Tepmetko 225 mg comprimidos recubiertos con pelicula

Summary of Product Characteristics: Information for the Patient

TEPMETKO 225 mg Film-Coated Tablets

tepotinib

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this summary of product characteristics carefully before starting to take this medicine, as it contains important information for you.

• Keep this summary of product characteristics, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• 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, consult your doctor or pharmacist,even if they are not listed in this summary of product characteristics. See section4.

TEPMETKO contains the active ingredient tepotinib, which belongs to a group of medicines called «protein kinase inhibitors» used to treat cancer.

TEPMETKO is used to treat adults with lung cancer that has spread to other parts of the body or cannot be removed by surgery. The medicine is administered when the tumor cells have an alteration in the MET gene (epithelial-mesenchymal transition factor) and previous treatment has not helped to stop their disease.

An alteration in the MET gene may lead to the production of an abnormal protein, which in turn may cause uncontrolled cell growth and cancer. By blocking the action of this abnormal protein, TEPMETKO may slow down or stop cancer growth. It may also help to reduce the size of the cancer.

Do not take TEPMETKO

• if you are allergic to tepotinib or any of the other ingredients in this medication (listed in section6).

Warnings and precautions

Consult your doctor before starting this medication if you have any doubts.

Lung or respiratory problems

TEPMETKO may sometimes cause sudden difficulty breathing that may be associated with fever and cough. Inform your doctor immediately if you experience new symptoms or if your symptoms worsen (see section4), as this could be a sign of a severe lung disorder (interstitial lung disease) that requires immediate attention. Your doctor may need to treat you with other medications and discontinue your TEPMETKO treatment.

Liver function monitoring

Your doctor will perform blood tests to check how well your liver is functioning before starting TEPMETKO treatment and as needed during treatment.

Cardiac function monitoring

Your doctor will perform electrocardiograms (ECG) as needed during treatment to check if TEPMETKO affects your heart rhythm.

Contraception

Do not use this medication during pregnancy, as it may harm the fetus. Men and women should use effective contraceptive methods during TEPMETKO treatment and for at least 1week after the last dose. Your doctor will indicate the appropriate contraceptive methods. See "Pregnancy" below.

Children and adolescents

This medication has not been studied in patients under 18years.

Other medications and TEPMETKO

Inform your doctor if you are using, have used recently, or may need to use any other medication.

TEPMETKO may affect the functioning of the following medications and/or increase the adverse effects of these medications:

• dabigatran, used to prevent stroke or venous thromboembolism/pulmonary embolism
• digoxin, used to treat irregular heart rhythm or other heart problems
• aliskiren, used to treat high blood pressure
• everolimus, used to treat cancer
• sirolimus, used to prevent organ transplant rejection
• rosuvastatin, used to treat high levels of cholesterol in the blood
• methotrexate, used to treat inflammatory diseases or cancer
• topotecan, used to treat cancer
• metformin, used to treat diabetes

Pregnancy and breastfeeding

Pregnancy

Do not take TEPMETKO if you are pregnant or suspect you are pregnant, unless your doctor tells you to. This medication may harm the fetus. It is recommended to perform a pregnancy test before starting TEPMETKO treatment.

Contraception in men and women

If you are a woman with childbearing potential, use an effective contraceptive method to avoid pregnancy during TEPMETKO treatment and for at least 1week after the last dose.Inform your doctor if you take hormonal contraceptives (e.g., "the pill"), as you will need to use a second contraceptive method during this period.

If you are a man, use a barrier contraceptive method to avoid your partner becoming pregnant during your TEPMETKO treatment and for at least 1week after the last dose.

Your doctor will inform you about the appropriate contraceptive methods.

Breastfeeding

The effect of TEPMETKO on the baby through breast milk is unknown. Discontinue breastfeeding during TEPMETKO treatment and for at least 1week after the last dose.

Driving and operating machinery

The influence of TEPMETKO on the ability to drive and operate machinery is negligible.

TEPMETKO contains lactose

TEPMETKO contains 4.4mg of lactose monohydrate in each tablet. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is 2TEPMETKO tablets taken orally once a day. You can continue taking this medication daily as long as it is beneficial for you and you do not experience intolerable side effects. In case of intolerable side effects, your doctor may instruct you to reduce the dose to 1tablet per day or to interrupt treatment for several days.

Take the tablets with food or shortly after a meal, swallow them whole and do not chew them. This will ensure that you take the complete dose.

If you have trouble swallowing the tablets, you can mix them with water:

• Place the tablets in a glass without crushing them.
• Add 30ml (equivalent to two teaspoons) of water without gas: do not use any other liquid.
• Stir the water until the tablets disintegrate into very small fragments, which may take a few minutes: the tablets will not dissolve completely.
• Drink the liquid within one hour.
• To ensure that you have taken the entire medication, rinse the glass well with another 30ml of water and drink the contents immediately.

If you have a nasogastric tube (NG) of 8French or larger:

• Follow the same instructions to mix the tablets in 30ml of water without gas as described above.
• Administer the liquid within 1hour according to the manufacturer's instructions for the NG tube.
• To ensure that you have taken the entire medication, rinse the glass and syringe twice with another 30ml of water each to ensure that there are no medication residues in the glass or syringe and that the complete dose is administered.

If you take more TEPMETKO than you should

The experience with TEPMETKO overdose is limited. The symptoms of overdose are likely to be similar to those mentioned in «Possible side effects» (see section4). If you have taken more TEPMETKO than you should, inform your doctor.

If you forgot to take TEPMETKO

If you forget to take a dose of TEPMETKO, take it as soon as you remember. If it has been less than 8hours since the next dose is due, ignore the missed dose and take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Severe Adverse Effects

Lung or Respiratory Problems

Inform your doctor immediately if you experience new symptoms or if your symptoms worsen, for example, sudden difficulty breathing, coughing, or fever, as this could be a sign of a severe lung disorder (interstitial lung disease) that requires immediate attention. This adverse effect is frequent (may affect up to 1 in 10 people).

Other Adverse Effects

Inform your doctor if you experience any other adverse effects. These may include:

Very Frequent Adverse Effects (may affect more than 1 in 10 people)

• Swelling caused by fluid accumulation in the body (edema)
• Nausea or vomiting
• Diarrhea
• Elevated creatinine levels in the blood (a sign of possible kidney problems)
• Elevated alanine-aminotransferase, aspartate-aminotransferase, or alkaline phosphatase levels in the blood (a sign of possible liver problems)
• Elevated amylase or lipase levels in the blood (a sign of possible digestive problems)
• Reduced albumin levels in the blood

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Change in heart electrical activity observed on an ECG (prolongation of the QT interval)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 and the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of TEPMETKO

• The active ingredient is tepotinib. Each film-coated tablet contains 225mg of tepotinib (as hydrochloride hydrate).
• The other components are mannitol, anhydrous colloidal silica, crospovidone, magnesium stearate, and microcrystalline cellulose in the tablet core and hypromellose, lactose monohydrate (see section2, "TEPMETKO contains lactose"), macrogol, triacetin, iron oxide red (E172), and titanium dioxide (E171) in the film coating.

Appearance of the product and content of the container

TEPMETKO film-coated tablets are white-pink, oval, and biconvex, approximately 18x9mm in size, with the inscription "M" on one face and no inscription on the other face. Each container contains 60tablets in a transparent blister pack, consisting of a multi-layered laminate and an aluminum foil laminate.

Marketing authorization holder

Merck Europe B.V.

Gustav Mahlerplein102

1082MA Amsterdam

Netherlands

Responsible for manufacturing

Merck Healthcare KGaA

Frankfurter Strasse250

64293Darmstadt

Germany

Last review date of this leaflet:

Other sources of information

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