Nintedanib eugia

Package leaflet: Information for the user

Nintedanib Eugia, 100 mg, soft capsules
Nintedanib Eugia, 150 mg, soft capsules
Nintedanibum
Read the entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents

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

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

Nintedanib Eugia contains the active substance nintedanib, which belongs to a group of medicines known as tyrosine kinase inhibitors. It is used to treat the following conditions:

Idiopathic pulmonary fibrosis (IPF) in adults
IPF is a disease in which lung tissue gradually becomes thicker, stiffer, and scarred. As a result, scarring reduces the lungs' ability to transfer oxygen into the bloodstream, and deep breathing becomes difficult. Nintedanib Eugia helps reduce further scarring and lung stiffness.

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype in adults
Besides IPF, there are other conditions in which lung tissue gradually becomes thicker, stiffer, and scarred (pulmonary fibrosis) and continues to worsen over time (progressive phenotype). Examples of these conditions include hypersensitivity pneumonitis, autoimmune ILD (e.g. ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassified idiopathic interstitial pneumonia, and other ILDs. Nintedanib Eugia helps reduce further scarring and stiffness of the lungs.

Clinically significant, progressive fibrosing interstitial lung diseases (ILD) in children and adolescents aged 6 to 17 years
In patients with childhood interstitial lung disease (chILD), lung fibrosis may occur. In such cases, lung tissue in children and adolescents gradually becomes thickened, stiff, and scarred over time. Nintedanib Eugia helps reduce further scarring and stiffness of the lungs.

Interstitial lung disease associated with systemic sclerosis (SSc-ILD) in adults, children, and adolescents 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 stiffness) of the skin and other internal organs, including the lungs. The presence of lung fibrosis is called interstitial lung disease (ILD), hence the condition is referred to as SSc-ILD. Lung fibrosis reduces the ability to deliver oxygen into the bloodstream, making breathing difficult. Nintedanib Eugia helps reduce further scarring and stiffness of the lungs.

2. Information before taking Nintedanib Eugia

When not to take Nintedanib Eugia

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

Warnings and precautions
Before starting treatment with Nintedanib Eugia, discuss this with your doctor or pharmacist if:

• the patient has or has had liver problems,
• the patient has or has had kidney problems or increased protein levels in the urine have been detected,
• the patient has or has had bleeding problems,
• the patient is taking medicines that reduce blood clotting (such as warfarin, phenprocoumon, or heparin) to prevent blood clots,
• the patient is taking pirfenidone, as this may increase the risk of diarrhoea, vomiting, and liver problems,
• the patient has or has had heart problems (e.g. heart attack),
• the patient has recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Eugia is usually temporarily discontinued if the patient undergoes surgery. Your doctor will decide when treatment should be resumed.
• if the patient has high blood pressure,
• if the patient has pulmonary hypertension (abnormally high blood pressure in the blood vessels of the lungs),
• if the patient has or has had an aneurysm (a bulge and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.

Based on this information, your doctor may perform blood tests, for example, to check liver function. Your doctor will discuss the results of these tests with you and decide whether you can take Nintedanib Eugia.
Contact your doctor immediately if, while taking this medicine:

• the patient develops diarrhoea. Early treatment of diarrhoea is important (see section 4, "Possible side effects");
• the patient vomits or feels nauseous;
• the patient experiences unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown (tea-coloured) urine, pain in the upper right part of the abdomen, more frequent than usual bleeding or bruising, or a feeling of fatigue. These may be signs of serious liver problems;
• the patient develops severe stomach pain, fever, chills, nausea, vomiting, or a hard or swollen abdomen, as these may be signs of a perforation (a hole) in the wall of the intestine (gastrointestinal perforation). You should also inform your doctor if the patient has previously had stomach ulcers or diverticular disease of the intestine, or if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) (used to treat pain and swelling) or steroids (used to treat inflammatory and allergic conditions) at the same time, as these factors increase this risk;
• the patient simultaneously experiences severe pain or cramps in the abdomen, red blood in the stool, or diarrhoea, as these may be signs of intestinal inflammation due to inadequate blood supply to the intestine;
• the patient develops pain, swelling, redness, and increased temperature in a limb, as these may be signs of a blood clot forming in a vein (a type of blood vessel);
• the patient experiences chest tightness or pain, typically on the left side of the body, pain in the neck, jaw, arm, or hand, rapid heartbeat, shortness of breath, nausea, or vomiting, as these may be signs of a heart attack;
• the patient experiences serious bleeding;
• the patient develops cyanosis (bluish discoloration), bleeding, fever, fatigue, and confusion. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA).
• the patient experiences symptoms such as headache, visual disturbances, disorientation, seizures, or other neurological disorders such as weakness in the arms or legs, with or without high blood pressure. These may be symptoms of a brain disorder called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents
Nintedanib Eugia must not be used in children and adolescents under 6 years of age.
Your doctor may perform regular dental examinations at least every 6 months until tooth development is complete and monitor the patient's growth once a year (bone imaging) during treatment with this medicine.

