NINTEDANIB TEVA 150 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Nintedanib Teva 150 mg Soft Capsules EFG

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, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience 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 pack

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

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

Nintedanib Teva 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 hard to breathe deeply. Nintedanib helps 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 disorders in which the tissue in your lungs becomes thickened, scarred, and stiffened over time (pulmonary fibrosis) and continues to worsen (progressive phenotype). Some examples of these disorders include hypersensitivity pneumonitis, autoimmune ILD (such as ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, idiopathic unclassifiable interstitial pneumonia, and other ILD. Nintedanib helps reduce new scarring and new 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 helps reduce new scarring and new stiffening of the lungs.

2. What you need to know before you take Nintedanib Teva

Do not take Nintedanib Teva

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Nintedanib Teva:

• 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 you experiencing 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 this medicine will usually be stopped for a while 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 (enlargement 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.

Tell your doctor immediately while you are 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 your stomach (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 abdominal stiffness or swelling, as these could be symptoms of having 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 anti-inflammatory medicines (NSAIDs) (used to relieve pain and swelling) or steroids (used to treat inflammation and allergies), as all 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 having 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 major 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 Teva.

Other medicines and Nintedanib Teva

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 may interact with other medicines. The following medicines may increase the levels of nintedanib in your blood and, therefore, increase the risk of you experiencing 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 the levels of nintedanib in your blood and, thus, reduce the effectiveness of nintedanib:

• 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.

A pregnancy test should be performed to ensure you are not pregnant before starting treatment with Nintedanib Teva. Talk to your doctor.

Contraception

• Women who may become pregnant must use a highly effective method of contraception to prevent pregnancy when starting to take Nintedanib Teva, while taking Nintedanib Teva, and for at least 3 months after stopping treatment.
• Talk to your doctor about the most suitable contraceptive methods for you.
• Vomiting and/or diarrhea or other gastrointestinal disorders may affect the absorption of hormonal contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, if you experience any of these situations, talk to 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.

Breastfeeding

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

Driving and using machines

Nintedanib Teva has little influence on the ability to drive and use machines. Do not drive or use machines if you feel dizzy.

3. How to take Nintedanib Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to 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 the level of nintedanib constant in your blood. Swallow the capsules whole with water, without chewing. It is recommended that you take the capsules with food, i.e., during meals or immediately before or after meals. Do not open or crush the capsule (see section 5).

Adults

The recommended dose is one 150 mg capsule twice a day (a total of 300 mg per day).

Do not take more than the recommended dose of two Nintedanib Teva 150 mg capsules per day.

If you cannot tolerate the recommended dose of two nintedanib 150 mg capsules per day (see possible side effects in section 4), your doctor may advise you to stop taking this medicine. Do not reduce the dose or stop treatment by yourself without first talking to your doctor.

Your doctor may reduce the recommended dose to 100 mg twice a day (a total of 200 mg per day). In this case, your doctor will prescribe Nintedanib Teva 100 mg capsules for your treatment. Do not take more than the recommended dose of two nintedanib 100 mg capsules per day if your daily dose has been reduced to 200 mg per day.

If you take more Nintedanib Teva than you should

Contact your doctor or pharmacist immediately. In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Nintedanib Teva

Do not take two capsules together if you have missed your previous dose. You should take your next dose of nintedanib according to the schedule established and recommended by your doctor or pharmacist.

If you stop taking Nintedanib Teva

Do not stop taking nintedanib without talking to 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

Diarrhea can cause dehydration: a loss of important fluids and salts from the body (electrolytes, such as sodium or potassium). If you experience 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 adverse effects have also been observed during treatment with this medicine.

Consult 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
• Pain in the lower half of the body (abdomen)
• Abnormal liver 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., yellow color in 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 available data)

• Kidney failure
• Increased and weakened blood vessel wall or tear in the blood vessel wall (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)

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

Very Common Adverse Effects(may affect more than 1 in 10 people)

• Nausea
  • Vomiting

• Pain in the lower half of the body (abdomen)
• Abnormal liver 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., yellow color in the skin and whites of the eyes due to high bilirubin levels
• Increased and weakened blood vessel wall or tear in the blood vessel wall (aneurysms and arterial dissections)
  • Hair loss (alopecia)
  • Increased 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Nintedanib Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton and blister pack after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not use this medicine if you notice that the blister pack containing the capsules is open or that a capsule is broken.

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.

Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofNintedanib Teva 150 mg Soft Capsules EFG

• The active ingredient is nintedanib. Each capsule contains 100 mg of nintedanib (as esylate).
• The other ingredients are:
  • Capsule contents: medium-chain triglycerides, semi-synthetic solid glycerides, and polyglyceryl-3 dioleate.
  • Capsule shell: gelatin, glycerol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), and purified water.
  • Printing ink: shellac, black iron oxide (E172), and propylene glycol (E1520).

Appearance of the Product and Package Contents

Nintedanib Teva 150 mg capsules are soft gelatin capsules, oblong, opaque, and brown in color, containing a viscous yellow suspension, engraved in black "NT 150" and approximately 17 mm in length.

Nintedanib Teva 150 mg soft capsules are available in cartons with perforated single-dose OPA/Al/PVC-Aluminum blisters of 30 and 60 soft capsules.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura, 11, Edificio Albatros B 1st floor

Alcobendas 28108, Madrid

Spain

Manufacturer

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

Malta

Teva Operations Poland Sp. z.o.o.

Ul. Mogilska 80

31-546 Cracow

Poland

QUALIMETRIX S.A.

579 MESOGEION AVENUE AGIA PARASKEVI,

Athens, 15343, Greece

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

Austria Nintedanib ratiopharm 150 mg – Soft Capsules

Belgium Nintedanib Teva 150 mg soft capsules/capsules molles/Weichkapseln

Czech Republic Nintedanib Teva

Germany Nintedanib-ratiopharm 150 mg Weichkapseln

Denmark Nintedanib Teva

Estonia Nintedanib Teva

Greece Nintedanib/Teva

Spain Nintedanib Teva 150 mg soft capsules EFG

Finland Nintedanib ratiopharm 150 mg capsule, soft

France NINTEDANIB TEVA 150mg, capsule molle

Croatia Nintedanib Teva 100 mg, 150 mg soft capsules

Iceland Nintedanib Teva

Italy Nintedanib Teva

Lithuania Nintedanib Teva 150 mg soft capsules

Latvia Nintedanib Teva 150 mg soft capsules

Luxembourg Nintedanib Teva 150 mg capsules molles

Netherlands Nintedanib Teva 150 mg, soft capsules

Norway Nintedanib Teva

Poland Nintedanib Teva

Portugal Nintedanib Zidrium

Romania Nintedanib Teva 100 mg, 150 mg soft capsules

Sweden Nintedanib Teva

Slovakia Nintedanib Teva 150 mg soft capsules

Date of the Last Revision of this Leaflet: March 2025

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

You can access detailed and updated information on this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89431/P_89431.html

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