Nintedanib Sandoz

Package Leaflet: Information for the User

Nintedanib Sandoz, 150 mg, Soft Capsules

Nintedanib

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

Nintedanib Sandoz contains the active substance nintedanib, a medicine belonging to a group of medicines called tyrosine kinase inhibitors, and is used to treat idiopathic pulmonary fibrosis (IPF), other chronic and progressive fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults.
Idiopathic pulmonary fibrosis (IPF)
IPF is a disease in which the lung tissue gradually becomes thicker, stiffer, and scarred. This scarring reduces the ability to transport oxygen from the lungs to the blood. Deep breathing is difficult. This medicine reduces further scarring and stiffness of the lungs.
Other chronic and progressive fibrosing interstitial lung diseases (ILD) with a progressive phenotype
Aside from IPF, there are other diseases in which the lung tissue becomes thicker, stiffer, and scarred over time (lung fibrosis) and worsens continuously (progressive phenotype). Examples of these diseases include allergic alveolitis, autoimmune ILD (e.g., ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassified idiopathic interstitial pneumonia, and other ILD. This medicine helps reduce further scarring and stiffness of the lungs.
Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Systemic sclerosis (also known as scleroderma) is a rare autoimmune disease that affects the connective tissue in many parts of the body. Systemic sclerosis (SSc) causes scarring (fibrosis and stiffness) of the skin and internal organs, such as the lungs. The presence of fibrosis in the lungs is called interstitial lung disease (ILD) and is referred to as SSc-ILD. Lung fibrosis reduces the ability to deliver oxygen to the bloodstream, reducing the ability to breathe. This medicine helps reduce further scarring and stiffness of the lungs.

2. Important information before taking Nintedanib Sandoz

When not to take Nintedanib Sandoz

• if the patient is allergic to nintedanib or any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant.

Warnings and precautions

Before starting to take Nintedanib Sandoz, the patient should discuss it with their doctor or pharmacist if:

• the patient has or has had liver problems,
• the patient has or has had kidney problems or has been found to have increased protein in their urine,
• the patient has or has had bleeding problems,
• the patient is taking medicines to prevent blood clotting (such as warfarin, phenprocoumon, heparin),
• the patient is taking pirfenidone, as this may increase the risk of diarrhea, nausea, vomiting, and liver problems,
• the patient has or has had heart problems (e.g., heart attack),
• the patient has recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Sandoz is usually interrupted for a period of time if the patient undergoes surgery. The doctor will decide when to resume treatment with this medicine.
• if the patient has high blood pressure,
• if the patient has high blood pressure in the blood vessels of the lungs (pulmonary hypertension),
• if the patient has or has had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Given this information, the doctor may perform blood tests, for example, to check liver function. The doctor will discuss the results of these tests with the patient and decide whether the patient can take Nintedanib Sandoz.
The patient should immediately inform their doctor if, while taking this medicine,

• they experience diarrhea. Early treatment of diarrhea is important (see section 4);
• they vomit or feel nauseous;
• they experience unexplained symptoms, such as yellowing of the skin or whites of the eyes (jaundice), dark or brown (tea-colored) urine, pain in the upper right abdomen, more frequent than usual bleeding or bruising, or feeling tired. These may be symptoms of severe liver problems;
• they experience severe stomach pain, fever, chills, nausea, vomiting, or a hard stomach or bloating, as these may be symptoms of a hole in the wall of the intestine (gastrointestinal perforation). The patient should also inform their doctor if they have had stomach ulcers or diverticulitis in the past or if they are taking nonsteroidal anti-inflammatory drugs (NSAIDs) (used to treat pain and swelling) or steroids (used to treat inflammation and allergies), as these factors increase the risk;
• they experience severe abdominal pain or cramps, bloody stools, or diarrhea, as these may be symptoms of inflammation of the intestine due to insufficient blood supply;
• they experience pain, swelling, redness, and increased temperature of a limb, as these may be symptoms of a blood clot in a vein (a type of blood vessel);

and

• they experience a feeling of pressure in the chest or pain, typically on the left side of the body, pain in the neck, jaw, arm, or hand, rapid heartbeat, shortness of breath, nausea, vomiting, as these may be symptoms of a heart attack;
• they experience severe bleeding;
• they experience discoloration, bleeding, fever, fatigue, and confusion. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA).
• they experience symptoms such as headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arm or leg, with high blood pressure or without it. These may be symptoms of a brain disease called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents

Children and adolescents under 18 years of age should not take Nintedanib Sandoz.

