Nintedanib Teva 100 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Nintedanib Teva 100 mg soft capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Nintedanib Teva contains the active substance nintedanib, a medicine that belongs to a class known as tyrosine kinase inhibitors. It is used to treat idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and interstitial lung disease associated with systemic sclerosis (SSc-ILD) in adults.

Idiopathic pulmonary fibrosis (IPF)

IPF is a disease that causes thickening, hardening, and scarring of the tissue in your lungs over time. As a result, this scarring reduces the ability to transfer oxygen from the lungs into the bloodstream, making it difficult to breathe deeply. Nintedanib helps reduce the development of further scarring and hardening 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 of your lungs becomes thickened, hardened, 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. Nintedanib helps reduce new scarring and hardening of the lungs.

Interstitial lung disease associated with systemic sclerosis (SSc-ILD)

Systemic sclerosis (SSc), also known as scleroderma, 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 called interstitial lung disease (ILD), and thus the condition is referred to as SSc-ILD. Fibrosis in the lungs reduces the ability to transfer oxygen into the bloodstream and impairs breathing capacity. Nintedanib helps reduce new scarring and hardening of the lungs.

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

Do not take Nintedanib Teva

• 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

Talk to your doctor or pharmacist before starting to take 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 the blood (such as warfarin, phenprocoumon or heparin) to prevent blood clots;
• if you are taking pirfenidone, as this may increase the risk of developing diarrhoea, 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 wounds heal. Therefore, treatment with this medicine will generally be paused for a period 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 the lungs (pulmonary hypertension);
• if you have or have had an aneurysm (a bulge and weakening of the blood vessel wall) 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.

Tell your doctor immediately while you are taking this medicine:

• if you have diarrhoea. It is important to treat diarrhoea early (see section 4);
• if you have vomiting or feel sick (nausea);
• if you develop unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown-coloured urine (like tea), pain in the upper right part of the abdomen, easy bruising or bleeding, or feel tired. These could be symptoms of serious liver problems;
• if 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 intestine ("gastrointestinal perforation"). Also inform your doctor if you have had peptic ulcers or diverticular disease in the past or if you are being treated with non-steroidal anti-inflammatory drugs (NSAIDs) (used to relieve pain and inflammation) or steroids (used for inflammation and allergies), as these may increase this risk;
• if you have a combination of severe or colicky stomach pain, red blood in the stools or diarrhoea, 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 a blood clot in one of your veins (a type of blood vessel);
• if you have chest pressure or pain, 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;
• if you have a major bleeding episode;
• if you experience bruising, bleeding, fever, fatigue and confusion, as these may be signs of a blood vessel disorder 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 Teva must not be used in children and adolescents under 18 years of age.

Other medicines and Nintedanib Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might need to 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 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 the blood levels of nintedanib and thus reduce its effectiveness:

• 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 confirm you are not pregnant before starting treatment with Nintedanib Teva. Consult your doctor.

Contraception

• Women who could become pregnant must use a highly effective method of contraception to prevent pregnancy when starting Nintedanib Teva, while taking Nintedanib Teva, 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 a more appropriate alternative contraceptive method.
• Inform your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with nintedanib.

Breastfeeding

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

Driving and using machines

Nintedanib Teva has minor influence on the ability to drive and use machines. You should not drive or operate machinery if you feel dizzy.

3. How to take Nintedanib Teva

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 way, you ensure a constant level of nintedanib in your blood. Swallow the capsules whole with water, without chewing them. It is recommended that you take the capsules with food, that is, during meals or immediately before or after meals. Do not open or break the capsule (see section 5).

Adults

The recommended dose is one 100 mg capsule twice daily (a total of 200 mg daily).

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

If you do not tolerate the recommended dose of two 100 mg nintedanib capsules per day (see possible side 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.

If you take more Nintedanib Teva than you should

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

If you forget to take Nintedanib Teva

Do not take two capsules together if you have forgotten to take your previous dose. You should take your next dose of nintedanib at the next scheduled time as recommended by your doctor or pharmacist.

If you stop taking Nintedanib Teva

Do not stop taking nintedanib without first consulting your doctor. It is important to take this medicine every day for 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 will experience them.

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

Diarrhoea (very common, may affect more than 1 in 10 people):

Diarrhoea may lead to dehydration: a loss of body fluids and important salts (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 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
• 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 levels of bilirubin
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Frequency not known (cannot be estimated from available data)

• Renal failure
• Enlargement and weakening of a 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 disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior 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
• Serious 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 levels of bilirubin
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Frequency not known (cannot be estimated from available data)

• Renal failure
• Enlargement and weakening of a 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 disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior 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
• Serious liver problems
• Renal 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 levels of bilirubin
• Enlargement and weakening of a blood vessel wall or tear in the 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, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, including any possible adverse effects 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 Teva

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nintedanib Teva 100 mg soft capsules EFG

• The active substance is nintedanib. Each capsule contains 100 mg of nintedanib (as esilate).
• The other components are:
  • Capsule contents: medium-chain triglycerides, solid semisynthetic glycerides and dioleoyl triglycerol
  • Capsule shell: gelatin, glycerol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) and purified water
  • Printing ink: shellac, carmine acid (E 120), propylene glycol (E 1520) and simethicone

Appearance of the product and contents of the container

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

Nintedanib Teva 100 mg soft capsules are available in cardboard packs containing either 30 or 60 soft capsules in perforated unit-dose blisters made of OPA/Al/PVC–Aluminium.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.
Anabel Segura, 11, Edificio Albatros B, 1st floor
Alcobendas 28108, Madrid
Spain

Manufacturers

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 Kraków
Poland

QUALIMETRIX S.A.
579 MESOGEION AVENUE AGIA PARASKEVI
Athens, 15343
Greece

This medicinal product is authorised in the European Economic Area member states under the following names:

Austria: Nintedanib ratiopharm 100 mg – Weichkapseln
Belgium: Nintedanib Teva 100 mg zachte capsules/capsules molles/Weichkapseln
Czech Republic: Nintedanib Teva
Germany: Nintedanib-ratiopharm 100 mg Weichkapseln
Denmark: Nintedanib Teva
Estonia: Nintedanib Teva
Greece: Nintedanib/Teva
Spain: Nintedanib Teva 100 mg cápsulas blandas EFG
Finland: Nintedanib ratiopharm 100 mg kapseli, pehmeä
France: NINTEDANIB TEVA 100mg, capsule molle
Croatia: Nintedanib Teva 100 mg, 150 mg meke kapsule
Iceland: Nintedanib Teva
Italy: Nintedanib Teva
Lithuania: Nintedanib Teva 100 mg minkštosios kapsulės
Latvia: Nintedanib Teva 100 mg mikstas kapsulas
Luxembourg: Nintedanib Teva 100 mg capsules molles
Netherlands: Nintedanib Teva 100 mg, zachte capsules
Norway: Nintedanib Teva
Poland: Nintedanib Teva
Portugal: Nintedanib Zidrium
Romania: Nintedanib Teva 100 mg, 150 mg capsule moi
Sweden: Nintedanib Teva
Slovakia: Nintedanib Teva 100 mg mäkké kapsuly

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

Detailed information about this medicinal product 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 up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89430/P_89430.html

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