Nintedanib Zentiva

Package Leaflet: Information for the Patient

Nintedanib Zentiva, 150 mg,

soft capsules
Nintedanib

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Nintedanib Zentiva contains the active substance nintedanib, a medicine belonging to a group of medicines called 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 in which the lung tissue gradually becomes thicker, stiffer, and scarred. This scarring reduces the ability to transport oxygen from the lungs to the blood. Deep breathing is difficult. This medicine reduces further scarring and stiffness of the lungs.
Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype
In addition to IPF, there are other diseases in which the lung tissue becomes thicker, stiffer, and scarred over time (lung fibrosis) and worsens continuously (progressive phenotype). Examples of these diseases include allergic alveolitis, autoimmune ILD (e.g., ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassified idiopathic interstitial pneumonia, and other ILD. This medicine helps reduce further scarring and stiffness of the lungs.
Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Systemic sclerosis (SSc), also known as scleroderma, is a rare autoimmune disease that affects the connective tissue in many parts of the body. Systemic sclerosis (SSc) causes scarring (scarring and stiffness) of the skin and other internal organs, such as the lungs. The presence of scarring in the lungs is called interstitial lung disease (ILD) and is therefore referred to as SSc-ILD. Lung scarring reduces the ability to supply oxygen to the bloodstream, making breathing difficult. This medicine helps reduce further scarring and stiffness of the lungs.

2. Important information before taking Nintedanib Zentiva

When not to take Nintedanib Zentiva

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

Warnings and precautions

Before starting to take Nintedanib Zentiva, the patient should discuss it with their doctor or pharmacist if they have or have had liver problems, kidney problems or protein in their urine, bleeding problems, are taking blood thinning medicines (such as warfarin, phenprocoumon, heparin) to prevent blood clotting, are taking pirfenidone, as this may increase the risk of diarrhea, nausea, vomiting, and liver problems, have or have had heart problems (e.g., heart attack), have recently undergone surgery. Nintedanib may affect wound healing. Therefore, nintedanib treatment is usually interrupted for a period of time if the patient undergoes surgery. The doctor will decide when to resume treatment with this medicine, if the patient has high blood pressure, if the patient has high blood pressure in the blood vessels of the lungs (pulmonary hypertension), or if the patient has or has had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

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 Zentiva.
The patient should immediately inform their doctor if they experience diarrhea, vomiting, or nausea (nausea) while taking this medicine, unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or tea-colored urine, pain in the upper right abdomen, more frequent than usual bleeding or bruising, or feeling tired. These may be symptoms of severe liver damage, severe stomach pain, fever, chills, nausea, vomiting, or a hard stomach or bloating, as these may be symptoms of a hole in the wall of the intestine (perforation of the digestive tract). The patient should also inform their doctor if they have a history of stomach ulcers or diverticulitis or are taking non-steroidal anti-inflammatory drugs (NSAIDs) (used to treat pain and swelling) or steroids (used to treat inflammation and allergies), as these factors increase the risk, severe abdominal pain or cramps, red blood in the stool, or diarrhea, as these may be symptoms of inflammation of the intestine due to insufficient blood supply, pain, swelling, redness, and increased temperature of a limb, as these may be symptoms of a blood clot in one of the veins (a type of blood vessel), chest pain or discomfort, typically 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, severe bleeding, bruising, bleeding, fever, fatigue, and confusion. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA), headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arms or legs, with high blood pressure or without high blood pressure (posterior reversible encephalopathy syndrome, PRES).

Children and adolescents

Nintedanib Zentiva should not be taken by children and adolescents under 18 years of age.

Nintedanib Zentiva and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including herbal products and medicines that can be bought without a prescription.
Nintedanib Zentiva may interact with certain other medicines. The following medicines may increase the level of nintedanib in the blood and thus 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 the immune system (cyclosporine).

The following medicines are examples of medicines that may decrease the level of nintedanib in the blood, and thus decrease the effectiveness of Nintedanib Zentiva:

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn baby and cause birth defects.
Before starting treatment with this medicine, a pregnancy test must be performed to ensure that the patient is not pregnant. The patient should discuss this with their doctor.
Contraceptives

• Women who may become pregnant must use highly effective contraception to prevent pregnancy while taking Nintedanib Zentiva, throughout the treatment with Nintedanib Zentiva, and for at least 3 months after stopping treatment.
• The patient should discuss the best contraceptive methods with their doctor.
• Vomiting and/or diarrhea or other gastrointestinal disorders may affect the absorption of oral hormonal contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, if such disorders occur, the patient should discuss the use of an alternative, more suitable contraceptive method with their doctor.

If the patient becomes pregnant or thinks they may be pregnant while taking this medicine, they should immediately inform their doctor or pharmacist.

Breastfeeding
Do not breastfeed while taking this medicine, as it may cause changes in the baby.

Driving and using machines

This medicine may have a minor influence on the ability to drive and use machines.
If the patient feels nauseous, they should not drive or operate machinery.

3. How to take Nintedanib Zentiva

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The patient should take the capsules twice a day, approximately 12 hours apart, at the same time every day, for example, one capsule in the morning and one capsule in the evening. This will ensure that the patient has a constant amount of nintedanib in their blood. The capsules should be swallowed whole, with water; they should not be sucked or chewed. It is recommended to take the capsules with food, i.e., during or immediately before or after a meal. The capsules should not be opened or crushed (see section 5).

Adults

The recommended dose is one capsule containing 150 mg twice a day (a total of 300 mg per day).
Do not take more than the recommended dose of two soft Nintedanib Zentiva 150 mg capsules per day.
If the patient does not tolerate the recommended dose of two Nintedanib Zentiva 150 mg capsules per day (see possible side effects in section 4), the doctor may reduce the daily dose of Nintedanib Zentiva. Do not reduce the dose or stop treatment without consulting a doctor first!
The doctor may reduce the recommended dose to 100 mg twice a day (a total of 200 mg per day). In this case, the doctor will prescribe Nintedanib Zentiva 100 mg soft capsules for further treatment. Do not exceed the recommended dose of two soft Nintedanib Zentiva 100 mg capsules per day if the patient's daily dose has been reduced to 200 mg per day.

Taking a higher dose of Nintedanib Zentiva than recommended

Contact a doctor or pharmacist immediately.

Missing a dose of Nintedanib Zentiva

Do not take two capsules at the same time if a dose is missed. Take the next dose of Nintedanib Zentiva as planned, at the usual time, and in the dose prescribed by the doctor or pharmacist.

Stopping treatment with Nintedanib Zentiva

Do not stop taking Nintedanib Zentiva without consulting a doctor first.
It is important to take the medicine regularly, every day, for as long as the doctor prescribes.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Nintedanib Zentiva can cause side effects, although not everybody gets them.
The patient should pay special attention to the following side effects while taking Nintedanib Zentiva.
Diarrhea(Very common, may affect more than 1 in 10 people)
Diarrhea can lead to dehydration: loss of water and important substances (electrolytes, such as sodium or potassium) from the body. If the patient experiences the first symptoms of diarrhea, they should drink plenty of fluids and contact their doctor immediately. Start appropriate anti-diarrheal treatment as soon as possible, for example with loperamide.

Other side effects that have been observed with this medicine.

If the patient experiences any side effects, they should tell their doctor.
Idiopathic pulmonary fibrosis (IPF)
Very common side effects(may affect more than 1 in 10 people)

• nausea (nausea),
• abdominal pain,
• abnormal liver function test results.

Common side effects(may affect less than 1 in 10 people)

• vomiting,
• loss of appetite,
• weight loss,
• bleeding,
• rash,
• headache.

