Nintedanib Stada

Package Leaflet: Information for the Patient

Nintedanib STADA, 150 mg, Soft Capsules

Nintedanib

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

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

Nintedanib STADA 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 and progressive 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 and Progressive Fibrosing 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 medicine 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 other internal organs, such as the lungs. The presence of fibrosis in the lungs is called interstitial lung disease (ILD) and is referred to as SSc-ILD. Lung fibrosis 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 STADA

When Not to Take Nintedanib STADA

Warnings and Precautions

Before starting treatment with Nintedanib STADA, discuss with your doctor or pharmacist if you:

• have or have had liver problems.
• have or have had kidney problems or have been found to have increased protein in your urine.
• have or have had bleeding problems.
• are taking medicines to prevent blood clotting (such as warfarin, phenprocoumon, heparin).
• 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 medicine is usually interrupted for a while if you undergo surgery. Your doctor will decide when to resume treatment with this medicine.
• 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 the wall of a blood vessel) or a tear in the wall of a blood vessel.

Considering this information, your doctor may perform blood tests, for example, to check liver function. Your doctor will discuss the results of these tests with you and decide whether you can take Nintedanib STADA.

Tell your doctor immediately if you experience any of the following while taking this medicine:

• 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 abdomen, more frequent than usual bleeding or bruising, or feeling tired. These may be signs of severe liver problems.
• severe stomach pain, fever, chills, nausea, vomiting, or a hard stomach or bloating, as these may be signs of a hole in the wall of the intestine (gastrointestinal perforation). You should also tell your doctor if you have had stomach ulcers or diverticulitis in the past or if you are taking nonsteroidal 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 cramping, bloody stools, or diarrhea, as these may be signs of inflammation of the intestine due to insufficient blood supply.
• pain, swelling, redness, and increased temperature of a limb, as these may be signs 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 signs 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).

Children and Adolescents

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

Nintedanib STADA and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including herbal products and medicines that can be bought without a prescription.

Nintedanib STADA may interact with certain other medicines. The following medicines may increase the level of nintedanib in your 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 your blood and thus decrease the effectiveness of Nintedanib STADA:

• 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 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.

Before starting treatment with this medicine, a pregnancy test must be performed to ensure you are not pregnant. You should discuss this with your doctor.

Contraceptives

• Women who may become pregnant must use highly effective contraception to prevent pregnancy while taking Nintedanib STADA, throughout treatment with Nintedanib STADA, and for at least 3 months after stopping treatment.
• Discuss the best methods of contraception with your 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. In such cases, you should discuss with your doctor the use of an alternative, more suitable method of contraception.
• If you become pregnant or think you may be pregnant while taking this medicine, tell your doctor or pharmacist immediately.

Breastfeeding

Do not breastfeed while taking this medicine, as there may be a risk of harm to the breastfed child.

Driving and Using Machines

This medicine may have a minor influence on the ability to drive and use machines. If you feel nauseous, do not drive or operate machinery.

3. How to Take Nintedanib STADA

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Take one capsule twice a day, approximately 12 hours apart, for example, one capsule in the morning and one capsule in the evening. This will help keep a steady level of nintedanib in your blood. Swallow the capsules whole with water; do not suck or chew the capsules.

It is recommended to take the capsules with food, i.e., during or immediately before or after a meal.

Do not open or crush the capsules (see section 5).

Adults

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

Do not exceed the recommended dose of two Nintedanib STADA 150 mg soft capsules per day. If you do not tolerate the recommended dose of two Nintedanib STADA 150 mg capsules per day (see possible side effects in section 4), your doctor may reduce the daily dose of Nintedanib STADA. Do not reduce the dose or stop treatment without consulting your doctor first.

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

Taking More Than the Recommended Dose of Nintedanib STADA

Contact your doctor or pharmacist immediately.

Missing a Dose of Nintedanib STADA

Do not take two capsules at the same time if you miss a dose. Take the next dose of Nintedanib STADA as planned at the usual time and in the dose recommended by your doctor or pharmacist.

Stopping Treatment with Nintedanib STADA

Do not stop taking Nintedanib STADA without consulting your doctor first. It is important to take this medicine regularly, every day, for as long as your doctor tells you.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should be aware of the following side effects when taking Nintedanib STADA.

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 you experience the first symptoms of diarrhea, drink plenty of fluids and contact your doctor immediately. Start appropriate anti-diarrheal treatment as soon as possible, for example, with loperamide.

Other Side Effects Observed with This Medicine

If you experience any side effects, tell your doctor. Idiopathic Pulmonary Fibrosis (IPF)

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

• nausea (feeling sick),
• abdominal pain (stomach ache),
• abnormal liver function tests.

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 (inflammation of the pancreas),
• colitis (inflammation of the colon),
• severe liver problems,
• low platelet count (thrombocytopenia),
• high blood pressure (hypertension),
• jaundice (yellowing of the skin and 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).

Other Chronic and Progressive Fibrosing 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 (stomach ache),
• abnormal liver function tests.

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 (inflammation of the pancreas),
• colitis (inflammation of the colon),
• low platelet count (thrombocytopenia),
• jaundice (yellowing of the skin and 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).

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 (stomach ache),
• abnormal liver function tests.

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 (inflammation of the colon),
• 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 (inflammation of the pancreas),
• jaundice (yellowing of the skin and 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),
• excessive hair loss (alopecia),
• increased protein in the urine (proteinuria).

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Nintedanib STADA

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

There are no special storage instructions for this medicine.

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

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Nintedanib STADA 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, and polyglycerol 3-diolein. 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 STADA Looks Like and Contents of the Pack

Nintedanib STADA 150 mg is a brown, opaque, elongated, soft capsule with the imprint "NT 150" in black ink, approximately 17 mm in length, containing a yellow, viscous suspension.

Nintedanib STADA 150 mg soft capsules are available in cardboard boxes containing perforated unit dose blisters of OPA/Aluminum/PVC/Aluminum foil.

Package sizes:

30 x 1 soft capsule

60 x 1 soft capsule

Not all pack sizes may be marketed.

Marketing Authorization Holder

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

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

STADA Arzneimittel AG, Stadastrasse 2 - 18, 61118 Bad Vilbel, Germany

Centrafarm Services B.V., Van de Reijtstraat 31 E, 4814NE Breda, Netherlands

STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna, Austria

For further information, contact your local representative of the marketing authorization holder:

STADA Pharm Sp. z o.o., ul. Krakowiaków 44, 02-255 Warsaw, Tel. +48 22 737 79 20

This Medicine is Authorized in the Member States of the European Economic Area Under the Following Names:

Sweden

Nintedanib STADA 150 mg mjuka kapslar

Romania

Nintedanib Stada 150 mg capsule moi

Norway

Nintedanib STADA 150 mg myke kapsler

Netherlands

Nintedanib CF 150 mg, zachte capsules

Latvia

Nintedanib STADA 150 mg mīkstās kapsulas

Luxembourg

Nintedanib EG 150 mg capsules molles

Lithuania

Nintedanib STADA 150 mg minkštosios kapsulės

Croatia

Nintedanib STADA 150 mg meke kapsule

Estonia

Nintedanib STADA 150 mg pehmekapsel

Germany

Nintedanib IPF AL 150 mg Weichkapseln

Belgium

Nintedanib EG 150 mg zachte capsules

Iceland

Nintedanib STADA 150 mg mjúk hylki

Austria

Nintedanib STADA 150 mg Weichkapseln

Denmark

Nintedanib STADA

Spain

Nintedanib STADA 150 mg cápsulas blandas

EFG

France

NINTEDANIB EG 150 mg, capsule molle

Finland

Nintedanib STADA 150 mg pehmeät kapselit

Greece

NINTEDANIB/STADA

Date of Last Revision of the Leaflet:April 2025