NINTEDANIB SANDOZ 100 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Nintedanib Sandoz 100 mg Soft Capsules EFG

nintedanib

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

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

Nintedanib Sandoz 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 interstitial lung disease associated with systemic sclerosis (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. This medicine 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 include hypersensitivity pneumonitis, autoimmune ILD (such as ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILD. This medicine helps reduce new scarring and hardening 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 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, therefore, 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. This medicine helps reduce new scarring and hardening of the lungs.

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

Do not take Nintedanib Sandoz

• 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 this medicine:

• 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 suffering from 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 this medicine 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 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 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 the stomach area (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 having a hole in the wall of the 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 anti-inflammatory medicines (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 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 having 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);
• if you experience symptoms such as headache, changes in vision, confusion, seizures, or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure, which could be symptoms of a brain disorder called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents

Children and adolescents under 18 years should not take nintedanib.

Other medicines and Nintedanib Sandoz

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 suffering from 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 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 the fetus and cause birth defects.

A pregnancy test should be performed to ensure you are not pregnant before starting treatment with this medicine. Talk to your doctor.

Contraception

• Women who may become pregnant must use a highly effective method of contraception to avoid pregnancy when starting to take nintedanib, while 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 oral 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 more suitable for you.
• Tell your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with this medicine.

Breastfeeding

Do not breastfeed your baby during treatment with this medicine, as it may harm the baby.

Driving and using machines

This medicine 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 Sandoz

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

Take the capsules twice a day, with approximately 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 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 to avoid accidental exposure to the capsule contents (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 do not 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 by yourself without first talking to your doctor.

If you take more Nintedanib Sandoz 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Nintedanib Sandoz

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 Sandoz

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 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 nintedanib (the active substance of 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)

• Nausea
• Abdominal pain
• Abnormal liver blood 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
• Colitis
• Severe liver problems
• Low platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Jaundice, i.e., yellow color in 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)
• Brain disorder with symptoms such as headache, changes in vision, confusion, seizures, or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

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

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

• Nausea
• Vomiting
• Loss of appetite
• 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
• Colitis
• Low platelet count (thrombocytopenia)
• Jaundice, i.e., yellow color in 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)
• Brain disorder with symptoms such as headache, changes in vision, confusion, seizures, or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

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

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

• Nausea
• Vomiting
• Abdominal pain
• Abnormal liver blood 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
• 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 in 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)
• Brain disorder with symptoms such as headache, changes in vision, confusion, seizures, or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

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 to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nintedanib Sandoz

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 CAD/EXP. The expiry date is the last day of the month indicated.

Store the blister in the original packaging to protect it from moisture.

Do not use this medicine if you notice that the blister containing the capsules is open or that 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. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Nintedanib Sandoz

• The active substance is nintedanib. Each capsule contains nintedanib esylate equivalent to 100 mg of nintedanib.
• The other ingredients are:

• Capsule content: medium-chain triglycerides, semi-synthetic solid glycerides, and dioleoyl triglycerol (E 475).
• Outer capsule shell: gelatin (E 441), glycerol (85%) (E 422), titanium dioxide (E 171), red iron oxide (E 172), and yellow iron oxide (E 172).
• Printing ink: shellac (E 904), carmine (E 120), propylene glycol (E 1520), and simethicone.

Appearance and package contents of the product

Nintedanib Sandoz 100 mg soft capsules (capsules) are oblong, opaque, and peach-colored soft gelatin capsules, measuring between 13.5 and 17.5 mm in length, containing a viscous yellow suspension and marked in red ink with “NT 100”.

Nintedanib Sandoz 100 mg soft capsules are available in cardboard boxes containing

30 x 1 and 60 x 1 soft capsules in single-dose precut OPA/AL/PVC/aluminum blisters.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte, Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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 SGN 3000,

Malta

Or

Qualimetrix S.A.

579 Mesogeion Avenue,

Agia Paraskevi,

Athens, 15343,

Greece

Or

Lek Pharmaceuticals d.d.,

Verovškova ulica 57,

1526 Ljubljana,

Slovenia

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

Austria: Nintedanib Sandoz 100 mg – Weichkapsel

Denmark: Nintedanib Sandoz

Spain: Nintedanib Sandoz 100 mg soft capsules EFG

Estonia: Nintedanib Sandoz

Finland: Nintedanib Sandoz 100 mg pehmeät kapselit

France: NINTEDANIB SANDOZ 100 mg, capsule molle

Hungary: Nintedanib Sandoz 100 mg lágy kapszula

Iceland: Nintedanib Sandoz

Italy: Nintedanib Sandoz

Latvia: Nintedanib Sandoz 100 mg mikstas kapsulas

Lithuania: Nintedanib Sandoz 100 mg minkštosios kapsules

Norway: Nintedanib Sandoz

Netherlands: Nintedanib Sandoz 100 mg, zachte capsules

Poland: Nintedanib Sandoz

Portugal: Nintedanib Sandoz 100 mg soft capsules

Czech Republic: Nintedanib Sandoz

Sweden: Nintedanib Sandoz

Date of last revision of this leaflet:October 2024.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.