Nintedanib Viatris

Package leaflet: Information for the patient

Nintedanib Viatris 100 mg soft capsules, 150 mg soft capsules

nintedanib
Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Nintedanib Viatris contains the active substance nintedanib, a medicine belonging to the class of tyrosine kinase inhibitors, and is used for the treatment of the following conditions:

Idiopathic pulmonary fibrosis (IPF) in adults
IPF is a condition in which lung tissue over time becomes thick, stiff, and scarred. As a result, scarring reduces the ability to transfer oxygen from the lungs to the bloodstream, making deep breathing difficult. Nintedanib Viatris helps reduce the further progression of scarring and lung stiffening.

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype in adults
In addition to IPF, there are other conditions in which lung tissue over time becomes thick, stiff, and scarred (pulmonary fibrosis) and continues to worsen (progressive phenotype). Examples of these conditions include hypersensitivity pneumonitis, autoimmune ILDs (e.g., ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. Nintedanib Viatris helps reduce the further progression of scarring and lung stiffening.

Clinically significant progressive fibrosing interstitial lung diseases (ILD) in children and adolescents aged 6 to 17 years
In children with pediatric interstitial lung disease (chILD), pulmonary fibrosis may occur. When this happens, the lung tissue in children and adolescents becomes thick, stiff, and scarred over time. Nintedanib helps reduce the further progression of scarring and lung stiffening.

Interstitial lung disease associated with systemic sclerosis (SSc-ILD) in adults, children, and adolescents aged 6 to 17 years
Systemic sclerosis (SSc), or scleroderma (and juvenile systemic sclerosis in children and adolescents), is a rare chronic autoimmune disease affecting connective tissue in various parts of the body. SSc causes fibrosis (scarring and stiffening) of the skin and other internal organs such as the lungs. When the lungs are affected by fibrosis, it is referred to as interstitial lung disease (ILD), and the condition is known as SSc-ILD. Fibrosis in the lungs reduces their ability to transfer oxygen to the blood and impairs breathing capacity. Nintedanib Viatris helps reduce the further progression of scarring and lung stiffening.

2. What you need to know before taking Nintedanib Viatris

Do not take Nintedanib Viatris

• if you are pregnant.
• if you are allergic to nintedanib, peanuts, or soy, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Nintedanib Viatris:

• if you have or have had liver problems,
• if you have or have had kidney problems or if protein has been detected in your urine,
• if you have or have had bleeding problems,
• if you are taking medicines that thin the blood (for example warfarin, phenprocoumon, or heparin) to prevent blood clots,
• if you are taking pirfenidone, which may increase the risk of developing diarrhoea, nausea, vomiting, and liver problems,
• if you have or have had heart problems (for example a heart attack),
• if you have recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with Nintedanib Viatris will usually be stopped for a certain period if you undergo surgery. Your doctor will decide when you can resume treatment with this medicine,
• if you have high blood pressure,
• if the pressure in the blood vessels of your lungs is too high (pulmonary hypertension),
• if you have or have had an aneurysm (a bulging and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.

Based on this information, your doctor may carry out blood tests, for example to check liver function. Your doctor will discuss the test results with you and decide whether you can take Nintedanib Viatris.
Inform your doctor immediately while taking this medicine:

• if you have diarrhoea. It is important to treat diarrhoea early (see section 4, “Possible side effects”);
• if you vomit or feel unwell (nausea);
• if you experience unexplained symptoms such as yellowing of the skin or the whites of the eyes (jaundice), dark or brown-coloured urine (like tea), pain in the upper right part of the stomach area (abdomen), bleeding or bruising more easily than usual, or feeling tired. These could be symptoms of serious liver problems;
• if you have severe stomach pain, fever, chills, feeling unwell, vomiting, or abdominal stiffness or swelling, as these could be symptoms of a hole in the wall of the intestine (“gastrointestinal perforation”). Also inform your doctor if you have previously suffered from peptic ulcers or diverticular disease, or if you are taking concomitant anti-inflammatory medicines (NSAIDs) (used to relieve pain and treat swelling) or steroids (used for inflammation and allergies), as this may increase this risk;
• if you have a combination of severe stomach pain or cramps, red blood in the stools, or diarrhoea, as these could be symptoms of intestinal inflammation due to inadequate blood supply;
• if you have pain, swelling, redness, or warmth in a limb, as these could be symptoms of a blood clot in a vein (a type of blood vessel);
• if you feel pressure or pain in your chest, particularly on the left side of the body, pain in the neck, jaw, shoulder, or arm, rapid heartbeat, shortness of breath, nausea, or vomiting, as these could be symptoms of a heart attack;
• if you have significant bleeding;
• if you develop bruises, bleeding, fever, fatigue, or confusion. These could be signs of damage to blood vessels known as thrombotic microangiopathy (TMA);
• if you experience symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure. These may be symptoms of a brain condition called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents
Nintedanib Viatris must not be taken by children under 6 years of age.
Your doctor may schedule regular dental check-ups at least once every 6 months until your teeth have fully developed, and monitor your growth annually (bone imaging tests) while you are taking this medicine.
Other medicines and Nintedanib Viatris
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines and medicines without a prescription.
Nintedanib Viatris can interact with certain medicines. The following medicines are some examples of medicines that may increase nintedanib levels in the blood, potentially increasing 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 that affects the immune system (cyclosporine)