Nintedanib Eugia and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including herbal products and over-the-counter medicines.
Nintedanib Eugia may interact with certain other medicines. The following medicines may increase the concentration of nintedanib in the blood and thus 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 affecting the immune system (cyclosporine)

The following medicines are examples of medicines that may decrease the concentration of nintedanib in the blood and thus reduce the effectiveness of Nintedanib Eugia:

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn child and cause congenital malformations.
Before starting treatment with Nintedanib Eugia, a pregnancy test must be performed in female patients to confirm that they are not pregnant. The patient should discuss this with her doctor.
Contraceptive methods

• Women who can become pregnant must use a highly effective method of contraception to prevent pregnancy, both when starting treatment with Nintedanib Eugia, throughout the entire treatment period, and for at least 3 months after stopping treatment.
• Discuss the most suitable contraceptive methods with your doctor.
• 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 such disorders occur, discuss with your doctor the use of an alternative, more appropriate method of contraception.
• If the patient becomes pregnant or suspects she may be pregnant during treatment with Nintedanib Eugia, she should immediately inform her doctor or pharmacist.

Breastfeeding
Do not breastfeed while taking Nintedanib Eugia, as it may harm the breastfed child.

Driving and operating machinery
Nintedanib Eugia may have a minor influence on the ability to drive and use machines. If the patient feels nauseous, he or she should not drive or operate machinery.

Nintedanib Eugia contains soy lecithin
If the patient is allergic to soy or peanuts, he or she should not take this medicine (see section 2, "When not to take Nintedanib Eugia").

3. How to take Nintedanib Eugia

This medicine should always be taken as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
The capsules should be taken twice daily, approximately 12 hours apart at the same time each
day, for example one capsule in the morning and one in the evening. This ensures a constant level
of nintedanib in the patient's bloodstream. Swallow the capsules whole with water; do not chew
the capsules. It is recommended to take the capsules with food, either during, immediately before, or immediately after a meal. The capsules must not be opened or crushed (see section 5, "How to store Nintedanib
Eugia").
To facilitate swallowing, the capsules may be taken with a small amount (one teaspoonful) of cold or soft food at room temperature, such as applesauce or chocolate pudding. They should be swallowed immediately and must not be chewed, so that the capsule remains intact.
For the 100 mg dose:
Adults
The recommended dose is one capsule containing 100 mg taken twice daily (total 200 mg per day).
Do not take more than the recommended dose of two capsules of Nintedanib Eugia 100 mg per day.
If the patient does not tolerate the recommended dose of two capsules of Nintedanib Eugia 100 mg per day (see possible adverse reactions in section 4), the physician may advise discontinuation of this medicine. Do not reduce the dose or stop treatment on your own without first consulting your physician.
For the 150 mg dose:
Adults
The recommended dose is one capsule containing 150 mg taken twice daily (total 300 mg per day).
Do not take more than the recommended dose of two capsules of Nintedanib Eugia 150 mg per day.
If the patient does not tolerate the recommended dose of two capsules of Nintedanib Eugia 150 mg per day (see possible adverse reactions in section 4), the physician may reduce the daily dose of Nintedanib
Eugia. Do not reduce the dose or stop treatment on your own without first consulting your physician.
The physician may reduce the recommended dose to 100 mg twice daily (total 200 mg per day).
In such a case, the physician will prescribe Nintedanib Eugia 100 mg capsules for treatment.
Do not take more than the recommended dose of two capsules of Nintedanib Eugia 100 mg per
day if the daily dose has been reduced to 200 mg per day.
Use in children and adolescents
The recommended dose depends on the patient's body weight.
Inform the physician if at any time during treatment the patient's body weight drops below
13.5 kg.
Inform the physician if the patient has liver problems.
The physician will determine the correct dose. The physician may adjust the dose as treatment progresses.
If the patient does not tolerate the recommended daily dose of nintedanib (see possible adverse reactions in section 4), the physician may reduce the daily dose of nintedanib.
Do not reduce the dose or stop treatment on your own without first consulting your physician.
Nintedanib dosing in children and adolescents according to body weight:

Taking a higher than recommended dose of Nintedanib Eugia
Contact your doctor or pharmacist immediately.
Missing a dose of Nintedanib Eugia
Do not take two capsules together if you have missed a previous dose. Take the next dose of Nintedanib Eugia at the usual time according to your doctor’s or pharmacist’s instructions.
Stopping treatment with Nintedanib Eugia
Do not stop taking Nintedanib Eugia without first consulting your doctor. It is important to take the medicine regularly every day for as long as your doctor recommends.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Special attention should be paid to the occurrence of the following side effects during treatment with
Nintedanib Eugia.
Diarrhoea (very common, may occur in more than 1 in 10 people)
Diarrhoea may lead to dehydration: loss of water and important substances (electrolytes such as
sodium or potassium) from the body. If the first symptoms of diarrhoea occur, the patient should drink
plenty of fluids and contact the doctor immediately. Appropriate anti-diarrhoeal treatment should be
started as soon as possible, for example with loperamide.
The following other side effects have been observed during treatment with this medicine.
If any side effects occur in the patient, inform the doctor.
Idiopathic pulmonary fibrosis (IPF)
Very common side effects (may occur in more than 1 in 10 people)

• Nausea
• Abdominal pain
• Abnormal liver function test results

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

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

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

• Pancreatitis
• Colitis
• 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 bilirubin levels
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased protein in the urine (proteinuria)

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

• Kidney failure
• Enlargement and weakening of the blood vessel wall or rupture of the blood vessel wall (aneurysms and arterial dissections)
• Brain disorder with symptoms such as headache, visual changes, confusion, seizures, or other neurological disturbances such as weakness in arms or legs, with or without high blood pressure (posterior reversible encephalopathy syndrome)

Other chronic fibrosing interstitial lung diseases (ILD) with progressive phenotype
Very common side effects (may occur in more than 1 in 10 people)

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

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

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

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

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

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

• Kidney failure
• Enlargement and weakening of the blood vessel wall or rupture of the blood vessel wall (aneurysm and arterial dissection)
• Brain disorder with symptoms such as headache, visual changes, confusion, seizures, or other neurological disturbances such as weakness in arms or legs, with or without high blood pressure (posterior reversible encephalopathy syndrome)

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Very common side effects (may occur in more than 1 in 10 people)

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

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

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

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

• Colitis
• Serious liver problems
• Kidney failure
• Low platelet count (thrombocytopenia)
• Rash
• Itching

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

• Heart attack
• Pancreatitis
• Jaundice, i.e. yellowing of the skin and whites of the eyes due to high bilirubin levels
• Enlargement and weakening of the blood vessel wall or rupture of the blood vessel wall (aneurysm and arterial dissection)
• Hair loss (alopecia)
• Increased protein in the urine (proteinuria)
• Brain disorder with symptoms such as headache, visual changes, confusion, seizures, or other neurological disturbances such as weakness in arms or legs, with or without high blood pressure (posterior reversible encephalopathy syndrome)

Fibrosing interstitial lung diseases (ILD) in children and adolescents
Side effects in children and adolescents were similar to those in adult patients.
Consult the doctor if any side effects occur in the patient.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 may also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Nintedanib Eugia

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: EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging to protect from moisture.
Do not use this medicine if the blister pack containing the capsules is open or if a capsule appears damaged. In case of contact with the capsule contents, wash hands immediately with plenty of water (see section 3, "How to take Nintedanib Eugia").
Medicines must 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. Contents of the pack and other information

What Nintedanib Eugia contains

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

• Other ingredients are:
  Capsule contents: medium-chain triglycerides, hard fat, soy lecithin.
  Capsule shell: gelatin, glycerol (85%), titanium dioxide, yellow iron oxide (E 172), red iron oxide (E 172).
  Printing ink (black): black iron oxide (E 172), propylene glycol (E 1520), hypromellose 2910 (6 cP) (E 464).

• The active substance is nintedanib. Each capsule contains 150 mg of nintedanib (as nintedanib esilate).

• Other ingredients are:
  Capsule contents: medium-chain triglycerides, hard fat, soy lecithin.
  Capsule shell: gelatin, glycerol (85%), titanium dioxide, yellow iron oxide (E 172), red iron oxide (E 172).
  Printing ink (black): black iron oxide (E 172), propylene glycol (E 1520), hypromellose 2910 (6 cP) (E 464).

What Nintedanib Eugia looks like and contents of the pack
Soft capsules
Nintedanib Eugia 100 mg, soft capsule:
Nintedanib Eugia 100 mg, soft capsules are peach-coloured, opaque, elongated, soft gelatin capsules with a black imprint “N100”, containing a light yellow suspension.
Nintedanib Eugia 150 mg, soft capsule:
Nintedanib Eugia 150 mg, soft capsules are brown, opaque, elongated, soft gelatin capsules with a black imprint “N150”, containing a light yellow suspension.
Nintedanib Eugia 100 mg, 150 mg, soft capsules
Nintedanib Eugia 100 mg, 150 mg, soft capsules are available in blisters containing 30, 60, or 120 soft capsules, and in perforated unit-dose blisters containing 60 x 1 soft capsule, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Eugia Pharma (Malta) Limited
Vault 14, level 2
Valletta Waterfront
Floriana, FRN 1914
Malta
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus N 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Nintedanib Eugia 100 mg zachte capsules / capsules molles / Weichkapseln
Nintedanib Eugia 150 mg zachte capsules / capsules molles / Weichkapseln
Portugal: Nintedanib Eugia
France: NINTEDANIB ARROW 100 mg, capsule molle
NINTEDANIB ARROW 150 mg, capsule molle
Germany: Nintedanib PUREN 100 mg Weichkapseln
Nintedanib PUREN 150 mg Weichkapseln
Italy: Nintedanib Aurobindo
Netherlands: Nintedanib Eugia 100 mg, zachte capsules
Nintedanib Eugia 150 mg, zachte capsules
Poland: Nintedanib Eugia
Spain: Nintedanib Eugia 100 mg cápsulas blandas EFG
Nintedanib Eugia 150 mg cápsulas blandas EFG