Nintedanib Cinfa 100 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Nintedanib cinfa 100 mg soft capsules EFG

Nintedanib

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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Nintedanib cinfa contains the active substance nintedanib, a medicine belonging to the 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, this scarring reduces the ability to transfer oxygen from the lungs into the bloodstream, making it difficult to breathe deeply. Nintedanib cinfa helps reduce the progression of further scarring and hardening of the lungs.

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 progressively thickens, hardens, and scars 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 cinfa helps reduce the progression of further scarring and hardening of the lungs.

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

Pulmonary fibrosis may 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 progression of further scarring and hardening of the lungs.

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

Systemic sclerosis (SSc), 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. 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 cinfa helps reduce the progression of further scarring and hardening of the lungs.

2. What you need to know before starting Nintedanib Cinfa

Do not take Nintedanib cinfa

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Nintedanib cinfa

• 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 the blood (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 the way wounds heal. Therefore, treatment with Nintedanib cinfa will usually be interrupted 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 wall of a blood vessel) or a tear in the wall of a blood vessel.

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

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 have symptoms without an obvious cause such as yellowing of the skin or whites of the eyes (jaundice), dark or brown-coloured urine (tea-coloured), pain in the upper right side of the stomach area (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 previously had peptic ulcers or diverticular disease, 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 cramp-like stomach pain, red blood in the 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, difficulty breathing, nausea or vomiting, as these could be symptoms of a heart attack;
• if you have a major bleeding episode;
• 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 one 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 under 6 years of age must not take Nintedanib cinfa.

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

Other medicines and Nintedanib cinfa

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

Nintedanib cinfa may interact with other medicines. The following medicines are examples that may increase blood levels of nintedanib and therefore increase the risk of adverse 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 blood levels of nintedanib and thus reduce the effectiveness of Nintedanib cinfa:

• 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 unborn baby and cause birth defects.

A pregnancy test should be performed to make sure you are not pregnant before starting treatment with Nintedanib cinfa. Consult your doctor.

Contraception

• Women who can become pregnant must use a highly effective method of contraception to prevent pregnancy when starting Nintedanib cinfa, while taking Nintedanib cinfa, and for at least 3 months after stopping treatment.
• Consult your doctor about the most appropriate contraceptive methods for you.
• Vomiting and/or diarrhoea or other gastrointestinal disorders may affect the absorption of hormonal oral 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 think you may be pregnant while being treated with Nintedanib cinfa.

Breastfeeding

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

Driving and use of machines

Nintedanib cinfa has a 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 cinfa

Always follow exactly the instructions for administration of this medicine 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 that a constant level of nintedanib is maintained in your blood. Swallow the capsules whole with water and do not chew the capsules. It is recommended to take the capsules with food, that is, during meals or immediately before or after meals. Do not open or split the capsule (see section 5).

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 cinfa 100 mg capsules per day.

If you do not tolerate the recommended dose of two Nintedanib cinfa 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.

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 nintedanib.

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

Dosage based on weight for nintedanib capsules in children and adolescents:

#Nintedanib cinfa is only available in 100 mg and 150 mg soft capsules. Therefore, it is not possible to administer Nintedanib cinfa to pediatric patients who require a dose lower than the full 100 mg dose. If an alternative dose is required, other nintedanib products offering this option may be used.

If you take more Nintedanib cinfa than you should

Contact your doctor or pharmacist immediately.

If you forget to take Nintedanib cinfa

Do not take two capsules together if you have missed your previous dose. You should take your next 100 mg dose of Nintedanib cinfa at the next scheduled and recommended time according to your doctor or pharmacist.

If you stop treatment with Nintedanib cinfa

Do not stop taking Nintedanib cinfa without first consulting your doctor. It is important to take this medicine every day 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 cinfa:

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 been observed during treatment with this medicine.

Contact your doctor if you experience any adverse effects.

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 (reversible posterior 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 (reversible posterior 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 (reversible posterior encephalopathy syndrome)

Fibrosing interstitial lung diseases (ILD) in children and adolescents

Adverse effects in children and adolescents were similar to those observed in adult patients. Inform your doctor if you experience any adverse effects.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nintedanib cinfa

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 pack. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Store in the original packaging to protect from moisture.

Do not use this medicine if you notice that the blister pack 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nintedanib cinfa

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

Contents of the capsule: Macrogol 400.

Capsule shell: Gelatin (E441), sorbitol (liquid, partially dehydrated) (E420), glycerol (E422), titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).

Description of the product and contents of the pack

Nintedanib cinfa 100 mg soft capsules EFG are oblong, opaque, peach-colored soft gelatin capsules.

There are two pack sizes available for Nintedanib cinfa 100 mg soft capsules EFG:

• 30 × 1 soft capsules in single-dose blisters, pre-perforated or non-pre-perforated, made of PET/Alu - Polyamide/Alu/PVC.
• 60 × 1 soft capsules in single-dose blisters, pre-perforated or non-pre-perforated, made of PET/Alu - Polyamide/Alu/PVC.

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Cyndea Pharma S.L., Polígono Industrial Emiliano Revilla Sanz,

Avenida Agreda 31, Olvega, Soria, 42110, Spain

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

Date of the most recent review of this leaflet: January 2026

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90483/P_90483.html

QR code link: https://cima.aemps.es/cima/dochtml/p/90483/P_90483.html