Nintedanib Teva

Package Leaflet: Information for the Patient

Nintedanib Teva, 100 mg, Soft Capsules

Nintedanib

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

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

Package Leaflet Contents

• 1. What is Nintedanib Teva and What is it Used For
• 2. Important Information Before Taking Nintedanib Teva
• 3. How to Take Nintedanib Teva
• 4. Possible Side Effects
• 5. How to Store Nintedanib Teva
• 6. Package Contents and Other Information

1. What is Nintedanib Teva and What is it Used For

Nintedanib Teva contains the active substance nintedanib, which belongs to a group of medicines called tyrosine kinase inhibitors, and is used to treat idiopathic pulmonary fibrosis (IPF), other chronic and progressive 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 transfer oxygen from the lungs to the blood. Deep breathing is difficult. This medication reduces further scarring and stiffness of the lungs.

Other Chronic and Progressive Interstitial Lung Diseases (ILD) with a Progressive Phenotype

Besides 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 ILDs. This medication helps reduce further scarring and stiffness of the lungs.

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

Systemic sclerosis (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 (fibrosis and stiffness) of the skin and internal organs, such as the lungs. The presence of scarring in the lungs is called interstitial lung disease (ILD), and the disease is referred to as SSc-ILD. Lung scarring reduces the ability to supply oxygen to the bloodstream, making breathing difficult. This medication helps reduce further scarring and stiffness of the lungs.

2. Important Information Before Taking Nintedanib Teva

When Not to Take Nintedanib Teva

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

Warnings and Precautions

Before starting to take Nintedanib Teva, the patient should discuss with their doctor or pharmacist if they:

• have or have had liver problems,
• have or have had kidney problems or have been found to have increased protein in their urine,
• have or have had bleeding problems,
• are taking blood-thinning medications (such as warfarin, phenprocoumon, or 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, treatment with this medication is usually suspended for a period if the patient undergoes surgery. The doctor will decide when to resume treatment with this medication.
• have high blood pressure,
• have high blood pressure in the blood vessels of the lungs (pulmonary hypertension),
• have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.

Considering 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 Teva.

The patient should immediately inform their doctor if they experience any of the following while taking this medication:

• diarrhea. Early treatment of diarrhea is important (see section 4);
• vomiting or nausea;
• unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown (tea-colored) 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 severe liver problems;
• 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 (gastrointestinal perforation). The patient should also inform their doctor if they have had stomach ulcers or diverticulitis in the past or are taking nonsteroidal anti-inflammatory drugs (NSAIDs) (used to treat pain and swelling) or steroids (used to treat inflammatory and allergic conditions), as these factors increase the risk;
• severe abdominal pain or cramps, bloody stools, or diarrhea, as these may be symptoms of intestinal ischemia;
• pain, swelling, redness, and increased temperature of a limb, as these may be symptoms of a blood clot in a vein (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);
• 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. These may be symptoms of a brain disease called posterior reversible encephalopathy syndrome (PRES).

Children and Adolescents

Children and adolescents under 18 years of age should not take Nintedanib Teva.

Nintedanib Teva and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including herbal products and over-the-counter medications.

Nintedanib Teva may interact with certain other medications. The following medications may increase the level of nintedanib in the blood and thus increase the risk of side effects (see section 4):

• medications used to treat fungal infections (ketoconazole)
• medications used to treat bacterial infections (erythromycin)
• medications that affect the immune system (cyclosporine)

The following medications are examples of medications that may decrease the level of nintedanib in the blood and thus decrease the effectiveness of Nintedanib Teva:

• antibiotics used to treat tuberculosis (rifampicin)
• medications used to treat epilepsy (carbamazepine, phenytoin)
• herbal remedies 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 child, they should consult their doctor or pharmacist before taking this medication.

Pregnancy

Do not take this medication during pregnancy, as it may harm the unborn child and cause birth defects.

Before starting treatment with this medication, a pregnancy test should be performed to ensure 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 Teva, throughout the treatment period, 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 medication, they should immediately inform their doctor or pharmacist.

Driving and Using Machines

This medication 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 Teva

This medication 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, for example, one capsule in the morning and one capsule in the evening. This will ensure a steady level of nintedanib in the patient's blood. The capsules should be swallowed whole with water; do not chew the capsules. 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 100 mg capsule twice a day (a total of 200 mg per day).

Do not exceed the recommended dose of two 100 mg Nintedanib Teva capsules per day.

If the patient does not tolerate the recommended dose of two 100 mg Nintedanib Teva capsules per day (see possible side effects in section 4), the doctor may advise stopping treatment with this medication. Do not reduce the dose or stop treatment without consulting the doctor first.

Taking More Than the Recommended Dose of Nintedanib Teva

The patient should contact their doctor or pharmacist immediately.

Missing a Dose of Nintedanib Teva

Do not take two capsules at once if a dose is missed. The patient should take the next 100 mg dose of Nintedanib Teva as scheduled, at the usual time prescribed by the doctor or pharmacist.

Stopping Treatment with Nintedanib Teva

Do not stop taking Nintedanib Teva without consulting the doctor first. It is essential to take the medication regularly, every day, for as long as the doctor prescribes.

If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Nintedanib Teva can cause side effects, although not everybody gets them.

The patient should pay particular attention to the following side effects while taking Nintedanib Teva.

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

Diarrhea can lead to dehydration: loss of water and important salts (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. They should start appropriate anti-diarrheal treatment as soon as possible, for example, with loperamide.

Other Side Effects Observed with Nintedanib (the Active Substance of this Medication)

If the patient experiences any side effects, they should inform their doctor.

Idiopathic Pulmonary Fibrosis (IPF)

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

• nausea (feeling sick)
• abdominal pain
• abnormal liver function test results

Common Side Effects(may affect up to 1 in 10 people)

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

Uncommon Side Effects(may affect up to 1 in 100 people)

• pancreatitis
• colitis
• severe liver problems
• low platelet count (thrombocytopenia)
• high blood pressure (hypertension)
• jaundice (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 a blood vessel wall or tear in a blood vessel wall (aneurysm and arterial dissection)
• brain disease with 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)

Other Chronic and Progressive Interstitial Lung Diseases (ILD) with a Progressive Phenotype

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

• nausea (feeling sick)
• vomiting
• loss of appetite
• abdominal pain
• abnormal liver function test results

Common Side Effects(may affect up to 1 in 10 people)

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

Uncommon Side Effects(may affect up to 1 in 100 people)

• pancreatitis
• colitis
• low platelet count (thrombocytopenia)
• jaundice (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 a blood vessel wall or tear in a blood vessel wall (aneurysm and arterial dissection)
• brain disease with 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)

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

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

• nausea (feeling sick)
• vomiting
• abdominal pain
• abnormal liver function test results

Common Side Effects(may affect up to 1 in 10 people)

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

Uncommon Side Effects(may affect up to 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 (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 (aneurysm and arterial dissection)
• excessive hair loss (alopecia)
• increased protein in the urine (proteinuria)
• brain disease with 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)

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. 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.: +48 22 49 21 301

fax: +48 22 49 21 309

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be gathered on the safety of this medication.

5. How to Store Nintedanib Teva

The medication should be stored out of sight and reach of children.

Do not use this medication after the expiry date stated on the carton and blister after "EXP".

The expiry date refers to the last day of the month stated.

There are no special storage instructions for this medication.

Do not use this medication if the blister containing the capsules is open or if the capsule is damaged.

In case of contact with the contents of the capsule, the patient should immediately wash their hands with plenty of water (see section 3).

Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Nintedanib Teva Contains

• The active substance of this medication is nintedanib. Each capsule contains 100 mg of nintedanib (as nintedanib esylate).
• Other ingredients are:
• capsule contents: medium-chain triglycerides, solid fat, polyglyceryl-3 dioleate
• capsule shell: gelatin, glycerol, titanium dioxide (E 171), iron oxide red (E 172), and iron oxide yellow (E 172), purified water
• printing ink: shellac, carmine (E 120), propylene glycol (E 1520), simethicone

What Nintedanib Teva Looks Like and Contents of the Package

Nintedanib Teva 100 mg is a soft, oblong, orange-red capsule, approximately 16 mm in length, containing a yellow, viscous suspension, with red printing "NT 100".

Nintedanib Teva 100 mg soft capsules are available in single-dose perforated blisters made of OPA/Aluminum/PVC/Aluminum foil in a cardboard box.

Package sizes:

30 x 1 soft capsules

60 x 1 soft capsules

Not all package sizes may be marketed.

Marketing Authorization Holder

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

tel.: +48 22 345 93 00

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

San Gwann, SGN 3000

Malta

QUALIMETRIX S.A.

579 MESOGEION AVENUE AGIA PARASKEVI,

Athens, 15343, Greece

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Krakow

This Medicinal Product is Authorized in the Member States of the European Economic Area 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, meke kapsule

Iceland:

Nintedanib Teva

Italy:

Nintedanib Teva

Lithuania:

Nintedanib Teva 100 mg minkštosios kapsulės

Latvia:

Nintedanib Teva 100 mg mīkstās 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, capsule moi

Sweden:

Nintedanib Teva

Slovakia:

Nintedanib Teva 100 mg mäkké kapsuly

Date of Last Revision of the Package Leaflet: March 2025