Nintedanib Dr. Reddy's 100 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Nintedanib Dr. Reddys 100 mg soft capsules EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should 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 these are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

1. What Nintedanib Dr. Reddys is and what it is used for
2. What you need to know before starting Nintedanib Dr. Reddys
3. How to take Nintedanib Dr. Reddys
4. Possible side effects
5. How to store Nintedanib Dr. Reddys
6. Contents of the pack and other information

1. What Nintedanib Dr. Reddys is and what it is used for

Nintedanib Dr. Reddys contains the active substance nintedanib, a medicine that belongs to a class of drugs known as tyrosine kinase inhibitors, and is used to treat the following conditions:

Idiopathic pulmonary fibrosis (IPF) in adults

IPF is a disease that causes thickening, hardening, and scarring of 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 lung stiffening.

Other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype in adults

In addition to IPF, there are other diseases in which lung tissue becomes thickened, hardened, and scarred over time (pulmonary fibrosis) and continues to worsen (progressive phenotype). Examples of these diseases 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 the development of further scarring and stiffening of the lungs.

Clinically significant progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents aged 6 to 17 years

Pulmonary fibrosis can occur in patients with childhood interstitial lung disease. In this case, the lung tissue in children and adolescents becomes thickened, hardened, and scarred over time. Nintedanib helps reduce the development of further scarring and stiffening of the lungs.

Interstitial lung disease associated with systemic sclerosis (ILD-SS) in adults, adolescents, and children aged 6 years and older

Systemic sclerosis (SS), also known as scleroderma (and juvenile systemic sclerosis in children and adolescents), is a rare chronic autoimmune disease affecting connective tissue in many parts of the body. SS 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 ILD-SS. Fibrosis in the lungs reduces the ability to transfer oxygen into the bloodstream and impairs breathing capacity. Nintedanib helps reduce the development of further scarring and stiffening of the lungs.

Non-small cell lung cancer (NSCLC) in adults

By blocking the activity of a group of proteins involved in the development of new blood vessels that cancer cells need for nourishment and oxygen, nintedanib may help stop cancer growth and spread.

Nintedanib is used in combination with another anticancer medicine (docetaxel) to treat a type of lung cancer called non-small cell lung cancer (NSCLC). It is intended for adult patients with a specific type of NSCLC (adenocarcinoma) who have already received prior treatment for this cancer but whose tumor has started to grow again.

2. What you need to know before starting to take Nintedanib Dr. Reddys

Do not take Nintedanib Dr. Reddys

• if you are allergic to nintedanib or to any of the other ingredients of this medicine (listed in section 6).
• for the treatment of IPF, PSP or PSP-SS if you are pregnant.

Warnings and precautions

Consult your doctor or pharmacist before starting nintedanib

• 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, particularly recent bleeding in the lung.
• if you are taking medications to thin the blood (such as warfarin, phenprocoumon, heparin, or acetylsalicylic acid) and prevent blood clots. Treatment with nintedanib may increase the risk of bleeding.
• if you are taking pirfenidone, as it may increase the risk of 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 how wounds heal. Therefore, treatment with nintedanib will usually be interrupted for a period 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.
• if you have cancer that has spread to the brain.

Based on this information, your doctor may perform 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.

Inform your doctor immediately while taking this medicine

• if you have diarrhea. It is important to treat diarrhea early (see section 4).
• if you have vomiting or feel nauseous.
• if you experience unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown-colored urine (like tea), pain in the upper right part of the abdomen (stomach area), bleeding, or you bruise more easily than usual, or feel tired. These could be signs of serious liver problems.
• if you have severe stomach pain, fever, chills, dizziness, vomiting, 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 previously had peptic ulcers or diverticular disease, or if you are being treated simultaneously with anti-inflammatory medicines (NSAIDs) (used to relieve pain and swelling) or steroids (used for inflammation and allergies), as all of these may increase this risk.
• if you have a combination of severe or cramp-like stomach pain, red 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 chest pressure or chest pain, 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 significant bleeding.
• if you experience bruising, bleeding, fever, fatigue, and confusion, as these may be signs of damage to blood vessels known as thrombotic microangiopathy (TMA).
• if you experience symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure, which could be symptoms of a brain disorder called reversible posterior encephalopathy syndrome (PRES).
• if you develop fever, chills, rapid breathing, or a fast heartbeat. These could be signs of infection or blood infection (sepsis) (see section 4).
• if any of the side effects you may experience (see section 4) worsen.

Children and adolescents

Idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and interstitial lung disease associated with systemic sclerosis (ILD-SSc)

Children under 6 years of age must not take nintedanib.

Your doctor may perform periodic dental examinations at least every 6 months until dental development is complete, and may monitor growth once a year (bone imaging study) while the child is taking this medicine.

Non-small cell lung cancer (NSCLC)

This medicine has not been studied in children and adolescents for the treatment of lung cancer (NSCLC) and should therefore not be administered to children and adolescents under 18 years of age.

Other medicines and Nintedanib Dr. Reddys

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

Nintedanib can interact with other medicines. The following medicines may increase blood levels of nintedanib and, therefore, increase the risk of experiencing adverse effects (see section 4, “Possible adverse effects”):

• 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 blood levels of nintedanib and thereby reduce the effectiveness of Nintedanib Dr. Reddys:

• 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take this medicine during pregnancy, as it may harm the fetus and cause congenital defects.

A pregnancy test must be performed to confirm that you are not pregnant before starting treatment with Nintedanib Dr. Reddys. Consult your doctor.

Contraception

• Women who are capable of becoming pregnant must use a highly effective method of contraception to prevent pregnancy when starting nintedanib, during treatment with nintedanib, and for at least 3 months after stopping treatment.
• Discuss with your doctor the most appropriate contraceptive methods for you.
• Vomiting and/or diarrhea or other gastrointestinal disorders may affect the absorption of oral hormonal contraceptives, such as contraceptive pills, and may reduce their effectiveness. Therefore, if you experience any of these conditions, consult your doctor to consider a more appropriate alternative 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 Dr. Reddys, as it may cause harm to the breastfed infant.

Fertility

The effect of this medicine on human fertility has not been investigated.

Driving and Use of Machines

Nintedanib Dr. Reddy's has little 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 Dr. Reddys

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

For the treatment of idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and interstitial lung disease associated with systemic sclerosis (ILD-SSc):

Take the capsules twice daily, approximately 12 hours apart and at approximately the same time each day; for example, one capsule in the morning and one capsule in the evening. This will ensure that a constant level of nintedanib is maintained in your blood. Swallow the capsules whole with water, without chewing them. It is recommended to take the capsules with food, that is, during, immediately before, or immediately after a meal. Do not open or split the capsule (see section 5, "Storage of Nintedanib Dr. Reddys").

To make swallowing the capsules easier, you may take them with a small amount (one teaspoonful) of soft food at cool or room temperature, such as apple sauce or chocolate pudding. Swallow the capsules immediately and do not chew them to ensure they remain intact.

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 interrupt treatment on your own without first consulting your doctor.

Use in children and adolescents

The recommended dose depends on the patient's body weight.

Inform your doctor if at any time during treatment the patient's weight is below 13.5 kg.

Inform your doctor if you have liver problems.

Your doctor will determine the correct dose. Your doctor may adjust the dose during the course of treatment.

If you do not tolerate the recommended daily dose of nintedanib capsules (see possible adverse effects in section 4), your doctor may reduce the daily dose of this medicine.

Do not reduce the dose or stop treatment on your own without first consulting your doctor.

