Nintedanib Dr. Reddy's: detailed information

Package leaflet: Information for the patient

Nintedanib Dr. Reddy’s 100 mg soft capsules

nintedanib
Generic medicine
Please read 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Nintedanib Dr. Reddy’s is and what it is used for
What you need to know before taking Nintedanib Dr. Reddy’s
How to take Nintedanib Dr. Reddy’s
Possible side effects
How to store Nintedanib Dr. Reddy’s
Contents of the pack and other information

1. What Nintedanib Dr. Reddy’s is and what it is used for

Nintedanib Dr. Reddy’s contains the active substance nintedanib, a medicine belonging to the class of tyrosine kinase inhibitors, and is used to treat the following conditions:
Idiopathic pulmonary fibrosis (IPF) in adults
IPF is a condition in which, over time, lung tissue becomes thick, stiff, and scarred. As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream, making deep breathing difficult. Nintedanib Dr. Reddy’s helps reduce further scarring and stiffening of the lungs.
Other chronic fibrosing interstitial lung diseases (ILD) with progressive phenotype in adults
In addition to IPF, there are other conditions in which, over time, lung tissue 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 Dr. Reddy’s helps reduce further scarring and stiffening of the lungs.
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 of children and adolescents becomes thick, stiff, and scarred over time. Nintedanib helps reduce further scarring and stiffening 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), 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, this 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 into the blood and impairs breathing capacity. Nintedanib Dr. Reddy’s helps reduce 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 tumor cells need to receive nutrients and oxygen, nintedanib may help stop the growth and spread of cancer.
Nintedanib Dr. Reddy’s 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 whose NSCLC is of a specific type (“adenocarcinoma”) and who have already received treatment with another medicine for this cancer, but whose tumor has started to grow again.

2. What you should know before taking Nintedanib Dr. Reddy’s

Do not take Nintedanib Dr. Reddy’s

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, ILD, or SSc-ILD if you are pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine

if you have or have had liver problems,
if you have or have had kidney problems or if increased protein levels have been detected in your urine,
if you have or have had bleeding problems, particularly recent lung bleeding,
if you are taking blood-thinning medicines (for example, warfarin, phenprocoumon, heparin, or acetylsalicylic acid) to prevent blood clots. Treatment with Nintedanib Dr. Reddy’s may increase the risk of bleeding,
if you are taking pirfenidone, which may increase the risk of developing diarrhoea, nausea, vomiting, and liver problems,
if you have or have had heart problems (e.g. a heart attack),
if you have recently undergone or are about to undergo surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Dr. Reddy’s is usually interrupted 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 you have high blood pressure in the blood vessels of the lungs (pulmonary hypertension),
if you have or have had an aneurysm (a weakened and dilated 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 blood tests, for example, to
check liver function and to determine how long it takes for your blood to clot.
Your doctor will discuss the test results with you and decide whether you can receive Nintedanib Dr.
Reddy’s.
Inform your doctor immediately while taking this medicine

if you have diarrhoea. It is important to treat diarrhoea early (see section 4);
if you vomit or feel unwell (nausea);
if you experience unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown (tea-coloured) urine, pain in the upper right part of the stomach area (abdomen), bleeding or bruising more easily than usual, or feeling tired. These could be signs of serious liver problems;
if you have severe stomach pain, fever, chills, feeling unwell, vomiting, or abdominal stiffness or swelling, as these could be symptoms of a hole in the wall of the intestine (“gastrointestinal perforation”). Inform your doctor also if you have previously suffered from 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 stool, diarrhoea, constipation, nausea, or vomiting, as these could be symptoms of intestinal inflammation due to reduced blood supply (“ischaemic colitis”);
if you have pain, swelling, redness, or warmth in a limb, or if you have chest pain and difficulty breathing, as these could 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 could be symptoms of a heart attack;
if you have significant bleeding:
if bruises, bleeding, fever, fatigue, 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 an arm or leg, with or without high blood pressure. These may be symptoms of a brain condition called reversible posterior encephalopathy syndrome (PRES);
if you have fever, chills, rapid breathing, or rapid heartbeat. These could be signs of infection or blood infection (sepsis) (see section 4);
if you experience one or more side effects that may occur (see section 4) and that could be life-threatening.

Children and adolescents
Idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILD) with
progressive phenotype, and interstitial lung disease associated with systemic sclerosis (SSc-ILD)
Nintedanib must not be taken by children under 6 years of age.
Your doctor may perform regular dental examinations at least every 6 months until dental development is complete and monitor your growth (bone imaging) annually during treatment with the drug.
Non-small cell lung cancer (NSCLC)
This medicine has not been studied in children or adolescents for the treatment of lung cancer (NSCLC), and therefore must not be taken by children or adolescents under 18 years of age.

Other medicines and Nintedanib Dr. Reddy’s
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 Dr. Reddy’s may interact with certain medicines. The following medicines are some examples of medicines that may increase nintedanib levels 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 affects the immune system (cyclosporine)

The following medicines are some examples of medicines that may decrease nintedanib levels in the blood, potentially reducing the effectiveness of Nintedanib Dr. Reddy’s:

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, breastfeeding, and fertility
If you are pregnant, think you might 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 child and cause birth defects.
Before starting treatment with Nintedanib Dr. Reddy’s, you must undergo a pregnancy test to confirm that 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 Dr. Reddy’s, during treatment with Nintedanib Dr. Reddy’s, and for at least 3 months after stopping treatment.
Speak to your doctor to evaluate the most suitable contraceptive methods for you.
Vomiting and/or diarrhoea or other gastrointestinal problems may affect the absorption of oral hormonal contraceptives, such as the pill, and may reduce their effectiveness. Therefore, if you experience these symptoms, speak to your doctor to evaluate a more appropriate alternative contraceptive method.
Inform your doctor or pharmacist immediately if you start or suspect you are pregnant during treatment with Nintedanib Dr. Reddy’s.

Breastfeeding
Do not breastfeed during treatment with Nintedanib Dr. Reddy’s, as there is a potential risk of harm to breastfed infants.
Fertility
The effect of this medicine on human fertility has not been studied.

Driving and using machines
Nintedanib Dr. Reddy’s may have a slight influence on the ability to drive and use machines. If you do not feel well, you must not drive or operate machinery.

3. How to take Nintedanib Dr. Reddy’s

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
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)
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 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).
To facilitate swallowing, 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.
Adults
The recommended dose is one 100 mg capsule twice daily (for a total of 200 mg daily). Do not take a dose
higher than the recommended dose of two Nintedanib Dr. Reddy’s 100 mg capsules per day.
If you do not tolerate the recommended dose of two Nintedanib Dr. Reddy’s 100 mg capsules per day
(for possible side effects, see 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.
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. Your doctor may adjust the dose as treatment progresses.
If you do not tolerate the recommended daily dose of Nintedanib Dr. Reddy’s capsules (for possible
side effects, see section 4), your doctor may reduce the daily dose of nintedanib.
Do not reduce the dose or stop treatment without first consulting your doctor.
Dosing of Nintedanib capsules according to weight in children and adolescents:

Weight range in kilograms (kg)	Dose of Nintedanib 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	150 mg (one 150 mg capsule or six 25 mg capsules) twice daily

For dosages that cannot be achieved with this medicine, other medicines containing nintedanib in more appropriate dosages are available.
For the treatment of non-small cell lung cancer (NSCLC)
Do not take Nintedanib Dr. Reddy’s on the same day as chemotherapy treatment with docetaxel.
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).
The recommended dose is four capsules per day (i.e. a total of 400 mg of nintedanib per day).
Do not take a higher dose.
This daily dose should be divided into two doses of two capsules taken approximately 12 hours apart, for example two capsules in the morning and two capsules in the evening. These two doses should be taken at approximately the same time each day. Following these instructions 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 adverse effects (see section 4), your doctor may reduce the daily dose of Nintedanib Dr. Reddy’s. 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 capsules of 150 mg). In this case, your doctor will prescribe treatment with Nintedanib Dr. Reddy’s 150 mg soft capsules.
If necessary, your doctor may further reduce the daily dose to 200 mg per day (two capsules of 100 mg). In this case, your doctor will prescribe capsules of the appropriate dosage.
In both cases, you must take one capsule of the appropriate dosage twice daily, approximately 12 hours apart and at approximately the same time each day, with food (e.g. in the morning and in the evening).
If your doctor has discontinued chemotherapy with docetaxel, you should continue taking Nintedanib Dr. Reddy’s twice daily.

