Nintedanib Accord 100 mg soft capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Nintedanib Accord 100 mg soft capsules

nintedanib

Read the entire leaflet carefully before you start taking this medicine, as 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Nintedanib Accord is and what it is used for
2. What you need to know before taking Nintedanib Accord
3. How to take Nintedanib Accord
4. Possible side effects
5. How to store Nintedanib Accord
6. Contents of the pack and other information

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

Nintedanib Accord contains the active substance nintedanib, a medicine that belongs to the class of drugs known as tyrosine kinase inhibitors, and is used to treat the following conditions:

Idiopathic pulmonary fibrosis (IPF) in adults

IPF is a disease that causes progressive thickening, hardening, and scarring of lung tissue over time. As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream, making it difficult to breathe deeply.

Nintedanib Accord helps reduce the development of further scarring and lung tissue stiffening.

Other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype in adults

In addition to IPF, there are other disorders in which lung tissue progressively thickens, hardens, and scars over time (pulmonary fibrosis) and continues to worsen (progressive phenotype). Examples of these disorders include hypersensitivity pneumonitis, autoimmune ILDs (such as ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, idiopathic organizing pneumonia, and other ILDs. Nintedanib Accord helps reduce new scarring and further stiffening of the lungs.

Clinically significant progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents aged 6 to 17 years

Pulmonary fibrosis may occur in patients with Childhood Interstitial Lung Disease (ChILD). In this case, the lung tissue in children and adolescents undergoes progressive thickening, hardening, and scarring over time. Nintedanib Accord helps reduce the development of further scarring and stiffening of the lungs.

Interstitial lung disease associated with systemic sclerosis (ILD-SSc) in adults, adolescents, and children aged 6 years and older

Systemic sclerosis (SSc), also known as scleroderma (and juvenile systemic sclerosis in children and adolescents), is a rare chronic autoimmune disease affecting connective tissue in many parts of the body. SSc causes fibrosis (scarring and hardening) of the skin and other internal organs, such as the lungs.

When the lungs are affected by fibrosis, it is called interstitial lung disease (ILD), and thus the condition is referred to as ILD-SSc. Fibrosis in the lungs reduces the ability to transfer oxygen into the bloodstream and impairs breathing capacity. Nintedanib Accord helps reduce new scarring and further stiffening of the lungs.

2. What you need to know before taking Nintedanib Accord

Do not take Nintedanib Accord

• if you are pregnant,
• 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 treatment with Nintedanib Accord

• if you have or have had liver problems,
• 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 have or have had bleeding problems,
• if you are taking medicines to thin the blood (such as warfarin, phenprocoumon, or heparin) to prevent blood clots,
• if you are taking pirfenidone, as this may increase the risk of developing diarrhoea, nausea, vomiting, and liver problems,
• if you have or have had heart problems (such as a heart attack),
• if you have recently undergone surgery. Nintedanib may affect how wounds heal. Therefore, treatment with Nintedanib Accord is usually paused for a period of time if you undergo surgery. Your doctor will decide when to restart treatment with this medicine.
• if you have high blood pressure,
• if you have abnormally high blood pressure in the blood vessels of the lungs (pulmonary hypertension),
• 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. Your doctor will discuss the results of these tests with you to determine whether you can take Nintedanib Accord.

Tell your doctor immediately while you are taking this medicine

• if you have diarrhoea. It is important to treat diarrhoea early (see section 4 “Possible side effects”);
• if you have vomiting or feel sick (nausea);
• if you experience unexplained symptoms such as yellowing of the skin or the whites of the eyes (jaundice), dark or brown-coloured urine (like tea), pain in the upper right side of the stomach (abdomen), bleeding or bruising more easily than normal, or feel tired. These could be signs of serious liver problems;
• if you have sudden 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 intestine (“gastrointestinal perforation”). Also inform your doctor if you have previously had peptic ulcers or diverticular disease, or if you are being treated with anti-inflammatory medicines (NSAIDs) (used to relieve pain and swelling) or steroids (used for inflammation and allergies), as these may increase this risk;
• if you have a combination of severe or cramp-like stomach pain, red blood in the stools or diarrhoea, as these could be symptoms of intestinal inflammation due to insufficient blood supply;
• if you have pain, swelling, redness, or warmth in a limb, as these could be symptoms of a blood clot in one of your veins (a type of blood vessel);
• if you have pressure or pain in the chest, usually on the left side of the body, pain in the neck, jaw, shoulder, or arm, rapid heartbeat, shortness of breath, nausea or vomiting, as these could be symptoms of a heart attack;
• if you have a significant bleeding episode;
• if you experience bruising, bleeding, fever, fatigue, and confusion, as these may be signs of damage to blood vessels known as thrombotic microangiopathy (TMA);
• if you experience symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure, which could be symptoms of a brain disorder called reversible posterior encephalopathy syndrome (RPES).

Children and adolescents

Children under 6 years of age must not take Nintedanib Accord.

Your doctor may recommend periodic dental examinations at least every 6 months until tooth development is complete and monitor your growth once a year (bone imaging study) while you are taking this medicine.

Other medicines and Nintedanib Accord

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.

Nintedanib Accord may interact with other medicines. The following medicines may increase the blood levels of nintedanib and therefore increase the risk of side effects (see section 4 “Possible side effects”):

• a medicine used to treat fungal infections (ketoconazole)
• a medicine used to treat bacterial infections (erythromycin)
• a medicine that affects your immune system (cyclosporine)

The following medicines are examples that may decrease the blood levels of nintedanib and thus reduce the effectiveness of Nintedanib Accord:

• an antibiotic used to treat tuberculosis (rifampicin)
• medicines used to treat seizures (carbamazepine, phenytoin)
• a herbal medicine used to treat depression (St. John’s wort)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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.

You must be given a pregnancy test to confirm that you are not pregnant before starting treatment with Nintedanib Accord. Consult your doctor.

Contraception

• Women who could become pregnant must use a highly effective method of contraception to prevent pregnancy when starting Nintedanib Accord, while taking Nintedanib Accord, and for at least 3 months after stopping treatment.
• Discuss with your doctor the most appropriate contraceptive methods for you.
• 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 an alternative, more appropriate method of contraception.

• Inform your doctor or pharmacist immediately if you become pregnant or think you may be pregnant while being treated with Nintedanib Accord.

Breastfeeding

Do not breastfeed during treatment with Nintedanib Accord, as it may cause harm to the breastfed infant.

Driving and using machines

Nintedanib Accord has minor influence on the ability to drive and use machines. You should not drive or operate machinery if you feel dizzy.

Nintedanib Accord contains soya lecithin

If you are allergic to soya or peanuts, do not take this medicine (see section 2 “Do not take Nintedanib Accord”).

3. How to take Nintedanib Accord

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take the capsules twice daily, approximately 12 hours apart and at approximately the same time each day; for example, one capsule in the morning and one capsule in the evening. This will ensure that a constant level of nintedanib is maintained in your blood. Swallow the capsules whole with water, without chewing them. It is recommended that you 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 “Storage of Nintedanib Accord”).

To make swallowing the capsules easier, you may take them with a small amount (one teaspoonful) of soft food at room temperature or cold, such as apple sauce or chocolate pudding. Swallow the capsules immediately and do not chew them, to ensure they remain intact.

Adults

The recommended dose is one 100 mg capsule twice daily (a total of 200 mg daily).

Do not take more than the recommended dose of two Nintedanib Accord 100 mg capsules per day.

If you do not tolerate the recommended dose of two Nintedanib Accord 100 mg capsules per day (see possible adverse effects in section 4), your doctor may recommend that you stop taking this medicine. Do not reduce the dose or stop treatment on your own without first consulting your doctor.

Use in children and adolescents

The recommended dose depends on the patient's body weight.

Inform your doctor if at any time during treatment the patient's weight falls below 13.5 kg. Inform your doctor if you have liver problems.

Your doctor will determine the correct dose. Your doctor may adjust the dose during the course of treatment. If you do not tolerate the recommended daily dose of nintedanib capsules (see possible adverse effects in section 4), your doctor may reduce the daily dose of nintedanib. Do not reduce the dose or interrupt treatment on your own without first consulting your doctor.

Dosage based on weight for Nintedanib Accord capsules in children and adolescents:

• Nintedanib Accord is only available in 100 mg and 150 mg soft capsules. Therefore, it is not possible to administer Nintedanib Accord to pediatric patients who require less than a full 100 mg dose. If an alternative dosage is required, other nintedanib-containing products offering this option should be used.

If you take more Nintedanib Accord than you should

Contact your doctor or pharmacist immediately.

If you forget to take Nintedanib Accord

Do not take two capsules together if you have missed your previous dose. You should take your next dose of Nintedanib Accord at the next scheduled and recommended time according to your doctor or pharmacist.

If you stop taking Nintedanib Accord

Do not stop taking Nintedanib Accord without first consulting your doctor. It is important to take this medicine every day as long as your doctor prescribes it.

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 Accord:

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

Diarrhoea may lead to dehydration: a loss of fluids and important salts from the body (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.

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

Contact your doctor if you experience any type of adverse effect.

Idiopathic pulmonary fibrosis (IPF)

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

• Nausea
• Abdominal pain
• Abnormal liver function test results

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

• Vomiting
• Loss of appetite
• Weight loss
• Bleeding
• Rash
• Headache

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

• Pancreatitis
• Inflammation of the large intestine
• Serious liver problems
• Low platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Jaundice, i.e., yellowing of the skin and whites of the eyes due to high levels of bilirubin
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Frequency not known (cannot be estimated from available data)

• Kidney failure
• Weakening and enlargement of a blood vessel wall or tear in the 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 (reversible posterior encephalopathy syndrome)

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype

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

• Nausea
• Vomiting
• Loss of appetite
• Abdominal pain
• Abnormal liver function test results

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

• Weight loss
• High blood pressure (hypertension)
• Bleeding
• Serious liver problems
• Rash
• Headache

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

• Pancreatitis
• Inflammation of the large intestine
• Low platelet count (thrombocytopenia)
• Jaundice, i.e., yellowing of the skin and whites of the eyes due to high levels of bilirubin
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Frequency not known (cannot be estimated from available data)

• Kidney failure
• Weakening and enlargement of a blood vessel wall or tear in the 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 (reversible posterior encephalopathy syndrome)

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)

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

• Nausea
• Vomiting
• Abdominal pain
• Abnormal liver function test results

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

• Bleeding
• High blood pressure (hypertension)
• Loss of appetite
• Weight loss
• Headache

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

• Inflammation of the large intestine
• Serious liver problems
• Kidney failure
• Low platelet count (thrombocytopenia)
• Rash
• Itching

Frequency not known (cannot be estimated from available data)

• Heart attack
• Pancreatitis
• Jaundice, i.e., yellowing of the skin and whites of the eyes due to high levels of bilirubin
• Weakening and enlargement of a blood vessel wall or tear in the blood vessel wall (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)
• 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 (reversible posterior encephalopathy syndrome)

Fibrosing interstitial lung diseases (ILD) in children and adolescents

Adverse effects in children and adolescents were similar to those in adult patients. Inform your doctor if you experience any type of adverse effect.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nintedanib Accord

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 indicated.

This medicine requires no 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 capsule contents, wash your hands immediately with plenty of water (see section 3 "How to take Nintedanib Accord").

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nintedanib Accord

• The active substance is nintedanib. Each soft capsule contains nintedanib esilate equivalent to 100 mg of nintedanib.
• The other components are:

Capsule contents: medium-chain triglycerides, lauroyl macrogol glycerides, 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)

Appearance of Nintedanib Accord and contents of the pack

Nintedanib Accord 100 mg capsules are soft gelatin capsules approximately 16 mm in size, oblong-shaped, opaque, peach-colored, with "JF1" printed in black ink, containing a bright yellow-greenish to pale yellow suspension.

Nintedanib Accord 100 mg capsules are available in packs containing:

• Aluminium/aluminium blisters available in 30, 60 and 120 soft capsules (multipack containing 2 boxes of 60 soft capsules each).
• Aluminium/aluminium blisters available in single-dose perforated blisters of 30 x 1, 60 x 1 and 120 x 1 soft capsules (multipack containing 2 boxes of 60 soft capsules each).

Only certain pack sizes may be marketed.

Marketing Authorization 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

Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht, The Netherlands

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK

Accord Healthcare S.L.U.
Tel: +34 93 301 00 64

EL

Win Medica Α.Ε.
Tel: +30 210 74 88 821

Date of the latest revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu