a hard abdomen or bloating, as these may be signs of a perforation in the intestinal wall (gastrointestinal perforation);
• the patient experiences several or all of the following symptoms simultaneously: sudden severe abdominal pain or cramps, presence of red blood in stool, diarrhoea or constipation, nausea, and vomiting, as these may be signs 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 signs of blood clot formation in a vein (thrombosis);
• the patient experiences serious bleeding;
• the patient develops 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 signs 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 lung cancer (NDRP) and is therefore not intended for use in children and adolescents under 18 years of age.
Nintedanib Accordpharma and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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 (a medicine 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 using this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn child and cause congenital malformations.
Contraception

• Women of childbearing potential who are taking Nintedanib Accordpharma must use a highly effective method of contraception to prevent pregnancy, both when starting treatment with Nintedanib Accordpharma, throughout the treatment period, and for at least 3 months after stopping treatment.
• Discuss with the 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 the doctor the use of an alternative, more suitable method of contraception.
• If the patient becomes pregnant or suspects she may be pregnant during treatment with Nintedanib Accordpharma, she must immediately inform her doctor or pharmacist.

Breastfeeding
It is not known whether the medicine passes into human milk and whether it could harm a breastfed child.
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 using machines
Nintedanib Accordpharma may have a minor influence on the ability to drive and use machines. 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 hypersensitivity to peanuts or soya has been diagnosed.

3. How to take Nintedanib Accordpharma

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Do not take Nintedanib Accordpharma on the same day that the patient receives chemotherapy with docetaxel.
The capsules should be swallowed whole with water; do not chew them. It is recommended to take the capsule
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 two capsules per day (providing 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, approximately 12 hours apart, for
example one capsule in the morning and one capsule in the evening. These two doses should be taken at
approximately the same times each day. Taking the medicine in 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 300 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 prior consultation with your doctor.
The doctor may reduce the daily dose of Nintedanib Accordpharma to 200 mg per day (two capsules of
100 mg). In such a case, the doctor will prescribe Nintedanib Accordpharma 100 mg soft capsules for
continued treatment.
One capsule of this strength should be taken twice daily, approximately 12 hours apart, together with
food (e.g. in the morning and evening), at approximately the same time each day.
If the doctor discontinues chemotherapy with docetaxel, the patient should continue taking Nintedanib
Accordpharma twice daily.
Accidental overdose of Nintedanib Accordpharma
Contact your doctor or pharmacist immediately.
Missed 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 schedule, at the usual time and in the dose prescribed by your doctor or pharmacist.
Stopping treatment with 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 advises. 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, consult 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.
• Febrile neutropenia and sepsis (common, may occur in up to 1 in 10 people) Treatment with Nintedanib Accordpharma may lead to a decrease in the number of certain types of white blood cells ( neutropenia ), which are very important for the body's defence against bacterial or fungal infections. As a consequence of neutropenia, fever ( febrile neutropenia ) and blood infection ( sepsis ) may occur. If the patient develops fever, chills, rapid breathing or rapid heartbeat, inform the doctor 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 during treatment 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
• 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 oral mucositis )
• Rash
• Decreased appetite
• Electrolyte imbalance
• Increased liver enzyme activity (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase in blood) visible 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 ( febrile neutropenia )
• 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 are observed, seek medical help immediately).
• High blood pressure ( hypertension )
• Loss of fluids from the body ( dehydration )
• Abscesses
• Low number of platelets ( thrombocytopenia )
• Jaundice ( hyperbilirubinemia )
• Increased activity of liver enzyme (gamma-glutamyl transferase) in blood, visible in blood test results
• Decreased body weight
• Itching
• Headache
• Increased amount of 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

Not known (frequency cannot be estimated from available data)

• Inflammation of the large intestine
• 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, disorientation, 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, tell your doctor or nurse. Adverse reactions can be reported
directly to the Department for Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Do not use this medicine if the blister containing the capsules is open or if a capsule is cracked.
If you come into contact with the capsule contents, wash your 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 Package and Other Information

What Nintedanib Accordpharma contains

• The active substance is nintedanib. Each soft capsule contains nintedanib esilate equivalent to 150 mg of nintedanib.
• Other ingredients are:
  Capsule contents: medium-chain triglycerides, macrogol glycerides laurates, 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 150 mg capsules are soft gelatin capsules approximately 18 mm long, brown in colour, opaque, elongated in shape, printed with black ink with the mark "JF2", containing a suspension ranging in colour from bright greenish-yellow to pale yellow.
Nintedanib Accord 100 mg capsules are available in cartons containing:

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

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
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 countries under the following names: