NINTEDANIB ACCORDPHARMA 150 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Nintedanib Accordpharma 150 mg Soft Capsules EFG

Read all of this leaflet carefully before you start 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Nintedanib Accordpharma and what is it used for
2. What you need to know before you take Nintedanib Accordpharma
3. How to take Nintedanib Accordpharma
4. Possible side effects
5. Storage of 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 blocks the activity of a group of proteins involved in the development of new blood vessels that cancer cells need to supply food and oxygen. By blocking the activity of these proteins, nintedanib can help 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). It is intended for adult patients with a specific type of NSCLC (“adenocarcinoma”) who have already received treatment with another medicine for this cancer, but in whom the tumor has started to grow again.

2. What you need to know before you take Nintedanib Accordpharma

Do not take Nintedanib Accordpharma

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

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine

• if you have or have had liver problems, if you have or have had bleeding problems, particularly recent bleeding in the lung
• if you have or have had kidney problems or if you have been detected with an increase in the amount of protein in the urine
• if you are taking medicines to thin the blood (such as warfarin, phenprocoumon, heparin, or acetylsalicylic acid) to prevent blood clots. Treatment with nintedanib may produce a higher risk of bleeding
• if you have recently undergone surgery or have a planned intervention. Nintedanib may affect the way wounds heal. Therefore, treatment with this medicine will generally be interrupted if you undergo surgery. Your doctor will decide when to 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 (enlargement 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 some blood tests, for example, to check your liver function and to determine how quickly your blood can clot. Your doctor will discuss the results of these tests with you to decide if you can receive this medicine.

Tell your doctor immediately while taking this medicine

• if you have diarrhea. It is essential to treat diarrhea as soon as the first symptoms appear (see section 4).
• if you have vomiting or feel like vomiting (nausea).
• if you have symptoms without an apparent cause such as yellowing of the skin or the whites of the eyes (jaundice), dark or brown urine (the color of tea), pain in the upper right side of the stomach area (abdomen), bleeding or bruising more easily than usual, or feeling tired. They could be symptoms of serious liver problems.
• if you have a fever, chills, rapid breathing, or a rapid heart rate, which could be signs of infection or blood infection (sepsis) (see section 4).
• if you experience severe pain in the stomach area, fever, chills, dizziness, vomiting, or abdominal stiffness or swelling, as these could be symptoms of having a hole in the wall of the intestines (“gastrointestinal perforation”).
• if you experience a combination of some or all of the following symptoms: severe and sudden abdominal pain, blood in the stool, diarrhea or constipation, nausea, and vomiting, as these could be symptoms of intestinal inflammation due to reduced blood flow (“ischemic colitis”).
• if you experience pain, swelling, redness, or warmth in a limb or if you experience chest pain and difficulty breathing, as these could be symptoms of having a blood clot in one of your veins.
• if you have a significant bleeding.
• if you experience pressure or pain in the chest, usually on the left side of the body, pain in the neck, jaw, shoulder, or arm, a rapid heart rate, difficulty breathing, 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 disorders such as weakness in an arm or leg, with or without high blood pressure, which could be symptoms of a brain disorder called posterior reversible encephalopathy syndrome (PRES).
• if any of the side effects you may have (see section 4) worsen.

Children and adolescents

This medicine has not been studied in children or adolescents to treat lung cancer (NSCLC) and, therefore, children and adolescents under 18 years of age should not take it.

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 obtained without a prescription.

This medicine may interact with other medicines. The following medicines may increase the blood levels of nintedanib, the active substance of this medicine, and therefore increase 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 the blood levels of nintedanib and thus reduce the efficacy of nintedanib:

• Rifampicin (an antibiotic used to treat tuberculosis)
• Carbamazepine, phenytoin (used to treat seizures)
• St. John's Wort (a herbal medicine used to treat depression)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take this medicine during pregnancy, as it may harm the fetus and cause birth defects.

Contraception

• Women who can become pregnant must use a highly effective method of contraception to avoid becoming pregnant when starting to take nintedanib, while taking nintedanib, and for at least three months after finishing treatment.
• Consult your doctor to determine the most suitable contraceptive methods.
• Vomiting and/or diarrhea or other gastrointestinal disorders may affect the absorption of hormonal oral contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, if you experience any of these situations, consult your doctor to assess an alternative contraceptive method.
• Tell your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with nintedanib.

Breastfeeding

It is not known whether the medicine passes into breast milk and may harm the breastfed child. Therefore, women should not breastfeed during treatment with nintedanib.

Fertility

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

Driving and using machines

Nintedanib has little influence on the ability to drive and use machines. Do not drive or use machines if you feel dizzy.

Nintedanib Accordpharma contains soy lecithin

The capsules contain soy lecithin. If you are allergic to peanuts or soy, do not take this medicine.

3. How to take Nintedanib Accordpharma

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Do not take nintedanib on the same day you receive chemotherapy treatment with docetaxel.

Swallow the capsules whole with water, without chewing them. It is recommended to take the capsules with food, i.e., during meals or immediately before or after meals.

Do not open or break the capsule (see section 5).

The recommended dose is two capsules a day (for a total of 300 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 with approximately 12 hours between them, for example, one capsule in the morning and one capsule in the evening. The two doses should be taken approximately at the same time each day. If you take the medicine in this way, you will ensure that a constant level of nintedanib is maintained in the body.

Dose reduction

If you cannot tolerate the recommended dose of 300 mg per day due to the appearance of side effects (see section 4), your doctor may reduce your daily dose of this medicine. Do not reduce the dose or interrupt treatment without consulting your doctor first.

Your doctor may reduce the recommended dose to 200 mg per day (two 100 mg capsules). In this case, your doctor will prescribe nintedanib 100 mg soft capsules for your treatment. You should take one capsule of this concentration twice a day with food, with approximately 12 hours between them (e.g., in the morning and in the evening) and approximately at the same time of day.

If your doctor has suspended chemotherapy with docetaxel, you should continue taking this medicine twice a day.

If you take more Nintedanib Accordpharma than you should

Contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Nintedanib Accordpharma

Do not take a double dose to make up for forgotten doses. Take your next dose of nintedanib according to the established schedule and the recommended dose by your doctor or pharmacist.

If you stop taking Nintedanib Accordpharma

Do not stop taking nintedanib without consulting your doctor first. It is essential to take this medicine every day while your doctor prescribes it. If you do not take this medicine as your doctor has prescribed, this cancer treatment may not work properly.

If you have any further questions on 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 special attention if you experience the following side effects during treatment with nintedanib:

• Diarrhea(very common, may affect more than 1 in 10 people)

Diarrhea can cause a loss of important fluids and salts (electrolytes, such as sodium or potassium) from the body. At the first symptoms of diarrhea, drink plenty of fluids and consult your doctor immediately. Start appropriate antidiarrheal treatment as soon as possible, for example, by taking loperamide, after consulting your doctor.

• Febrile neutropeniaandsepsis(common, may affect up to 1 in 10 people)

Treatment with nintedanib may cause a reduction in the number of a type of white blood cell (neutropenia), which are important for the body to react adequately to bacterial or fungal infections. As a consequence of neutropenia, fever (febrile neutropenia) and blood infection (sepsis) may occur. Tell your doctor immediately if you have a fever, chills, rapid breathing, or a rapid heart rate.

During treatment with nintedanib, your doctor will perform periodic analyses of your blood cells and check for 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
• Pain, numbness, and/or tingling in the fingers of the hands or feet (peripheral neuropathy)
• Discomfort (nausea)
• Vomiting
• Abdominal pain (abdomen)
• Bleeding
• Reduced 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
• Decreased appetite
• Electrolyte imbalance
• Increased liver enzyme values (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase in blood), which are detected in blood tests
• Hair loss (alopecia)

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

• Blood infection (sepsis); see above
• Reduced 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 and cause chest pain and difficulty breathing (if you notice any of these symptoms, seek medical attention immediately)
• High blood pressure (hypertension)
• Fluid loss (dehydration)
• Abscesses
• Low platelet count (thrombocytopenia)
• Jaundice (hyperbilirubinemia)
• Increased liver enzyme values (gamma-glutamyltransferase) in blood, which are detected 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)

• Holes in the wall of the intestines (gastrointestinal perforation)
• Severe liver problems
• Pancreatitis (inflammation of the pancreas)
• Heart attack (myocardial infarction)
• Kidney failure

Frequency not known (cannot be estimated from the available data)

• Inflammation of the large intestine
• Enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysms and arterial dissections)
• Brain disorder 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 (posterior reversible encephalopathy syndrome).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton and blister after “EXP”. The expiry date is the last day of the month shown.

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 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 no longer required. These measures will help protect the environment.

6. Container Contents and Additional Information

Composition of Nintedanib Accordpharma

• The active substance is nintedanib. Each capsule contains 150 mg of nintedanib (as esilate).
• The other components (excipients) are:

• Capsule content:Medium-chain triglycerides, lauryl macrogolglycerides, lecithin (E322) (see section 2)
• Outer 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)

Appearance and Container Contents of the Product

The Nintedanib Accordpharma capsule is approximately 18 mm in length, a soft gelatin oblong capsule, opaque, and brown in color, with "JF2" printed in black ink, containing a bright yellow-green to pale yellow suspension.

Nintedanib Accordpharma is available in the following package sizes:

• Aluminum-aluminum blisters of 60 and 120 soft capsules (multipack containing 2 packs of 60 soft capsules each).
• Aluminum-aluminum blisters are available in single-dose precut blisters of 60 x 1 and 120 x 1 soft capsules (multipack containing 2 packs of 60 soft capsules each).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6th Floor

08039 Barcelona

Spain

Manufacturer:

Accord Healthcare Polska Sp. z.o.o.

ul. Lutomierska 50,

95-200, Pabianice,

Poland

Or

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola, PLA 3000,

Malta

Or

Accord Healthcare B.V.

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Or

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 the last revision of this leaflet:December 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es