Nintedanib sandoz

Package leaflet: Information for the user

Nintedanib Sandoz, 150 mg, soft capsules
Nintedanibum
Please read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Nintedanib Sandoz is and what it is used for
2. What you need to know 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, which belongs to a group of medicines called tyrosine kinase inhibitors. It is used to treat the following conditions:

Idiopathic pulmonary fibrosis (IPF) in adults
IPF is a disease in which lung tissue gradually becomes thicker, stiff, and scarred. This scarring reduces the ability of the lungs to transfer oxygen into the blood. 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 becomes progressively thicker, stiffer, and scarred (lung fibrosis) and continues to worsen over time (progressive phenotype). Examples of these conditions include hypersensitivity pneumonitis, autoimmune ILD (e.g. ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassified 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
In patients with childhood interstitial lung disease (chILD), lung fibrosis may occur. In such cases, the 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. SSc causes fibrosis (scarring and stiffening) of the skin and other internal organs, such as the lungs. The presence of fibrosis in the lungs is called interstitial lung disease (ILD), and the condition is therefore referred to 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 (abnormally high blood pressure in the blood vessels of the lungs),
• if the patient has or has previously had an aneurysm (a weakened and bulging blood vessel wall) or a tear in the blood vessel wall.

Based on this information, your doctor may perform blood tests, for example,
to check liver function. Your doctor will discuss the results of these tests
with you and decide whether you can take Nintedanib Sandoz.
You should contact your doctor immediately if, while taking this medicine:

• the patient develops diarrhoea. Early treatment of diarrhoea is important (see section 4);
• the patient vomits or has nausea;
• the patient develops unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brownish (tea-coloured) urine, pain in the upper right part of the abdomen, more frequent than usual bleeding or bruising, or a feeling of fatigue. These may be symptoms of serious liver problems;
• the patient develops severe stomach pain, fever, chills, nausea, vomiting, or a hard abdomen or bloating, as these may be symptoms of a perforation in the intestinal wall (gastrointestinal perforation). You should also inform your doctor if:

the patient has previously had peptic ulcers or diverticular disease of the intestine
or if the patient is also taking anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, NSAIDs) (used to treat pain and swelling) or steroids (used
to treat inflammatory and allergic conditions), as these factors increase this risk;

• the patient simultaneously develops severe abdominal pain or cramps, red blood in the stool or diarrhoea, as these may be symptoms of intestinal inflammation due to inadequate blood supply;
• the patient develops pain, swelling, redness and increased temperature in a limb, 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, 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 damage to blood vessels called thrombotic microangiopathy (TMA).
• the patient develops symptoms such as headache, visual disturbances, disorientation, seizures or other neurological disorders such as weakness in the arm or leg, 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.
Your doctor may perform regular dental examinations at least every 6 months until dental development is complete and monitor the patient's growth annually (bone imaging) during treatment with this medicine.
Nintedanib Sandoz and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including herbal products and over-the-counter medicines.
Nintedanib Sandoz may interact with certain other medicines. The following medicines
may increase the blood concentration of nintedanib 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 (cyclosporine).

The following medicines are examples of those that may decrease the blood concentration of nintedanib,
and thus 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 become pregnant, she should consult her doctor or pharmacist before using 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.
Contraception

• Women who could 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.
• Discuss the most suitable contraceptive methods with your 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 appropriate method of contraception.
• If the 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 exactly as prescribed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Take the capsules twice daily, approximately 12 hours apart, at approximately the same times each day, for example one capsule in the morning and one in the evening.
This will help maintain a constant level of nintedanib in the patient's bloodstream. 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. The capsules must not be opened or crushed to avoid unintended exposure to the capsule contents (see section 5). To make swallowing easier, 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 150 mg taken twice daily (total 300 mg daily).
Do not exceed the recommended dose: two soft capsules of Nintedanib Sandoz 150 mg per day.
If the patient does not tolerate the recommended dose of two capsules of Nintedanib Sandoz 150 mg per day (see possible adverse reactions in section 4), the doctor may reduce the daily dose of Nintedanib Sandoz. Do not reduce the dose or discontinue treatment on your own without first consulting your doctor.
The doctor may reduce the recommended dose to 100 mg twice daily (total 200 mg daily).
In such a case, the doctor will prescribe the patient Nintedanib Sandoz 100 mg soft capsules for continued treatment. Do not exceed the recommended dose of two soft capsules of Nintedanib Sandoz 100 mg per day if the patient's daily 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 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 adverse reactions 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 consulting your doctor.
Dosing of Nintedanib Sandoz capsules in children and adolescents according to body weight:

If 25 mg Nintedanib Sandoz capsules are not available, consider alternative medicines available on the market.
Taking more Nintedanib Sandoz than prescribed
Contact your doctor or pharmacist immediately.
If you forget to take Nintedanib Sandoz
Do not take two capsules together if you have missed a previous dose.
Take the next dose of Nintedanib Sandoz as scheduled, at the usual time and in the dose recommended by your doctor or pharmacist.
Stopping Nintedanib Sandoz treatment
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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Special attention should be paid to the occurrence of the following side effects during
treatment with Nintedanib Sandoz.
Diarrhoea (Very common: may affect more than 1 in 10 people)
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. Begin appropriate anti-diarrhoeal treatment as soon as possible, for example with loperamide.
The following other side effects have been observed during treatment with nintedanib (the active substance of this medicine).
If any side effects occur in the patient, inform the doctor immediately.

Idiopathic pulmonary fibrosis (IPF)
Very common side effects (may affect more than 1 in 10 people)

• nausea,
• abdominal 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,
• 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 in the urine (proteinuria).

Frequency unknown (cannot be estimated from the available data)

• renal failure,
• enlargement and weakening of the blood vessel wall or tear in the blood vessel wall (aneurysm and arterial dissection),
• brain disease 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 side effects (may affect more than 1 in 10 people)

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

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

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

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

• 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 in the urine (proteinuria).

Frequency unknown (cannot be estimated from the available data)

• renal failure,
• enlargement and weakening of the blood vessel wall or tear in the blood vessel wall (aneurysm and arterial dissection),
• brain disease 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 side effects (may affect more than 1 in 10 people)

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

Frequency unknown (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 in the urine (proteinuria),
• brain disease 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
Side effects in children and adolescents were similar to those in adult patients.
Consult a doctor if any side effects occur in the patient.

Reporting of side effects
If any side effects occur, including any not mentioned in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of 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
Side effects can also be reported to the responsible entity.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Nintedanib Sandoz

Keep this medicine out of 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 stated month.
Store in the original packaging to protect from moisture.
Do not use this medicine if 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Nintedanib Sandoz contains

• The active substance is nintedanib. Each capsule contains 150 mg of nintedanib esilate, equivalent to 150 mg of nintedanib.
• The other components are:
  Capsule contents: medium-chain triglycerides, hardened fat, polyglyceryl-3 dioleate (E475)
  Capsule shell: gelatin (E441), glycerol (85%) (E422), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), purified water
  Printing ink: 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 (capsules) are elongated, opaque, soft gelatin capsules, brown in colour, 15 mm to 19 mm in length, with a black imprint "NT 150", containing a yellow, viscous suspension.
Nintedanib Sandoz 150 mg, soft capsules are available in cardboard packaging containing 30 x 1 or 60 x 1 soft capsules in aluminium, perforated blisters OPA/Aluminium/PVC.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area under the following names:
Netherlands Nintedanib esilaat Sandoz 150 mg, zachte capsules
Austria Nintedanib Sandoz 150 mg –Weichkapseln
Czech Republic Nintedanib Sandoz
Denmark Nintedanib Sandoz
Estonia Nintedanib Sandoz
Spain Nintedanib Sandoz 150 mg cápsulas blandas EFG
Finland Nintedanib Sandoz 150 mg pehmeät kapselit
France NINTEDANIB SANDOZ 150 mg, capsule molle
Hungary Nintedanib Sandoz 150 mg lágy kapszula
Iceland Nintedanib Sandoz
Italy Nintedanib Sandoz
Lithuania Nintedanib Sandoz 150 mg minkštosios kapsulės
Latvia Nintedanib Sandoz 150 mg mīkstās kapsulas
Norway Nintedanib Sandoz
Portugal Nintedanib Sandoz 150 mg cápsulas moles
Sweden Nintedanib Sandoz
Greece Nintedanib/Sandoz
{responsible entity logo}