Nintedanib teva

Package leaflet: Information for the patient

Nintedanib Teva, 100 mg, soft capsules
Nintedanibum
Please read this leaflet carefully before taking this medicine, because 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 a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 the group of so-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 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 over time becomes thicker, stiff, and scarred (lung fibrosis) and continuously worsens (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 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. This medicine 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 (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 internal organs such as the lungs. The presence of fibrosis in the lungs is called interstitial lung disease (ILD), and thus the condition is referred to as SSc-ILD. Lung fibrosis reduces the ability to deliver oxygen into the bloodstream, making breathing difficult. This medicine helps reduce further scarring and stiffening of the lungs.

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 interrupted if the patient undergoes surgery. The doctor will decide when treatment with this medicine should be resumed.
• the patient has high blood pressure,
• the patient has pulmonary hypertension (high blood pressure in the blood vessels of the lungs),
• 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, 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 Teva.
Immediately inform the doctor if, while taking this medicine:

• the patient develops diarrhoea. Early treatment of diarrhoea is important (see section 4 “Possible side effects”);

• the patient experiences vomiting or nausea;

• the patient develops unexplained symptoms 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 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). 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 concurrently 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 pain or cramps in the abdomen, red blood in the stool or diarrhoea, as these may be symptoms of intestinal inflammation due to insufficient 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 disturbances, 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.
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 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 thereby 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 reduce the blood concentration of nintedanib and thereby 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 baby, 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 this medicine, a pregnancy test must be performed in female patients to confirm that they are not pregnant. The patient should discuss this with her treating doctor.

Contraceptive methods

• 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 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 disorders may affect the absorption of oral hormonal contraceptives, such as contraceptive pills, and may reduce their effectiveness. Therefore, in the event of such disorders, discuss with the doctor the use of an alternative, more appropriate method of contraception.
• If the patient becomes pregnant or suspects she may be pregnant while being treated 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 prescribed by the doctor or pharmacist.
If in doubt, consult the 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 will ensure a constant level of nintedanib in the patient's bloodstream. The capsules should be swallowed 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.
The capsules must not be opened or crushed (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 100 mg taken twice daily (total 200 mg per day).
Do not use a higher dose than the recommended dose of two Nintedanib Teva 100 mg capsules per day.
If the patient does not tolerate the recommended dose of two Nintedanib Teva 100 mg capsules per day (see section 4: "Possible side effects"), the doctor may advise discontinuation of this medicine. 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 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.

Dosage 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 a higher than recommended dose of Nintedanib Teva
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 100 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 the medicine regularly every day for as long as your doctor recommends.
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 everybody will experience them.
Special attention should be paid to the following side effects during treatment with Nintedanib Teva.
Diarrhoea (Very common – may occur in 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. Start 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 occur in more than 1 in 10 people)

• nausea
• abdominal pain
• abnormal liver function test results

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

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

Uncommon side effects (may occur in 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 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 disorder with symptoms such as headache, visual changes, confusion, seizures, or other neurological disturbances 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 occur in more than 1 in 10 people)

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

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

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

Uncommon side effects (may occur in 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 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 disorder with symptoms such as headache, visual changes, confusion, seizures, or other neurological disturbances 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 occur in more than 1 in 10 people)

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

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

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

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

• colitis
• 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 in the urine (proteinuria)
• brain disorder with symptoms such as headache, visual changes, confusion, seizures, or other neurological disturbances 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 any side effects occur in the patient.
Reporting of side effects
If any side effects occur, including any side effects 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
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 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 after "EXP".
The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Do not use this medicine if the blister pack containing the capsules is open or if a capsule
appears damaged.
If you come into contact with the capsule contents, wash hands immediately with plenty of water (see
section 3 "How to take Nintedanib Teva").
Medicines should 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 100 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, carmine (E 120), propylene glycol (E 1520), simethicone

What Nintedanib Teva looks like and contents of the pack
Nintedanib Teva 100 mg is an opaque, peach-coloured, elongated soft capsule approximately 16 mm in length, containing a yellow, viscous suspension, printed in red ink with the marking “NT 100”.
Nintedanib Teva 100 mg soft capsules are available in perforated unit-dose blisters made of OPA/Aluminium/PVC/Aluminium, packed in a cardboard box.
Pack sizes:
30 x 1 soft capsules
60 x 1 soft capsules
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 marketing in the Member States of the European Economic Area under the following names:
Austria: Nintedanib ratiopharm 100 mg – Weichkapseln
Belgium: Nintedanib Teva 100 mg zachte capsules/capsules molles/Weichkapseln
Czech Republic: Nintedanib Teva
Germany: Nintedanib-ratiopharm 100 mg Weichkapseln
Denmark: Nintedanib Teva
Estonia: Nintedanib Teva
Greece: Nintedanib/Teva
Spain: Nintedanib Teva 100 mg cápsulas blandas EFG
Finland: Nintedanib ratiopharm 100 mg kapseli, pehmeä
France: NINTEDANIB TEVA 100mg, capsule molle
Croatia: Nintedanib Teva 100 mg, meke kapsule
Iceland: Nintedanib Teva
Italy: Nintedanib Teva
Lithuania: Nintedanib Teva 100 mg minkštosios kapsulės
Latvia: Nintedanib Teva 100 mg mīkstās kapsulas
Luxembourg: Nintedanib Teva 100 mg capsules molles
Netherlands: Nintedanib Teva 100 mg, zachte capsules
Norway: Nintedanib Teva
Poland: Nintedanib Teva
Portugal: Nintedanib Zidrium
Romania: Nintedanib Teva 100 mg, capsule moi
Sweden: Nintedanib Teva
Slovakia: Nintedanib Teva 100 mg mäkké kapsuly