NINTEDANIB ACCORD 100 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Nintedanib Accord 100 mg Soft Capsules

nintedanib

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 Package Leaflet

What is Nintedanib Accord and what is it used for

What you need to know before you take Nintedanib Accord

How to take Nintedanib Accord

Possible side effects

Storage of Nintedanib Accord

Contents of the pack and further information

1. What is Nintedanib Accord and what is it 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 idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults.

Idiopathic Pulmonary Fibrosis (IPF)

IPF is a disease that causes thickening, scarring, and stiffening of the tissue in your lungs 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 to reduce the progression of further scarring and stiffening of the lungs.

Other Chronic Fibrosing Interstitial Lung Diseases (ILD) with a Progressive Phenotype

In addition to IPF, there are other conditions where the tissue in your lungs becomes thickened, scarred, and stiffened over time (pulmonary fibrosis) and continues to worsen (progressive phenotype). Some examples of these conditions include hypersensitivity pneumonitis, autoimmune ILD (such as ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, idiopathic unclassifiable interstitial pneumonia, and other ILD. Nintedanib Accord helps to reduce new scarring and stiffening of the lungs.

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

Systemic sclerosis (SSc), also known as scleroderma, is a rare chronic autoimmune disease that affects the connective tissue in many parts of the body. SSc causes fibrosis (scarring and stiffening) 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 disease is called SSc-ILD. Fibrosis in the lungs reduces the ability to transfer oxygen into the bloodstream and reduces the ability to breathe. Nintedanib Accord helps to reduce new scarring and stiffening of the lungs.

2. What you need to know before you take 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

Consult 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 an increased amount of protein in your urine,
• if you have or have had bleeding problems,
• if you are taking medicines to thin your blood (such as warfarin, phenprocoumon, or heparin) to prevent blood clots,
• if you are taking pirfenidone, as this may increase the risk of diarrhea, 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 the way your wounds heal. Therefore, treatment with Nintedanib Accord will usually be stopped 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 your 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 perform some blood tests, for example, to check your liver function. Your doctor will discuss the results of these tests with you to decide if you can take Nintedanib Accord.

Tell your doctor immediately while taking this medicine

• if you have diarrhea. It is important to treat diarrhea early (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 normal, or feeling tired. These could be symptoms of serious liver problems;
• if you have severe stomach pain, fever, chills, dizziness, vomiting, or stiffness or swelling of the abdomen, as these could be symptoms of a hole in the wall of your intestines ("gastrointestinal perforation"). Also, tell your doctor if you have had stomach ulcers or diverticular disease in the past or if you are being treated with non-steroidal anti-inflammatory drugs (NSAIDs) (used to relieve pain and swelling) or steroids (used against inflammation and allergies), as these may increase this risk;
• if you have a combination of severe or colicky stomach pain, blood in your stool, or diarrhea, 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 your chest, usually on the left side of your body, pain in your neck, jaw, shoulder, or arm, rapid heartbeat, difficulty breathing, nausea, or vomiting, as these could be symptoms of a heart attack;
• if you have a severe bleeding.
• if you experience bruising, bleeding, fever, fatigue, and confusion, as these may be a sign of a blood vessel injury known as thrombotic microangiopathy (TMA). 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).

Children and Adolescents

Children and adolescents under 18 years should not take Nintedanib Accord.

Other Medicines and Nintedanib Accord

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.

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

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

The following medicines are examples that may decrease the levels of nintedanib in your blood and, thus, reduce the efficacy 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 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 your unborn baby and cause birth defects.

You should have a pregnancy test before starting treatment with Nintedanib Accord. Ask your doctor.

Contraception

• Women who may become pregnant must use a highly effective method of contraception to prevent pregnancy when starting to take Nintedanib Accord, while taking Nintedanib Accord, and for at least 3 months after stopping treatment.
• Consult your doctor about the most suitable contraceptive methods for you.
• 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 more suitable for you.

• Tell your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with Nintedanib Accord.

Breastfeeding

Do not breastfeed your baby during treatment with Nintedanib Accord, as it may harm your baby.

Driving and Using Machines

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

Nintedanib Accord contains Soybean Lecithin

If you are allergic to soy or peanuts, do not take this medicine (see section 2).

3. How to Take Nintedanib Accord

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Take the capsules twice a day, approximately 12 hours apart, and at about the same time each day; for example, one capsule in the morning and one capsule in the evening. This will help keep a constant level of nintedanib in your blood. Swallow the capsules whole with water, without chewing. It is recommended that you take the capsules with food, i.e., during or immediately before or after meals. Do not open or crush the capsule (see section 5).

Adults

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

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

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

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 time and as recommended by your doctor or pharmacist.

If you stop taking Nintedanib Accord

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

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 Accord:

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

Diarrhea can cause dehydration: a loss of fluids and important 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 anti-diarrheal treatment as soon as possible, for example, by taking loperamide.

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

Tell your doctor if you experience any side effects.

Idiopathic Pulmonary Fibrosis (IPF)

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

• Feeling sick (nausea)
• Stomach pain (abdominal pain)
• Abnormal liver blood tests

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

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

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

• Pancreatitis
• Inflammation of the large intestine
• Low platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Yellowing of the skin or the whites of the eyes (jaundice)
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

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

• Kidney failure
• 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)

Other Chronic Fibrosing Interstitial Lung Diseases (ILD) with a Progressive Phenotype

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

• Feeling sick (nausea)
• Vomiting
• Lack of appetite
• Stomach pain (abdominal pain)
• Abnormal liver blood tests

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

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

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

• Pancreatitis
• Inflammation of the large intestine
• Low platelet count (thrombocytopenia)
• Yellowing of the skin or the whites of the eyes (jaundice)
• Itching
• Heart attack
• Hair loss (alopecia)

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

• Kidney failure
• 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)

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

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

• Feeling sick (nausea)
• Vomiting
• Stomach pain (abdominal pain)
• Abnormal liver blood tests

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

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

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

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

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

• Heart attack
• Pancreatitis
• Yellowing of the skin or the whites of the eyes (jaundice)
• Enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)
• 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 via the national reporting system listed in Appendix V. By reporting side 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 which is stated on the carton and on the blister.

The expiry date refers to 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 that a capsule is damaged.

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. Package Contents and Additional Information

Composition of Nintedanib Accord

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

Capsule content: medium-chain triglycerides, 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 of Nintedanib Accord and Package Contents

Nintedanib Accord 100 mg capsules are approximately 16 mm, soft gelatin capsules of oblong shape, opaque and peach-colored, with “JF1” printed in black ink containing a bright yellow-green to pale yellow suspension.

Nintedanib Accord 100 mg capsules are available in boxes containing:

• Aluminum/aluminum blisters are available in 30, 60, and 120 soft capsules (multipack containing 2 boxes of 60 soft capsules each).
• Aluminum/aluminum blisters are 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)

Not all 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, Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

For further information about this medicine, please 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.

Τηλ: +30 210 74 88 821

Date of Last Revision of this Leaflet:

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