The following medicines are some examples of medicines that may decrease nintedanib levels in the blood, potentially reducing the effectiveness of Nintedanib Viatris:

• an antibiotic used to treat tuberculosis (rifampicin)
• medicines used to treat epilepsy (carbamazepine, phenytoin)
• a herbal medicine used to treat depression (St. John’s wort)

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn baby and cause birth defects.
Before starting treatment with Nintedanib Viatris, you must have a pregnancy test to confirm that you are not pregnant. Speak to your doctor.
Contraception

• Women of childbearing potential must use a highly effective method of contraception to prevent pregnancy when starting treatment with Nintedanib Viatris, during treatment with Nintedanib Viatris, and for at least 3 months after stopping treatment.
• Talk to your doctor to evaluate the most suitable contraceptive methods for you.
• Vomiting and/or diarrhoea or other gastrointestinal problems may affect the absorption of oral hormonal contraceptives, such as the pill, and may reduce their effectiveness. Therefore, if you experience these symptoms, consult your doctor to evaluate a more appropriate alternative contraceptive method.
• Inform your doctor or pharmacist immediately if you become pregnant or suspect you are pregnant during treatment with Nintedanib Viatris.

Breastfeeding
Do not breastfeed during treatment with Nintedanib Viatris, as there is a possible risk of harm to breastfed infants.
Driving and using machines
Nintedanib Viatris has a minor influence on the ability to drive and use machines. If you do not feel well, you must not drive or operate machinery.
Nintedanib Viatris contains soy lecithin
If you are allergic to soy or peanuts, do not take this medicine (see section 2, under “Do not take Nintedanib Viatris”).

3. How to take Nintedanib Viatris

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Take the capsules twice daily, approximately 12 hours apart and at approximately the same time each day,
for example one capsule in the morning and one capsule in the evening. This ensures that a
constant amount of nintedanib is maintained in the bloodstream. Swallow the capsules whole with water and do not
chew them. It is recommended to take the capsules with food, either during a meal or
immediately before or after. Do not open or crush the capsule (see section 5, under “How to store Nintedanib Viatris”). To facilitate swallowing, you may take the capsules with a small
amount (one teaspoon) of soft food, such as apple puree or chocolate pudding, cold or at
room temperature. Swallow the capsules immediately and do not chew them, to ensure they
remain intact.
Adults
The recommended dose is one 100 mg capsule or one 150 mg capsule twice daily (for a total daily dose of 200 mg or 300 mg).
Do not take a higher dose than the recommended dose of 200 mg or 300 mg per day.
If you do not tolerate the recommended dose (for possible side effects, see section 4), your
doctor may reduce the daily dose of Nintedanib Viatris or advise you to stop treatment with Nintedanib Viatris.
Do not reduce the dose or stop treatment without first consulting your doctor.
Use in children and adolescents
The recommended dose depends on the patient's body weight.
Inform your doctor if the patient's weight drops below 13.5 kg at any time during treatment.
Inform your doctor if you have liver problems.
Your doctor will determine the correct dose. The doctor may adjust the dose as treatment progresses.
If you do not tolerate the recommended daily dose of Nintedanib Viatris capsules (for possible side effects, see section 4), your doctor may reduce the daily dose of Nintedanib Viatris.
Do not reduce the dose or stop treatment without first consulting your doctor.
Dosing of nintedanib capsules according to weight in children and adolescents:

Nintedanib Viatris is available only in 100 mg and 150 mg soft capsules. Therefore, it is not possible to administer Nintedanib Viatris to pediatric patients requiring a dose lower than the full 100 mg dose. If an alternative dose is required, other nintedanib-containing products offering such an option should be used.
If you take more Nintedanib Viatris than you should
Contact your doctor or pharmacist immediately.
If you forget to take Nintedanib Viatris
Do not take two capsules at the same time if you have missed a previous dose. Take the next dose of Nintedanib Viatris at the next scheduled time, as planned and recommended by your doctor or pharmacist.
If you stop taking Nintedanib Viatris
Do not stop treatment with Nintedanib Viatris without first consulting your doctor. It is important to take this medicine every day for the entire duration prescribed by your doctor.
If you have any doubts about how to use 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.
You should pay particular attention if you experience the following side effects during treatment with
Nintedanib Viatris:
Diarrhoea (very common, may affect more than 1 in 10 people):
Diarrhoea may cause dehydration: loss of fluids and important salts (electrolytes such as sodium or
potassium) from the body. At the first signs of diarrhoea, drink plenty of fluids and contact your doctor
immediately. Start appropriate treatment for diarrhoea as soon as possible, for example with loperamide.
The following side effects have also been observed during treatment with this medicine.
Contact your doctor if you experience any side effect.

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

• Feeling unwell (nausea)
• Pain in the lower part of the body (abdomen)
• Abnormal liver function tests

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

• Vomiting
• Loss of appetite
• Weight loss
• Bleeding
• Rash
• Headache (cephalalgia)

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

• Pancreatitis
• Inflammation of the large intestine
• Severe 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 levels of bilirubin
• Itching (pruritus)
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Not known (frequency cannot be estimated from the available data)

• Kidney failure
• Widening and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)
• Brain condition with symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome)

Chronic fibrosing interstitial lung diseases (ILD) with progressive phenotype
Very common side effects (may affect more than 1 in 10 people)

• Feeling unwell (nausea)
• Vomiting
• Loss of appetite
• Pain in the lower part of the body (abdomen)
• Abnormal liver function tests

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

• Weight loss
• High blood pressure (hypertension)
• Bleeding
• Severe liver problems
• Rash
• Headache (cephalalgia)

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 levels of bilirubin
• Itching (pruritus)
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Not known (frequency cannot be estimated from the available data)

• Kidney failure
• Widening and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)
• Brain condition with symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome)

Interstitial lung disease associated with systemic sclerosis (SSc-ILD)
Very common side effects (may affect more than 1 in 10 people)

• Feeling unwell (nausea)
• Vomiting
• Pain in the lower part of the body (abdomen)
• Abnormal liver function tests

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

• Bleeding
• High blood pressure (hypertension)
• Loss of appetite
• Weight loss
• Headache (cephalalgia)

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

• Inflammation of the large intestine
• Severe liver problems
• Kidney failure
• Low platelet count (thrombocytopenia)
• Rash
• Itching (pruritus)

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 levels of bilirubin
• Widening and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)
• Brain condition with symptoms such as headache, changes in vision, confusion, seizures, or other neurological disturbances such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome)

Fibrosing interstitial lung diseases (ILD) in children and adolescents
Side effects in children and adolescents are similar to those in adult patients.
Contact your doctor if you experience any side effect.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Nintedanib Viatris

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. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that the blister containing the capsules is open or if a capsule is broken.
If you come into contact with the capsule contents, wash your hands immediately with plenty of water (see section 3).
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nintedanib Viatris contains

• The active substance is nintedanib. Each Nintedanib Viatris 100 mg soft capsule contains nintedanib esilate equivalent to 100 mg of nintedanib. Each Nintedanib Viatris 150 mg soft capsule contains nintedanib esilate equivalent to 150 mg of nintedanib.
• The other components are:
• Capsule contents: medium-chain triglycerides, lauroyl macrogol glycerides and soybean lecithin (E322).
• Capsule shell: gelatin, glycerol (E422), titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
• Black printing ink: shellac, black iron oxide (E172), ammonium hydroxide and propylene glycol (E1520).

Description of the appearance of Nintedanib Viatris and contents of the pack
Nintedanib Viatris 100 mg soft capsules are peach-coloured, opaque, oblong soft gelatin capsules, imprinted with "JF1", approximately 16 mm x 6 mm in size.
Nintedanib Viatris 150 mg soft capsules are brown-coloured, opaque, oblong soft gelatin capsules, imprinted with "JF2", approximately 18 mm x 7 mm in size.
Nintedanib Viatris is available in divisible blisters for unit dose packaging containing 30 x 1 or 60 x 1 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer
Mylan Germany GmbH,
Benzstrasse 1
61352 Bad Homburg v. d. Hohe
Germany
Mylan Hungary Kft./Mylan Hungary Ltd.
Mylan utca 1
Komarom
2900, Hungary

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0) 2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: +36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf.: +45 28 11 69 32 Tel: +356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: +48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: +351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 0000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: +386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: +39 (0)2 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
CPO Pharmaceuticals Limited Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.