Nintedanib Cipla: detailed information

Package leaflet: Information for the patient

Nintedanib Cipla 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 their symptoms are the same as yours, because it may 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 Cipla is and what it is used for
What you need to know before taking Nintedanib Cipla
How to take Nintedanib Cipla
Possible side effects
How to store Nintedanib Cipla
Contents of the pack and other information

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

Nintedanib Cipla contains the active substance nintedanib, a medicine belonging to the class of so-called 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 Cipla helps reduce the further development of 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, 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 Cipla helps reduce the 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 helps reduce the further development of scarring and lung stiffening.

Interstitial lung disease associated with systemic sclerosis (SSc-ILD) in adults, children, and adolescents 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 Cipla helps reduce the further development of scarring and lung stiffening.

2. What you should know before taking Nintedanib Cipla

Do not take Nintedanib Cipla

if you are pregnant,
if you are allergic to nintedanib, peanuts, or soya, 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 Cipla,

if you have or have had liver problems,
if you have or have had kidney problems or if you have been found to have increased levels of protein in your urine,
if you have or have 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 had heart problems (for example a heart attack),
if you have recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Cipla will usually be stopped for a certain period if you undergo surgery. Your doctor will decide when you can resume treatment with Nintedanib Cipla,
if you have high blood pressure,
if the pressure in the blood vessels of your lungs is too high (pulmonary hypertension),
if you have or have had an aneurysm (a 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 carry out blood tests, for example to check liver function. Your doctor will discuss the test results with you and decide whether you can take Nintedanib Cipla.
Immediately inform your doctor while taking Nintedanib Cipla

if you develop diarrhoea. It is important to treat diarrhoea early (see section 4);
if you develop vomiting or nausea;
if you experience unexplained symptoms such as yellowing of the skin or the 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 that appears more easily than usual, or feeling tired. These could be symptoms 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”). Also inform your doctor 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 stools or diarrhoea, as these could be symptoms of intestinal inflammation due to inadequate blood supply;
if you have pain, swelling, redness, or warmth in a limb, 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 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 an arm or leg, with or without high blood pressure. These could be symptoms of a brain condition called reversible posterior encephalopathy syndrome (PRES).

Other medicines and Nintedanib Cipla
Inform 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 Cipla 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 Cipla:

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, planning to become pregnant, or 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 Cipla, you must have 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 prevent pregnancy when starting treatment with Nintedanib Cipla, during treatment with Nintedanib Cipla, and for at least 3 months after stopping treatment.
Talk 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 problems, consult your doctor to consider a more appropriate alternative contraceptive method.
Immediately inform your doctor or pharmacist if you become pregnant or suspect pregnancy during treatment with Nintedanib Cipla.

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

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

Nintedanib Cipla contains soya lecithin
If you are allergic to soya or peanuts, do not use this medicine (see section 2).

3. How to take Nintedanib Cipla

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
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 daily dose of 200 mg).
Do not take more than the recommended dose of two Nintedanib Cipla 100 mg capsules per day.
If you do not tolerate the recommended dose of two Nintedanib Cipla 100 mg capsules per day (see
possible side effects in section 4), your doctor may advise you to stop taking Nintedanib Cipla.
Do not reduce the dose or stop treatment on your own without first consulting your doctor.
Use in children and adolescents
The recommended dose depends on the patient's body weight.
Inform your doctor if at any time during treatment the patient's weight falls below 13.5 kg.
Inform your doctor if you have liver problems.
Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment.
If you do not tolerate the recommended daily dose of nintedanib capsules (see possible side
effects in section 4), your doctor may reduce the daily dose of nintedanib.
Do not reduce the dose or stop treatment on your own initiative without first consulting your doctor.
Dosing based on weight for nintedanib capsules in children and adolescents:

Weight range in kilograms (kg)	Nintedanib dose 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 and above	150 mg (one 150 mg capsule or six 25 mg capsules*) twice daily

*Nintedanib Cipla is available only in 100 mg and 150 mg soft capsules. Therefore, it is not possible
to administer Nintedanib Cipla to paediatric patients requiring a dose lower than 100 mg.
If an alternative dose is required, other products containing nintedanib that offer such an option should be used.
If you take more Nintedanib Cipla than you should
If you take more Nintedanib Cipla than you should, contact your doctor immediately or go to the nearest
hospital. Take the medicine pack and this leaflet with you.
If you forget to take Nintedanib Cipla
Do not take two capsules at the same time to make up for a missed dose. Take the next dose of Nintedanib Cipla
as scheduled, at the next planned time, as recommended by your doctor or pharmacist.
If you stop taking Nintedanib Cipla
Do not stop treatment with Nintedanib Cipla without first consulting your doctor. It is important to take this
medicine every day for the entire duration prescribed by your doctor.
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 everybody gets them.
You should pay particular attention if you experience the following side effects during treatment with
Nintedanib Cipla:
Diarrhoea (very common, may affect more than 1 in 10 people):
Diarrhoea may lead to 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 affect more than 1 in 10 people

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 levels of protein in the urine (proteinuria)

Not known: frequency cannot be estimated from the available data

Kidney failure
Weakening and dilation of a blood vessel wall or a tear in a blood vessel wall (aneurysms and arterial dissections)
A brain condition with symptoms such as headache, vision changes, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome).

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

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 levels of protein in the urine (proteinuria)

Not known: frequency cannot be estimated from the available data

Kidney failure
Weakening and dilation of a blood vessel wall or a tear in a blood vessel wall (aneurysms and arterial dissections)
A brain condition with symptoms such as headache, vision changes, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome).

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

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
Weakening and dilation of a blood vessel wall or a tear in a blood vessel wall (aneurysms and arterial dissections)
Hair loss (alopecia)
Increased levels of protein in the urine (proteinuria)
A brain condition with symptoms such as headache, vision changes, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome).

Fibrosing interstitial lung diseases (ILD) in children and adolescents
Side effects in children and adolescents are similar to those observed in adult patients. Contact your doctor if any side effect occurs.

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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Nintedanib Cipla

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.
Do not store 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 damaged.
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 Cipla contains

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

Contents of the capsule: Medium-chain triglycerides, solid semisynthetic glycerides, soybean lecithin (E322)
(see section 2)
Capsule shell: Gelatin, glycerol (E422), titanium dioxide (E171), red iron oxide (E172),
yellow iron oxide (E172), purified water.

Description of the appearance of Nintedanib Cipla and package contents
Nintedanib Cipla 100 mg capsules are oblong, opaque, brownish-yellow soft gelatin capsules containing a homogeneous fluorescent yellow dispersion. Size: approximately 17 x 6 mm.
Nintedanib Cipla 100 mg capsules are available in cartons containing 3 laminated films Ply Al-Al (OPA/AL FOIL/PVC with PRIMER) / aluminum blisters.
Pack: 10 soft capsules in a blister.

Marketing Authorisation Holder and Manufacturer
Cipla Europe NV
De Keyserlei 60c, Bus 1301, 2018 Antwerp, Belgium

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria Nintedanib Cipla 100 mg Weichkapseln
Germany Nintedanib Cipla 100 mg Weichkapseln
Spain Nintedanib Cipla 100 mg cápsulas blandas EFG
France Nintedanib Cipla 100 mg, capsule molles
Italy Nintedanib Cipla
Netherlands Nintedanib Cipla
Poland Nintedanib Cipla

Package leaflet: Information for the user

Nintedanib Cipla 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Nintedanib Cipla contains the active substance nintedanib, a medicine belonging to the class of so-called tyrosine kinase inhibitors, and is used to treat the following conditions:

Other chronic fibrosing interstitial lung diseases (ILD) with a 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 Cipla helps reduce the further development of scarring and lung stiffening.

Interstitial lung disease associated with systemic sclerosis (SSc-ILD) in adults, children, and adolescents 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 internal organs such as the lungs. When the lungs are affected by fibrosis, this is known as interstitial lung disease (ILD), and the condition is referred to as SSc-ILD. Fibrosis in the lungs reduces their ability to transfer oxygen into the blood and impairs breathing capacity. Nintedanib Cipla helps reduce the further development of scarring and lung stiffening.

2. What you should know before taking Nintedanib Cipla

Do not take Nintedanib Cipla

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 Cipla,

if you have or have had liver problems,
if you have or have had kidney problems or if an increased amount of protein in your urine has been detected,
if you have or have had bleeding problems,
if you are taking medicines that thin the blood (e.g. 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 had heart problems (e.g. a heart attack),
if you have recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Cipla will usually be stopped for a certain period around the time of surgery. Your doctor will decide when you can resume treatment with Nintedanib Cipla,
if you have high blood pressure,
if you have or have had high blood pressure in the blood vessels of the lungs (pulmonary hypertension),
if you have or have had an aneurysm (a bulging and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.

Based on this information, your doctor may carry out blood tests, for example, to check liver function. Your doctor will discuss the test results with you and decide whether you can take Nintedanib Cipla.
Immediately inform your doctor while taking Nintedanib Cipla

if you develop diarrhoea. It is important to treat diarrhoea early (see section 4);
if you experience vomiting or nausea;
if you have unexplained symptoms such as yellowing of the skin or the 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 that occurs more easily than usual, or feeling tired. These could be symptoms 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 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 could be symptoms of intestinal inflammation due to inadequate blood supply;
if you have pain, swelling, redness, or warmth in a limb, 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 bruising, 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 a leg, with or without high blood pressure. These could be symptoms of a brain condition called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents
Nintedanib Cipla 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 have fully developed, and monitor your growth annually (bone imaging tests) while you are taking this medicine.
Other medicines and Nintedanib Cipla
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 Cipla 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 Cipla:

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, suspect you may be pregnant, plan 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 Cipla, 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 prevent pregnancy when starting Nintedanib Cipla, during treatment with Nintedanib Cipla, and for at least 3 months after stopping treatment.
Speak to your doctor to evaluate the most appropriate 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.
Immediately inform your doctor or pharmacist if you become pregnant or suspect you are pregnant during treatment with Nintedanib Cipla.

Breastfeeding
Do not breastfeed during treatment with Nintedanib Cipla, as there is a possible risk of harm to breastfed infants.
Driving and using machines
Nintedanib Cipla has a minor influence on the ability to drive and use machines. If you do not feel well, you must not drive or use machines.
Nintedanib Cipla contains soya lecithin
If you are allergic to soya or peanuts, do not use this medicine (see section 2).

3. How to take Nintedanib Cipla

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 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 level 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 (a 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 daily dose of 300 mg).
Do not take more than the recommended dose of two Nintedanib Cipla 150 mg capsules per day.
If you do not tolerate the recommended dose of two Nintedanib Cipla 150 mg capsules per day (see
possible side effects in section 4), your doctor may reduce the daily dose of Nintedanib Cipla.
Do not reduce the dose or stop treatment on your own 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 Cipla 100 mg capsules.
Do not take more than the recommended dose of two Nintedanib Cipla 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 at any time during treatment the patient's weight falls below 13.5 kg.
Inform your doctor if you have liver problems.
Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment.
If you do not tolerate the recommended daily dose of nintedanib capsules (see possible side effects in section 4), your doctor may reduce the daily dose of nintedanib.
Do not reduce the dose or stop treatment on your own initiative without first consulting your doctor.
Weight-based dosing for nintedanib capsules in children and adolescents:

Weight range in kilograms (kg)	Nintedanib dose 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 and above	150 mg (one 150 mg capsule or six 25 mg capsules*) twice daily

*Nintedanib Cipla is available only in 100 mg and 150 mg soft capsules. Therefore,
it is not possible to administer Nintedanib Cipla to pediatric patients requiring a dose lower than 100 mg.
If an alternative dose is required, other nintedanib-containing products offering such an option should be used.
If you take more Nintedanib Cipla than you should
If you take more Nintedanib Cipla than you should, contact your doctor immediately or go to the nearest hospital.
Take the medicine pack and this leaflet with you.
If you forget to take Nintedanib Cipla
Do not take two capsules at the same time to make up for a missed dose. Take the next dose of Nintedanib Cipla
at the next scheduled time as recommended by your doctor or pharmacist.
If you stop taking Nintedanib Cipla
Do not stop treatment with Nintedanib Cipla without first consulting your doctor. It is important to take this
medicine every day for the entire duration prescribed by your doctor.
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 everybody gets them.
You should be particularly careful if you experience the following side effects during treatment with
Nintedanib Cipla:
Diarrhoea (very common, may affect more than 1 in 10 people):
Diarrhoea may lead to 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 affect more than 1 in 10 people

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 protein in the urine (proteinuria)

Not known: frequency cannot be estimated from the available data

Kidney failure
Dilation 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, visual changes, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome).

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

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 protein in the urine (proteinuria)

Not known: frequency cannot be estimated from the available data

Kidney failure
Dilation 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, visual changes, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome).

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

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
Dilation 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 protein in the urine (proteinuria)
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 (posterior reversible 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 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 Cipla

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.
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 blister containing the capsules is open or if a capsule is damaged.
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 Cipla contains

The active substance is nintedanib. Each soft capsule contains 150 mg of nintedanib (as esilate).
The other components are:

Capsule content: Medium-chain triglycerides, solid semisynthetic glycerides, soya lecithin (E322)
(see section 2)
Capsule shell: Gelatin, glycerol (E422), titanium dioxide (E171), iron oxide red (E172),
iron oxide yellow (E172), purified water.

Description of the appearance of Nintedanib Cipla and package contents

Nintedanib Cipla 150 mg capsules are oblong, opaque, light brown soft gelatin capsules containing a homogeneous fluorescent yellow dispersion. Size: approximately 19 x 7 mm.

Nintedanib Cipla 150 mg capsules are available in cartons containing 3 Ply Al-Al (OPA/AL. FOIL/PVC with PRIMER) / aluminium blisters.
Pack size: 10 soft capsules in blister.

Marketing Authorisation Holder and Manufacturer

Cipla Europe NV
De Keyserlei 60c, Bus 1301, 2018 Antwerp, Belgium

This medicinal product is authorised in the European Economic Area countries under the following names:

Austria: Nintedanib Cipla 150 mg Weichkapseln
Germany: Nintedanib Cipla 150 mg Weichkapseln
Spain: Nintedanib Cipla 150 mg cápsulas blandas EFG
France: Nintedanib Cipla 150 mg, capsule molles
Italy: Nintedanib Cipla
Netherlands: Nintedanib Cipla
Poland: Nintedanib Cipla