Nintedanib Aurobindo

Patient Information Leaflet

Nintedanib Aurobindo 100 mg soft capsules, 150 mg soft capsules

Medicinal product equivalent
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Nintedanib Aurobindo contains the active substance nintedanib, a medicine belonging to the class of tyrosine kinase inhibitors, and is used for the treatment of the following diseases:
Idiopathic pulmonary fibrosis (IPF) in adults
IPF is a condition in which lung tissue over time becomes thick, stiff, and scarred. As a result, scarring reduces the ability to transfer oxygen from the lungs to the bloodstream, making it difficult to breathe deeply. Nintedanib Aurobindo helps reduce further scarring and stiffening of the lungs.
Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype in adults
In addition to IPF, there are other conditions in which lung tissue over time becomes thick, stiff, and scarred (pulmonary fibrosis) and continues to worsen (progressive phenotype). Examples of these conditions include hypersensitivity pneumonitis, autoimmune ILDs (e.g., ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. Nintedanib Aurobindo helps reduce further development of scarring and lung stiffening.
Clinically significant progressive fibrosing interstitial lung diseases (ILD) in children and adolescents aged 6 to 17 years
In children with pediatric interstitial lung disease (chILD), pulmonary fibrosis may occur. When this happens, the lung tissue in children and adolescents becomes thick, stiff, and scarred over time. Nintedanib Aurobindo helps reduce further scarring and stiffening of the lungs.
Interstitial lung disease associated with systemic sclerosis (SSc-ILD) in adults, children, and adolescents aged 6 to 17 years
Systemic sclerosis (SSc), or scleroderma (and juvenile systemic sclerosis in children and adolescents), is a rare chronic autoimmune disease affecting connective tissue in various parts of the body. SSc causes fibrosis (scarring and stiffening) of the skin and other internal organs such as the lungs. When the lungs are affected by fibrosis, it is referred to as interstitial lung disease (ILD), and the condition is known as SSc-ILD. Fibrosis in the lungs reduces their ability to transfer oxygen to the blood and impairs breathing capacity. Nintedanib Aurobindo helps reduce further progression of scarring and stiffening of the lungs.

2. What you need to know before taking Nintedanib Aurobindo

Do not take Nintedanib Aurobindo

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Nintedanib Aurobindo:

• if you have or have previously had liver problems;
• if you have or have previously had kidney problems or if increased levels of protein in your urine have been detected;
• if you have or have previously had bleeding problems;
• if you are taking medicines that thin the blood (for example, warfarin, phenprocoumon, or heparin) to prevent blood clots;
• if you are taking pirfenidone, which may increase the risk of developing diarrhoea, nausea, vomiting, and liver problems;
• if you have or have previously had heart problems (for example, a heart attack);
• if you have recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Aurobindo is usually stopped for a certain period around the time of surgery. Your doctor will decide when you can resume treatment with this medicine;
• if you have high blood pressure;
• if the pressure in the blood vessels of your lungs is abnormally high (pulmonary hypertension);
• if you have or have previously had an aneurysm (a weakened and widened area in the wall of a blood vessel) or a tear in the wall of a blood vessel.

Based on this information, your doctor may perform blood tests, for example, to check liver function. Your doctor will discuss the test results with you and decide whether you can take Nintedanib Aurobindo.
Inform your doctor immediately while taking this medicine:

• if you develop diarrhoea. It is essential to treat diarrhoea early (see section 4, “Possible side effects”);
• if you experience vomiting or nausea;
• if you develop unexplained symptoms such as yellowing of the skin or the whites of the eyes (jaundice), dark or brownish (tea-coloured) urine, pain in the upper right part of the stomach (abdomen), bleeding, or bruising that occurs more easily than usual, or a feeling of tiredness. These may be symptoms of serious liver problems;
• if you have severe stomach pain, fever, chills, feeling unwell, vomiting, or abdominal stiffness or swelling, as these may be symptoms of a hole in the wall of the intestine (“gastrointestinal perforation”). Inform your doctor also if you have previously had peptic ulcers or diverticular disease, or if you are taking concomitant anti-inflammatory medicines (NSAIDs) (used to relieve pain and treat swelling) or steroids (used for inflammation and allergies), as this may increase this risk;
• if you experience a combination of severe stomach pain or cramps, red blood in the stools, or diarrhoea, as these may be symptoms of intestinal inflammation due to inadequate blood supply;
• if you have pain, swelling, redness, or warmth in a limb, as these may be symptoms of a blood clot in a vein (a type of blood vessel);
• if you feel pressure or pain in the chest, particularly 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 may be symptoms of a heart attack;
• if you have significant bleeding;
• if bruising, bleeding, fever, tiredness, and confusion occur. These could 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. These may be symptoms of a condition affecting the brain called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents
Nintedanib Aurobindo must not be taken by children under 6 years of age.
Your doctor may schedule regular dental check-ups at least once every 6 months until your teeth are fully developed and monitor your growth annually (bone imaging exams) while you are taking this medicine.

Other medicines and Nintedanib Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines and over-the-counter medicines.
Nintedanib Aurobindo may interact with certain medicines. The following medicines are examples of those that may increase nintedanib levels in the blood, potentially increasing the risk of side effects (see section 4, “Possible side effects”):

• a medicine used to treat fungal infections (ketoconazole);
• a medicine used to treat bacterial infections (erythromycin);
• a medicine that modifies the immune system (cyclosporine).

The following medicines are examples of those that may decrease nintedanib levels in the blood, potentially reducing the effectiveness of Nintedanib Aurobindo:

• an antibiotic used to treat tuberculosis (rifampicin);
• medicines used to treat epilepsy (carbamazepine, phenytoin);
• a herbal medicine used to treat depression (St. John’s wort).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn baby and cause birth defects.
Before starting treatment with Nintedanib Aurobindo, you must have a pregnancy test to confirm you are not pregnant. Speak to your doctor.

Contraception

• Women of childbearing potential must use a highly effective method of contraception to avoid pregnancy when starting treatment with Nintedanib Aurobindo, during treatment, and for at least 3 months after stopping treatment.
• Discuss with your doctor the most suitable contraceptive methods for your individual case.
• Vomiting and/or diarrhoea or other gastrointestinal disorders may affect the absorption of oral hormonal contraceptives, such as the pill, and may reduce their effectiveness. Therefore, if you experience these symptoms, consult your doctor to consider a more appropriate alternative contraceptive method.
• Inform your doctor or pharmacist immediately if you become pregnant or suspect you are pregnant during treatment with Nintedanib Aurobindo.

Breastfeeding
Do not breastfeed during treatment with Nintedanib Aurobindo, as there is a potential risk of harm to breastfed infants.

Driving and using machines
Nintedanib Aurobindo has a minor influence on the ability to drive and use machines. If you do not feel well, you should not drive or operate machinery.

Nintedanib Aurobindo contains soy lecithin
If you are allergic to soy or peanuts, do not take this medicine (see section 2, under “Do not take Nintedanib Aurobindo”).

3. How to take Nintedanib Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the capsules twice daily, approximately 12 hours apart, at approximately the same times each day, for example one capsule in the morning and one capsule in the evening. This ensures that a constant amount of nintedanib is maintained in the bloodstream. Swallow the capsules whole with water and do not chew them. It is recommended to take the capsules with food, either during a meal or immediately before or after. Do not open or crush the capsule (see section 5 below, “How to store Nintedanib Aurobindo”).
To make swallowing easier, you may take the capsules with a small amount (one teaspoon) of soft food, such as apple puree or chocolate pudding, cold or at room temperature. Swallow the capsules immediately and do not chew them, to ensure they remain intact.

For 100 mg:
Adults
The recommended dose is one 100 mg capsule twice daily (for a total daily dose of 200 mg).
Do not take a higher dose than the recommended dose of two Nintedanib Aurobindo 100 mg capsules per day.
If you do not tolerate the recommended dose of two Nintedanib Aurobindo 100 mg capsules per day (see possible side effects in section 4), your doctor may advise you to discontinue treatment with this medicine. Do not reduce the dose or stop treatment without first consulting your doctor.

For 150 mg:
Adults
The recommended dose is one 150 mg capsule twice daily (for a total daily dose of 300 mg).
Do not take a higher dose than the recommended dose of two Nintedanib Aurobindo 150 mg capsules per day.
If you do not tolerate the recommended dose of two Nintedanib Aurobindo 150 mg capsules per day (see possible side effects in section 4), your doctor may reduce your daily dose of Nintedanib Aurobindo. Do not reduce the dose or stop treatment without first consulting your doctor.
Your doctor may reduce the recommended dose to 100 mg twice daily (for a total daily dose of 200 mg). In this case, your doctor will prescribe treatment with Nintedanib Aurobindo 100 mg capsules. Do not take more than the recommended dose of two Nintedanib Aurobindo 100 mg capsules per day if your dose has been reduced to 200 mg per day.

Use in children and adolescents
The recommended dose depends on the patient's body weight.
Inform your doctor if the patient's weight drops below 13.5 kg at any time during treatment.
Inform your doctor if you have liver problems.
Your doctor will determine the correct dose. The doctor may adjust the dose as treatment progresses.
If you do not tolerate the recommended daily dose of Nintedanib Aurobindo capsules (for possible side effects, see section 4), your doctor may reduce the daily dose of Nintedanib Aurobindo.
Do not reduce the dose or stop treatment without first consulting your doctor.

Dosing of Nintedanib Aurobindo capsules according to weight in children and adolescents:

If you take more Nintedanib Aurobindo than you should
Contact your doctor or pharmacist immediately.

If you forget to take Nintedanib Aurobindo
Do not take two capsules at the same time if you have forgotten to take the previous dose.
Take the next dose of Nintedanib Aurobindo as scheduled, at the next planned time, as recommended by your doctor or pharmacist.

If you stop taking Nintedanib Aurobindo
Do not stop treatment with Nintedanib Aurobindo without first consulting your doctor. It is important to take this medicine every day for the entire duration indicated by your doctor.

If you have any doubts about the use of this medicine, consult 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 particular attention if you experience the following side effects during treatment with
Nintedanib Aurobindo:
Diarrhoea (very common, may occur in more than 1 in 10 patients):
Diarrhoea can cause dehydration: loss of fluids and important salts (electrolytes such as sodium or
potassium) from the body. At the first signs of diarrhoea, drink plenty of fluids and contact your doctor immediately. Start appropriate treatment for diarrhoea as soon as possible, for example with loperamide.
The following side effects have also been observed during treatment with this medicine.
Contact your doctor if you experience any side effect.
Idiopathic pulmonary fibrosis (IPF)
Very common side effects (may occur in more than 1 in 10 patients)

• Feeling unwell (nausea)
• Pain in the lower part of the body (abdomen)
• Abnormal liver function tests

Common side effects (may occur in less than 1 in 10 patients)

• Vomiting
• Loss of appetite
• Weight loss
• Bleeding
• Rash
• Headache (cephalalgia)

Uncommon side effects (may occur in less than 1 in 100 patients)

• 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 levels of bilirubin
• Itching (pruritus)
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Not known (frequency cannot be estimated from the available data)

• Kidney failure
• Enlargement and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)
• Brain condition with 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 (reversible posterior encephalopathy syndrome).

Other chronic fibrosing interstitial lung diseases (ILD) with progressive phenotype
Very common side effects (may occur in more than 1 in 10 patients)

• Feeling unwell (nausea)
• Vomiting
• Loss of appetite
• Pain in the lower part of the body (abdomen)
• Abnormal liver function tests

Common side effects (may occur in less than 1 in 10 patients)

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

Uncommon side effects (may occur in less than 1 in 100 patients)

• 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 levels of bilirubin
• Itching (pruritus)
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Not known (frequency cannot be estimated from the available data)

• Kidney failure
• Enlargement and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)
• Brain condition with 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 (reversible posterior encephalopathy syndrome).

Interstitial lung disease associated with systemic sclerosis (SSc-ILD)
Very common side effects (may occur in more than 1 in 10 patients)

• Feeling unwell (nausea)
• Vomiting
• Pain in the lower part of the body (abdomen)
• Abnormal liver function tests

Common side effects (may occur in less than 1 in 10 patients)

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

Uncommon side effects (may occur in less than 1 in 100 patients)

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

Not known (frequency cannot be estimated from the available data)

• Heart attack
• Pancreatitis
• Jaundice, i.e. yellowing of the skin and whites of the eyes due to high levels of bilirubin
• Enlargement and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)
• Brain condition with 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 (reversible posterior encephalopathy syndrome).

Fibrosing interstitial lung diseases (ILD) in children and adolescents
Side effects in children and adolescents are similar to those in adult patients.
Contact your doctor if you experience any side effect.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nintedanib Aurobindo

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 or blister after
EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice that the capsule blister 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, “How to take Nintedanib Aurobindo”).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nintedanib Aurobindo contains

• The active substance is nintedanib. Each capsule contains 100 mg of nintedanib (as esilate).
• The other components are: Capsule contents: medium-chain triglycerides, semisynthetic solid glycerides, lecithin (soy). Capsule shell: gelatin, glycerol (85%), titanium dioxide, yellow iron oxide (E172), red iron oxide (E172). Printing ink (black): black iron oxide NF (E172), propylene glycol (E1520), hypromellose 2910 (6 cP) (E464).
• The active substance is nintedanib. Each capsule contains 150 mg of nintedanib (as esilate).
• The other components are: Capsule contents: medium-chain triglycerides, semisynthetic solid glycerides, lecithin (soy). Capsule shell: gelatin, glycerol (85%), titanium dioxide, yellow iron oxide (E172), red iron oxide (E172). Printing ink (black): black iron oxide NF (E172), propylene glycol (E1520), hypromellose 2910 (6 cP) (E464).

Description of the appearance of Nintedanib Aurobindo and package contents
Soft capsules.
Nintedanib Aurobindo 100 mg soft capsules:
Nintedanib Aurobindo 100 mg soft capsules are peach-coloured, opaque, oblong soft gelatin capsules, printed with ‘N100’ in black ink, containing a bright yellow suspension.
Nintedanib Aurobindo 150 mg soft capsules:
Nintedanib Aurobindo 150 mg soft capsules are brown-coloured, opaque, oblong soft gelatin capsules, printed with ‘N150’ in black ink, containing a bright yellow suspension.
Nintedanib Aurobindo 100 mg and 150 mg soft capsules
Nintedanib Aurobindo 100 mg and 150 mg soft capsules are available in blister packs containing 30, 60, 120 soft capsules and in perforated blister strips containing 60x1 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Eugia Pharma (Malta) Limited
Valletta Waterfront,
14 Vault, 2nd Level,
Floriana, FRN 1914, Malta
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Qasam Industrijali Hal Far, Birzebbuga, BBG 3000
Malta
Generis Farmacêutica S.A.
Rua João de Deus, 19 Venda Nova,
2700-487 Amadora
Portugal
Arrow Génériques
26 avenue Tony Garnier,
Lyon, 69007
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Nintedanib Eugia 100 mg zachte capsules / capsules molles / Weichkapseln
Nintedanib Eugia 150 mg zachte capsules / capsules molles / Weichkapseln
Portugal: Nintedanib Eugia
France: Nintedanib Arrow 100 mg, capsule molles
Nintedanib Arrow 150 mg, capsule molles
Germany: Nintedanib Puren 100 mg Weichkapseln
Nintedanib Puren 150 mg Weichkapseln
Italy: Nintedanib Aurobindo
Netherlands: Nintedanib Eugia 100 mg, zachte capsules
Nintedanib Eugia 150 mg, zachte capsules
Poland: Nintedanib Eugia
Spain: Nintedanib Eugia 100 mg cápsulas blandas EFG
Nintedanib Eugia 150 mg cápsulas blandas EFG