NINTEDANIB 100 mg Soft Capsule

Зміст інструкції

1. Nintedanib Aurobindo 100 mg soft capsules, 150 mg soft capsules
   1. What is Nintedanib Aurobindo and what is it 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. Package contents and other information

Nintedanib Aurobindo 100 mg soft capsules, 150 mg soft capsules

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Nintedanib Aurobindo and what is it used for

Nintedanib Aurobindo contains the active ingredient nintedanib, a medicine belonging to the class
of tyrosine kinase inhibitors, and is used 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 (SSc-ILD) in adults.
Idiopathic pulmonary fibrosis (IPF)
IPF is a condition in which the tissue of the lungs becomes thick, stiff and
scarred over time. As a result, the scars reduce the ability to transfer oxygen from the lungs
to the bloodstream, making it difficult to breathe deeply. Nintedanib Aurobindo
helps to reduce further scarring and stiffness of the lungs.
Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype
In addition to IPF, there are other conditions in which the tissue of the lungs becomes
thick, stiff and scarred (pulmonary fibrosis) and continues to worsen (progressive phenotype).
Examples of these conditions are hypersensitivity pneumonitis, autoimmune ILDs (e.g. ILD
associated with rheumatoid arthritis), nonspecific idiopathic interstitial pneumonia, unclassifiable idiopathic
interstitial pneumonia and other ILDs. Nintedanib Aurobindo helps to reduce
further scarring and stiffening of the lungs.
Interstitial lung disease associated with systemic sclerosis (SSc-ILD)
Systemic sclerosis (SSc), or scleroderma, is a rare chronic autoimmune disease that affects the
connective tissue of 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 pathology is called SSc-ILD. Fibrosis in
the lungs reduces their ability to transfer oxygen to the blood and breathing capacity.
Nintedanib Aurobindo helps to further reduce the appearance 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, to 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 had in the past, liver problems;
• if you have, or have had in the past, kidney problems or if an increase in the amount of protein in your urine has been detected;
• if you have, or have had in the past, bleeding problems;
• if you are taking medicines that thin the blood (such as warfarin, phenprocoumon or heparin) to prevent blood clots;
• if you are taking pirfenidone, which may lead to an increased risk of developing diarrhoea, nausea, vomiting and liver problems;
• if you have, or have had in the past, heart problems (such as a heart attack);
• if you have recently had surgery. Nintedanib may alter wound healing. Therefore, treatment with Nintedanib Aurobindo will usually be stopped for a certain period in case of surgery. Your doctor will decide when you can start treatment with this medicine again;
• if you have high blood pressure;
• if the pressure in the blood vessels in your lungs is excessively high (pulmonary hypertension);
• if you have or have had an aneurysm (bulging 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 blood tests, for example to
check your liver function. Your doctor will discuss the results of the tests with you and decide if you
can receive Nintedanib Aurobindo.
Tell your doctor immediately while taking this medicine:

• if you develop diarrhoea. It is crucial to treat diarrhoea early (see section 4);
• if you develop vomiting or feeling unwell (nausea);
• if you experience unexplained symptoms such as yellowing of the skin or the white part of your eyes (jaundice), dark or brown urine (tea-colored), pain in the upper right part of your stomach area (abdomen), bleeding or bruising more easily than usual, or feeling tired. These may be symptoms of serious liver problems;
• if you have severe stomach pain, fever, chills, feeling unwell, vomiting or stiffness or swelling of the abdomen, as these may be symptoms of an opening in the wall of the intestine (“gastrointestinal perforation”). Tell your doctor even if you have suffered from peptic ulcers or diverticular disease in the past or if you are being treated at the same time with anti-inflammatory drugs (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 your stool, or diarrhoea, as these may be symptoms of inflammation of the intestine 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 your chest, especially on the left side of your body, pain in your neck, jaw, shoulder or arm, rapid heartbeat, shortness of breath, nausea, vomiting, as these may be symptoms of a heart attack;
• if you have significant bleeding;
• if bruises, bleeding, fever, fatigue and confusion appear. 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 disorders such as weakness in an arm or leg, with or without high blood pressure. These may be symptoms of a brain condition called reversible posterior encephalopathy syndrome (PRES).

Children and adolescents
Nintedanib Aurobindo should not be given to children and adolescents under 18
years of age.

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 medicines you bought without a prescription.
Nintedanib Aurobindo can interact with some medicines. The following medicines are some
examples of medicines that can increase the levels of nintedanib in the blood, potentially increasing
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 alters the immune system (cyclosporine).

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

• an antibiotic used to treat tuberculosis (rifampicin);
• medicines used to treat epilepsy (carbamazepine, phenytoin);
• an herbal medicine for treating depression (St John's Wort).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the baby and cause
birth defects.
Before starting treatment with Nintedanib Aurobindo, you must have a pregnancy test to
make sure you are not pregnant. Talk to your doctor.
Contraception

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

Breastfeeding
Do not breastfeed while taking Nintedanib Aurobindo, as there is a possible
risk of harm to breastfed babies.

Driving and using machines
Nintedanib Aurobindo slightly affects the ability to drive and operate machines. If you do not
feel well, you should not drive or operate machines.

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

3. How to take Nintedanib Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
Take the capsules twice a day, approximately 12 hours apart and at similar 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, i.e. during a meal or immediately before or
after. Do not open or crush the capsule (see section 5).

For 100 mg:
Adults
The recommended dose is one 100 mg capsule twice a day (for a total of 200 mg per day).
Do not take a dose higher than the recommended dose, which is 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 suggest you stop treatment
with this medicine. Do not reduce the dose or stop treatment without first consulting your
doctor.

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 100 mg as scheduled, at the next
scheduled time, and as recommended by your doctor or pharmacist.

For 150 mg:
Adults
The recommended dose is one 150 mg capsule twice a day (for a total of 300 mg per day).
Do not take a dose higher than the recommended dose, which is 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 the 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 a day (for a total of 200 mg per
day). 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.

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 150 mg as scheduled, at the next
scheduled time, and 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 period indicated by your doctor.
If you have any questions about using 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 particular attention if you experience the following side effects during treatment with
Nintedanib Aurobindo:

Diarrhoea(very common, may affect more than 1 in 10 people):
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 immediately contact
your doctor. Start appropriate treatment for diarrhoea as soon as possible, for example with loperamide.

During treatment with this medicine, the following side effects have also been observed.
Contact your doctor if you experience any side effect.
Idiopathic pulmonary fibrosis (IPF)

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

• Pain in the lower part of the body (abdomen)
• Abnormal liver tests

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

• Vomiting
• Loss of appetite
• Weight loss
• Bleeding
• Skin rash
• Headache

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

• Pancreatitis
• Inflammation of the large intestine
• Serious liver problems
• Low platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Jaundice, i.e. a yellowing of the skin and the whites of the eyes due to high levels of bilirubin
• Itching
• 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
• Widening 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, convulsions or other neurological disorders 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 side effects (may affect more than 1 in 10 people)

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

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

• Weight loss
• High blood pressure (hypertension)
• Bleeding
• Serious liver problems
• Skin rash
• Headache

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

• Pancreatitis
• Inflammation of the large intestine
• Low platelet count (thrombocytopenia)
• Jaundice, i.e. a yellowing of the skin and the whites of the eyes due to high levels of bilirubin
• Itching
• 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
• Widening 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, convulsions or other neurological disorders 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 affect more than 1 in 10 people)

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

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

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

• Heart attack
• Pancreatitis
• Jaundice, i.e. a yellowing of the skin and the whites of the eyes due to high levels of bilirubin
• Widening 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, convulsions or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through 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 box or blister after
EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice that the blister containing the capsules is open or if 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).
Do not dispose of any medicine in 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 ingredient is nintedanib. Each capsule contains 100 mg of nintedanib (as hexilate).
• The other ingredients are: Capsule content: medium-chain triglycerides, solid semi-synthetic 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 (E1 520), hypromellose 2 910 (6 cP) (E464).
• The active ingredient is nintedanib. Each capsule contains 150 mg of nintedanib (as hexilate).
• The other ingredients are: Capsule content: medium-chain triglycerides, solid semi-synthetic 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 (E1 520), hypromellose 2 910 (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-colored, opaque, oblong, soft gelatin
capsules, with ‘N100’ printed in black ink, containing a bright yellow suspension.
Nintedanib Aurobindo 150 mg soft capsules:
Nintedanib Aurobindo 150 mg soft capsules are brown-colored, opaque, oblong,
soft gelatin capsules, with ‘N150’ printed 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 blisters containing 60x1 soft capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Eugia Pharma (Malta) Limited
Valletta Waterfront,
14 Vault, 2 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 designations:
Belgium: Nintedanib Eugia 100 mg soft capsules / capsules molles / Weichkapseln
Nintedanib Eugia 150 mg soft capsules / capsules molles / Weichkapseln
Portugal: Nintedanib Eugia
France: Nintedanib Arrow 100 mg, soft capsule
Nintedanib Arrow 150 mg, soft capsule
Germany: Nintedanib Puren 100 mg Weichkapseln
Nintedanib Puren 150 mg Weichkapseln
Italy: Nintedanib Aurobindo
Netherlands: Nintedanib Eugia 100 mg, soft capsules
Nintedanib Eugia 150 mg, soft capsules
Poland: Nintedanib Eugia
Spain: Nintedanib Eugia 100 mg soft capsules EFG
Nintedanib Eugia 150 mg soft capsules EFG