Nintedanib Sandoz and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including herbal products and medicines obtained without a prescription.
Nintedanib Sandoz may interact with certain other medicines. The following medicines may increase the level of nintedanib in the blood and thus increase the risk of side effects (see section 4):

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

The following medicines are examples of medicines that may decrease the level of nintedanib in the blood and thus decrease the effectiveness of Nintedanib Sandoz:

• an antibiotic used to treat tuberculosis (rifampicin),
• medicines used to treat epilepsy (carbamazepine, phenytoin),
• a herbal product used to treat depression (St. John's Wort).

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their 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 Sandoz, the patient must have a pregnancy test to make sure they are not pregnant. The patient should discuss this with their doctor.
Contraception

• Women who may become pregnant must use highly effective contraception to prevent pregnancy while taking Nintedanib Sandoz, throughout the treatment, and for at least 3 months after stopping the treatment.
• The patient should discuss the best contraceptive methods with their doctor.
• Vomiting and/or diarrhea or other gastrointestinal disorders may affect the absorption of oral hormonal contraceptives, such as birth control pills, and may reduce their effectiveness. In such cases, the patient should discuss the use of an alternative, more suitable contraceptive method with their doctor.

and

• If the patient becomes pregnant or thinks they may be pregnant while taking Nintedanib Sandoz, they should immediately inform their doctor or pharmacist.

Breastfeeding
Do not breastfeed while taking this medicine, as it may harm the breastfed baby.

Driving and using machines

This medicine may have a minor influence on the ability to drive and use machines.
If the patient feels nauseous, they should not drive or operate machinery.

3. How to take Nintedanib Sandoz

Take this medicine always exactly as the doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Take one capsule twice a day, approximately 12 hours apart, every day, at about the same times, for example, one capsule in the morning and one capsule in the evening.
This will help keep a steady level of nintedanib in the patient's blood. Swallow the capsules whole with water; do not suck or chew the capsules. It is recommended to take the capsules with food, i.e., during or immediately before or after a meal. Do not open or crush the capsules to avoid accidental exposure to the capsule contents (see section 5).

Adults

The recommended dose is one 150 mg capsule twice a day (a total of 300 mg per day).
Do not take more than the recommended dose: two 150 mg Nintedanib Sandoz soft capsules per day.
If the patient does not tolerate the recommended dose of two 150 mg Nintedanib Sandoz capsules per day (see possible side effects in section 4), the doctor may reduce the daily dose of Nintedanib Sandoz. Do not reduce the dose or stop treatment without consulting the doctor first.
The doctor may reduce the recommended dose to 100 mg twice a day (a total of 200 mg per day). In such cases, the doctor will prescribe Nintedanib Sandoz 100 mg soft capsules for further treatment. Do not exceed the recommended dose of two 100 mg Nintedanib Sandoz soft capsules per day if the patient's daily dose has been reduced to 200 mg per day.

Taking more than the recommended dose of Nintedanib Sandoz

Contact a doctor or pharmacist immediately.

Missing a dose of Nintedanib Sandoz

Do not take two capsules at the same time if a dose is missed.
Take the next dose of Nintedanib Sandoz as planned at the usual time and in the dose recommended by the doctor or pharmacist.

Stopping treatment with Nintedanib Sandoz

Do not stop taking Nintedanib Sandoz without consulting the doctor first.
It is important to take the medicine regularly, every day, for as long as the doctor recommends.
If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Nintedanib Sandoz can cause side effects, although not everybody gets them.
The patient should pay particular attention to the following side effects when taking Nintedanib Sandoz.
Diarrhea(Very common, may affect more than 1 in 10 people)
Diarrhea may lead to dehydration: loss of water and important substances (electrolytes, such as sodium or potassium) from the body. If the patient experiences the first symptoms of diarrhea, they should drink plenty of fluids and contact their doctor immediately. Start appropriate anti-diarrheal treatment as soon as possible, for example, with loperamide.

Other side effects observed during treatment with nintedanib (the active substance of this medicine)

If the patient experiences any side effects, they should inform their doctor.
Idiopathic pulmonary fibrosis (IPF)
Very common side effects(may affect more than 1 in 10 people)

• nausea (feeling sick),
• abdominal pain (lower back pain),
• abnormal liver function test results.

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

• vomiting,
• loss of appetite,
• weight loss,
• bleeding,
• rash,
• headache.

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

• pancreatitis,
• colitis,
• severe liver problems,
• low platelet count (thrombocytopenia),
• high blood pressure (hypertension),
• jaundice (yellowing of the skin and whites of the eyes due to high bilirubin levels),
• itching,
• heart attack,
• excessive hair loss (alopecia),
• increased protein in the urine (proteinuria).

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

• kidney failure,
• enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysm and arterial dissection),
• brain disease with symptoms such as headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arm or leg, with high blood pressure or without it (posterior reversible encephalopathy syndrome).

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

• nausea (feeling sick),
• vomiting,
• loss of appetite,
• abdominal pain (lower back pain),
• abnormal liver function test results.

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

• weight loss,
• high blood pressure (hypertension),
• bleeding,
• severe liver problems,
• rash,
• headache.

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

• pancreatitis,
• colitis,
• low platelet count (thrombocytopenia),
• jaundice (yellowing of the skin and whites of the eyes due to high bilirubin levels),
• itching,
• heart attack,
• excessive hair loss (alopecia),
• increased protein in the urine (proteinuria).

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

• kidney failure,
• enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysm and arterial dissection).
• brain disease with symptoms such as headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arm or leg, with high blood pressure or without it (posterior reversible encephalopathy syndrome).

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Very common side effects(may affect more than 1 in 10 people)

• nausea (feeling sick),
• vomiting,
• abdominal pain (lower back pain),
• abnormal liver function test results.

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

• bleeding,
• high blood pressure (hypertension),
• loss of appetite,
• weight loss,
• headache.

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

• colitis,
• severe liver problems,
• kidney failure,
• low platelet count (thrombocytopenia),
• rash,
• itching.

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

• heart attack,
• pancreatitis,
• jaundice (yellowing of the skin and whites of the eyes due to high bilirubin levels),
• enlargement and weakening of the wall of a blood vessel or tear in the wall of a blood vessel (aneurysm and arterial dissection),
• hair loss (alopecia),
• increased protein in the urine (proteinuria),
• brain disease with symptoms such as headache, changes in vision, disorientation, seizures, or other neurological disorders, such as weakness of the arm or leg, with high blood pressure or without it (posterior reversible encephalopathy syndrome).

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Nintedanib Sandoz

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 the month.
Store in the original package to protect from moisture.
Do not use this medicine if the blister containing the capsules is open or if the capsule is broken.
In case of contact with the capsule contents, wash hands immediately with plenty of water (see section 3).
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nintedanib Sandoz contains

• The active substance is nintedanib. Each capsule contains 150 mg of nintedanib esylate, which corresponds to 150 mg of nintedanib.
• The other ingredients are: Capsule contents: medium-chain triglycerides, hardened fat, polyglyceryl-3-diolenate (E475) Capsule shell: gelatin (E441), glycerol (85%) (E422), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)

The ink used for printing: shellac (E904), iron oxide black (E172), and propylene glycol (E1520)

What Nintedanib Sandoz looks like and contents of the pack

Nintedanib Sandoz 150 mg soft capsules are oblong, opaque, soft gelatin capsules, brown in color, approximately 15 mm to 19 mm in length, with black printing "NT 150", containing a yellow, viscous suspension.
Nintedanib Sandoz 150 mg soft capsules are available in a cardboard box containing 30 x 1 or 60 x 1 soft capsules in aluminum, perforated blisters OPA/Aluminum/PVC.
Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
Poland
Tel. 22 209 70 00

Manufacturer/Importer

Adalvo Limited
Malta Life Sciences Park Building 1 Floor 4
Sir Temi Zammit Buildings
San Gwann Industrial Estate, SGN 3000
Malta
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
Lek Pharmaceuticals d.d
Verovškova ulica 57
1526 Ljubljana
Slovenia
Qualimetrix S.A.
Mesogeion Avenue 579
Agia Paraskevi
Athens
153 43
Greece

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

Netherlands
Nintedanib esilaat Sandoz 150 mg, soft capsules
Austria
Nintedanib Sandoz 150 mg soft capsules
Czech Republic
Nintedanib Sandoz
Denmark
Nintedanib Sandoz
Estonia
Nintedanib Sandoz
Spain
Nintedanib Sandoz 150 mg soft capsules EFG
Finland
Nintedanib Sandoz 150 mg soft capsules
France
NINTEDANIB SANDOZ 150 mg, soft capsules
Hungary
Nintedanib Sandoz 150 mg soft capsules
Iceland
Nintedanib Sandoz
Italy
Nintedanib Sandoz
Lithuania
Nintedanib Sandoz 150 mg soft capsules
Latvia
Nintedanib Sandoz 150 mg soft capsules
Norway
Nintedanib Sandoz
Portugal
Nintedanib Sandoz 150 mg soft capsules
Sweden
Nintedanib Sandoz
Greece
Nintedanib/Sandoz
Date of last revision of the package leaflet:06/2025
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