Uncommon side effects(may affect less than 1 in 100 people)

• pancreatitis,
• colitis,
• severe 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,
• excessive hair loss (alopecia),
• increased protein in the urine (proteinuria).

Frequency not known(frequency 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 (aneurysm and dissection of the aorta).
• a brain disease characterized by symptoms such as headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arms or legs, with high blood pressure or without high blood pressure (posterior reversible encephalopathy syndrome, PRES).

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

• nausea (nausea),
• vomiting,
• loss of appetite,
• abdominal pain,
• abnormal liver function test results.

Common side effects(may affect less than 1 in 10 people)

• weight loss,
• high blood pressure (hypertension),
• bleeding,
• severe liver problems,
• rash,
• headache.

Uncommon side effects(may affect less than 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,
• excessive hair loss (alopecia),
• increased protein in the urine (proteinuria).

Frequency not known(frequency 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 (aneurysm and dissection of the aorta).
• a brain disease characterized by symptoms such as headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arms or legs, with high blood pressure or without high blood pressure (posterior reversible encephalopathy syndrome, PRES).

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

• nausea (nausea),
• vomiting,
• abdominal pain,
• abnormal liver function test results.

Common side effects(may affect less than 1 in 10 people)

• bleeding,
• high blood pressure (hypertension),
• loss of appetite,
• weight loss,
• headache.

Uncommon side effects(may affect less than 1 in 100 people)

• colitis,
• severe liver problems,
• kidney failure,
• low platelet count (thrombocytopenia),
• rash,
• itching.

Frequency not known(frequency 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 wall of a blood vessel or tear in the wall of a blood vessel (aneurysm and dissection of the aorta),
• excessive hair loss (alopecia),
• increased protein in the urine (proteinuria).
• a brain disease characterized by symptoms such as headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arms or legs, with high blood pressure or without high blood pressure (posterior reversible encephalopathy syndrome, PRES).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Nintedanib Zentiva

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.
This medicine does not require any special storage conditions.
Do not use this medicine if the blister containing the capsules is open or if the capsule is damaged.
If the patient comes into contact with the contents of the capsule, they should immediately wash their hands with plenty of water (see section 3).
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nintedanib Zentiva contains

• The active substance is nintedanib. Each capsule contains 150 mg of nintedanib (as nintedanib esylate).
• The other ingredients are: Capsule contents: triglycerides of fatty acids with a medium chain length, solid fat, polyglyceryl-3-diolenate Capsule shell: gelatin, glycerol, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), purified water Ink: shellac, iron oxide black (E 172), and propylene glycol (E 1520)

What Nintedanib Zentiva looks like and contents of the pack

Nintedanib Zentiva 150 mg is a non-transparent, elongated soft capsule of brown color, containing a yellow viscous suspension, with black printing "NT 150" and a length of 17 mm.
Nintedanib Zentiva, 150 mg, soft capsules are available in single-dose blisters made of OPA/Aluminum/PVC/Aluminum foil in a cardboard box.
Pack sizes:

• 30 x 1 capsules
• 60 x 1 capsules

Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer/Importer

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
Adalvo Limited
Malta Life Sciences Park Building 1 Level 4
Sir Temi Zammit Buildings
San Gwann Industrial Estate
SGN 3000 San Gwann
Malta
QUALIMETRIX S.A.
579 MESOGEION AVENUE AGIA PARASKEVI,
15343 Athens
Greece

This medicine has been authorized in the Member States of the European Economic Area under the following names:

Germany: Nintedanib Zentiva 150 mg soft capsules
Spain: NINTEDANIB ZENTIVA 150 MG soft capsules EFG
France: NINTEDANIB ZENTIVA 150 mg, soft capsule
Lithuania: Nintedanib Zentiva 150 mg soft capsules
Latvia: Nintedanib Zentiva 150 mg soft capsules
Denmark, Estonia, Finland, Iceland, Poland, Norway, Portugal, Sweden: Nintedanib Zentiva

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:January 2025