If you take more Nintedanib Dr. Reddy’s than you should
Contact your doctor or pharmacist immediately.

If you forget to take Nintedanib Dr. Reddy’s
Do not take a double dose to make up for the missed dose. Take the next dose of Nintedanib Dr. Reddy’s at the next scheduled time, as planned and recommended by your doctor or pharmacist.

If you stop treatment with Nintedanib Dr. Reddy’s
Do not stop treatment with Nintedanib Dr. Reddy’s without first consulting your doctor. It is important to take this medicine every day for the entire period indicated by your doctor.

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 questions 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.
Idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILD) with progressive phenotype, and interstitial lung disease associated with systemic sclerosis (SSc-ILD)
You should pay particular attention if you experience the following side effects during treatment with Nintedanib Dr. Reddy’s:
Diarrhoea (very common, may affect more than 1 in 10 people)
Diarrhoea can cause 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 anti-diarrhoeal treatment 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 affect more than 1 in 10 people)

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

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

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

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

Pancreatitis
Inflammation of the large intestine (colitis)
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 elevated bilirubin levels
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)
A 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 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 function tests

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

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

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

Pancreatitis
Inflammation of the large intestine (colitis)
Low platelet count (thrombocytopenia)
Jaundice, i.e. yellowing of the skin and whites of the eyes due to elevated bilirubin levels
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)
A 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 affect more than 1 in 10 people)

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

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

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

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

Inflammation of the large intestine (colitis)
Severe 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 elevated bilirubin levels
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)
A 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 observed in adult patients.
Contact your doctor if you experience any side effect.

Non-small cell lung cancer (NSCLC)
You should pay particular attention if you experience the following side effects during treatment with Nintedanib Dr. Reddy’s:

Diarrhoea (very common, may affect more than 1 in 10 people). Diarrhoea can cause 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 anti-diarrhoeal treatment, for example with loperamide, as soon as possible after contacting your doctor.
Febrile neutropenia and sepsis (common, may affect up to 1 in 10 people). Treatment with Nintedanib Dr. Reddy’s may lead to a reduction in the number of a type of white blood cells (neutropenia), which are important for the body's response to bacterial or fungal infections. As a consequence of neutropenia, fever (febrile neutropenia) and blood infections (sepsis) may occur. Inform your doctor immediately if you develop fever, chills, rapid breathing, or rapid heartbeat. During treatment with Nintedanib Dr. Reddy’s, your doctor will regularly monitor your blood cells and check 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)

Diarrhoea – see above
Sensation of pain, numbness, and/or tingling in fingers and toes (peripheral neuropathy)
Feeling unwell (nausea)
Vomiting
Abdominal pain
Bleeding
Decrease in white blood cell count (neutropenia)
Inflammation of the mucous membranes lining the digestive tract, including mouth sores and ulcers (mucositis, including stomatitis)
Rash
Reduced appetite
Electrolyte imbalance
Increased levels of liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) in the blood, as shown by blood tests
Hair loss (alopecia)

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

Blood poisoning (sepsis) – see above
Decrease in white blood cell count accompanied by fever (febrile neutropenia)
Blood clots in the veins (venous thromboembolism), especially in the legs (symptoms include pain, redness, swelling, and warmth in a limb), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if any of these symptoms occur, consult your doctor immediately)
High blood pressure (hypertension)
Fluid loss (dehydration)
Abscesses
Low platelet count (thrombocytopenia)
Jaundice (hyperbilirubinemia)
Increased levels of liver enzymes (gamma-glutamyltransferase) in the blood, as shown by blood tests
Weight loss
Itching (pruritus)
Headache (cephalalgia)
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)
Life-threatening liver problems
Inflammation of the pancreas (pancreatitis)
Myocardial infarction
Kidney failure

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

Inflammation of the large intestine (colitis)
Enlargement and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)
A 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)

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Nintedanib Dr. Reddy’s

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 that month.
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 broken. If you come into contact with the capsule contents, wash your hands immediately with plenty of water (see section 3).
Do not dispose of medicines 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 Dr. Reddy’s contains

The active substance is nintedanib. Each soft capsule contains nintedanib esilate, equivalent to 100 mg of nintedanib.
The other components are:
- Capsule contents: medium-chain triglycerides, solid fats, polysorbate 80 and sorbitan oleate
- Capsule shell: gelatin, glycerol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), purified water.
- Printing ink: shellac, black iron oxide (E172) and propylene glycol (E1520).

Description of the appearance of Nintedanib Dr. Reddy’s and package contents
Peach-coloured, opaque, oblong soft capsules (approximately 16 x 6 mm), filled with a bright yellow suspension, printed with "100" in black ink.
The capsules are available in blisters and in perforated unit dose blisters in the following pack sizes:
30, 30 x 1, 60, 60 x 1, 120 and 120 x 1.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Dr. Reddy´s S.r.l
Piazza Santa Maria Beltrade 1
20123, Milan (MI)
Italy
Manufacturer
betapharm Arzneimittel GmbH,
Kobelweg 95, 86156 Augsburg,
Germany
Pharmadox Healthcare Ltd., KW20A
Kordin Industrial Park, Paola PLA
3000, Malta
DR. REDDY’S LABORATORIES ROMÂNIA
S.R.L., Str. Daniel Danielopolu, nr. 30-32, Spațiul
2, Etaj 5,
Sectorul 1, Bucureşti, cod poștal
014134, Romania
Rual Laboratories SRL, 313, Splaiul
Unirii, Building H, 1st floor, sector
3, Bucuresti, 030138, Romania
This medicinal product is authorised in the European Economic Area Member States under the
following names:
Austria Nintedanib Reddy 100 mg
Soft capsules
Germany Nintedanib beta 100 mg
Soft capsules
Italy Nintedanib Dr. Reddy’s
Netherlands Nintedanib Reddy 100 mg
soft capsules
Romania Nintedanib Dr. Reddy’s 100
mg soft capsules
Spain Nintedanib Dr. Reddys 100 mg
soft capsules EFG
Sweden Nintedanib Reddy

Patient information leaflet

Nintedanib Dr. Reddy’s 150 mg soft capsules

nintedanib
Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Nintedanib Dr. Reddy’s is and what it is used for
What you need to know before taking Nintedanib Dr. Reddy’s
How to take Nintedanib Dr. Reddy’s
Possible side effects
How to store Nintedanib Dr. Reddy’s
Contents of the pack and other information

1. What Nintedanib Dr. Reddy’s is and what it is used for

Nintedanib Dr. Reddy’s contains the active substance nintedanib, a medicine belonging to the class of tyrosine kinase inhibitors, and is used to treat the following conditions:
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 into the bloodstream, making deep breathing difficult. Nintedanib Dr. Reddy’s helps reduce further scarring and lung stiffening.
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 Dr. Reddy’s helps reduce further 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 helps reduce further scarring and lung stiffening.
Interstitial lung disease associated with systemic sclerosis (SSc-ILD) in adults, adolescents, and children aged 6 years and older
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. Lung fibrosis reduces the lungs’ ability to transfer oxygen into the blood and impairs breathing capacity. Nintedanib Dr. Reddy’s helps reduce further scarring and lung stiffening.
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 tumor cells need to receive nutrients and oxygen, nintedanib may help stop the growth and spread of cancer.
Nintedanib Dr. Reddy’s 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 whose NSCLC is of a specific type (“adenocarcinoma”) and who have previously been treated with another medicine for this cancer, but whose tumor has started to grow again.

2. What you need to know before taking Nintedanib Dr. Reddy’s

Do not take Nintedanib Dr. Reddy’s

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, ILD or SSc-ILD if you are pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine

if you have or have had liver problems;
if you have or have had kidney problems or if increased levels of protein have been detected in your urine;
if you have or have had bleeding problems, especially recent lung bleeding;
if you are taking blood-thinning medicines (e.g. warfarin, phenprocoumon, heparin or acetylsalicylic acid) to prevent blood clots. Treatment with Nintedanib Dr. Reddy’s may increase the risk of bleeding;
if you are taking pirfenidone, which may increase the risk of developing diarrhoea, nausea, vomiting and liver problems;
if you have or have had heart problems (e.g. a heart attack);
if you have recently undergone surgery or are about to undergo surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Dr. Reddy’s will usually be 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 you have high blood pressure in the blood vessels of the lungs (pulmonary hypertension);
if you have or have had an aneurysm (a bulge and weakening in the wall of a blood vessel) 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 carry out blood tests, for example to
check liver function and to determine how long it takes for your blood to clot.
Your doctor will discuss the test results with you and decide whether you can receive Nintedanib Dr.
Reddy’s.
Inform your doctor immediately while taking this medicine

if you have diarrhoea. It is important to treat diarrhoea early (see section 4);
if you vomit or feel unwell (nausea);
if you experience unexplained symptoms such as yellowing of the skin or the whites of the eyes (jaundice), dark or brown-coloured urine (like tea), pain in the upper right part of the abdomen, bleeding or bruising more easily than usual, or feeling tired. These could be symptoms of serious liver problems;
if you have severe abdominal pain, fever, chills, feeling unwell, vomiting, or abdominal stiffness or swelling, as these could be symptoms of a perforation in the wall of the intestine (“gastrointestinal perforation”). Inform your doctor also if you have previously suffered from 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 abdominal pain or cramps, red blood in the stools, diarrhoea, constipation, nausea or vomiting, as these could be symptoms of intestinal inflammation due to reduced blood supply (“ischaemic colitis”);
if you have pain, swelling, redness or warmth in a limb, or if you have chest pain and difficulty breathing, as these could 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, if you have a rapid heartbeat, shortness of breath, nausea or vomiting, as these could 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 disturbances 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);
if you have fever, chills, rapid breathing or rapid heartbeat. These could be signs of infection or blood infection (sepsis) (see section 4);
if you experience one or more of the side effects that may occur (see section 4) and which could be life-threatening.

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 (SSc-ILD)
Nintedanib must not be taken by children under 6 years of age.
Your doctor may perform regular dental check-ups at least every 6 months until dental development is complete and monitor your growth annually (bone imaging) during treatment with the medicine.
Non-small cell lung cancer (NSCLC)
This medicine has not been studied in children or adolescents for the treatment of lung cancer (NSCLC), and therefore must not be taken by children and adolescents under 18 years of age.

Other medicines and Nintedanib Dr. Reddy’s
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 Dr. Reddy’s may interact with certain medicines. The following medicines are some examples of medicines that may increase nintedanib levels 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 affects the immune system (cyclosporine).

The following medicines are some examples of medicines that may decrease nintedanib levels in the blood, potentially reducing the effectiveness of Nintedanib Dr. Reddy’s:

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, breastfeeding and fertility
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 child and cause birth defects.
Before starting treatment with Nintedanib Dr. Reddy’s, you must undergo a pregnancy test to confirm that 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 Dr. Reddy’s, during treatment with Nintedanib Dr. Reddy’s, and for at least 3 months after stopping treatment.
Speak to your doctor to evaluate the most suitable contraceptive methods for you.
Vomiting and/or diarrhoea or other gastrointestinal problems may affect the absorption of oral hormonal contraceptives, such as the pill, and may reduce their effectiveness. Therefore, if you experience these symptoms, speak to 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 Dr. Reddy’s.

Breastfeeding
Do not breastfeed during treatment with Nintedanib Dr. Reddy’s, as there is a possible risk of harm to breastfed infants.
Fertility
The effect of this medicine on human fertility has not been studied.

Driving and using machines
Nintedanib Dr. Reddy’s may have a minor influence on the ability to drive and use machines. If you feel unwell, you must not drive or operate machinery.

3. How to take Nintedanib Dr. Reddy’s

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
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)
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 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).
To ease swallowing, 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.
Adults
The recommended dose is one 150 mg capsule twice daily (for a total of 300 mg daily). Do not take a dose higher than the recommended dose of two Nintedanib Dr.
Reddy’s 150 mg capsules per day.
If you do not tolerate the recommended dose of two Nintedanib Dr. Reddy’s 150 mg capsules per day
(for possible side effects, see 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.
Your doctor may reduce the recommended dose to 100 mg twice daily (for a total of 200 mg
daily). In this case, your doctor will prescribe Nintedanib Dr. Reddy’s 100 mg capsules for
your treatment. Do not take more than the recommended dose of two 100 mg Nintedanib
Dr. Reddy’s capsules per day if your daily dose has been reduced to 200 mg daily.
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
continues.
If you do not tolerate the recommended daily dose of Nintedanib Dr. Reddy’s capsules
(for possible side effects, see section 4), your doctor may reduce the daily dose of nintedanib.
Do not reduce the dose or stop treatment without first consulting your doctor.
Dosing of Nintedanib capsules according to body weight in children and adolescents:

Weight range in kilograms (kg)	Dose of Nintedanib 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	150 mg (one 150 mg capsule or six 25 mg capsules) twice daily

For dosages that cannot be achieved with this medicine, other medicinal products containing nintedanib in more appropriate dosages are available.
For the treatment of non-small cell lung cancer (NSCLC)
Do not take Nintedanib Dr. Reddy’s on the same day as chemotherapy treatment with docetaxel.
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).
The recommended dose is four capsules per day (i.e. a total of 400 mg of nintedanib per day).
Do not take a higher dose.
This daily dose should be divided into two doses of two capsules taken approximately 12 hours apart, for example two capsules in the morning and two capsules in the evening. These two doses should be taken at approximately the same time each day. Following these instructions ensures that a constant amount of nintedanib is maintained in the body.

Dose reduction
If you do not tolerate the recommended dose of 300 mg per day due to adverse effects (see section 4), your doctor may reduce the daily dose of Nintedanib Dr. Reddy’s to 200 mg per day (two capsules of 100 mg). In this case, your doctor will prescribe treatment with Nintedanib Dr. Reddy’s 100 mg soft capsules.
You must take one capsule of the correct dosage twice daily, approximately 12 hours apart and at approximately the same time each day, with food (e.g. in the morning and in the evening).
Do not reduce the dose or stop treatment without first consulting your doctor.
If your doctor has stopped chemotherapy with docetaxel, you should continue taking Nintedanib Dr. Reddy’s twice daily.

If you take more Nintedanib Dr. Reddy’s than you should
Contact your doctor or pharmacist immediately.

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

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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

You should pay particular attention if you experience the following side effects during treatment with Nintedanib Dr. Reddy’s:

Diarrhoea (very common, may affect more than 1 in 10 people)
Diarrhoea can lead to 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 anti-diarrhoeal treatment 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 affect more than 1 in 10 people)

Feeling unwell (nausea)
Abdominal pain
Abnormal liver function tests

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

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

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

Pancreatitis
Inflammation of the large intestine (colitis)
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 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)
A brain condition with symptoms such as headache, visual 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 progressive phenotype

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

Feeling unwell (nausea)
Vomiting
Loss of appetite
Abdominal pain
Abnormal liver function tests

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

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

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

Pancreatitis
Inflammation of the large intestine (colitis)
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)
A brain condition with symptoms such as headache, visual 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)

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
Abdominal pain
Abnormal liver function tests

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

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

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

Inflammation of the large intestine (colitis)
Severe 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)
A brain condition with symptoms such as headache, visual 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)

Non-small cell lung cancer (NSCLC)
You should pay particular attention if you experience the following side effects during treatment with Nintedanib Dr. Reddy’s:

Diarrhoea (very common, may affect more than 1 in 10 people)
Diarrhoea can cause 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 anti-diarrhoeal treatment, for example with loperamide, as soon as possible after contacting your doctor.
Febrile neutropenia and sepsis (common, may affect up to 1 in 10 people)
Treatment with Nintedanib Dr. Reddy’s may reduce the number of a type of white blood cells (neutrophils), which are important for the body's response to bacterial or fungal infections. As a result of neutropenia, fever (febrile neutropenia) and blood infections (sepsis) may occur. Inform your doctor immediately if you experience fever, chills, rapid breathing, or rapid heartbeat. During treatment with Nintedanib Dr. Reddy’s, your doctor will regularly monitor your blood cells and check 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)

Diarrhoea – see above
Sensation of pain, numbness, and/or tingling in fingers and toes (peripheral neuropathy)
Feeling unwell (nausea)
Vomiting
Abdominal pain
Bleeding
Decrease in white blood cell count (neutropenia)
Inflammation of the mucous membranes lining the digestive tract, including mouth sores and ulcers (mucositis, including stomatitis)
Rash
Reduced appetite
Electrolyte imbalance
Increased liver enzyme levels (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) in the blood, as shown in blood tests
Hair loss (alopecia)

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

Blood poisoning (sepsis) – see above
Decrease in white blood cell count accompanied by fever (febrile neutropenia)
Blood clots in veins (venous thromboembolism), especially in the legs (symptoms include pain, redness, swelling, and warmth in a limb), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if any of these symptoms occur, consult your doctor immediately)
High blood pressure (hypertension)
Fluid loss (dehydration)
Abscesses
Low platelet count (thrombocytopenia)
Jaundice (hyperbilirubinemia)
Increased liver enzyme levels (gamma-glutamyl transferase) in the blood, as shown in blood tests
Weight loss
Itching (pruritus)
Headache (cephalalgia)
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)
Life-threatening liver problems
Inflammation of the pancreas (pancreatitis)
Myocardial infarction
Kidney failure

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 Dr. Reddy’s

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 that month.
This medicine requires no special storage conditions.
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).
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 Dr. Reddy’s contains

The active substance is nintedanib. Each soft capsule contains nintedanib esilate, equivalent to 150 mg of nintedanib.
The other components are:
- Capsule contents: medium-chain triglycerides, solid fats, polysorbate 80 and sorbitan oleate
- Capsule shell: gelatin, glycerol, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172), purified water.
Printing ink: shellac, black iron oxide (E172) and propylene glycol (E1520).

Description of the appearance of Nintedanib Dr. Reddy’s and contents of the pack
Brown, opaque, oblong soft capsules (approximately 17 x 7 mm), filled with a bright yellow suspension and printed with "150" in black ink.
The capsules are available in blisters and in perforated unit-dose blisters in the following pack sizes:
30, 30 x 1, 60, 60 x 1, 120 and 120 x 1.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Dr. Reddy´s S.r.l
Piazza Santa Maria Beltrade 1
20123, Milan (MI)
Italy

Manufacturer
betapharm Arzneimittel GmbH,
Kobelweg 95, 86156 Augsburg,
Germany
Pharmadox Healthcare Ltd., KW20A
Kordin Industrial Park, Paola PLA
3000, Malta
DR. REDDY’S LABORATORIES ROMÂNIA
S.R.L., Str. Daniel Danielopolu, nr. 30-32, Spațiul
2, Etaj 5,
Sectorul 1, Bucureşti, cod poștal
014134, Romania
Rual Laboratories SRL, 313, Splaiul
Unirii, Building H, 1st floor, sector
3, Bucuresti, 030138, Romania

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Nintedanib Reddy 150 mg
Soft capsules
Germany Nintedanib beta 150 mg
Soft capsules
Italy Nintedanib Dr. Reddy’s
Netherlands Nintedanib Reddy 150 mg
Soft capsules
Romania Nintedanib Dr. Reddy’s 150
mg soft capsules
Spain Nintedanib Dr. Reddys 150 mg
soft capsules EFG
Sweden Nintedanib Reddy