Nintedanib teva

Package leaflet: Information for the patient

Nintedanib Teva, 150 mg, soft capsules
Nintedanibum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. This medicine may harm other people, 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.

Leaflet contents

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

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

Nintedanib Teva contains the active substance nintedanib, a medicine belonging to a group called
tyrosine kinase inhibitors, and 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 oxygen to pass from the lungs into the blood. Deep breathing becomes difficult. This medicine helps reduce further scarring and lung stiffness.

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype in adults
Besides IPF, there are other conditions in which lung tissue over time becomes thicker, stiff, and scarred (pulmonary fibrosis) and continues to worsen (progressive phenotype). Examples of these conditions include hypersensitivity pneumonitis, autoimmune ILD (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 lung stiffness.

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 pulmonary fibrosis. In such cases, the lung tissue in children and adolescents gradually becomes thickened, stiff, and scarred over time. This medicine helps reduce further scarring and lung stiffness.

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 (and juvenile systemic sclerosis in children and adolescents), 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. The presence of fibrosis in the lungs is called interstitial lung disease (ILD), and thus the condition is known as SSc-ILD. Pulmonary fibrosis reduces the ability to deliver oxygen into the bloodstream, making breathing difficult. This medicine helps reduce further scarring and lung stiffness.

2. Important information before taking Nintedanib Teva

When not to take Nintedanib Teva

• 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 Teva, discuss with your doctor or pharmacist if:

• the patient has or has had liver problems,
• the patient has or has had kidney problems or if protein in urine has been detected,
• the patient has or has had bleeding problems,
• the patient is taking medicines that reduce blood clotting (such as warfarin, phenprocoumon or 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 this medicine is usually temporarily stopped if the patient undergoes surgery. Your doctor will decide when to resume treatment.
• the patient has high blood pressure,
• the patient has abnormally high blood pressure in the blood vessels of the lungs (pulmonary hypertension),
• 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.

Taking these factors into account, your doctor may carry out 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 Teva.
You must contact your doctor immediately if, while taking this medicine:

• the patient develops diarrhoea. Early treatment of diarrhoea is important (see section 4 “Possible side effects”);
• the patient vomits or has nausea (feeling sick);
• the patient experiences 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 feeling tired. These may be signs 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 hole in the wall of the intestine (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 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 experiences severe pain or cramps in the abdominal cavity, red blood in the stool or diarrhoea, as these may be symptoms of intestinal inflammation due to inadequate blood supply to the intestine;
• the patient develops pain, swelling, redness and increased temperature in a limb, as these may be symptoms of a blood clot forming in one of the veins (a type of blood vessel);
• the patient experiences 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;
• 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);
• the patient develops symptoms such as headache, visual disturbances, disorientation, seizures or other neurological disorders such as weakness in the arms or legs, with or without high blood pressure. These may be symptoms of a brain disorder called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents
Nintedanib should not be given to children under 6 years of age.
Your doctor may carry out 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 Teva 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 Teva may interact with certain other medicines. The following medicines may increase the blood concentration of nintedanib and thus increase the risk of side effects (see section 4 “Possible side effects”):

• 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 Teva:

• an antibiotic used to treat tuberculosis (rifampicin)
• medicines used to treat epileptic seizures (carbamazepine, phenytoin)
• a herbal medicine 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 using this medicine.

Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn child and cause congenital malformations.
A pregnancy test must be performed in female patients before starting treatment with this medicine to confirm that she is not pregnant. The patient should discuss this with her treating doctor.

Contraceptive medicines

• Women who could become pregnant must use a highly effective method of contraception to prevent pregnancy, both when starting treatment with Nintedanib Teva, throughout the 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 disorders may affect the absorption of oral hormonal contraceptives, such as contraceptive pills, and may reduce their effectiveness. Therefore, if such disorders occur, 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 this medicine, she should immediately inform her doctor or pharmacist.

Breastfeeding
Do not breastfeed during treatment with this medicine, as there is a risk of adverse effects in 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 Teva

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Take the capsules twice daily, approximately 12 hours apart, for example one capsule in the morning and one in the evening. This ensures a constant level of nintedanib in the patient's bloodstream. Swallow the capsules whole with water; do not 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 (see section 5 "How to store Nintedanib Teva").
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. They 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 per day).
Do not exceed the recommended dose of two Nintedanib Teva 150 mg capsules per day.
If the patient does not tolerate the recommended dose of two Nintedanib Teva 150 mg capsules per day (see section 4: "Possible side effects"), the doctor may reduce the daily dose of Nintedanib Teva. Do not reduce the dose or stop treatment on your own without first consulting your doctor.
The doctor may reduce the recommended dose to 100 mg twice daily (total 200 mg per day). In such a case, the doctor will prescribe Nintedanib Teva 100 mg soft capsules for continued treatment. Do not exceed the recommended dose of two Nintedanib Teva 100 mg capsules 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 Teva capsules (see section 4 "Possible side effects"), the doctor may reduce the daily dose of nintedanib.
Do not reduce the dose or stop treatment on your own without first consulting your doctor.
Dosing of Nintedanib Teva capsules in children and adolescents according to body weight:

In cases where doses cannot be achieved using this medicine, other medicines containing nintedanib in more appropriate doses are available.
Taking more Nintedanib Teva than prescribed
Contact your doctor or pharmacist immediately.
Missing a dose of Nintedanib Teva
Do not take two capsules together if you have missed a previous dose. Take the next 150 mg dose of Nintedanib Teva according to schedule, at the usual time recommended by your doctor or pharmacist.
Stopping treatment with Nintedanib Teva
Do not stop taking Nintedanib Teva without first consulting your doctor. It is important to take this medicine regularly every day for as long as your doctor has instructed.
If you have any further questions regarding 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 everyone will experience them.
Particular attention should be paid to the following side effects during treatment with
Nintedanib Teva.
Diarrhoea (Very common – may affect more than 1 in 10 people)
Diarrhoea may lead to dehydration: loss of water and important salts (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 should be started 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
• pain in the lower part of the body (abdomen)
• 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
• inflammation of the large intestine
• 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 levels in urine (proteinuria)

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

• kidney failure
• enlargement and weakening of the blood vessel wall or tearing of the blood vessel wall (aneurysm and arterial dissection)
• brain disease characterised by symptoms such as headache, visual disturbances, disorientation, seizures or other neurological disorders such as weakness in arms or legs, 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
• pain in the lower part of the body (abdomen)
• 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
• inflammation of the large intestine
• 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 levels in urine (proteinuria)

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

• kidney failure
• enlargement and weakening of the blood vessel wall or tearing of the blood vessel wall (aneurysm and arterial dissection)
• brain disease characterised by symptoms such as headache, visual disturbances, disorientation, seizures or other neurological disorders such as weakness in arms or legs, 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
• pain in the lower part of the body (abdomen)
• 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)

• inflammation of the large intestine
• serious 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, 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 tearing of the blood vessel wall (aneurysm and arterial dissection)
• excessive hair loss (alopecia)
• increased protein levels in urine (proteinuria)
• brain disease characterised by symptoms such as headache, visual disturbances, disorientation, seizures or other neurological disorders such as weakness in arms or legs, 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 observed in adult patients.
Consult a doctor if the patient experiences any side effects.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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
Phone: +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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Nintedanib Teva

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 following:
"EXP". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Do not use this medicine if the blister pack 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 "How to take Nintedanib Teva").
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the pack and other information

What Nintedanib Teva contains

• The active substance is nintedanib. Each capsule contains 150 mg of nintedanib (as nintedanib esilate).
• The other ingredients are:
  • Capsule contents: medium-chain triglycerides, solid fat, polyglycerol-3 dioleate
  • Capsule shell: gelatin, glycerol, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), purified water
  • Printing ink: shellac, iron oxide black (E 172), and propylene glycol (E 1520)

What Nintedanib Teva looks like and contents of the pack
Nintedanib Teva 150 mg is an opaque, brown, elongated capsule approximately 17 mm in length, containing a yellow, viscous suspension, marked with black ink "NT 150".
Nintedanib Teva 150 mg soft capsules are available in single-dose perforated blisters made of OPA/Aluminium/PVC/Aluminium foil, packed in a cardboard box.
Pack sizes:
30 x 1 soft capsule
60 x 1 soft capsule
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel: +48 22 345 93 00

Manufacturer/Importer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Adalvo Limited
Malta Life Sciences Park Building 1 Level 4
Sir Temi Zammit Buildings
San Gwann Industrial Estate
San Gwann, SGN 3000
Malta
QUALIMETRIX S.A.
579 MESOGEION AVENUE AGIA PARASKEVI,
Athens, 15343, Greece
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków

This medicinal product is authorised for sale in the European Economic Area under the following names:
Austria: Nintedanib ratiopharm 150 mg – Weichkapseln
Belgium: Nintedanib Teva 150 mg zachte capsules/capsules molles/Weichkapseln
Czech Republic: Nintedanib Teva
Germany: Nintedanib-ratiopharm 150 mg Weichkapseln
Denmark: Nintedanib Teva
Estonia: Nintedanib Teva
Greece: Nintedanib/Teva
Spain: Nintedanib Teva 150 mg cápsulas blandas EFG
Finland: Nintedanib ratiopharm 150 mg kapseli, pehmeä
France: NINTEDANIB TEVA 150mg, capsule molle
Croatia: Nintedanib Teva 150 mg, meke kapsule
Iceland: Nintedanib Teva
Italy: Nintedanib Teva
Lithuania: Nintedanib Teva 150 mg minkštosios kapsulės
Latvia: Nintedanib Teva 150 mg mīkstās kapsulas
Luxembourg: Nintedanib Teva 150 mg capsules molles
Netherlands: Nintedanib Teva 150 mg, zachte capsules
Norway: Nintedanib Teva
Poland: Nintedanib Teva
Portugal: Nintedanib Zidrium
Romania: Nintedanib Teva 150 mg, capsule moi
Sweden: Nintedanib Teva
Slovakia: Nintedanib Teva 150 mg mäkké kapsuly