Nintedanib Zentiva 100 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Nintedanib Zentiva 100 mg soft capsules EFG

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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Nintedanib Zentiva is and what it is used for
2. What you need to know 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 Nintedanib Zentiva is and what it is used for

Nintedanib Zentiva 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 thickening, stiffening, 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. This medicine helps reduce the progression of further scarring and stiffening of the lungs.

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 becomes thickened, stiffened, and scarred 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, unclassifiable idiopathic interstitial pneumonia, and other ILDs. This medicine helps reduce further scarring and 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. In this case, the lung tissue in children and adolescents becomes thickened, stiffened, and scarred over time. Nintedanib helps reduce the progression 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 referred to as interstitial lung disease (ILD), and thus the condition is called ILD-SSc. Fibrosis in the lungs reduces the ability to transfer oxygen into the bloodstream and impairs breathing capacity. This medicine helps reduce further scarring and stiffening of the lungs.

2. What you need to know before taking Nintedanib Zentiva

Do not take Nintedanib Zentiva

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nintedanib Zentiva if:

• you have or have had liver problems,
• you have or have had kidney problems, or if you have been found to have an increased amount of protein in your urine,
• you have or have had bleeding problems,
• you are taking medicines to thin the blood (such as warfarin, phenprocoumon or heparin) to prevent blood clots,
• you are taking pirfenidone, as this may increase the risk of developing diarrhoea, nausea, vomiting and liver problems,
• you have or have had heart problems (such as a heart attack),
• you have recently undergone surgery. Nintedanib may affect the way wounds heal. Therefore, treatment with this medicine will usually be temporarily stopped if you undergo surgery. Your doctor will decide when to restart treatment with this medicine.
• you have high blood pressure,
• you have abnormally high blood pressure in the blood vessels of the lungs (pulmonary hypertension),
• 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 decide whether you can take Nintedanib Zentiva.

Inform your doctor immediately while you are taking this medicine if:

• you have diarrhoea. It is important to treat diarrhoea early (see section 4);
• you have vomiting or feel sick (nausea);
• you have 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 area (abdomen), you bleed or bruise more easily than normal, or you feel tired. These could be symptoms of serious liver problems;
• 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 intestines ("gastrointestinal perforation"). Also inform your doctor if you have had peptic ulcers or diverticular disease in the past or if you are being treated at the same time with anti-inflammatory medicines (NSAIDs) (used to relieve pain and swelling) or steroids (used for inflammation and allergies), as these may increase this risk;
• 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;
• 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);
• 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;
• you have significant bleeding.
• 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

Nintedanib Zentiva must not be taken by children under 6 years of age.

Your doctor may carry out 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 Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.

Nintedanib Zentiva may interact with other medicines. The following medicines may increase blood levels of nintedanib 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 (cyclosporine)

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

• 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.

A pregnancy test should be performed to ensure you are not pregnant before starting treatment with this medicine. Consult your doctor.

Contraception

• Women who can become pregnant must use a highly effective method of contraception to prevent pregnancy when starting Nintedanib Zentiva, while taking Nintedanib Zentiva, 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 hormonal oral contraceptives, such as birth control 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 during treatment with this medicine.

Breastfeeding

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

Driving and using machines

This medicine has little influence on the ability to drive and use machines. You should not drive or use machines if you feel dizzy.

3. How to take Nintedanib Zentiva

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 about the same time each day; for example, one capsule in the morning and one capsule in the evening. This ensures 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, for example, during meals or immediately before or after meals. Do not open or split the capsule (see section 5).

To make swallowing the capsules easier, you may take them with a small amount (one teaspoon) of cold or room temperature soft food, 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 per day).

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

If you do not tolerate the recommended dose of two Nintedanib Zentiva 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 is 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 capsules in children and adolescents:

Weight range (kilograms, kg)	Nintedanib dose 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 or more	150 mg (one 150 mg capsule or six 25 mg capsules) twice daily

Nintedanib Zentiva is only available in 100 mg and 150 mg soft capsules. Therefore, it is not possible to administer Nintedanib Zentiva to pediatric patients requiring less than a full dose of 100 mg. If an alternative dosage is required, other nintedanib-containing medicines offering such an option should be used.

If you take more Nintedanib Zentiva than you should

Contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Nintedanib Zentiva

Do not take two capsules together if you have forgotten your previous dose. You should take your next dose of 100 mg Nintedanib Zentiva at the next scheduled and recommended time according to your doctor or pharmacist.

If you stop taking Nintedanib Zentiva

Do not stop taking Nintedanib Zentiva 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 experiences them.

You should pay special attention if you experience the following adverse effects during treatment with Nintedanib Zentiva:

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 nintedanib (the active substance in 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
• 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
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Frequency not known (cannot be estimated from available data)

• Kidney failure
• Enlargement and weakening of a blood vessel wall or tear in a 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 (posterior reversible 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
• Severe 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 bilirubin levels
• 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
• Enlargement and weakening of a blood vessel wall or tear in a 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 (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
• 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
• Severe 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 bilirubin levels
• Enlargement and weakening of a blood vessel wall or tear in a 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 (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. Inform your doctor if you experience any type of adverse effect.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

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 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).

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, 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 further information

Composition of Nintedanib Zentiva

• The active substance is nintedanib. Each capsule contains 100 mg of nintedanib (as esilate).
• The other components are:
  • Capsule contents: medium-chain triglycerides, hard fat and glyceryl dioleate.
  • Capsule shell: gelatin, glycerol, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), purified water.
  • Printing ink: shellac, carmine acid (E 120), propylene glycol (E 1520) and simethicone.

Nature of the product and pack sizes

Nintedanib Zentiva 100 mg are soft, oblong, opaque peach-coloured capsules containing a yellow viscous suspension, printed with “NT 100” in red ink, approximately 16 mm in length.

Soft capsules of Nintedanib Zentiva 100 mg are available in cardboard boxes containing unit-dose aluminium blisters OPA/Al/PVC.

Pack sizes:

30 soft capsules

60 soft capsules

120 soft capsules

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva, k.s.

U Kabelovny 130

Dolní Měcholupy

102 37 Prague 10

Czech Republic

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

Or

Qualimetrix S.A.

579 Mesogeion Avenue,

Agia Paraskevi, Athens, 15343,

Greece

Or

Adalvo Limited

Malta Life Sciences Park, Building 1, Level 4,

Sir Temi Zammit Buildings

San Gwann Industrial Estate, SGN 3000,

Malta

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorised in the European Economic Area Member States under the following names:

Germany	NINTEDANIB ZENTIVA 100 mg soft capsules
Denmark	NINTEDANIB ZENTIVA
Spain	Nintedanib Zentiva 100 mg soft capsules EFG
Estonia	NINTEDANIB ZENTIVA
Finland	NINTEDANIB ZENTIVA 100 mg soft capsules
France	NINTEDANIB ZENTIVA 100 mg soft capsule
Iceland	NINTEDANIB ZENTIVA 100 mg soft capsules
Latvia	NINTEDANIB ZENTIVA 100 mg soft capsules
Lithuania	NINTEDANIB ZENTIVA 100 mg soft capsules
Norway	NINTEDANIB ZENTIVA
Poland	NINTEDANIB ZENTIVA
Portugal	NINTEDANIB ZENTIVA
Sweden	NINTEDANIB ZENTIVA 100 mg capsules, soft

Date of the most recent review of this leaflet: October 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/