Nintedanib AccordPharma 100 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Nintedanib Accordpharma 100 mg soft capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse 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 blocks the activity of a group of proteins involved in the formation of new blood vessels that cancer cells need to receive 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). It is intended for adult patients with a specific type of NSCLC (“adenocarcinoma”) who have already been treated with another anticancer therapy, 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, soy, or 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, or if you have or have had bleeding problems, particularly recent lung bleeding
• if you have or have had kidney problems or if you have been found to have increased levels of protein in your 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 increase the risk of bleeding
• if you have recently undergone surgery or have a planned surgical procedure. Nintedanib may affect how 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 (a bulge 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 carry out 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 whether you can take this medicine.

Tell your doctor immediately while taking this medicine

• if you have diarrhoea. It is important to treat diarrhoea as soon as the first symptoms appear (see section 4).
• if you have vomiting or feel sick (nausea).
• if you have unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown-coloured urine (tea-coloured), pain in the upper right side of the stomach area (abdomen), bleeding or bruising more easily than normal, or feel tired. These could be symptoms of serious liver problems.
• if you develop fever, chills, rapid breathing, or a fast heartbeat, which could be signs of infection or blood infection (sepsis) (see section 4).
• if you experience severe stomach pain, fever, chills, dizziness, vomiting, or abdominal stiffness or swelling, as these could be symptoms of a hole in the wall of the intestines (“gastrointestinal perforation”).
• if you experience a combination of some or all of the following symptoms: sudden and severe abdominal pain or cramps, red blood in the stools, diarrhoea or constipation, nausea and vomiting, as these could be symptoms of intestinal inflammation due to reduced blood flow (“ischaemic colitis”).
• if you experience pain, swelling, redness, or warmth in a limb, or if you have chest pain and difficulty breathing, as these could be symptoms of a blood clot in one of your veins.
• if you have a serious bleeding episode.
• 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 fast heartbeat, difficulty breathing, 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, which could be symptoms of a brain disorder called reversible posterior encephalopathy syndrome (RPES).
• if any of the side effects you may experience (see section 4) worsen.

Children and adolescents

This medicine has not been studied in children or adolescents for the treatment of non-small cell 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 need to take any other medicines, including herbal medicines and those obtained without a prescription.

This medicine may interact with other medicines. The following medicines may increase blood levels of nintedanib, the active substance in 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 blood levels of nintedanib and thereby reduce the effectiveness 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Contraception

• Women who can become pregnant must use a highly effective method of contraception to prevent pregnancy when starting treatment with nintedanib, during treatment with nintedanib, and for at least three months after stopping treatment.
• Consult your doctor to determine which contraceptive methods are most appropriate.
• 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, if you experience any of these conditions, consult your doctor to consider a more appropriate alternative contraceptive method.
• Inform your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with nintedanib.

Breastfeeding

It is unknown whether the medicine passes into breast milk and may harm the nursing infant. Therefore, women must 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 a minor influence on the ability to drive and use machines. You should not drive or operate machinery if you feel dizzy.

Nintedanib Accordpharma contains soya lecithin

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

3. How to take Nintedanib Accordpharma

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in 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, that is, during meals or immediately before or after meals.

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

The recommended dose is four capsules per day (which gives a total daily dose of 400 mg of nintedanib). Do not take a higher dose than this.

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. Taking the medicine in this way will ensure a constant level of nintedanib in the body.

Dose reduction

If you are unable to tolerate the recommended dose of 400 mg daily due to the occurrence of adverse effects (see section 4), your doctor may reduce your daily dose of this medicine. Do not reduce the dose or stop treatment on your own without first consulting your doctor.

Your doctor may reduce the recommended dose to 300 mg daily (two 150 mg capsules). In this case, your doctor will prescribe nintedanib 150 mg soft capsules for your treatment.

If necessary, your doctor may further reduce your daily dose to 200 mg daily (two 100 mg capsules). If this occurs, your doctor will prescribe the appropriate capsule strength.

In both cases, you should take one capsule of the appropriate strength twice daily with food, approximately 12 hours apart (for example, in the morning and in the evening), and at approximately the same time each day.

If your doctor has discontinued chemotherapy with docetaxel, you should continue taking this medicine twice daily.

If you take more Nintedanib Accordpharma than you should

Contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 5620420, indicating the medicine and the amount ingested.

If you forget to take Nintedanib Accordpharma

Do not take a double dose to make up for missed doses. Take your next dose of nintedanib at the next scheduled time and at the dose recommended by your doctor or pharmacist.

If you stop taking Nintedanib Accordpharma

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You should pay special attention if you experience the following adverse effects during treatment with nintedanib:

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

Diarrhoea may lead to loss of body fluids and important salts (electrolytes, such as sodium or potassium). At the first signs of diarrhoea, drink plenty of fluids and contact your doctor immediately. Start appropriate anti-diarrhoeal treatment as soon as possible, for example, by taking loperamide, after consulting with your doctor.

• Febrile neutropenia**andsepsis**(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 cells (neutropenia), which are important for the body to respond properly to bacterial or fungal infections. As a consequence of neutropenia, fever (febrile neutropenia) and blood infection (sepsis) may occur. Inform your doctor immediately if you develop fever, chills, rapid breathing, or a fast heartbeat.

During treatment with nintedanib, your doctor will perform periodic blood tests to monitor your blood cells and check for signs of infection, such as inflammation, fever, or fatigue.

The following adverse effects have been observed during treatment with this medicine:

Very common adverse effects (may affect more than 1 in 10 people)

• Diarrhoea; see above
• Sensation of pain, numbness, and/or tingling in fingers or toes (peripheral neuropathy)
• Feeling unwell (nausea)
• Vomiting
• Stomach pain (abdominal pain)
• Bleeding
• Reduction in the number of white blood cells (neutropenia)
• Inflammation of the mucous membranes lining the digestive tract, including mouth sores and ulcers (mucositis, including stomatitis)
• Rash
• Decreased appetite
• Electrolyte imbalance
• Increased levels of liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase in blood), detected in blood tests
• Hair loss (alopecia)

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

• Blood poisoning (sepsis); see above
• Reduction in the number of white blood cells 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 and cause chest pain and difficulty breathing (if you experience any of these symptoms, seek immediate medical attention)
• High blood pressure (hypertension)
• Loss of body fluids (dehydration)
• Abscesses
• Low platelet count (thrombocytopenia)
• Jaundice (hyperbilirubinemia)
• Increased levels of liver enzymes (gamma-glutamyl transferase) in blood, detected in blood tests
• Weight loss
• Itching
• Headache
• Increased amount of protein in the urine (proteinuria)

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

• Development of holes in the intestinal wall (gastrointestinal perforation)
• Severe liver problems
• Inflammation of the pancreas (pancreatitis)
• Myocardial infarction
• Kidney failure

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es.

By reporting adverse 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 stated on the carton and blister after “CAD” or “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the blister pack containing the capsules is open or if a capsule is broken.

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. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nintedanib Accordpharma

• The active substance is nintedanib. Each capsule contains 100 mg of nintedanib (as esilate).

• The other components (excipients) are:

• Capsule contents: Medium-chain triglycerides, lauroyl macrogol glycerides, 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)

Nature and contents of the container

The Nintedanib Accordpharma capsule is approximately 16 mm long, an opaque, oblong soft gelatin capsule of peach colour, printed with "JF1" in black ink, containing a bright yellow-green to pale yellow suspension.

Nintedanib Accordpharma is available in the following pack sizes:

• Aluminium-aluminium blisters containing 60 and 120 soft capsules (multipack containing 2 packs of 60 soft capsules each).
• Aluminium-aluminium blisters are available in pre-cut single-dose blisters of 60 x 1 and 120 x 1 soft capsules (multipack containing 2 packs of 60 soft capsules each).

Some pack sizes may not be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6a Planta

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,

The Netherlands

Or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, 32009

Greece

This medicinal product is authorised 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 about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es