Nintedanib sandoz

Package leaflet: Information for the user

Nintedanib Sandoz, 100 mg, soft capsules
Nintedanibum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

Idiopathic pulmonary fibrosis (IPF) in adults
IPF (idiopathic pulmonary fibrosis) is a disease in which lung tissue gradually becomes thicker, stiff, and scarred. This scarring reduces the ability to transfer oxygen from the lungs into the bloodstream. Deep breathing becomes difficult. This medicine helps reduce further scarring and stiffening of the lungs.

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype in adults
Besides IPF, there are other conditions in which lung tissue gradually becomes thicker, stiff, and scarred (lung fibrosis) and continues to worsen over time (progressive phenotype). Examples of these conditions include hypersensitivity pneumonitis, autoimmune ILD (interstitial lung disease) (e.g. ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. This medicine 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
Patients with childhood interstitial lung disease (chILD) may develop lung fibrosis. In such cases, lung tissue in children and adolescents gradually becomes thickened, stiff, and scarred over time. Nintedanib Sandoz 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), also known as scleroderma, is a rare autoimmune disease affecting connective tissue in many parts of the body. Systemic sclerosis (SSc) causes fibrosis (scarring and stiffening) of the skin and other internal organs, such as the lungs. When fibrosis occurs in the lungs, it is called interstitial lung disease (ILD), and the condition is therefore known as SSc-ILD. Lung fibrosis reduces the ability to deliver oxygen into the bloodstream, impairing breathing. This medicine helps reduce further scarring and stiffening 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 treatment with Nintedanib Sandoz, discuss with your doctor or pharmacist if:

• the patient has or has had liver problems,
• the patient has or has had kidney problems or increased protein levels in the urine have been detected,
• the patient has or has had bleeding problems,
• the patient is taking medicines that reduce blood clotting (such as warfarin, phenprocoumon, heparin) to prevent blood clots,
• the patient is taking pirfenidone, as this may increase the risk of diarrhoea, 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 temporarily discontinued if the patient undergoes surgery. Your doctor will decide when to resume treatment with this medicine.
• if the patient has high blood pressure,
• if the patient has pulmonary hypertension (high blood pressure in the blood vessels of the lungs),
• if the patient has or has previously had an aneurysm (a bulge and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.

Based on 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 inform the doctor immediately if, during treatment with this medicine:

• diarrhoea occurs. Early treatment of diarrhoea is important (see section 4);

• the patient experiences vomiting or nausea;

• unexplained symptoms occur, 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 abdomen, more frequent than usual bleeding or bruising, or feeling tired. These may be symptoms of serious liver problems;

• severe stomach pain, fever, chills, nausea, vomiting, or a hard abdomen or bloating occur, as these may be symptoms of a hole in the wall of the intestine (gastrointestinal perforation). The doctor should also be informed if the patient has previously had peptic ulcers or diverticular disease of the intestine,
  or if the patient is simultaneously taking anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, NSAIDs) (used to treat pain and swelling) or steroids (used to treat inflammatory conditions and allergies), as these factors may increase this risk;

• severe abdominal pain or cramps, red blood in the stool, or diarrhoea occur, as these may be symptoms of intestinal inflammation due to inadequate blood supply to the intestine;

• pain, swelling, redness, and increased temperature in a limb occur, as these may be symptoms of a blood clot in a vein (a type of blood vessel);

• the patient experiences chest tightness or pain, typically on the left side of the body, pain in the neck, jaw, arm, or hand, rapid heartbeat, shortness of breath, nausea, or vomiting, as these may be symptoms of a heart attack;

• the patient experiences serious bleeding;

• the patient develops bruising, bleeding, fever, fatigue, and confusion. This may be a sign of blood vessel damage called thrombotic microangiopathy (TMA);

• symptoms such as headache, visual disturbances, disorientation, seizures, or other neurological disturbances such as weakness in the arm or leg occur, with or without high blood pressure. These may be symptoms of a brain disorder called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents
Nintedanib Sandoz must not be used in children under 6 years of age.
The doctor may perform regular dental examinations at least every 6 months until tooth development is complete and monitor the patient's growth once a year (bone imaging) during treatment with this medicine.

Nintedanib Sandoz and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including herbal products and over-the-counter medicines.
Nintedanib Sandoz may interact with certain other medicines. The following medicines may increase nintedanib blood levels and thereby increase the risk of adverse effects (see section 4):

• a medicine used to treat fungal infections (ketoconazole),
• a medicine used to treat bacterial infections (erythromycin),
• a medicine affecting the immune system (cyclosporyne).

