Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vargatef

Document Subject

Generated Narrative: MedicinalProductDefinition mp83c6c3334f07b6c02aea88893af34509

identifier: http://ema.europa.eu/identifier/EU/1/14/954/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Vargatef 100 mg soft capsules

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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part: nan

type: Strength part

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-83c6c3334f07b6c02aea88893af34509

identifier: http://ema.europa.eu/identifier/EU/1/14/954/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - vargatef

Attesters

What is in 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

Vargatef capsules contain the active substance nintedanib. Nintedanib blocks the activity of a group of proteins which are involved in the development of new blood vessels that cancer cells need to supply them with food and oxygen. By blocking the activity of these proteins, nintedanib can help stop the growth and spread of the cancer. This medicine is used in combination with another cancer medicine (docetaxel) to treat a cancer of the lung called non-small cell lung cancer (NSCLC). It is for adult patients whose NSCLC is of a certain type ( adenocarcinoma ) and who had already received one treatment with another medicine to treat this cancer but whose tumour started to grow again.

Do not take Vargatef

if you are allergic to nintedanib, to peanut 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 had liver problems, if you have or had bleeding problems, particularly recent bleeding in the lung

if you have or have had problems with your kidneys or if an increased amount of protein has been detected in your urine

if you take blood-thinning medicines (such as warfarin, phenprocoumon, heparin or acetylsalicylic acid) to prevent blood clotting. Treatment with Vargatef may lead to a higher risk of bleeding

if you have recently had a surgery or plan to have a surgery. Nintedanib may affect the way your wounds heal. Therefore treatment with Vargatef will usually be interrupted if you are having surgery. Your doctor will decide when to resume your 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 (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall Based on this information your doctor may carry out some blood tests, for example to check your liver function and to determine how fast your blood can clot. Your doctor will discuss the results of these tests with you and decide whether you can be given Vargatef. Inform your doctor immediately while taking this medicine

if you get diarrhoea. Treatment of diarrhoea at the first signs is important (see section 4)

if you vomit or feel sick (nausea)

if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea coloured) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, or feeling tired. This could be symptoms of serious liver problems

if you develop fever, chills, fast breathing or a fast heartbeat. These could be signs of infection or infection of the blood (sepsis) (see section 4)

if you experience severe pain in your stomach area, fever, chills, sickness, vomiting, or abdominal rigidity or bloating, as these could be symptoms of a hole in the wall of your gut ( gastrointestinal perforation )

if you experience a combination of some or all of the symptoms thereafter: sudden severe abdominal pain or cramping, red blood in your stool, diarrhea or constipation, nausea and vomiting as these could be symptoms of a bowel inflammation from reduced blood flow ( ischaemic colitis )

if you experience pain, swelling, reddening, warmth of a limb or if you experience chest pain and difficulty to breathe as these could be symptoms of a blood clot in one of your veins

if you have any major bleeding

if you experience chest pressure or pain, typically on the left side of the body, pain in the neck, jaw, shoulder or arm, a fast heartbeat, shortness of breath, nausea, vomiting, as this could be symptoms of a heart attack

if any side effect(s) you may get (see section 4) becomes serious Children and adolescents This medicine has not been studied in children or adolescents to treat a cancer of the lung (NSCLC) and is therefore not to be taken by children and adolescents below 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 obtained without a prescription. This medicine can interact with certain other medicines. The following medicines may increase the blood levels of nintedanib, the active substance of Vargatef, and hence may increase the risk for side effects (see section 4):

Ketoconazole (used to treat fungal infections)

Erythromycin (used to treat bacterial infections) The following medicines may decrease the blood levels of nintedanib and thus may lead to reduction of the effectiveness of Vargatef:

Rifampicin (an antibiotic used to treat tuberculosis)

Carbamazepine, phenytoin (used to treat seizures)

St. John s Wort (a herbal medicine to treat depression) Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Do not take this medicine during pregnancy, as it can harm your unborn baby and cause birth defects. Contraception

Women who can become pregnant must use a highly effective method of birth control to prevent pregnancy, when they start taking Vargatef, while they are taking Vargatef and for at least 3 months after stopping treatment.

You should discuss the most appropriate methods of contraception for you with your doctor.

Vomiting and/or diarrhoea or other gastrointestinal conditions can affect the absorption of oral hormonal contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, if experiencing these, talk to your doctor to discuss an alternative more appropriate method of contraception.

Tell your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with Vargatef. Breast-feeding It is not known if the medicine passes into breast milk and could cause harm to a breast-fed child. Therefore, women should not breast-feed during treatment with Vargatef. Fertility The effect of this medicine on human fertility has not been investigated. Driving and using machines Vargatef may have minor influence on your ability to drive and use machines. You should not drive or use machines if you feel sick. Vargatef contains soya The capsules contain soya lecithin. If you are allergic to peanut or soya, do not use this medicine.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not take Vargatef on the same day as your 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 or immediately before or after a meal. Do not open or crush the capsule (see section 5). The recommended dose is four capsules per day (this is a total of 400 mg nintedanib per day). Do not take more than this dose. This daily dose should be split into two doses of two capsules about 12 hours apart, for example two capsules in the morning and two capsules in the evening. These two doses should be taken at around the same time each day. Taking the medicine this way ensures that a steady amount of nintedanib is maintained in the body. Dose reduction If you cannot tolerate the recommended dose of 400 mg per day because of side effects (see section 4), your doctor may reduce the daily dose of Vargatef. Do not reduce the dose or stop the treatment yourself without consulting your doctor first. Your doctor may reduce your recommended dose to 300 mg per day (two capsules of 150 mg). In this case your doctor will prescribe Vargatef 150 mg soft capsules for your treatment. If necessary, your doctor may further reduce your daily dose to 200 mg per day (two capsules of mg). You will be prescribed the appropriate capsule strength by your doctor if this happens. In both cases, you should take one capsule of the appropriate strength twice daily approximately 12 hours apart with food (for example in the morning and in the evening) at about the same time of the day. In case your doctor has stopped your chemotherapy with docetaxel you should continue to take Vargatef twice daily. 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 forgotten dose. Take your next dose of Vargatef as planned at the next scheduled time and at the dose recommended by your doctor or pharmacist. If you stop taking Vargatef Do not stop taking Vargatef without consulting your doctor first. It is important to take this medicine every day, as long as your doctor prescribes it for you. If you do not take this medicine as prescribed by your doctor, this cancer treatment may not work properly. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. You need to pay special attention if you get the following side effects during treatment with Vargatef:

Diarrhoea (very common, may affect more than 1 in 10 people) Diarrhoea may lead to a loss of fluid and important salts (electrolytes, such as sodium or potassium) in your body. At the first signs of diarrhoea drink plenty of fluids and contact your doctor immediately. Start appropriate anti-diarrhoeal treatment, e.g. with loperamide, as soon as possible after having contacted your doctor.

Febrile neutropenia and sepsis (common, may affect up to 1 in 10 people) Treatment with Vargatef may lead to a reduced number of a type of your white blood cells (neutropenia) which are important for the body s reaction against bacterial or fungal infections. As a consequence of neutropenia, fever (febrile neutropenia) and blood infection (sepsis) may occur. Tell your doctor immediately if you develop fever, chills, fast breathing or a fast heartbeat. During treatment with Vargatef your doctor will regularly monitor your blood cells and examine you for signs of infection, such as inflammation, fever or tiredness. The following side effects were observed under treatment with this medicine: Very common side effects (may affect more than 1 in 10 people)

Diarrhoea please see above

Painful, numb and/or tingling feeling in fingers and toes (peripheral neuropathy)

Feeling sick (nausea)

Throwing up (vomiting)

Pain in the stomach (abdomen)

Bleeding

Decrease in the 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)

Rash

Decreased appetite

Electrolyte imbalance

Increased liver enzyme values (alanine aminotransferase, aspartate aminotransferase, blood alkaline phosphatase) in the blood as seen from blood tests

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

Blood poisoning (sepsis) - please see above

Decrease in the 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 of a limb), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately)

High blood pressure (hypertension)

Fluid loss (dehydration)

Abscesses

Low platelet count (thrombocytopenia)

Jaundice (hyperbilirubinaemia)

Increased liver enzyme values (gamma-glutamyltransferase) in the blood as seen from blood tests

Weight loss

Itching

Headache

Increased amount of protein in your urine (proteinuria) Uncommon side effects (may affect up to 1 in 100 people)

Occurrence of holes in the wall of your gut (gastrointestinal perforation)

Serious liver problems

Inflammation of the pancreas (pancreatitis)

Myocardial infarction

Renal failure Not known (cannot be estimated from the available data)

Inflammation of the large bowel

An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 carton, wrapper and blisters. The expiry date refers to the last day of that month. Do not store above 25 C. Store in the original package in order to protect from moisture. Do not use this medicine if you notice that the blister containing the capsules is opened or a capsule is broken. If you are in contact with the content of the capsule, wash off your hands immediately with plenty of water (see section 3). Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Vargatef contains The active substance is nintedanib. Each soft capsule contains 100 mg nintedanib (as esilate). The excipients are: Capsule content: Triglycerides medium-chain, hard fat, soya lecithin (E322) Capsule shell: Gelatin, glycerol (85 %), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172) Printing ink:
Shellac, iron oxide black (E172), propylene glycol (E1520) What Vargatef looks like and contents of the pack Vargatef 100 mg soft capsules (capsules) are peach-coloured, opaque, oblong capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure 100 . Three pack-sizes of Vargatef 100 mg soft capsules are available:

One box containing 60 capsules (6 aluminium blisters of 10 capsules each).

One box containing 120 capsules (12 aluminium blisters of 10 capsules each).

A multipack containing 120 capsules (2 boxes of 60 capsules each, bundled together by a wrapping foil). Not all pack-sizes of Vargatef 100 mg soft capsules may be marketed. Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Strasse 55216 Ingelheim am Rhein Germany Manufacturer Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 55216 Ingelheim am Rhein Germany Boehringer Ingelheim France 100-104 Avenue de France 75013 Paris France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel: +370 5 2595 . -

: +359 2 958 79 Luxembourg/Luxemburg Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 esk republika Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 Magyarorsz g Boehringer Ingelheim RCV GmbH & Co KG Magyarorsz gi Fi ktelepe Tel: +36 1 299 89 Danmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 Malta Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Deutschland Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 Nederland Boehringer Ingelheim B.V. Tel: +31 (0) 800 22 55 Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Tel: +372 612 8Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13
Boehringer Ingelheim A.E. T : +30 2 10 89 06 sterreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-7Espa a Boehringer Ingelheim Espa a, S.A. Tel: +34 93 404 51 Polska Boehringer Ingelheim Sp. z o.o. Tel: +48 22 699 0 France Boehringer Ingelheim France S.A.S. T l: +33 3 26 50 45 Portugal Boehringer Ingelheim Portugal, Lda. Tel: +351 21 313 53 Hrvatska Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 Rom nia Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucure ti Tel: +40 21 302 2Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podru nica Ljubljana Tel: +386 1 586 40 sland Vistor hf. S mi: +354 535 7Slovensk republika Boehringer Ingelheim RCV GmbH & Co KG organiza n zlo ka Tel: +421 2 5810 1Italia Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1 Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102
Boehringer Ingelheim A.E. T : +30 2 10 89 06 Sverige Boehringer Ingelheim AB Tel: +46 8 721 21 Latvija Boehringer Ingelheim RCV GmbH & Co KG Latvijas fili le Tel: +371 67 240 United Kingdom (Northern Ireland) Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. Package leaflet: Information for the patient Vargatef 150 mg soft capsules nintedanib Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.