VARGATEF 100 mg Софт Капсула

Святослав Чехун

Доктор Святослав Чехун — врач-онколог с международным клиническим и научным опытом, специализирующийся на современной медицинской онкологии и персонализированном подходе к лечению онкологических заболеваний.

В настоящее время (с 2025 года) он работает медицинским онкологом в Institut Català d’Oncologia (Жирона, Испания). Ранее проходил резидентуру по медицинской онкологии и занимался клиническими исследованиями в Hospital Universitari Germans Trias i Pujol.

Доктор Чехун имеет солидный академический и научный бэкграунд: он был преподавателем внутренней медицины в O.O. Bohomolets National Medical University, а также занимался научной работой в области экспериментальной онкологии в R.E Kavetsky Institute of experimental pathology oncology and radiobiology.

Ранее он работал врачом-онкологом в Киевском городском клиническом онкологическом центре, а также участвовал в регуляторной оценке лекарственных средств в Государственном экспертном центре Министерства здравоохранения Украины.

Когда стоит обратиться к доктору Чехуну:

при постановке или уточнении онкологического диагноза
для получения второго мнения (second opinion) по уже назначенному лечению
при необходимости составления персонализированного плана лечения
для интерпретации результатов анализов, КТ, МРТ, ПЭТ-КТ и биопсий
при выборе между различными методами терапии (химиотерапия, таргетная терапия, иммунотерапия)
при сомнениях в тактике лечения или прогрессировании заболевания

Формат консультаций

Доктор предоставляет онлайн-консультации, в рамках которых вы можете получить:

экспертное второе мнение
детальный разбор вашего случая
рекомендации по современным международным протоколам лечения
индивидуальный план терапии и наблюдения

Важно: назначение и контроль медикаментозного лечения должны осуществляться лечащим врачом в офлайн-формате. Онлайн-консультация не заменяет очный приём, но позволяет принять более обоснованные решения о лечении.

Доктор Святослав Чехун сочетает клиническую практику, научную деятельность и международный опыт, что позволяет ему предлагать пациентам современные и доказательные подходы в онкологии.

Записаться на онлайн-консультацию

zł1253

Больше времени

Материал предназначен для общего ознакомления. Для индивидуальных рекомендаций обратитесь к врачу. При тяжелых или быстро ухудшающихся симптомах обратитесь за неотложной медицинской помощью.

Инструкция по применению VARGATEF

Содержание инструкции

Vargatef 100 mg soft capsules
Vargatef 150 mg soft capsules

Vargatef 100 mg soft capsules

nintedanib

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Vargatef and what is it used for

Vargatef capsules contain the active substance nintedanib. Nintedanib blocks the activity of a group of
proteins that are involved in the development of new blood vessels that cancer cells need
to receive nutrients and oxygen. By blocking the activity of these proteins, nintedanib may help to
stop the growth and spread of cancer.
This medicine is used in association with another cancer medicine (docetaxel), to
treat lung cancer called non-small cell lung carcinoma (NSCLC). This
medicine is indicated for adult patients who have an NSCLC of a certain type (“ adenocarcinoma”) and
who have already received another medicine for the treatment of this cancer, but in whom the tumor has
started to grow again.

2. What you need to know before you take Vargatef

Do not take Vargatef

if you are allergic to nintedanib, to 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 this medicine

if you have or have had liver problems, if you have or have had bleeding problems, in particular recent bleeding in the lungs
if you have or have had kidney problems or if an increase in the amount of protein has been detected in your urine
if you are taking medicines that thin the blood (e.g. warfarin, phenprocoumon, heparin or acetylsalicylic acid) to prevent blood clots. Treatment with Vargatef may lead to an increased risk of bleeding
if you have had surgery recently or are going to have surgery soon. Nintedanib can affect wound healing. Therefore, treatment with Vargatef will usually be stopped in case of surgery. Your doctor will decide when you can start treatment again with

this medicine

if you have cancer that has spread to the brain
if you have high blood pressure
if you have or have had an aneurysm (bulging and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Based on this information, your doctor may perform blood tests, for example to
check liver function and to determine how long it takes for your blood to clot. Your
doctor will discuss the test results with you and decide if you can receive Vargatef.
Tell your doctor immediately while taking this medicine

if you have diarrhoea. Treatment of diarrhoea is important when the first signs appear (see section 4)
if you vomit or feel unwell (nausea)
if you experience unexplained symptoms such as yellowing of the skin or the white part of the eyes (jaundice), dark or brown urine (tea-coloured), pain in the upper right part of the stomach area (abdomen), bleeding or bruising more easily than usual, or feeling tired. These may be symptoms of serious liver problems
if you have fever, chills, rapid breathing or heartbeat. These may be signs of infection or blood infection (sepsis) (see section 4)
if you have severe stomach pain, fever, chills, feeling unwell, vomiting or stiffness or swelling of the abdomen, as these may be symptoms of an opening in the wall of the intestine (“gastrointestinal perforation”)
if you experience a combination of some or all of the following symptoms: sudden onset of severe abdominal pain or cramping, red blood in your stool, diarrhoea or constipation, nausea and vomiting, as these may be symptoms of inflammation of the intestine due to reduced blood supply (“ischemic colitis”)
if you have pain, swelling, redness or warmth in a limb or if you have chest pain and difficulty breathing, as these may be symptoms of a blood clot in a vein
if you have significant bleeding
if you feel pressure or pain in your chest, especially on the left side of your body, pain in your neck, jaw, shoulder or arm, if you have a rapid heartbeat, shortness of breath, nausea or vomiting, as these may be symptoms of a heart attack
if you experience symptoms such as headache, changes in vision, confusion, seizures or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure. These may be symptoms of a brain condition called reversible posterior encephalopathy syndrome (PRES)
if one or more side effects that can occur (see section 4) become serious

Children and adolescents
This medicine has not been studied in children or adolescents for the treatment of lung cancer (NSCLC), therefore it should not be taken by children and adolescents under the age of
18 years.

Other medicines and Vargatef
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including herbal medicines and medicines you bought without a prescription.
This medicine can interact with some medicines. The following medicines can increase the
levels of nintedanib, the active ingredient of Vargatef, in the blood, potentially increasing the risk
of side effects (see section 4):

ketoconazole (used to treat fungal infections)
erythromycin (used to treat bacterial infections) The following medicines can decrease the levels of nintedanib in the blood, potentially reducing the effectiveness of Vargatef:
rifampicin (an antibiotic used to treat tuberculosis)
carbamazepine, phenytoin (used to treat epilepsy)
St John's wort (a herbal medicine used to treat depression)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the baby or cause
birth defects.
Contraception

Women of childbearing potential must use a highly effective contraceptive method to avoid pregnancy when starting to take Vargatef, during treatment with Vargatef 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 can affect the absorption of oral hormonal contraceptives, such as the pill, and can reduce their effectiveness. Therefore, if you experience these disorders, talk to your doctor to evaluate a more appropriate alternative contraceptive method.
Tell your doctor or pharmacist immediately if you become pregnant or suspect you may be pregnant while taking Vargatef.

Breastfeeding
It is not known whether the medicine passes into breast milk and whether it can harm a breastfed baby.
Therefore, it is recommended not to breastfeed during treatment with
Vargatef.

Fertility
The effect of this medicine on human fertility has not been studied.

Driving and using machines
Vargatef may slightly impair the ability to drive and operate machines. If you do not feel
well, you should not drive or operate machines.

Vargatef contains soy
The capsules contain soy lecithin. If you are allergic to peanuts or soy, do not use this
medicine.

3. How to take Vargatef

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Do not take Vargatef on the same day as chemotherapy treatment with docetaxel.
Swallow the capsules whole with water and do not chew them. It is recommended to take the capsules with
food, i.e. during a meal or immediately before or after.
Do not open or crush the capsule (see section 5).
The recommended dose is four capsules a day (i.e. a total of 400 mg of nintedanib a day).
Do not take a higher dose.
This daily dose must be divided into two doses of two capsules approximately 12 hours apart, for
example two capsules in the morning and two capsules in the evening. These two doses must be taken at
approximately the same time each day. Following these instructions ensures that a constant amount of
nintedanib is maintained in the body.

Dose reduction
If you do not tolerate the recommended dose of 400 mg a day due to undesirable effects (see
section 4), your doctor may reduce the daily dose of Vargatef. Do not reduce the dose or stop the
treatment without first consulting your doctor.
Your doctor may reduce the recommended dose to 300 mg a day (two 150 mg capsules). In this
case, your doctor will prescribe treatment with Vargatef 150 mg soft capsules.
If necessary, your doctor may further reduce the daily dose to 200 mg a day (two 100 mg capsules). In this
case, your doctor will prescribe the capsules of the correct dosage.
In both cases, you must take one capsule of the correct dosage twice a day, approximately
12 hours apart and at approximately the same time, with food (for example in the morning and in the evening).
If your doctor has stopped chemotherapy with docetaxel, you must continue to take Vargatef twice
a day.

If you take more Vargatef than you should
Contact your doctor or pharmacist immediately.

If you forget to take Vargatef
Do not take a double dose to make up for a missed dose. Take the next dose of
Vargatef at the next scheduled time, as programmed, and at the dose recommended by your doctor or
pharmacist.

If you stop taking Vargatef
Do not stop treatment with Vargatef without first consulting your doctor. It is important to take
this medicine every day for the entire period indicated by your doctor. If you do not take this
medicine as prescribed by your doctor, this cancer treatment may not work
correctly.
If you have any questions about the use of this medicine, ask 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
Vargatef:

Diarrhoea(very common, may affect more than 1 in 10 people)Diarrhoea can cause 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 see your doctor immediately. Start appropriate treatment for diarrhoea, for example with loperamide, as soon as possible after consulting your doctor.
Febrile neutropeniaandsepsis(common, may affect up to 1 in 10 people)Treatment with Vargatef can cause a reduction in the number of a type of white blood cells (neutropenia) that are important for the body's reaction to infections caused by bacteria or fungi. As a consequence of neutropenia, fever (febrile neutropenia) and blood infection (sepsis) can occur. If you have a fever, chills, rapid breathing or a fast heartbeat, tell your doctor immediately. During treatment with Vargatef, your doctor will regularly monitor your blood cells and examine you regularly to rule out signs of infection, such as inflammation, fever or fatigue.

The following side effects have been observed during treatment with this medicine:

Very common side effects (may affect more than 1 in 10 people)

Diarrhoea - see above
Sensation of pain, numbness and/or tingling in the fingers of the hands and feet (peripheral neuropathy)
Feeling unwell (nausea)
Vomiting
Stomach pain (abdomen)
Bleeding
Decreased number of white blood cells (neutropenia)
Inflammation of the mucous membranes lining the digestive tract, including sores and ulcers in the mouth (mucositis, including stomatitis)
Skin rash
Reduced appetite
Electrolyte imbalance
Increased levels of liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) in the blood, detected by blood tests
Hair loss (alopecia)

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

Blood infection (sepsis) - see above
Decreased number of white blood cells accompanied by fever (febrile neutropenia)
Blood clots in the veins (venous thromboembolism), especially in the legs (symptoms include pain, redness, swelling and warmth in a limb) which can move through the blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, see a doctor immediately)
High blood pressure (hypertension)
Loss of fluids (dehydration)
Abscesses
Low platelet count (thrombocytopenia)
Jaundice (hyperbilirubinemia)
Increased levels of liver enzymes (gamma-glutamyltransferase) in the blood, detected by blood tests
Weight loss
Itching
Headache (cephalalgia)
Increased amount of protein in the urine (proteinuria)

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

Formation of openings in the wall of the intestine (gastrointestinal perforation)
Serious liver problems
Inflammation of the pancreas (pancreatitis)
Heart attack
Kidney failure

Not known (frequency cannot be estimated from available data)

Inflammation of the large intestine
Dilation and weakening of the wall of a blood vessel or rupture of the wall of a blood vessel (aneurysms and arterial dissections)
Condition of the brain with symptoms such as headache, changes in vision, confusion, convulsions or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome).

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store Vargatef

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box, packaging and on the
blisters. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Store in the original packaging to protect the medicine from moisture.
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 any medicine in 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 Vargatef contains
The active ingredient is nintedanib. Each soft capsule contains 100 mg of nintedanib (as esilate).
The excipients are:

Capsule contents: Medium-chain saturated triglycerides, solid semi-synthetic glycerides, lecithin of
soybean (E322)

Capsule shell:Gelatin, glycerol (85%), titanium dioxide (E171), red iron oxide
(E172), yellow iron oxide (E172)

Description of Vargatef and package contents
Vargatef 100 mg soft capsules (capsules) are peach-colored, opaque, oblong
capsules (approximately 16 x 6 mm), with the Boehringer Ingelheim company logo and “100” imprinted on one side.
Three package sizes of Vargatef 100 mg soft capsules are available:

One pack containing 60 capsules (6 aluminum blisters of 10 capsules each).
One pack containing 120 capsules (12 aluminum blisters of 10 capsules each).
A multi-pack of 120 capsules (2 boxes of 60 capsules each, held together by a film).

Not all pack sizes of Vargatef 100 mg soft capsules may be marketed.

Marketing Authorisation Holder
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim France
100‑104 Avenue de France
75013 Paris
France
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel: +370 5 2595942

България
Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ ‑
клон България
Тел.: +359 2 958 79 98

Luxembourg/Luxemburg
Boehringer Ingelheim SComm
Tél/Tel: +32 2 773 33 11

Česká republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111

Magyarország
Boehringer Ingelheim RCV GmbH & Co KG
Magyarországi Fióktelepe
Tel.: +36 1 299 89 00

Danmark
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 88

Malta
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG
Tel: +49 (0) 800 77 90 900

Nederland
Boehringer Ingelheim B.V.
Tel: +31 (0) 800 22 55 889

Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti filiaal
Tel: +372 612 8000

Norge
Boehringer Ingelheim Danmark
Norwegian branch
Tlf: +47 66 76 13 00

Ελλάδα
Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E.
Τηλ: +30 2 10 89 06 300

Österreich
Boehringer Ingelheim RCV GmbH & Co KG
Tel: +43 1 80 105‑7870

España
Boehringer Ingelheim España, S.A.
Tel: +34 93 404 51 00

Polska
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699

France
Boehringer Ingelheim France S.A.S.
Tél: +33 3 26 50 45 33

Portugal
Boehringer Ingelheim Portugal, Lda.
Tel: +351 21 313 53 00

Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600

România
Boehringer Ingelheim RCV GmbH & Co KG
Viena – Sucursala Bucureşti
Tel: +40 21 302 2800

Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620

Slovenija
Boehringer Ingelheim RCV GmbH & Co KG
Podružnica Ljubljana
Tel: +386 1 586 40 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Boehringer Ingelheim RCV GmbH & Co KG
organizačná zložka
Tel: +421 2 5810 1211

Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1

Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800

Κύπρος
Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E.
Τηλ: +30 2 10 89 06 300

Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00

Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Tel: +371 67 240 011

United Kingdom (Northern Ireland)
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu .

Vargatef 150 mg soft capsules

nintedanib

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Vargatef and what is it used for

2. What you need to know before taking Vargatef

Do not take Vargatef

if you are allergic to nintedanib, peanuts or soya 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 this medicine

if you have or have had liver problems, if you have or have had bleeding problems, in particular recent bleeding in the lungs
if you have or have had kidney problems or if an increase in the amount of protein has been detected in your urine
if you are taking medicines that thin the blood (e.g. warfarin, phenprocoumon, heparin or acetylsalicylic acid) to prevent blood clots. Treatment with Vargatef may lead to an increased risk of bleeding
if you have recently had surgery or are going to have surgery soon. Nintedanib may affect wound healing. Therefore, treatment with Vargatef will normally be stopped in case of surgery. Your doctor will decide when you can start treatment with

this medicine

if you have cancer that has spread to the brain
if you have high blood pressure
if you have or have had an aneurysm (bulging and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Based on this information, your doctor may perform blood tests, for example to
check your liver function and to determine how long it takes for your blood to clot. Your
doctor will discuss the test results with you and decide if you can receive Vargatef.
Tell your doctor immediately while taking this medicine

if you have diarrhoea. Treatment of diarrhoea is important when the first signs appear (see section 4)
if you vomit or feel unwell (nausea)
if you experience unexplained symptoms such as yellowing of the skin or the white of your eyes (jaundice), dark or brown urine (tea-coloured), pain in the upper right area of the stomach (abdomen), bleeding or bruising more easily than usual, or feeling tired. These could be symptoms of serious liver problems
if you have fever, chills, rapid breathing or rapid heartbeat. These could be signs of infection or blood infection (sepsis) (see section 4)
if you have severe pain in the abdomen, fever, chills, feeling unwell, vomiting or stiffness or swelling of the abdomen, as these may be symptoms of an opening in the wall of the intestine (“gastrointestinal perforation”)
if you experience a combination of some or all of the following symptoms: sudden onset of severe abdominal pain or cramps, red blood in your stools, diarrhoea or constipation, nausea and vomiting, as these may be symptoms of inflammation of the intestine due to reduced blood supply (“ischemic colitis”)
if you have pain, swelling, redness or warmth in a limb or if you have chest pain and difficulty breathing, as these may be symptoms of a blood clot in a vein
if you have significant bleeding
if you feel pressure or pain in your chest, especially on the left side of your body, pain in your neck, jaw, shoulder or arm, if you have a rapid heartbeat, shortness of breath, nausea or vomiting, as these may be symptoms of a heart attack
if you experience symptoms such as headache, changes in vision, confusion, convulsions or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure. These may be symptoms of a brain condition called reversible posterior encephalopathy syndrome (PRES)
if one or more side effects that may occur (see section 4) become serious

ketoconazole (used to treat fungal infections)
erythromycin (used to treat bacterial infections) The following medicines can decrease the levels of nintedanib in the blood, potentially reducing the effectiveness of Vargatef:
rifampicin (an antibiotic used to treat tuberculosis)
carbamazepine, phenytoin (used to treat epilepsy)
St John’s wort (a herbal medicine used to treat depression)

Women of childbearing potential must use a highly effective method of contraception to avoid pregnancy when starting to take Vargatef, during treatment with Vargatef and for at least 3 months after stopping treatment.
Talk to your doctor to assess the most suitable methods of contraception for you.
Vomiting and/or diarrhoea or other gastrointestinal problems can affect the absorption of oral hormonal contraceptives, such as the pill, and can reduce their effectiveness. Therefore, if you experience these disorders, talk to your doctor to assess a more appropriate alternative method of contraception.
Tell your doctor or pharmacist immediately if you become or suspect you are pregnant during treatment with Vargatef.

Breastfeeding
It is not known whether the medicine passes into breast milk and whether it can harm a breastfed
baby. Therefore, it is recommended not to breastfeed during treatment with
Vargatef.

Fertility
The effect of this medicine on human fertility has not been studied.

Driving and using machines
Vargatef may slightly impair the ability to drive and operate machines. If you do not feel
well, you should not drive or operate machines.

Vargatef contains soya
The capsules contain soya lecithin. If you are allergic to peanuts or soya, do not use this
medicine.

3. How to take Vargatef

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Do not take Vargatef on the same day as chemotherapy treatment with docetaxel.
Swallow the capsules whole with water and do not chew them. It is recommended to take the capsule with
food, i.e. during a meal or immediately before or after.
Do not open or crush the capsule (see section 5).
The recommended dose is two capsules a day (i.e. a total of 300 mg of nintedanib per day).
Do not take a higher dose.
This daily dose must be divided into two doses of one capsule approximately 12 hours apart, for
example one capsule in the morning and one capsule in the evening. The two doses must be taken at
approximately the same time each day. Following these instructions ensures that a constant amount of
nintedanib is maintained in the body.

Dose reduction
If you do not tolerate the recommended dose of 300 mg per day due to undesirable effects (see
section 4), your doctor may reduce the recommended daily dose of Vargatef to 200 mg per day
(two 100 mg capsules). In this case, your doctor will prescribe you treatment with Vargatef 100 mg
soft capsules.
You must take one capsule of this strength twice a day, approximately 12 hours apart and
at approximately the same time, with food (for example in the morning and in the evening).
Do not reduce the dose or stop treatment without first consulting your doctor.
If your doctor has stopped chemotherapy with docetaxel, you should continue to take Vargatef twice
a day.

If you take more Vargatef than you should
Contact your doctor or pharmacist immediately.

If you stop taking Vargatef
Do not stop treatment with Vargatef without first consulting your doctor. It is important to take
this medicine every day for the entire period indicated by your doctor. If you do not take this
medicine as prescribed by your doctor, this cancer treatment may not work
correctly.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Diarrhoea(very common, may affect more than 1 in 10 people)Diarrhoea can cause 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 consult your doctor immediately. Start appropriate treatment for diarrhoea, for example with loperamide, as soon as possible after consulting your doctor.
Febrile neutropeniaandsepsis(common, may affect up to 1 in 10 people)Treatment with Vargatef can cause a decrease in the number of a type of white blood cells (neutropenia) that are important for the body's reaction to infections caused by bacteria or fungi. As a consequence of neutropenia, fever (febrile neutropenia) and blood infection (sepsis) may occur. If you have a fever, chills, rapid breathing or a rapid heartbeat, inform your doctor immediately. During treatment with Vargatef, your doctor will regularly monitor your blood cells and examine you regularly to rule out signs of infection, such as inflammation, fever or fatigue.

The following side effects have been observed during treatment with this medicine:

Very common side effects (may affect more than 1 in 10 people)

Diarrhoea - see above
Sensation of pain, numbness and/or tingling in the fingers of the hands and feet (peripheral neuropathy)
Feeling unwell (nausea)
Vomiting
Stomach pain (abdomen)
Bleeding
Decreased number of white blood cells (neutropenia)
Inflammation of the mucous membranes lining the digestive tract, including sores and ulcers in the mouth (mucositis, including stomatitis)
Skin rash
Reduced appetite
Electrolyte imbalance
Increased levels of liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline hematophosphatase) in the blood, detected by blood tests
Hair loss (alopecia)

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

Blood infection (sepsis) - see above
Decreased number of white blood cells accompanied by fever (febrile neutropenia)
Blood clots in the veins (venous thromboembolism), especially in the legs (symptoms include pain, redness, swelling and warmth in a limb) that can move through the blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical attention immediately)
High blood pressure (hypertension)
Loss of fluids (dehydration)
Abscesses
Low platelet count (thrombocytopenia)
Jaundice (hyperbilirubinemia)
Increased levels of liver enzymes (gamma-glutamyltransferase) in the blood, detected by blood tests
Weight loss
Itching
Headache (cephalalgia)
Increased amount of protein in the urine (proteinuria)

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

Formation of openings in the wall of the intestine (gastrointestinal perforation)
Severe liver problems
Inflammation of the pancreas (pancreatitis)
Myocardial infarction
Kidney failure

Not known (frequency cannot be estimated from available data)

Inflammation of the large intestine
Dilation and weakening of the wall of a blood vessel or rupture of the wall of a blood vessel (aneurysms and arterial dissections)
Condition of the brain with symptoms such as headache, changes in vision, confusion, convulsions or other neurological disorders such as weakness in an arm or leg, with or without high blood pressure (reversible posterior encephalopathy syndrome).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system
mentioned in Annex V. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Vargatef

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the blister(s). The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Store in the original package to protect the medicine from moisture.
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 any medicine in 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 Vargatef contains
The active ingredient is nintedanib. Each soft capsule contains 150 mg of nintedanib (as esilate).
The excipients are:

Capsule contents: Medium-chain saturated triglycerides, solid semi-synthetic glycerides, lecithin of
soybean (E322)

Capsule shell:Gelatin, glycerol (85%), titanium dioxide (E171), red iron oxide
(E172), yellow iron oxide (E172)

Description of the appearance of Vargatef and package contents
Vargatef 150 mg soft capsules (capsules) are brown, opaque, oblong
capsules (approximately 18 x 7 mm), with the Boehringer Ingelheim company logo and “150” imprinted on one side.
One pack contains 60 capsules (6 aluminum blisters of 10 capsules each).

Marketing Authorization Holder
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany