Nintedanib Accordpharma

Leaflet accompanying the packaging: patient information

Nintedanib Accordpharma, 100 mg, soft capsules

Nintedanib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Nintedanib Accordpharma capsules contain the active substance nintedanib. Nintedanib blocks the activity of a certain group of proteins involved in the development of new blood vessels, which are necessary for cancer cells to receive nutrients and oxygen. By blocking the activity of these proteins, nintedanib can inhibit the growth and spread of cancer cells.
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). It is intended for adult patients whose NSCLC is a certain type of cancer ("adenocarcinoma") and who have already been treated with another cancer medicine, but whose tumor 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Nintedanib Accordpharma, the patient should discuss with their doctor or pharmacist if:

• the patient has or has had liver problems, has or has had bleeding problems, especially recent bleeding in the lung;
• the patient has or has had kidney problems or if they have been found to have an increased amount of protein in their urine;
• the patient is taking medicines to prevent blood clotting (such as warfarin, phenprocoumon, heparin, or acetylsalicylic acid (aspirin)), as treatment with Nintedanib Accordpharma may increase the risk of bleeding;
• the patient has recently had surgery or is planning to have surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Accordpharma is usually interrupted if the patient is undergoing surgery. The doctor will decide when to resume treatment with this medicine;
• the patient has cancer that has spread to the brain;
• if the patient has high blood pressure;
• if the patient has or has had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Considering this information, the doctor may perform blood tests, for example, to check liver function or to check how quickly the blood clots. The doctor will discuss the results of these tests with the patient and decide whether the patient can take Nintedanib Accordpharma.
The patient should immediately inform their doctor if, while taking this medicine,

• they experience diarrhea. It is essential to treat diarrhea immediately after the first symptoms appear (see section 4);
• they experience vomiting or nausea;
• they experience unexplained symptoms, such as yellowing of the skin or whites of the eyes (jaundice), dark or brown (tea-colored) 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 severe liver disorders;
• they experience fever, chills, rapid breathing, or rapid heartbeat. These may be symptoms of infection or blood infection (sepsis) (see section 4);
• they experience severe abdominal pain, fever, chills, nausea, vomiting, or a hard stomach or bloating, as these may be symptoms of a hole in the wall of the intestine (gastrointestinal perforation);
• they experience several or all of the following symptoms: sudden severe abdominal pain or cramps, presence of red blood in the stool, diarrhea or constipation, nausea, and vomiting, as these may be symptoms of inflammation of the intestine caused by reduced blood flow (ischemic colitis);
• they experience pain, swelling, redness, and increased temperature of a limb or if they experience chest pain and difficulty breathing, as these may be symptoms of a blood clot in one of the veins;
• they experience severe bleeding;
• they experience 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, vomiting, as these may be symptoms of a heart attack;
• any side effect that occurs in the patient (see section 4) becomes serious.

Children and adolescents

This medicine has not been studied in children and adolescents for the treatment of lung cancer (NSCLC), and therefore, it is not intended for use in children and adolescents under 18 years of age.

Nintedanib Accordpharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including herbal products and medicines available without a prescription.
This medicine may interact with certain other medicines. The following medicines may increase the blood levels of nintedanib, the active substance of Nintedanib Accordpharma, and thus may increase the risk of side effects (see section 4):

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn baby and cause birth defects.
Contraception

• Women who may become pregnant and are taking Nintedanib Accordpharma must use highly effective contraception to prevent pregnancy, starting when they begin taking Nintedanib Accordpharma, during treatment, and for at least 3 months after stopping treatment.
• The patient should discuss the best method of contraception with their doctor.
• Vomiting and/or diarrhea or other gastrointestinal disorders may affect the absorption of oral hormonal contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, if such disorders occur, the patient should discuss with their doctor the use of an alternative, more suitable method of contraception.
• If the patient becomes pregnant or thinks they may be pregnant while taking Nintedanib Accordpharma, they should immediately inform their doctor or pharmacist.

Breastfeeding
It is not known whether the medicine passes into human milk and whether it may harm the breastfed baby.
Therefore, women should not breastfeed while taking Nintedanib Accordpharma.

Fertility

The effect of Nintedanib Accordpharma 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 the patient feels nauseous, they should not drive or operate machinery.

Nintedanib Accordpharma contains soy lecithin

The capsules contain soy lecithin. Do not take if you are hypersensitive to peanuts or soy.

3. How to take Nintedanib Accordpharma

Take this medicine always exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Do not take Nintedanib Accordpharma on the same day that you receive docetaxel chemotherapy.
Swallow the capsules 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 a day (which gives a total of 400 mg of nintedanib per day). Do not take a higher dose than this.
This daily dose should 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 should be taken at approximately the same time every day. Taking the medicine in this way will ensure that a constant amount of nintedanib is maintained in the patient's body.

Dose reduction

If the patient cannot tolerate the recommended dose of 400 mg per day due to side effects (see section 4), the doctor may reduce the daily dose of Nintedanib Accordpharma. Do not reduce the dose or stop treatment 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 Nintedanib Accordpharma, 150 mg, soft capsules for further 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 for capsules of the appropriate strength from the doctor.
In both cases, the patient should take one capsule of the appropriate strength twice a day, approximately 12 hours apart, with food (e.g., in the morning and evening), at approximately the same time of day.
If the doctor interrupts docetaxel chemotherapy, the patient should continue to take Nintedanib Accordpharma twice a day.

Taking a higher dose of 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 as planned, at the usual time, and in the dose recommended by your doctor or pharmacist.

Stopping treatment with Nintedanib Accordpharma

Do not stop taking Nintedanib Accordpharma without consulting your doctor first.
It is essential to take the medicine every day, as long as the doctor recommends. If the patient does not take the medicine as recommended by the doctor, the cancer treatment may not be effective.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Pay particular attention to the following side effects when taking Nintedanib Accordpharma.

• Diarrhea(very common, may affect more than 1 in 10 people)Diarrhea may lead to loss of water and essential substances (electrolytes, such as sodium or potassium) from the body. If the first symptoms of diarrhea occur, drink plenty of fluids and contact your doctor immediately. Start appropriate anti-diarrheal treatment as soon as possible, for example, with loperamide, after consulting your doctor.
• Neutropenic feverandsepsis(common, may affect up to 1 in 10 people)Treatment with Nintedanib Accordpharma may lead to a decrease in the number of a certain type of white blood cell (neutropenia), which is essential for the body to fight bacterial or fungal infections. As a result of neutropenia, fever (neutropenic fever) and blood infection (sepsis) may occur. If the patient experiences fever, chills, rapid breathing, or rapid heartbeat, they should immediately inform their doctor. During treatment with Nintedanib Accordpharma, the doctor will regularly check the blood cell count and monitor the patient for signs of infection, such as inflammation, fever, or fatigue.

The following side effects have been observed with this medicine:
Very common side effects (may affect more than 1 in 10 people)

• Diarrhea - see above
• Pain, numbness, and/or tingling of the fingers of the hands and feet (peripheral neuropathy)
• Nausea (nausea)
• Vomiting
• Abdominal pain
• Bleeding
• Decreased white blood cell count (neutropenia)
• Inflammation of the mucous membranes of the gastrointestinal tract, including mouth ulcers and ulceration (mucositis, including oral mucositis)
• Rash
• Decreased appetite
• Electrolyte imbalance
• Increased activity of liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) in blood tests
• Hair loss (alopecia)

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

• Sepsis (sepsis) - see above
• Decreased white blood cell count with fever (neutropenic fever)
• Formation of blood clots in the veins (venous thromboembolic disease), particularly in the legs (symptoms are pain, redness, swelling, and increased temperature of the limb), which can move through the bloodstream 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 the liver enzyme (gamma-glutamyltransferase) in blood tests
• Weight loss
• Itching
• Headache
• Increased amount of protein in the urine (proteinuria)

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

• Formation of a hole in the wall of the intestine (gastrointestinal perforation)
• Severe liver disorders
• Pancreatitis
• Heart attack
• Kidney failure

Unknown frequency (cannot be estimated from the available data)

• Colitis
• Enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysms and arterial dissections)
• A brain disease with symptoms such as headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arms or legs, with high blood pressure or without high blood pressure (posterior reversible encephalopathy syndrome).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
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. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Do not use this medicine if you notice that the blister containing the capsules is open or that the 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).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nintedanib Accordpharma contains

• The active substance is nintedanib. Each soft capsule contains nintedanib esylate equivalent to 100 mg of nintedanib.
• The other ingredients are: Capsule content: triglycerides of fatty acids of medium chain length, macrogolglycerides, soybean 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, and propylene glycol (E1520)

What Nintedanib Accordpharma looks like and contents of the pack

Nintedanib Accordpharma 100 mg soft capsules are soft gelatin capsules, approximately 16 mm in length, peach-colored, opaque, with a longitudinal shape, with a black ink print "JF1", containing a suspension with a color ranging from bright yellowish-green to pale yellow.
Nintedanib Accordpharma 100 mg soft capsules are available in cartons containing:

• Blisters of aluminum/aluminum foil with 60 and 120 soft capsules (packaging containing 2 cartons of 60 capsules) in a cardboard carton
• aluminum/aluminum foil blisters, single-dose and perforated, with 60 × 1 and 120 × 1 soft capsules (packaging containing 2 cartons of 60 capsules) in a cardboard carton

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 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 authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: