Nintedanib Stada 100 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Nintedanib Stada 100 mg soft capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Nintedanib Stada is and what it is used for
2. What you need to know 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 Nintedanib Stada is and what it is used for

Nintedanib Stada contains the active substance nintedanib, a medicine that belongs to a class of drugs known as tyrosine kinase inhibitors. It is used to treat idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and interstitial lung disease associated with systemic sclerosis (SSc-ILD) in adults.

Idiopathic pulmonary fibrosis (IPF)

IPF is a disease that causes thickening, stiffening, and scarring of the lung tissue over time. As a result, this 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 stiffening 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, stiffened, and scarred over time (pulmonary fibrosis) and continues to worsen (progressive phenotype). Some examples of these disorders include hypersensitivity pneumonitis, autoimmune ILDs (such as ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. Nintedanib helps reduce new scarring and new stiffening of the lungs.

Interstitial lung disease associated with systemic sclerosis (SSc-ILD)

Systemic sclerosis (SSc), also known as scleroderma, is a rare chronic autoimmune disease affecting 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 condition is referred to as SSc-ILD. Lung fibrosis reduces the ability to transfer oxygen into the bloodstream and impairs breathing capacity. Nintedanib helps reduce new scarring and new stiffening of the lungs.

2. What you need to know before taking Nintedanib Stada

Do not take Nintedanib Stada

• if you are allergic to nintedanib or to 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 starting to take 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 blood-thinning medicines (such as warfarin, phenprocoumon, or heparin) to prevent blood clots;
• if you are taking pirfenidone, as this may increase the risk of developing diarrhoea, 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 how wounds heal. Therefore, treatment with nintedanib is usually paused for a period of time 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 the lungs (pulmonary hypertension);
• if you have or have had an aneurysm (a bulge and weakening of the blood vessel wall) or a tear in the wall of a blood vessel.

Based on this information, your doctor may carry out certain blood tests, for example, to check your liver function. Your doctor will discuss the results of these tests with you to determine whether you can take nintedanib.

Tell your doctor immediately while you are taking this medicine:

• if you have diarrhoea. It is important to treat diarrhoea early (see section 4);
• if you have vomiting or feel sick (nausea);
• if you experience unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown-coloured urine (like tea), pain in the upper right side of the stomach (abdomen), bleeding or bruising more easily than normal, or feel tired. These could be symptoms of serious liver problems;
• if you have sudden, severe stomach 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 at the same time with anti-inflammatory medicines (NSAIDs) (used to relieve pain and swelling) or steroids (used for inflammation and allergies), as these may increase this risk;
• if you have a combination of severe or cramping stomach pain, red blood in your stools or diarrhoea, 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, shortness of breath, nausea, or vomiting, as these could be symptoms of a heart attack;
• if you have a significant bleeding episode;
• if you experience bruising, bleeding, fever, fatigue, and confusion, as these may be signs of a blood vessel disorder known as thrombotic microangiopathy (TMA).

Children and adolescents

Nintedanib must not be used in children and adolescents under 18 years of age.

Other medicines and Nintedanib Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal remedies and medicines obtained without a prescription.

Nintedanib may interact with other medicines. The following medicines may increase the blood levels of nintedanib 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 (cyclosporine).

The following medicines are examples that may decrease the blood levels of nintedanib and thus reduce its effectiveness:

• an antibiotic used to treat tuberculosis (rifampicin);
• medicines used to treat seizures (carbamazepine, phenytoin);
• a herbal remedy 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

A pregnancy test should be performed to confirm that you are not pregnant before starting treatment with nintedanib. Please consult your doctor.

Contraception

• Women who could become pregnant must use a highly effective method of contraception to prevent pregnancy when starting nintedanib, while taking nintedanib, and for at least 3 months after stopping treatment.
• Discuss with your doctor the most appropriate contraceptive methods for you.
• Vomiting and/or diarrhoea or other gastrointestinal disorders may affect the absorption of oral hormonal contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, if you experience any of these conditions, consult your doctor to consider an alternative, more appropriate contraceptive method.
• Inform your doctor or pharmacist immediately if you become pregnant or suspect you may be pregnant during treatment with nintedanib.

Breastfeeding

Do not breastfeed during treatment with nintedanib, as it may cause harm to the breastfed infant.

Driving and using machines

Nintedanib has minor influence on the ability to drive and use machines. You should not drive or operate machinery if you feel dizzy.

3. How to take Nintedanib Stada

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take the capsules twice daily, 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 a consistent 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, that is, during meals 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 daily (a total of 200 mg per day).

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

If you do not tolerate the recommended dose of two nintedanib 100 mg capsules per day (see possible adverse effects in section 4), your doctor may recommend that you stop taking this medicine. Do not reduce the dose or stop treatment on your own without first consulting your doctor.

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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Nintedanib Stada

Do not take two capsules together if you have forgotten to take your previous dose. You should take your next dose of nintedanib 100 mg according to the prescribed schedule at the next recommended time as advised by your doctor or pharmacist.

If you stop taking Nintedanib Stada

Do not stop taking nintedanib without first talking to your doctor. It is important to take this medicine every day for as long as your doctor prescribes it.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

Diarrhoea may lead to dehydration: a loss of important body fluids and salts (electrolytes, such as sodium or potassium). At the first signs of diarrhoea, drink plenty of fluids and contact your doctor immediately. Start appropriate anti-diarrhoeal treatment as soon as possible, for example, by taking loperamide.

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

Contact your doctor if you experience any type of adverse effect.

Idiopathic pulmonary fibrosis (IPF)

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

• Nausea
• Abdominal pain
• Abnormal liver function test results

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

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

Uncommon adverse effects (may affect up to 1 in 100 people)

• Pancreatitis
• Inflammation of the large intestine
• Serious 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
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Frequency not known (cannot be estimated from available data)

• Kidney failure
• Enlargement and weakening of a blood vessel wall or tear in a blood vessel wall (arterial aneurysms and dissections)

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

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

• Nausea
• Vomiting
• Loss of appetite
• Abdominal pain
• Abnormal liver function test results

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

• Weight loss
• High blood pressure (hypertension)
• Bleeding
• Serious liver problems
• Rash
• Headache

Uncommon adverse effects (may affect up to 1 in 100 people)

• Pancreatitis
• Inflammation of the large intestine
• Low platelet count (thrombocytopenia)
• Jaundice, i.e. yellowing of the skin and 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 available data)

• Kidney failure
• Enlargement and weakening of a blood vessel wall or tear in a blood vessel wall (arterial aneurysms and dissections)

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)

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

• Nausea
• Vomiting
• Abdominal pain
• Abnormal liver function test results

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

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

Uncommon adverse effects (may affect up to 1 in 100 people)

• Inflammation of the large intestine
• Serious liver problems
• Kidney failure
• Low platelet count (thrombocytopenia)
• Rash
• Itching

Frequency not known (cannot be estimated from 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 a blood vessel wall or tear in a blood vessel wall (arterial aneurysms and dissections)
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

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 capsule contents, wash your hands immediately with plenty of water (see section 3).

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nintedanib Stada

• The active substance is nintedanib. Each capsule contains 100 mg of nintedanib (as esilate).

• The other components are:

• Capsule contents: medium-chain triglycerides, solid semisynthetic glycerides, and glycerol dioleate

• Capsule shell: gelatin, glycerol, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), and purified water.

• Printing ink: shellac, carmine acid (E 120), propylene glycol (E 1520), and simethicone.

Appearance of the product and contents of the pack

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

Nintedanib Stada 100 mg capsules are available in cardboard boxes with single-dose OPA/Al/PVC-Al perforated blisters.

Pack sizes:

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

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 Wien

Austria

This medicinal product is authorized in the European Economic Area member states 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 cápsulas blandas 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 kapsulės

Latvia: Nintedanib STADA 100 mg mikstas kapsulas

Estonia: Nintedanib STADA 100 mg pehmekapsel

Date of the most recent review of this summary: December 2023

Other sources of information Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)