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AstraZeneca

Vargatef
nintedanib

Package leaflet: Information for the patient


Vargatef 100 mg soft capsules

nintedanib


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


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.


  1. How to take Vargatef


    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 100 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.


  2. Possible side effects


    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

      image

      not listed in this leaflet. You can also report side effects directly via thenationalreportingsystem listed in Appendix V. By reporting side effects you can help provide more information on the safety of

      this medicine.


  3. 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 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.


  4. Contents of the pack and other information 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 173

55216 Ingelheim am Rhein Germany


Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173

55216 Ingelheim am Rhein

image

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:


België/Belgique/Belgien

SCS Boehringer Ingelheim Comm.V

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

SCS Boehringer Ingelheim Comm.V

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 8900


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 Norway KS

Tlf: +47 66 76 13 00


Ελλάδα

Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E.

Tηλ: +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 Bucuresti 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 hf.

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. Tηλ: +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


This leaflet was last revised in


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