Nintedanib Stada

Package Leaflet: Information for the Patient

Nintedanib STADA, 100 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 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 condition 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 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 ILD. 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 internal organs, such as the lungs. The presence of fibrosis in the lungs is called interstitial lung disease (ILD), and in this context, the disease 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 to take Nintedanib STADA, discuss with your doctor or pharmacist if you have or have had liver problems, kidney problems or high levels of protein in your urine, bleeding problems, are taking blood thinners (such as warfarin, phenprocoumon, 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 medicine is usually interrupted for a period of time if you undergo surgery. Your doctor will decide when to resume treatment with this medicine, if you have high blood pressure, if you have high blood pressure in the blood vessels of the 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.

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.
Immediately inform your doctor if, while taking this medicine, you experience diarrhea, vomiting, or nausea (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 symptoms of severe liver damage, 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). Also, inform your doctor if you 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, if you experience severe abdominal pain or cramps, red blood in your stool, or diarrhea, as these may be symptoms of inflammation of the intestine due to insufficient blood supply, if you experience pain, swelling, redness, and increased temperature of a limb, as these may be symptoms of a blood clot in one of the veins (a type of blood vessel), if you experience chest tightness or pain, 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, if you experience severe bleeding, if you experience 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 the 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 the 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 the unborn baby and cause birth defects.
Before starting treatment with this medicine, a pregnancy test must be performed to ensure that you are not pregnant. You should discuss this with your treating doctor.
Contraceptives

• Women who may become pregnant must use highly effective contraception to prevent pregnancy, when starting to take Nintedanib STADA, during treatment with Nintedanib STADA, and for at least 3 months after stopping treatment.
• Discuss the best methods of contraception with your treating doctor.
• Vomiting and/or diarrhea or other stomach and intestinal 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, you should immediately inform your doctor or pharmacist.

Breastfeeding
Do not breastfeed while taking this medicine, as there may be a risk of changes in 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 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 that a constant amount of nintedanib is maintained in your blood. Swallow the capsules 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.
Do not open or crush the capsules (see section 5).

Adults

The recommended dose is one capsule containing 100 mg twice a day (a total of 200 mg per day).
Do not exceed the recommended dose of two Nintedanib STADA 100 mg soft capsules per day.
If you do not tolerate the recommended dose of two Nintedanib STADA 100 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 yourself without consulting your doctor first!

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 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 the medicine regularly, every day, for as long as your doctor recommends.
If you have any further questions about 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.
Pay special attention to 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 (nausea),
• abdominal pain (lower abdomen),
• 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, i.e., yellowing of the skin and whites of the eyes due to high bilirubin levels,
• itching,
• heart attack,
• excessive hair loss (alopecia),
• increased protein levels 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 Interstitial Lung Diseases (ILD) with a Progressive Phenotype
Very Common Side Effects(may affect more than 1 in 10 people)

• nausea (nausea),
• vomiting,
• abdominal pain (lower abdomen),
• 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, i.e., yellowing of the skin and whites of the eyes due to high bilirubin levels,
• itching,
• heart attack,
• excessive hair loss (alopecia),
• increased protein levels 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 (nausea),
• vomiting,
• abdominal pain (lower abdomen),
• 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, i.e., yellowing of the skin and whites of the 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 levels 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. 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:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
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 broken.
In case of 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 100 mg of nintedanib (as nintedanib esylate).
• The other ingredients are: Capsule contents: medium-chain triglycerides, solid fat, and polyglyceryl-3-diisostearate Capsule shell: gelatin, glycerol, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), purified water Ink: shellac, carmine (E 120), propylene glycol (E 1520), and simethicone

What Nintedanib STADA Looks Like and Contents of the Pack

Nintedanib STADA 100 mg is a soft capsule, which is not transparent, oblong, and peach-colored with the imprint "NT 100" in red ink, approximately 16 mm in length, containing a yellow, viscous suspension.
Nintedanib STADA 100 mg soft capsules are available in cardboard boxes containing unit-dose blisters made of OPA/Aluminum/PVC/Aluminum foil.
Pack 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
To obtain more detailed information, contact the local representative of the marketing authorization holder:
STADA Pharm Sp. z o.o.
Krakowiaków 44 Street
02-255 Warsaw
Phone: +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 100 mg soft capsules
Romania
Nintedanib Stada 100 mg soft capsules
Norway
Nintedanib STADA 100 mg soft capsules
Netherlands
Nintedanib CF 100 mg, soft capsules
Latvia
Nintedanib STADA 100 mg soft capsules
Luxembourg
Nintedanib EG 100 mg soft capsules
Lithuania
Nintedanib STADA 100 mg soft capsules
Croatia
Nintedanib STADA 100 mg soft capsules
Estonia
Nintedanib STADA 100 mg soft capsules
Germany
Nintedanib IPF AL 100 mg soft capsules
Belgium
Nintedanib EG 100 mg soft capsules
Iceland
Nintedanib STADA 100 mg soft capsules
Austria
Nintedanib STADA 100 mg soft capsules
Denmark
Nintedanib STADA
Spain
Nintedanib STADA 100 mg soft capsules
EFG
France
NINTEDANIB EG 100 mg, soft capsules
Finland
Nintedanib STADA 100 mg soft capsules
Greece
NINTEDANIB/STADA

Date of Last Revision of the Leaflet: