Nintedanib stada

Package leaflet: Information for the patient

Nintedanib STADA, 100 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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, 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 STADA is and what it is used for
2. Important information before taking Nintedanib STADA
3. How to take Nintedanib STADA
4. Possible side effects
5. How to store Nintedanib STADA
6. Contents of the pack and other information

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

Nintedanib STADA contains the active substance nintedanib, which belongs to a group of medicines known as tyrosine kinase inhibitors. It is used to treat idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and interstitial lung disease associated with systemic sclerosis (SSc-ILD) in adults.

Idiopathic pulmonary fibrosis (IPF)
IPF is a disease in which lung tissue gradually becomes thicker, stiffer, and scarred (fibrotic). This scarring reduces the ability of the lungs to transfer oxygen 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 addition to IPF, there are other conditions in which lung tissue over time becomes thicker, stiffer, and scarred (pulmonary fibrosis), and which continuously 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 stiffening of the lungs.

Interstitial lung disease associated with systemic sclerosis (SSc-ILD)
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 affects the lungs, it is called interstitial lung disease (ILD), and the condition is referred to as SSc-ILD. Pulmonary fibrosis reduces the ability of the lungs 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 STADA

When not to take Nintedanib STADA

• 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 STADA, discuss with your doctor or pharmacist if:

• the patient has or has had liver problems,
• the patient has or has had kidney problems or protein in the 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, 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 paused for a certain period if the patient undergoes surgery. The doctor will decide when treatment should be resumed.
• if the patient has hypertension,
• 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 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 with the patient and decide whether the patient can take Nintedanib STADA.

The patient should immediately inform the doctor 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 brownish ("tea-coloured") urine, pain in the upper right part of the abdomen, bleeding or bruising more easily than usual, or feeling tired. These may be signs of serious liver problems;
• severe stomach pain, fever, chills, nausea, vomiting, a hard abdomen or bloating occur, as these may be symptoms of a perforation (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 intestinal diverticular disease, or if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) (used to treat pain and swelling) or steroids (used to treat inflammatory and allergic conditions) at the same time, as these factors increase this risk;
• severe pain or cramps in the abdomen, red blood in the stool or diarrhoea occur simultaneously, as these may be symptoms of intestinal inflammation due to insufficient blood supply to the intestine;
• pain, swelling, redness and increased temperature in a limb occur, as these may be signs of a blood clot forming 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;
• serious bleeding occurs;
• the patient develops bruising, bleeding, fever, fatigue and confusion. These may be symptoms of blood vessel damage called thrombotic microangiopathy (TMA).

Children and adolescents
Nintedanib STADA must not be used in children and adolescents under 18 years of age.

Nintedanib STADA and other medicines
Tell 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 STADA 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 thereby reduce the effectiveness of Nintedanib STADA:

• an antibiotic used to treat tuberculosis (rifampicin),
• medicines used to treat epileptic seizures (carbamazepine, phenytoin),
• a herbal remedy 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 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 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 STADA, 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, if such disturbances occur, the use of an alternative, more appropriate contraceptive method should be discussed with the doctor.
• If the patient becomes pregnant or suspects she may be pregnant while being treated with this medicine, she must immediately inform her doctor or pharmacist.

Breastfeeding
Breastfeeding must be avoided during treatment with this medicine, as there is a risk of adverse effects in the breastfed infant.

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

3. How to take Nintedanib STADA

This medicine should always be taken as directed by the physician or pharmacist. If in doubt, consult the physician 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 maintenance of 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, immediately before, or immediately after a meal.
Do not open or crush the capsules (see section 5).
Adults
The recommended dose is one capsule containing 100 mg taken twice daily (total 200 mg per day).
The recommended dose should not exceed two soft capsules of Nintedanib STADA 100 mg per day.
If the patient does not tolerate the recommended dose of two capsules of Nintedanib STADA 100 mg per day (see possible adverse reactions in section 4), the physician may advise discontinuing the medicine. Do not reduce the dose or stop treatment on your own without prior consultation with the physician!
Taking more than the recommended dose of Nintedanib STADA
Contact your physician or pharmacist immediately.
Missing a dose of Nintedanib STADA
Do not take two capsules together if a previous dose has been missed. Take the next dose of Nintedanib STADA at the usual time according to the prescribed schedule.
Stopping treatment with Nintedanib STADA
Do not stop taking Nintedanib STADA without first consulting your physician. It is important to take the medicine regularly every day for as long as your physician has instructed.
If you have any further questions about the use of this medicine, consult your physician 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 following adverse reactions during treatment with Nintedanib STADA.
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. Initiate appropriate anti-diarrhoeal treatment as soon as possible, for example with loperamide.
The following other adverse reactions have been observed during treatment with this medicine.
If any adverse reactions occur, inform your doctor.

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

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

Common adverse reactions (may affect up to 1 in 10 people)

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

Uncommon adverse reactions (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 concentration in urine (proteinuria).

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

• renal failure,
• enlargement and weakening of the blood vessel wall or tear in the blood vessel wall (aneurysm and arterial dissection).

Other chronic fibrosing interstitial lung diseases (ILD) with progressive phenotype
Very common adverse reactions (may affect more than 1 in 10 people)

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

Common adverse reactions (may affect up to 1 in 10 people)

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

Uncommon adverse reactions (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 concentration in urine (proteinuria).

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

• renal failure,
• enlargement and weakening of the blood vessel wall or tear in the blood vessel wall (aneurysm and arterial dissection).

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

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

Common adverse reactions (may affect up to 1 in 10 people)

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

Uncommon adverse reactions (may affect up to 1 in 100 people)

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

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

• heart attack,
• pancreatitis,
• jaundice, i.e. yellowing of the skin and whites of the eyes due to high bilirubin concentration,
• enlargement and weakening of the blood vessel wall or rupture of the blood vessel wall (aneurysm and arterial dissection),
• excessive hair loss (alopecia),
• increased protein concentration in urine (proteinuria).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Nintedanib STADA

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 after 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 appears damaged.
If you come into contact with the capsule contents, wash your 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Nintedanib STADA contains

• The active substance is nintedanib. Each capsule contains 100 mg of nintedanib (as nintedanib esilate).
• Other components are:
  Capsule contents: medium-chain triglycerides, solid fat, polyglyceryl-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 STADA looks like and contents of the pack
Nintedanib STADA 100 mg is an opaque, peach-coloured, elongated capsule with the imprint "NT 100" in red ink, approximately 16 mm long, containing a yellow, viscous suspension.
Nintedanib STADA 100 mg, soft capsules, is available in cardboard boxes containing perforated unit dose blisters made of OPA/Aluminium/PVC/Aluminium.
Pack sizes:
30 x 1 soft capsule
60 x 1 soft capsule
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany

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
SGN 3000 San Gwann
Malta
QUALIMETRIX S.A.
579 MESOGEION AVENUE AGIA PARASKEVI,
15343 Athens
Greece
STADA Arzneimittel AG
Stadastrasse 2 - 18
61118 Bad Vilbel
Germany
Centrafarm Services B.V.
Van de Reijtstraat 31 E
4814NE Breda
The Netherlands
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria

For further information, please contact the local representative of the Marketing Authorisation Holder:
STADA Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised in the European Economic Area (EEA) under the following names:
Sweden: Nintedanib STADA 100 mg mjuka kapslar
Romania: Nintedanib Stada 100 mg capsule moi
Norway: Nintedanib STADA 100 mg myke kapsler
Netherlands: Nintedanib CF 100 mg, zachte capsules
Latvia: Nintedanib STADA 100 mg mīkstās kapsulas
Luxembourg: Nintedanib EG 100 mg capsules molles
Lithuania: Nintedanib STADA 100 mg minkštosios kapsulės
Croatia: Nintedanib STADA 100 mg meke kapsule
Estonia: Nintedanib STADA 100 mg pehmekapsel
Germany: Nintedanib IPF AL 100 mg Weichkapseln
Belgium: Nintedanib EG 100 mg zachte capsules
Iceland: Nintedanib STADA 100 mg mjúk hylki
Austria: Nintedanib STADA 100 mg Weichkapseln
Denmark: Nintedanib STADA
Spain: Nintedanib STADA 100 mg cápsulas blandas EFG
France: NINTEDANIB EG 100 mg, capsule molle
Finland: Nintedanib STADA 100 mg pehmeät kapselit
Greece: NINTEDANIB/STADA