The following medicines are examples of those that may reduce nintedanib blood levels and thereby reduce the effectiveness of Nintedanib Sandoz:

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn child and cause congenital malformations.
Before starting treatment with Nintedanib Sandoz, a pregnancy test must be performed in female patients to confirm that they are not pregnant. The patient should discuss this with her doctor.

Contraceptive methods

• Women who can become pregnant must use a highly effective method of contraception to prevent pregnancy, both when starting treatment with Nintedanib Sandoz, throughout the entire treatment period, and for at least 3 months after stopping treatment.
• The best contraceptive methods should be discussed with the treating doctor.
• Vomiting and/or diarrhoea or other gastrointestinal disturbances may affect the absorption of oral hormonal contraceptives, such as contraceptive pills, and may reduce their effectiveness. Therefore, in case of such disturbances, discuss with your doctor the use of an alternative, more suitable method of contraception.
• If a patient becomes pregnant or suspects she may be pregnant during treatment with Nintedanib Sandoz, she should immediately inform her doctor or pharmacist.

Breastfeeding
Do not breastfeed during treatment with this medicine, as it may harm the breastfed child.

Driving and using machines
This medicine may have a minor influence on the ability to drive and use machines.
If the patient experiences nausea, he or she should not drive or operate machinery.

3. How to take Nintedanib Sandoz

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.
Take the capsules twice daily, approximately 12 hours apart, at about the same times each day, for example one capsule in the morning and one in the evening.
This will ensure a constant level of nintedanib in the patient's bloodstream. The capsules must be swallowed 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. The capsules must not be opened or crushed to avoid unintended exposure to the capsule contents (see section 5). To facilitate swallowing, the capsules may be taken with a small amount (one teaspoon) of soft food, cold or at room temperature, such as apple sauce or chocolate pudding. The capsules should be swallowed immediately and not chewed, so that the capsule remains intact.
Adults
The recommended dose is one capsule containing 100 mg taken twice daily (total 200 mg daily).
Do not take a higher dose than recommended: two soft capsules of Nintedanib Sandoz 100 mg per day.
If the patient does not tolerate the recommended dose of two Nintedanib Sandoz 100 mg capsules per day (see possible side effects in section 4), the doctor may recommend discontinuation of the treatment. Do not reduce the dose or stop treatment on your own without prior consultation with the doctor.
Use in children and adolescents
The recommended dose depends on the patient's body weight.
Inform the doctor if at any time during treatment the patient's body weight drops below 13.5 kg.
Inform the doctor if the patient has liver problems.
The doctor will determine the correct dose. The doctor may adjust the dose as treatment progresses.
If the patient does not tolerate the recommended daily dose of Nintedanib Sandoz (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 on your own without first discussing it with the doctor.
Dosing of Nintedanib Sandoz capsules in children and adolescents according to body weight:

Nintedanib Sandoz 25 mg capsules are not available; consider alternative medicines available on the market.
Taking more Nintedanib Sandoz than prescribed
Contact your doctor or pharmacist immediately.
Missing a dose of Nintedanib Sandoz
Do not take two capsules together if you have missed a previous dose.
Take the next 100 mg dose of Nintedanib Sandoz as scheduled, at the usual time and in the dose prescribed by your doctor or pharmacist.
Stopping treatment with Nintedanib Sandoz
Do not stop taking Nintedanib Sandoz without first consulting your doctor.
It is important to take this medicine regularly every day for as long as your doctor recommends.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Particular attention should be paid to the occurrence of the following adverse reactions during
treatment with Nintedanib Sandoz.
Diarrhoea (Very common, may occur in more than 1 in 10 patients)
Diarrhoea may lead to dehydration: loss of water and important substances (electrolytes, such as
sodium or potassium) from the body. If the first symptoms of diarrhoea occur, drink plenty of fluids
and contact your doctor immediately. Anti-diarrhoeal treatment, for example with loperamide,
should be started as soon as possible.
The following other adverse reactions have been observed during treatment with nintedanib
(the active substance of this medicine).
If any adverse reactions occur in the patient, inform the doctor.

Idiopathic pulmonary fibrosis (IPF)
Very common adverse reactions (may occur in more than 1 in 10 patients)

• nausea,
• abdominal pain,
• abnormal liver function test results.

