NINTEDANIB STADA 150 mg SOFT CAPSULES

Introduction

Patient Information Leaflet

Nintedanib Stada 150 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 symptoms 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 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 to the bloodstream, making it difficult to breathe deeply. Nintedanib helps reduce the occurrence 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 lung tissue becomes thickened, hardened, and scarred over time (pulmonary fibrosis) and continues to worsen (progressive phenotype). Some examples of these disorders are hypersensitivity pneumonitis, autoimmune ILD (such as ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILD. Nintedanib reduces 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 the disease is called SSc-ILD. Fibrosis in the lungs reduces the ability to transfer oxygen to the bloodstream and reduces the ability to breathe. Nintedanib reduces 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

Consult your doctor or pharmacist before starting treatment with Nintedanib Stada:

• if you have or have had liver problems.
• if you have or have had kidney problems or if you have been detected with 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 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 wounds heal. Therefore, treatment with nintedanib will usually be suspended for a period if you undergo surgery. Your doctor will decide when to resume 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 (enlargement 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 taking this medicine

• if you have diarrhea. It is essential 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, pain in the upper right side of the abdomen, bleeding or bruising more easily than usual, or feeling tired. These could be symptoms of severe liver problems.
• if you have severe abdominal pain, fever, chills, dizziness, vomiting, or abdominal stiffness or swelling, as these could be symptoms of a hole in the wall of the intestines ("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 nonsteroidal anti-inflammatory drugs (NSAIDs) (used to relieve pain and swelling) or steroids (used against inflammation and allergies), as this may increase the risk.
• if you have a combination of severe or colicky abdominal pain, blood in the 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 the chest, usually on the left side of the body, pain in the 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 significant 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 the blood 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 (cyclosporin)

The following medicines are examples that may decrease the levels of nintedanib in the blood and, thus, 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 the fetus and cause congenital defects.

A pregnancy test should be performed to ensure you are not pregnant before starting treatment with nintedanib. Consult your doctor.

Contraception

• Women who may become pregnant should use a highly effective contraceptive method to avoid pregnancy when starting to take nintedanib, while taking nintedanib, and for at least 3 months after stopping treatment.
• Consult your doctor about the most suitable contraceptive methods for you.
• Vomiting and/or diarrhea 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 situations, consult your doctor to assess an alternative contraceptive method 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 during treatment with nintedanib, as it may harm the baby.

Driving and using machines

Nintedanib has a minor 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

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Take the capsules twice a day, 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 will ensure that you maintain 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, i.e., during meals or immediately before or after meals. Do not open or break the capsule (see section 5).

Adults

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

Do not take more than the recommended dose of two 150 mg nintedanib capsules per day.

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

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

If you take more Nintedanib Stada than you should

Contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating 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 150 mg according to the schedule established by your doctor or pharmacist.

If you stop taking Nintedanib Stada

Do not stop taking nintedanib without consulting your doctor first. It is essential 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 symptoms of diarrhea, drink plenty of fluids and consult your doctor immediately. Start appropriate antidiarrheal treatment as soon as possible, for example, by taking loperamide.

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

Consult your doctor if you experience any type of side effect.

Idiopathic pulmonary fibrosis (IPF)

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

• Feeling sick (nausea)
• Abdominal pain
• Abnormal liver test results

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
• Colitis
• Severe liver problems
• Low platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Jaundice, i.e., yellow color of the skin and the whites of the eyes due to high bilirubin levels
• 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
• Enlargement and weakening 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
• Abdominal pain
• Abnormal liver 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., yellow color of the skin and the whites of the eyes due to high bilirubin levels
• 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
• Enlargement and weakening 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
• Abdominal pain
• Abnormal liver test results

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)

• Colitis
• Severe liver problems
• Kidney failure
• Low platelet count (thrombocytopenia)
• Rash
• Itching

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

• Heart attack
• Pancreatitis
• Jaundice, i.e., yellow color of the skin and the 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 (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 Pharmacovigilance System for Human Use Medicines: 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 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 the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and further information

Composition of Nintedanib Stada

• The active ingredient is nintedanib. Each capsule contains 150 mg of nintedanib (as esilate).
• The other ingredients 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, black iron oxide (E 172), and propylene glycol (E 1520).

Appearance and packaging of the product

Nintedanib Stada 150 mg are soft brown capsules, opaque and oblong, containing a viscous yellow suspension, printed with "NT 150" in black ink and approximately 17 mm in length.

The 150 mg Nintedanib Stada capsules are available in a cardboard box with precut unit-dose OPA/Al/PVC-Al blisters.

Packaging sizes:

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

Only some packaging 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 150 mg mjúk hylki

Germany: Nintedanib IPF AL 150 mg Weichkapseln

Austria: Nintedanib STADA 150 mg Weichkapseln

Belgium: Nintedanib EG 150 mg zachte capsules

Denmark: Nintedanib STADA

Spain: Nintedanib STADA 150 mg soft capsules EFG

France: NINTEDANIB EG 150 mg, capsule molle

Finland: Nintedanib STADA 150 mg pehmeät kapselit

Greece: NINTEDANIB/STADA

Croatia: Nintedanib STADA 150 mg meke kapsule

Luxembourg: Nintedanib EG 150 mg capsules molles

Netherlands: Nintedanib CF 150 mg, zachte capsules

Norway: Nintedanib STADA 150 mg myke kapsler

Poland: Nintedanib STADA

Sweden: Nintedanib STADA 150 mg mjuka kapslar

Romania: Nintedanib Stada 150 mg capsule moi

Lithuania: Nintedanib STADA 150 mg minkštosios kapsules

Latvia: Nintedanib STADA 150 mg mikstas kapsulas

Estonia: Nintedanib STADA 150 mg pehmekapsel

Date of the last revision of this prospectus:December 2023

Other sources of information.

Detailed 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/)