Nintedanib onkogen

Patient Information Leaflet

Nintedanib Onkogen, 100 mg, soft capsules
Nintedanibum
Please read all of this leaflet carefully before taking this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

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

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

Nintedanib Onkogen 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. This scarring reduces the lungs' ability to transfer oxygen into the bloodstream and makes deep breathing difficult. Nintedanib Onkogen helps slow down further scarring and stiffening of the lungs.

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype in adults
Besides IPF, there are other conditions in which lung tissue becomes progressively 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, unclassifiable idiopathic interstitial pneumonia, and other ILDs. Nintedanib Onkogen helps reduce further scarring and stiffening 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 Onkogen helps reduce further scarring and stiffening of the lungs.

Interstitial lung disease associated with systemic sclerosis (SSc-ILD) 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 that affects 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. The presence of fibrosis in the lungs is referred to as interstitial lung disease (ILD), and the condition is therefore known as SSc-ILD. Lung fibrosis reduces the ability to transfer oxygen into the bloodstream, making breathing difficult. Nintedanib Onkogen helps reduce further scarring and stiffening of the lungs.

2. Important information before taking Nintedanib Onkogen

When not to take Nintedanib Onkogen

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

Warnings and precautions
Before starting treatment with Nintedanib Onkogen, discuss the following with your doctor or
pharmacist:

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

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

• the patient develops diarrhoea. Early treatment of diarrhoea is important (see section 4);
• the patient vomits or experiences nausea (feeling sick);
• the patient experiences unexplained symptoms such as yellowing of the skin or the 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 feeling tired. These may be symptoms of serious liver disease;
• the patient experiences severe stomach pain, fever, chills, nausea, vomiting, or a hard abdomen or bloating, as these may be symptoms of a perforation in the wall of the intestine (gastrointestinal perforation). You should also inform the doctor if the patient has previously had peptic ulcers or diverticular disease of the intestine, or if the patient is taking anti-inflammatory medicines (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 symptoms 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 symptoms of a blood clot forming in one of the veins (a type of blood vessel);
• the patient experiences chest tightness or pain, usually on the left side of the body, pain in the neck, jaw, arm or hand, rapid heartbeat, shortness of breath, nausea, vomiting, as these may be symptoms of a heart attack;
• the patient experiences serious bleeding.
• the patient develops bruising, bleeding, fever, fatigue and confusion. This may be a sign of damage to blood vessels called thrombotic microangiopathy (TMA).
• the patient experiences symptoms such as headache, visual disturbances, disorientation, seizures or other neurological disturbances 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 Onkogen must not be given to children below 6 years of age.
The 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 Onkogen with 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 medicines and over-the-counter medicines.
Nintedanib Onkogen may interact with certain other medicines. The following medicines are examples of those that may increase the blood concentration of nintedanib and thereby increase the risk of adverse effects (see section 4):

• 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 those that may reduce the blood concentration of nintedanib and thereby reduce the effectiveness of Nintedanib Onkogen:

• 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 plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn child and cause congenital malformations.
A pregnancy test should be performed before starting treatment with Nintedanib Onkogen to confirm that the patient is not pregnant. Consult your doctor about this.

Contraception

• Women who can become pregnant must use a highly effective method of contraception to prevent pregnancy at the time of starting treatment with Nintedanib Onkogen, during treatment, and for at least 3 months after stopping treatment.
• Discuss with your doctor the most suitable contraceptive method for the patient.
• Vomiting and/or diarrhoea or other gastrointestinal disturbances may affect the absorption of oral hormonal contraceptives, such as contraceptive pills, and may reduce their effectiveness. Therefore, if such disturbances 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 while taking Nintedanib Onkogen, she should immediately inform her doctor or pharmacist.

Breastfeeding
Do not breastfeed while being treated with Nintedanib Onkogen, as it may have harmful effects on the breastfed child.

Driving and using machines
Nintedanib Onkogen may have a minor influence on the ability to drive and use machines. If the patient experiences nausea, he or she should not drive or operate machinery.

3. How to take Nintedanib Onkogen

This medicine should always be taken as directed by the doctor or pharmacist. If in
doubt, consult the doctor or pharmacist.
Capsules should be taken twice daily, approximately 12 hours apart, at approximately the same
time each day, for example one capsule in the morning and one in the evening. This will ensure
a constant level of nintedanib in the patient's bloodstream. Capsules must be swallowed whole,
with water, and must not be chewed. It is recommended to take the capsules with food, i.e. during,
immediately before, or immediately after a meal. The capsules must not be opened or crushed (see section 5).
To make swallowing easier, the capsules may be taken with a small amount (one teaspoonful) of cool or soft food at room temperature, such as apple sauce or chocolate pudding.
They should be swallowed immediately and not chewed, so that the capsule remains intact.
Adults
The recommended dose is one capsule containing 100 mg taken twice daily (total 200 mg per day).
Do not take a higher dose than recommended: two capsules of Nintedanib Onkogen 100 mg per day.
If the patient does not tolerate the recommended dose of two capsules of Nintedanib Onkogen 100 mg
per day (see possible side effects in section 4), the doctor may advise completely
discontinuing the use of this medicine. Do not reduce the dose or stop treatment on your own
without first consulting the doctor.
Use in children and adolescents
The recommended dose depends on the patient's body weight.
Inform the doctor if, at any time during treatment, the patient's body weight drops
below 13.5 kg.
Inform the doctor if the patient has liver problems.
The doctor will determine the correct dose. The doctor may adjust the dose as treatment progresses.
If the patient does not tolerate the recommended daily dose of Nintedanib Onkogen capsules (see possible
side effects in section 4), the doctor may reduce the daily dose of Nintedanib
Onkogen.
Do not reduce the dose or stop treatment on your own without prior consultation
with the doctor.
Dosing of Nintedanib Onkogen capsules in children and adolescents according to body weight:
Body weight range Nintedanib Onkogen dose
in kilograms (kg) in milligrams (mg)
13.5–22.9 kg 50 mg (two 25 mg capsules) twice daily
23.0–33.4 kg 75 mg (three 25 mg capsules) twice daily
33.5–57.4 kg 100 mg (one 100 mg capsule or four
25 mg capsules) twice daily
57.5 kg and above 150 mg (one 150 mg capsule or six
25 mg capsules) twice daily
Nintedanib Onkogen is available only in the form of soft capsules with strengths of 100 mg
and 150 mg. Therefore, it is not possible to administer Nintedanib Onkogen to pediatric patients
who require a dose lower than the full 100 mg dose. If an alternative dose is required, other products containing nintedanib, which allow such dosing, may be used.
Taking more Nintedanib Onkogen than recommended
Contact the doctor or pharmacist immediately.
Missing a dose of Nintedanib Onkogen
Do not take two capsules at the same time if a previous dose has been missed.
Take the next dose of Nintedanib Onkogen 100 mg as scheduled, at the usual time, in accordance with the doctor's or pharmacist's instructions.
Stopping treatment with Nintedanib Onkogen
Do not stop taking Nintedanib Onkogen without first consulting the doctor.
It is important to take this medicine every day for as long as the doctor recommends.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Special attention should be paid if the following adverse effects occur during treatment with Nintedanib Onkogen:
Diarrhoea (very common, may affect more than 1 in 10 people):
Diarrhoea may lead to dehydration: loss of fluids and important salts (electrolytes such as sodium or potassium) from the body. If the first symptoms of diarrhoea occur, drink plenty of fluids and contact your doctor immediately. Appropriate anti-diarrhoeal treatment, e.g. with loperamide, should be started as soon as possible.

The following other adverse effects have been observed during treatment with this medicine.
If any adverse effects occur in the patient, inform the doctor.

Idiopathic pulmonary fibrosis (IPF)
Very common adverse effects (may affect more than 1 in 10 people)

• Nausea
• Pain in the lower part of the trunk (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
• Colitis
• Severe liver disease
• Decreased platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Jaundice, i.e. yellowing of the skin and whites of the eyes due to increased bilirubin concentration
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased protein in the urine (proteinuria)

Frequency unknown (frequency cannot be determined from available data)

• Renal failure
• Enlargement and weakening of the blood vessel wall or tearing of the blood vessel wall (aneurysm and arterial dissection)
• Brain disease characterised by symptoms such as headache, visual disturbances, disorientation, seizures, or other neurological disorders 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 adverse effects (may affect more than 1 in 10 people)

• Nausea
• Vomiting
• Loss of appetite
• Pain in the lower part of the trunk (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
• Severe liver disease
• Rash
• Headache

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

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

Frequency unknown (frequency cannot be determined from available data)

• Renal failure
• Enlargement and weakening of the blood vessel wall or tearing of the blood vessel wall (aneurysm and arterial dissection)
• Brain disease characterised by symptoms such as headache, visual disturbances, disorientation, seizures, or other neurological disorders 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 adverse effects (may affect more than 1 in 10 people)

• Nausea
• Vomiting
• Pain in the lower part of the trunk (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)

• Colitis
• Severe liver disease
• Renal failure
• Decreased platelet count (thrombocytopenia)
• Rash
• Itching

Frequency unknown (frequency cannot be determined from available data)

• Heart attack
• Pancreatitis
• Jaundice, i.e. yellowing of the skin and whites of the eyes due to increased bilirubin concentration
• Enlargement and weakening of the blood vessel wall or tearing of the blood vessel wall (aneurysm and arterial dissection)
• Hair loss (alopecia)
• Increased protein in the urine (proteinuria)
• Brain disease characterised by symptoms such as headache, visual disturbances, disorientation, seizures, or other neurological disorders 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
Adverse effects in children and adolescents were similar to those in adult patients. Consult a doctor if any adverse effects occur in the patient.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Nintedanib Onkogen

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 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).
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 Onkogen contains

• The active substance is nintedanib. One capsule contains 100 mg of nintedanib (in the form of nintedanib esylate).
• The other ingredients are: Capsule filling: macrogol 400. Capsule shell: gelatin 150, sorbitol liquid, partially dehydrated, glycerol (E 422), titanium dioxide (E 171), red iron oxide (E 172), and yellow iron oxide (E 172).

What Nintedanib Onkogen looks like and contents of the pack
Nintedanib Onkogen 100 mg is peach-coloured, opaque, elongated soft gelatin capsules.
Two pack sizes of Nintedanib Onkogen 100 mg soft capsules are available:

• 30 x 1 soft capsule in single-dose blisters, perforated or non-perforated, made of PET/Aluminium - PA/Aluminium/PVC foil
• 60 x 1 soft capsule in single-dose blisters, perforated or non-perforated, made of PET/Aluminium - PA/Aluminium/PVC foil

Not all pack types may be marketed.
Marketing Authorisation Holder
Onkogen Kft.
Bécsi út 77-79
1037 Budapest
Hungary
Email: [email protected]
Manufacturer
Cyndea Pharma, S.L.
Polígono Industrial Emiliano Revilla Sanz.
Avenida de Ágreda 31, 42110, Ólvega (Soria)
Spain
This medicinal product is authorised in the European Economic Area countries under the following names:
Croatia Nintedanib Onkogen 100 mg meke kapsule
Spain Nintedanib Cinfa 100 mg cápsulas blandas EFG
Netherlands Nintedanib Onkogen 100 mg zachte capsules
Poland Nintedanib Onkogen
Hungary Nintedanib Onkogen 100 mg lágy kapszula