Common adverse reactions (may occur in up to 1 in 10 patients)

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

Uncommon adverse reactions (may occur in up to 1 in 100 patients)

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

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

• renal failure,
• enlargement and weakening of the blood vessel wall or blood vessel wall rupture (aneurysm and arterial dissection),
• brain disorder with symptoms such as headache, visual disturbances, confusion, seizures or other neurological disorders such as weakness of the 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 adverse reactions (may occur in more than 1 in 10 patients)

• nausea,
• vomiting,
• loss of appetite,
• abdominal pain,
• abnormal liver function test results.

Common adverse reactions (may occur in up to 1 in 10 patients)

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

Uncommon adverse reactions (may occur in up to 1 in 100 patients)

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

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

• renal failure,
• enlargement and weakening of the blood vessel wall or blood vessel wall rupture (aneurysm and arterial dissection),
• brain disorder with symptoms such as headache, visual disturbances, confusion, seizures or other neurological disorders such as weakness of the arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome).

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Very common adverse reactions (may occur in more than 1 in 10 patients)

• nausea,
• vomiting,
• abdominal pain,
• abnormal liver function test results.

Common adverse reactions (may occur in up to 1 in 10 patients)

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

Uncommon adverse reactions (may occur in up to 1 in 100 patients)

• colitis,
• serious liver problems,
• renal failure,
• low platelet count (thrombocytopenia),
• rash,
• itching.

Frequency 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 bilirubin levels,
• enlargement and weakening of the blood vessel wall or rupture of the blood vessel wall (aneurysm and arterial dissection),
• hair loss (alopecia),
• increased protein concentration in urine (proteinuria),
• brain disorder with symptoms such as headache, visual disturbances, confusion, seizures or other neurological disorders such as weakness of the arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome).

Fibrosing interstitial lung diseases (ILD) in children and adolescents
Adverse reactions in children and adolescents were similar to those in adult patients.
Consult a doctor if the patient experiences any adverse reactions.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the 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 pack. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Do not use this medicine if you notice that the blister containing the capsules is open or if a capsule is cracked.
In case of contact with the capsule contents, wash hands immediately with plenty of water (see section 3).
Medicines must not be disposed of via wastewater or household waste. Ask your 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 100 mg of nintedanib esilate, equivalent to 100 mg of nintedanib.
• Other components are:
  Capsule contents: medium-chain triglycerides, hardened fat, polyglycerol polyricinoleate (E475)
  Capsule shell: gelatin (E441), glycerol (85%) (E422), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), purified water
  Printing ink: shellac (E904), carmine (E120), propylene glycol (E1520) and simethicone

What Nintedanib Sandoz looks like and contents of the pack
Nintedanib Sandoz, 100 mg, soft capsules are elongated, opaque, soft gelatin capsules, peach-coloured, 13.5 mm to 17.5 mm in length, with a red imprint reading "NT 100", containing a yellow, viscous suspension.
Nintedanib Sandoz, 100 mg, soft capsules are available in cardboard boxes containing 30 x 1 and 60 x 1 soft capsules in perforated blisters of OPA/Aluminium/PVC.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warszawa
Poland
Tel. 22 209 70 00

Manufacturer/Importer
Adalvo Limited
Malta Life Sciences Park Building 1, 4th Floor
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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands: Nintedanib esilaat Sandoz 100 mg, zachte capsules
Austria: Nintedanib Sandoz 100 mg –Weichkapseln
Czech Republic: Nintedanib Sandoz
Denmark: Nintedanib Sandoz
Estonia: Nintedanib Sandoz
Spain: Nintedanib Sandoz 100 mg cápsulas blandas EFG
Finland: Nintedanib Sandoz 100 mg pehmeät kapselit
France: NINTEDANIB SANDOZ 100 mg, capsule molle
Hungary: Nintedanib Sandoz 100 mg lágy kapszula
Iceland: Nintedanib Sandoz
Italy: Nintedanib Sandoz
Lithuania: Nintedanib Sandoz 100 mg minkštosios kapsulės
Latvia: Nintedanib Sandoz 100 mg mīkstās kapsulas
Norway: Nintedanib Sandoz
Portugal: Nintedanib Sandoz 100 mg cápsulas moles
Sweden: Nintedanib Sandoz
Greece: Nintedanib/Sandoz

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