Weight-based dosing for Nintedanib Dr. Reddys capsules in children and adolescents:

Weight range in kilograms (kg)	Dosage of Nintedanib Dr. Reddy's in milligrams (mg)
13.5–22.9 kg	50 mg (two 25 mg capsules) twice daily
23.0–33.4 kg	75 mg (three 25 mg capsules) twice daily
33.5–57.4 kg	100 mg (one 100 mg capsule or four 25 mg capsules) twice daily
57.5 kg or more	150 mg (one 150 mg capsule or six 25 mg capsules) twice daily

For doses that cannot be achieved with this medicinal product, there are other medicinal products containing nintedanib in more suitable concentrations.

For the treatment of non-small cell lung cancer (NSCLC):

Do not take nintedanib on the same day as your docetaxel chemotherapy treatment.

Swallow the capsules whole with water and do not chew them. It is recommended to take the capsules with food, i.e., during, immediately before, or immediately after a meal. Do not open or crush the capsule (see section 5).

The recommended dose is four capsules per day (a total of 400 mg of nintedanib per day). Do not exceed this dose.

This daily dose should be divided into two doses of two capsules each, approximately 12 hours apart, for example, two capsules in the morning and two in the evening. These two doses should be taken at approximately the same time each day. Taking the medicine in this way ensures that a constant amount of nintedanib is maintained in the body.

Dose reduction

If you do not tolerate the recommended dose of 400 mg per day due to side effects (see section 4), your doctor may reduce your daily dose of nintedanib. Do not reduce the dose or stop treatment without first consulting your doctor.

Your doctor may reduce the recommended dose to 300 mg per day (two 150 mg capsules). In this case, your doctor will prescribe soft capsules of nintedanib 150 mg for your treatment.

If necessary, your doctor may further reduce the daily dose to 200 mg per day (two 100 mg capsules). In this case, your doctor will prescribe the appropriate capsule dose.

In both cases, you should take one capsule of the appropriate dose twice daily with food, approximately 12 hours apart (e.g., in the morning and evening), at approximately the same time each day.

If your doctor has discontinued docetaxel chemotherapy, you should continue taking nintedanib twice daily.

If you take more Nintedanib Dr. Reddys 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 medication and the amount ingested.

If you forget to take Nintedanib Dr. Reddys

Do not take a double dose if you have forgotten your previous dose. You should take your next dose of Nintedanib Dr. Reddys at the next scheduled and recommended time according to your doctor or pharmacist.

If you interrupt treatment with Nintedanib Dr. Reddys

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

Non-small cell lung cancer (NSCLC)

If you do not take this medicine as prescribed by your doctor, this cancer treatment may not work properly.

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 may cause adverse effects, although not everyone experiences them.

Idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases with a progressive phenotype (ILD-PP), and interstitial lung disease associated with systemic sclerosis (SSc-ILD)

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.

Consult 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
• 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
• 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 the blood vessel wall (aneurysms and arterial dissections)
• Brain disorder with symptoms such as headache, vision changes, confusion, seizures, or other neurological disturbances 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 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
• Severe 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 the blood vessel wall (aneurysms and arterial dissections)
• Brain disorder with symptoms such as headache, vision changes, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

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
• Severe 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 the blood vessel wall (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)
• Brain disorder with symptoms such as headache, vision changes, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

Fibrosing interstitial lung diseases (ILD) in children and adolescents

Adverse effects in children and adolescents were similar to those in adult patients.

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

Non-small cell lung cancer (NSCLC)

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 may lead to 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 contact your doctor immediately. Start appropriate anti-diarrheal treatment, for example with loperamide, as soon as possible after consulting your doctor.

• Febrile neutropenia and sepsis (common, may affect up to 1 in 10 people)

Treatment with nintedanib may cause a reduction in the number of white blood cells (neutropenia), which are important for the body's response to bacterial or fungal infections. As a result of neutropenia, fever (febrile neutropenia) and blood infection (sepsis) may occur. Inform your doctor immediately if you develop fever, chills, rapid breathing, or rapid heartbeat.

During treatment with nintedanib, your doctor will periodically monitor your blood counts and examine you for signs of infection, such as inflammation, fever, or fatigue.

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

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

• Diarrhea (see above)
• Pain, numbness, or tingling sensation in fingers and toes (peripheral neuropathy)
• Nausea
• Vomiting
• Abdominal pain
• Bleeding
• Decreased number of white blood cells (neutropenia)
• Inflammation of the mucous membranes lining the digestive tract, including sores and ulcers in the mouth (mucositis, including stomatitis)
• Skin rash
• Decreased appetite
• Electrolyte imbalance
• Increased liver enzyme levels (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) in blood, detected in blood tests
• Hair loss (alopecia)

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

• Blood poisoning (sepsis) – see above
• Decreased number of white blood cells accompanied by fever (febrile neutropenia)
• Blood clots in the veins (venous thromboembolism), especially in the legs (symptoms include pain, redness, swelling, and warmth in one limb), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, consult a doctor immediately)
• High blood pressure (hypertension)
• Fluid loss (dehydration)
• Abscesses
• Low platelet count (thrombocytopenia)
• Jaundice (hyperbilirubinemia)
• Increased levels of liver enzymes (gamma-glutamyltransferase) in blood, as detected in blood tests
• Weight loss
• Itching
• Headache
• Increased amount of protein in the urine (proteinuria)

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

• Development of holes in the intestinal wall (gastrointestinal perforation)
• Severe liver problems
• Inflammation of the pancreas (pancreatitis)
• Myocardial infarction
• Kidney failure

Frequency not known (cannot be estimated from available data)

• Inflammation of the large intestine
• Enlargement and weakening of a blood vessel wall or tear in the blood vessel wall (aneurysms and arterial dissections)
• A brain condition with symptoms such as headache, vision changes, confusion, seizures, or other neurological disturbances such as weakness in an arm or a leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if these adverse reactions are not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Nintedanib Dr. Reddys

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. 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 damaged.

If you come into contact with the capsule contents, wash your hands immediately with plenty of water (see section 3).

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

• The active substance is nintedanib. Each capsule contains 100 mg of nintedanib esilate, equivalent to 100 mg of nintedanib.

• The other components are:

• Capsule contents: triglycerides, medium-chain triglycerides, polysorbate 80 and sorbitan oleate.

• Capsule shell: gelatin, glycerol, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172) and purified water.

• Printing ink: shellac glaze, iron oxide black (E172) and propylene glycol (E1520).

Appearance of the product and contents of the container

Soft gelatin capsules, oblong, opaque and peach-coloured (approx. 15 mm x 6 mm), filled with a bright yellow suspension and printed with "100" in black ink.

The capsules are available in blister packs and single-dose perforated blisters in the following pack sizes: 30, 30 x 1, 60, 60 x 1, 120 and 120 x 1.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona

Spain

Manufacturer responsible

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

or

Pharmadox Healthcare Ltd.,

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

or

DR. REDDY’S LABORATORIES ROMÂNIA S.R.L.

Str. Daniel Danielopolu, nr. 30-32, Spațiul 2, Etaj 5,

Sectorul 1, Bucuresti,

cod poștal 014134

Romania

or

Rual Laboratories SRL

313, Splaiul Unirii, Building H

1st floor, sector 3, Bucuresti, 030138

Romania

This medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Member State	Medicinal product name
Austria	Nintedanib Reddy 100 mg Soft Capsules
Germany	Nintedanib Reddy 100 mg Soft Capsules
Spain	Nintedanib Dr. Reddys 100 mg soft capsules EFG
Italy	Nintedanib Dr. Reddy’s 100 mg soft capsule
Netherlands	Nintedanib Reddy 100 mg soft capsules
Romania	Nintedanib Dr. Reddy’s 100 mg soft capsules
Sweden	Nintedanib Reddy 100 mg capsule, soft

Date of the last review of this leaflet: May 2025

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