NINTEDANIB EUGIA 100 mg SOFT CAPSULES

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

Do not takeNintedanib Eugia

• If you are pregnant.
• If you are allergic to nintedanib, peanuts, soy, or 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:

• 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 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 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 taking this medicine:

Children and adolescents

Children and adolescents under 18 years should not take this medicine.

Other medicines andNintedanib Eugia

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 (cyclosporine).

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

• 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. 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 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.

Nintedanib Eugia contains soy lecithin

Do not use this medicine if you are allergic to peanuts or soy (see section 2).

3. How to take Nintedanib Eugia

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, 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 help keep a constant level of nintedanib in your blood. Swallow the capsules whole with water, without chewing. It is recommended to take the capsules with food, i.e., during meals or immediately before or after meals. Do not open or split the capsule (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 consulting your doctor first.

If you take moreNintedanib Eugiathan 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 takeNintedanib Eugia

Do not take two capsules together if you have missed your previous dose. You should take your next dose of 100 mg of nintedanib according to the schedule established and recommended by your doctor or pharmacist.

If you stop taking Nintedanib Eugia

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 product, 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.

Talk to 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).
• Stomach pain (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.
• Inflammation of the large intestine.
• Low platelet count (thrombocytopenia).
• High blood pressure (hypertension).
• Yellowing of the skin or the whites of the eyes (jaundice).
• 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)

• Feeling sick (nausea).
• Vomiting.
• Lack of appetite.
• Stomach pain (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.
• Inflammation of the large intestine.
• Low platelet count (thrombocytopenia).
• Yellowing of the skin or the whites of the eyes (jaundice).
• 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)

• Feeling sick (nausea).
• Vomiting.
• Stomach pain (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)

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

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

• Heart attack.
• Pancreatitis.
• Yellowing of the skin or the whites of the eyes (jaundice).
• 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: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nintedanib Eugia

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 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 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 medicines at the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofNintedanib Eugia

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

Capsule content:medium-chain triglycerides, hard fat, lecithin (soy).

Capsule shell:gelatin, glycerol (85%), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Printing ink:black iron oxide (E172), propylene glycol (E1520), and hypromellose 2910 (6 cp) (E464).

Appearance and Package Contents of the Product

Soft capsules.

A soft gelatin capsule with an elongated shape, opaque peach-colored, with "N100" printed in black ink, containing a bright yellow suspension.

Nintedanib Eugia soft capsules are available in blister packs of 30, 60, or 120 soft capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Germany: Nintedanib Eugia 100 mg soft capsules

Belgium: Nintedanib Eugia 100 mg soft capsules / capsules molles / Weichkapseln

Spain: Nintedanib Eugia 100 mg soft capsules EFG

France: NINTEDANIB EUGIA PHARMA 100 mg, soft capsule

Italy: Nintedanib Eugia

Netherlands: Nintedanib Eugia 100 mg, soft capsules

Poland: Nintedanib Eugia

Portugal: Nintedanib Eugia

Date of the last revision of this leaflet: November 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/).