Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tabrecta

Document Subject

Generated Narrative: MedicinalProductDefinition mpbe5ceff4154e41596bab87f1698ba47a

identifier: http://ema.europa.eu/identifier/EU/1/22/1650/001-004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Tabrecta 150 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-be5ceff4154e41596bab87f1698ba47a

identifier: http://ema.europa.eu/identifier/EU/1/22/1650/001-004

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - tabrecta

Attesters

What is in this leaflet

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

What Tabrecta is Tabrecta contains the active substance capmatinib, which belongs to a class of medicines called protein kinase inhibitors.

What Tabrecta is used for Tabrecta is a medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). It is used if the lung cancer is advanced or has spread to other parts of the body (metastatic) and is caused by a change (mutation) in a gene that makes an enzyme called MET.

Your tumour or blood will be tested for certain mutations in this gene. Your cancer is likely to respond to treatment with Tabrecta if the test result is positive.

How Tabrecta works Tabrecta helps to slow down or stop the growth and spread of your lung cancer if it is caused by a mutation in a gene that makes MET.

If you have any questions about how Tabrecta works or why this medicine has been prescribed for you, ask your doctor or pharmacist.

Do not take Tabrecta

• if you are allergic to capmatinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Tabrecta:

• if you have or have had lung or breathing problems other than your lung cancer.
• if you have or have had liver problems.
• if you have or have had pancreatic problems.

Limit direct exposure to the sun or artificial ultraviolet (UV) light while using Tabrecta. Use sunscreen, wear sunglasess and clothes that cover your skin, and avoid sunbathing while you are taking Tabrecta and for at least 7 days after you stop taking it.

Tell your doctor, pharmacist or nurse immediately if you have an allergic reaction during treatment with Tabrecta:

• Symptoms of an allergic reaction may include rash, hives, fever, difficulty breathing, or low blood pressure.

Monitoring during your treatment with Tabrecta Your doctor will do blood tests before you start treatment with Tabrecta to check your liver and pancreatic function. Your doctor will continue to check your liver and pancreatic function during treatment with Tabrecta.

Children and adolescents Do not give this medicine to children and adolescents below 18 years of age because it has not yet been studied in this age group.

Other medicines and Tabrecta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines

It is particularly important that you mention any of the following medicines:

• medicines used to treat seizures, such as carbamazepine, phenobarbital, phenytoin
• St. John s wort (also known as Hypericum perforatum), a herbal product used to treat depression and other conditions
• medicines used to treat tuberculosis, such as rifampicin
• antibiotics used to treat bacterial infections, such as telithromycin, clarithromycin
• medicines used to treat fungal infections, such as ketoconazole, itraconazole, posaconazole, voriconazole
• medicines used to treat HIV/AIDS, such as ritonavir (either alone or in combination with lopinavir), saquinavir, indinavir, nelfinavir, efavirenz
• medicines used to treat hepatitis, such as telaprevir
• medicines used to treat depression, such as nefazodone
• medicines used to treat high blood pressure or heart problems, such as verapamil
• medicines used to treat breathing problems, such as theophylline
• medicines used to treat muscle spasms, such as tizanidine
• medicines used to treat heart problems, such as digoxin
• medicines used to treat blood clots, such as dabigatran etexilate
• medicines used to treat gout, such as colchicine
• medicines used to treat diabetes, such as sitagliptin, saxagliptin
• medicines used to treat high cholesterol, such as rosuvastatin, pravastatin
• medicines used to treat certain types of cancer or autoimune diseases, such as methotrexate, mitoxantrone
• sulfasalazine, a medicine used to treat bowel and rheumatic joint inflammation

Ask your doctor, pharmacist or nurse if you are not sure whether you are taking any of the medicines listed above.

You should also tell your doctor if you are prescribed a new medicine when you are already taking Tabrecta.

Pregnancy and breast-feeding Tabrecta can harm your unborn baby. If you are a woman who could become pregnant, your doctor will perform a pregnancy test before starting treatment with Tabrecta in order to ensure that you are not pregnant. You should use an effective method of contraception while taking Tabrecta and for at least 7 days after you stop taking it to avoid becoming pregnant. Ask your doctor about effective methods of contraception.

If you do become pregnant, or think you may be pregnant, while taking Tabrecta, tell your doctor straight away. Your doctor will discuss with you the potential risks of taking Tabrecta during pregnancy.

If you are a man with a partner who is pregnant or who could become pregnant you should use a condom while taking Tabrecta and for at least 7 days after you stop taking it.

It is not known if Tabrecta passes into breast milk. You should not breast-feed while you are taking Tabrecta and for at least 7 days after you stop taking it.

Driving and using machines Tabrecta is not expected to affect your ability to drive or use machines.

Tabrecta contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .

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 exceed the recommended dose prescribed by your doctor.

How much Tabrecta to take The recommended dose is 400 mg (two 200 mg tablets) taken by mouth twice a day with or without food. Taking Tabrecta twice a day at about the same time each day will help you to remember when to take your medicine. If you have difficulties swallowing tablets, take Tabrecta tablets with food.

Your doctor will tell you exactly how many tablets of Tabrecta to take. Your doctor may change the dose during treatment with Tabrecta if you have certain side effects. Do not change the dose without talking to your doctor.

Swallow Tabrecta tablets whole. Do not break, chew or crush the tablets.

If you vomit after you have taken Tabrecta, do not take any more Tabrecta tablets until it is time for your next dose.

How long to take Tabrecta Continue taking Tabrecta for as long as your doctor tells you.

This is a long-term treatment, possibly lasting for months or years. Your doctor will monitor your condition to check that the treatment is having the desired effect.

If you have questions about how long to take Tabrecta, talk to your doctor or pharmacist.

If you take more Tabrecta than you should If you have taken too much Tabrecta, or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately. Show the pack of Tabrecta. Medical treatment may be necessary.

If you forget to take Tabrecta Do not take a double dose to make up for a forgotten dose. Instead, wait until it is time for your next dose.

If you stop taking Tabrecta Your doctor may temporarily or permanently stop treatment with Tabrecta if you have certain side effects. Do not stop taking your medicine unless your doctor tells you to.

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.

Some side effects could be serious If you get any of the serious side effects listed below, tell your doctor immediately. They may advise you to stop taking the medicine or may change your dose.

Very common: may affect more than 1 in 10 people

• Abnormal blood test results such as a high level of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) which may be a sign of liver problems
• Abnormal blood test results such as a high level of amylase and/or lipase which may be a sign of pancreatic problems

Common: may affect up to 1 in every 10 people

• Abnormal blood test results such as a high level of bilirubin which may be a sign of liver problems
• Cough, fever, trouble breathing, shortness of breath, or wheezing which may be a sign of inflammation of the lungs (pneumonitis, interstitial lung disease)
• Passing urine less often than usual or passing smaller amounts of urine than usual which may be a sign of kidney problems (renal failure, acute kidney injury)

Uncommon: may affect up to 1 in every 100 people

• Severe upper stomach pain which may be a sign of inflammation of the pancreas (acute pancreatitis)
• Allergic reaction (hypersensitivity) which may include rash, hives, fever, difficulty breathing, or low blood pressure

Other possible side effects Other side effects include the following listed below. If these side effects become severe, tell your doctor, pharmacist or nurse.

Very common: may affect more than 1 in 10 people

• Swollen hands, ankles or feet (peripheral oedema)
• Nausea and/or vomitting
• Tiredeness and/or weakness (fatigue, asthenia)
• Shortness of breath (dyspnoea)
• Loss of appetite
• Changes in bowel movements (diarrhoea or constipation)
• Back pain
• Cough
• Pain in your chest
• Fever (pyrexia)
• Decreased weight

Common: may affect up to 1 in every 10 people

• Itching with or without a rash (pruritus or urticaria)
• Skin rash
• Pain, tenderness, redness, warmth, or swelling of your skin which may be a sign of bacterial skin infection (cellulitis)

Abnormal blood test results During Tabrecta treatment, the results of blood tests may be abnormal which may be a sign of problems with your kidney, liver, or electrolytes. These include the following:

Very common: may affect more than 1 in 10 people

• Low level of albumin in the blood
• High level of creatinine in the blood (a substance excreted by the kidney)
• Low level of phosphate in the blood
• Low level of sodium in the blood

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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 and the blister foil after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
• Do not use this medicine if you notice any damage to the packaging or if there are any signs of tampering.
• 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 Tabrecta contains

• The active substance is capmatinib.

• Each 150 mg film-coated tablet contains capmatinib dihydrochloride monohydrate equivalent to 150 mg capmatinib.

• Each 200 mg film-coated tablet contains capmatinib dihydrochloride monohydrate equivalent to 200 mg capmatinib.

• The other ingredients are:

• Tablet core: cellulose microcrystalline; mannitol; crospovidone; povidone; magnesium stearate; silica colloidal anhydrous; sodium laurilsulfate (see Tabrecta contains sodium
  in section 2).

• Film coating (150 mg): Hypromellose; titanium dioxide (E171); macrogol; talc; iron oxide, yellow (E172); iron oxide, red (E172); iron oxide, black (E172).

• Film coating (200 mg): Hypromellose; titanium dioxide (E171); macrogol; talc; iron oxide, yellow (E172).

What Tabrecta looks like and contents of the pack

Tabrecta 150 mg film-coated tablets (tablets) are pale orange brown ovaloid tablets. They have DU
on one side and NVR on the other side. Approximate size: 18.3 mm (length) x 7.3 mm (width).

Tabrecta 200 mg film-coated tablets (tablets) are yellow ovaloid tablets. They have LO on one side and NVR on the other side. Approximate size: 20.3 mm (length) x 8.1 mm (width).

Tabrecta film-coated tablets are provided in blisters and are available in packs containing 60 or 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer Novartis Pharma GmbH Roonstrasse 90429 Nuremberg Germany

Lek Pharmaceuticals d.d. Trimlini 2D 9220 Lendava Slovenia

Novartis Farmac utica S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

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

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD : +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: