Patient Information

Tabrecta 150 mg Film-Coated Tablets

Tabrecta 200 mg Film-Coated Tablets

capmatinib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, ask your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

What is Tabrecta

Tabrecta contains the active ingredient capmatinib, which belongs to a group of medicines called protein kinase inhibitors.

What is Tabrecta used for

Tabrecta is a medicine used to treat adult patients with a type of lung cancer called non-microcytic lung cancer (NMCL). It is used if the lung cancer is in an advanced state or has spread to other parts of the body (metastatic) and is caused by a change (mutation) in a gene that generates an enzyme called MET.

Blood or tumor analyses will be performed to detect certain mutations in this gene. If the result is positive, it is possible that your cancer may respond to treatment with Tabrecta.

How Tabrecta works

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

If you have any questions about how Tabrecta works or why you have been prescribed this medicine, consult 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

Consult your doctor, pharmacist or nurse before starting to take Tabrecta:

• if you have or have had lung problems or breathing difficulties other than lung cancer.
• if you have or have had liver problems.
• if you have or have had pancreatitis.

While taking Tabrecta, you should limit your direct exposure to the sun or artificial ultraviolet (UV) light. You should use sunscreen, wear sunglasses and cover your skin with clothing, and avoid taking the sun while taking Tabrecta and for at least 7 days after stopping treatment.

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

• The symptoms of an allergic reaction may include rash, urticaria, fever, difficulty breathing, or low blood pressure.

Monitoring during treatment with Tabrecta

Your doctor will perform blood tests before starting treatment with Tabrecta to check liver and pancreas function. Your doctor will continue to check liver and pancreas function during treatment with Tabrecta.

Children and adolescents

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

Other medicines and Tabrecta

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

It is particularly important to mention any of the following medicines:

• medicines used to treat seizures such as carbamazepine, phenobarbital, phenytoin
• St. John's Wort (also known asHypericum perforatum), a herbal product used to treat depression and other diseases
• 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 respiratory 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 autoimmune diseases, such as methotrexate, mitoxantrone
• sulfasalazine, a medicine used to treat inflammation in the intestine and rheumatoid arthritis in the joints

Consult your doctor, pharmacist or nurse if you are unsure whether you are taking any of the medicines listed above.

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

Pregnancy and breastfeeding

Tabrecta may harm the unborn baby. If you are a woman who may become pregnant, your doctor will perform a pregnancy test before starting treatment with Tabrecta to ensure that you are not pregnant. You should use an effective contraceptive method while taking Tabrecta and for at least 7 days after stopping treatment, to avoid becoming pregnant. Consult your doctor about effective contraceptive methods.

If you become pregnant or think you may be pregnant while taking Tabrecta, inform your doctor immediately. 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 may become pregnant, you should use condoms while taking Tabrecta and for at least 7 days after stopping treatment.

It is not known whether Tabrecta passes into breast milk. Do not breastfeed while taking Tabrecta and for at least 7 days after stopping treatment.

Driving and operating machinery

Tabrecta is not expected to affect the ability to drive or operate machinery.

Tabrecta contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not take more than the recommended dose prescribed by your doctor.

How Much Tabrecta to Take

The recommended dose is 400 mg (2 tablets of 200 mg) taken orally twice a day, with or without food. Taking Tabrecta twice a day at the same time each day will help you remember when to take your medication. If you have difficulty swallowing the tablets, take Tabrecta tablets with food.

Your doctor will inform you exactly how many tablets of Tabrecta you should take. Your doctor may change the dose during treatment with Tabrecta if you experience some adverse effects. Do not change the dose without talking to your doctor.

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

If you vomit after taking Tabrecta, do not take any more tablets of Tabrecta until it is time to take the next dose.

For How Long Should You Take Tabrecta

Continue taking Tabrecta for the time your doctor tells you to.

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

If you have questions about how long you should take Tabrecta, consult your doctor or pharmacist.

What to Do If You Take Too Much Tabrecta

If you have taken too many tablets of Tabrecta, or if someone has taken your medication by accident, contact your doctor or hospital immediately. You must show them the packaging of Tabrecta. You may need medical treatment.

What to Do If You Forget to Take Tabrecta

Do not take a double dose to make up for the missed doses. Wait until it is time to take the next dose.

What to Do If You Interrupt Treatment with Tabrecta

Your doctor may temporarily or permanently stop treatment with Tabrecta if you experience some adverse effects. Do not stop taking your medication unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects can be serious

If you experience any of the serious side effects listed below, inform your doctor immediately.They may advise you to stop taking the medicine or change the dose..

Very common:may affect more than 1 in 10 people

• Abnormal results in blood tests, such as high levels of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) that may be a sign of liver problems
• Abnormal results in blood tests, such as high levels of amylase and/or lipase that may be a sign of pancreatic problems.

Common:may affect up to 1 in 10 people

• Abnormal results in blood tests, such as high levels of bilirubin that may be a sign of liver problems
• Cough, fever, breathing problems, shortness of breath, or wheezing that may be a sign of lung inflammation (pneumonitis, interstitial lung disease)
• Urinating less frequently than usual or with less urine than normal, which may be a sign of kidney problems (renal insufficiency, acute kidney damage)

Rare:may affect up to 1 in 100 people

• Intense pain in the upper part of the stomach that may be a sign of pancreatitis (acute pancreatitis)
• Allergic reaction (hypersensitivity) that may include rash, urticaria, fever, difficulty breathing, or low blood pressure

Other possible side effects

Other side effects include the following list. If these side effects become serious, inform your doctor, pharmacist, or nurse.

Very common:may affect more than 1 in 10 people

• Swelling in the hands, elbows, or feet (peripheral edema)
• Nausea and/or vomiting
• Fatigue and/or weakness (asthenia)
• Shortness of breath
• Loss of appetite
• Changes in bowel movements (diarrhea or constipation)
• Back pain
• Cough
• Chest pain
• Fever (pyrexia)
• Weight loss

Common:may affect up to 1 in 10 people

• Itching with or without rash (pruritus or urticaria)
• Rash on the skin
• Pain, sensitivity, redness, heat, or swelling on the skin that may be a sign of bacterial skin infection (cellulitis)

Abnormal blood test results

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

Very common:may affect more than 1 in 10 people

• Low albumin levels in the blood
• High creatinine levels in the blood (a substance excreted by the kidneys)
• Low phosphate levels in the blood
• Low sodium levels in the blood

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box after CAD and on the blister pack after EXP. The expiration date is the last day of the month indicated.
• This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture.
• Do not use this medication if you observe any damage to the packaging or if it shows signs of handling.
• Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Tabrecta

• The active ingredient is capmatinib.
• Each film-coated tablet of 150 mg contains capmatinib dihydrochloride monohydrate equivalent to 150 mg of capmatinib.
• Each film-coated tablet of 200 mg contains capmatinib dihydrochloride monohydrate equivalent to 200 mg of capmatinib.
• The other components are:
• Tablet core: microcrystalline cellulose; mannitol; crospovidone; povidone; magnesium stearate; anhydrous colloidal silica; sodium lauryl sulfate (see "Tabrecta contains sodium" in section 2).
• Coating (150 mg): hypromellose; titanium dioxide (E171); macrogol; talc; iron oxide, yellow (E172); iron oxide, red (E172); iron oxide, black (E172).
• Coating (200 mg): hypromellose; titanium dioxide (E171); macrogol; talc; iron oxide, yellow (E172).

Appearance of Tabrecta and contents of the pack

Tabrecta 150 mg film-coated tablets are oval-shaped, light orange-brown tablets with the mark "DU" on one face and "NVR" on the other face. Approximate size: 18.3 mm (length) x 7.3 mm (width).

Tabrecta 200 mg film-coated tablets are oval-shaped, yellow tablets with the mark "LO" on one face and "NVR" on the other face. Approximate size: 20.3 mm (length) x 8.1 mm (width).

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

Not all pack sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible Person

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update date of this leafletn of this leaflet

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu