NINTEDANIB STADA 100 mg SOFT CAPSULES

Introduction

Patient Information Leaflet

Nintedanib Stada 100 mg soft capsules EFG

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

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

Nintedanib Stada 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, hardening, and scarring of the lung tissue over time. As a result, 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 conditions where the lung tissue becomes thickened, hardened, and scarred over time (pulmonary fibrosis) and continues to worsen (progressive phenotype). Some examples of these conditions include hypersensitivity pneumonitis, autoimmune ILD (such as ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILD. Nintedanib helps reduce new scarring and hardening 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 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 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 hardening of the lungs.

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

Do not take Nintedanib Stada

• 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 Stada:

• 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 nintedanib 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 (a bulge 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 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 non-steroidal anti-inflammatory drugs (NSAIDs) (used to relieve pain and swelling) or steroids (used against inflammation and allergies), as 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 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 severe 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).

Children and adolescents

Children and adolescents under 18 years should not take nintedanib.

Other medicines and Nintedanib Stada

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 (cyclosporin)

The following medicines are examples that may decrease the levels of nintedanib in your blood and, therefore, 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.

You will need to have a pregnancy test to make sure you are not pregnant before you start treatment with nintedanib. Talk to your doctor.

Contraception

• Women who may become pregnant must use a highly effective method of contraception to prevent pregnancy when they start taking nintedanib, while they are taking nintedanib, 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 that is 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 while you are taking nintedanib, as it may harm your baby.

Driving and using machines

Nintedanib 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 Stada

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, with about 12 hours in between, 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 in your blood steady. Swallow the capsules whole with water, without chewing them. It is recommended that you take the capsules with food, i.e., during 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 a day (a total of 200 mg per day).

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

If you cannot 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 yourself without first talking to your doctor.

If you take more Nintedanib Stada 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 Toxicological Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Nintedanib Stada

Do not take two capsules together if you have missed your previous dose. You should take your next dose of nintedanib 100 mg according to the schedule established by your doctor or pharmacist.

If you stop taking Nintedanib Stada

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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should pay special attention if you experience the following side effects during treatment with nintedanib:

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

Diarrhea can cause dehydration: a loss of fluids and important salts (electrolytes, such as sodium or potassium) from the body. At the first signs of diarrhea, drink plenty of fluids and talk to your doctor immediately. Start appropriate antidiarrheal treatment as soon as possible, for example, by taking loperamide.

The following side effects have also been reported during treatment with this medicine.

Talk to your doctor if you experience any side effects.

Idiopathic Pulmonary Fibrosis (IPF)

Very common side effects(may affect more than 1 in 10 people)

• Feeling sick (nausea)
• Stomach pain (abdominal pain)
• Abnormal liver blood tests

Common side effects(may affect up to 1 in 10 people)

• Vomiting
• Lack of appetite
• Weight loss
• Bleeding
• Rash
• Headache

Uncommon side 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)
• Yellowing of the skin and the whites of the eyes (jaundice)
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Frequency not known(cannot be estimated from the available data)

• Kidney failure
• Weakness and rupture of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysms and arterial dissections)

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype

Very common side effects(may affect more than 1 in 10 people)

• Feeling sick (nausea)
• Vomiting
• Lack of appetite
• Stomach pain (abdominal pain)
• Abnormal liver blood 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 large intestine
• Low platelet count (thrombocytopenia)
• Yellowing of the skin and the whites of the eyes (jaundice)
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Frequency not known(cannot be estimated from the available data)

• Kidney failure
• Weakness and rupture of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysms and arterial dissections)

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

Very common side effects(may affect more than 1 in 10 people)

• Feeling sick (nausea)
• Vomiting
• Stomach pain (abdominal pain)
• Abnormal liver blood tests

Common side effects(may affect up to 1 in 10 people)

• Bleeding
• High blood pressure (hypertension)
• Lack of appetite
• Weight loss
• Headache

Uncommon side 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 the available data)

• Heart attack
• Pancreatitis
• Yellowing of the skin and the whites of the eyes (jaundice)
• Weakness and rupture of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 on the blister after EXP. The expiry date is the last day of the month shown.

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 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. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and further information

Composition of Nintedanib Stada

• The active ingredient is nintedanib. Each capsule contains 100 mg of nintedanib (as esilate).
• The other components are:

• Capsule content: medium-chain triglycerides, semi-synthetic solid glycerides, and dioleoyl triglycerol
• Capsule shell: gelatin, glycerol, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), and purified water.
• Printing ink: shellac, carmine acid (E 120), propylene glycol (E 1520), and simethicone.

Appearance and packaging of the product

Nintedanib Stada 100 mg are soft peach-colored, opaque, and oblong capsules containing a viscous yellow suspension, printed with "NT 100" in red ink and approximately 16 mm in length.

The 100 mg Nintedanib Stada capsules are available in a cardboard box with precut unit-dose OPA/Al/PVC-Al blisters.

Package sizes:

• 30 x 1 soft capsules
• 60 x 1 soft capsules

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

or

Adalvo Limited

Malta Life Sciences Park Building 1 Level 4

Sir Temi Zammit Buildings

San Gwann Industrial Estate, SGN 3000

Malta

or

QUALIMETRIX S.A.

579 MESOGEION AVENUE

AGIA PARASKEVI, Athens,

15343, Greece

or

STADA Arzneimittel AG

Stadastrasse 2 - 18,

Dortelweil,

Bad Vilbel, Hesse, 61118

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E

4814NE Breda

Netherlands

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

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

Iceland: Nintedanib STADA 100 mg mjúk hylki

Germany: Nintedanib IPF AL 100 mg Weichkapseln

Austria: Nintedanib STADA 100 mg Weichkapseln

Belgium: Nintedanib EG 100 mg zachte capsules

Denmark: Nintedanib STADA

Spain: Nintedanib STADA 100 mg soft capsules EFG

France: NINTEDANIB EG 100 mg, capsule molle

Finland: Nintedanib STADA 100 mg pehmeät kapselit

Greece: NINTEDANIB/STADA

Croatia: Nintedanib STADA 100 mg meke kapsule

Luxembourg: Nintedanib EG 100 mg capsules molles

Netherlands: Nintedanib CF 100 mg, zachte capsules

Norway: Nintedanib STADA 100 mg myke kapsler

Poland: Nintedanib STADA

Sweden: Nintedanib STADA 100 mg mjuka kapslar

Romania: Nintedanib Stada 100 mg capsule moi

Lithuania: Nintedanib STADA 100 mg minkštosios kapsules

Latvia: Nintedanib STADA 100 mg mikstas kapsulas

Estonia: Nintedanib STADA 100 mg pehmekapsel

Date of the last revision of this prospectus:December 2023

Other sources of informationDetailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)