TEPMETKO 225 mg FILM-COATED TABLETS

2. What you need to know before you take TEPMETKO

Do not take TEPMETKO

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

Warnings and precautions

Talk to your doctor before starting treatment with this medicine if you have any questions.

Lung or breathing problems

TEPMETKO can sometimes cause sudden breathing difficulties that can be associated with fever and cough. Tell your doctor immediately if you get new symptoms or if your symptoms get worse (see section 4), as this could be a sign of a serious lung disorder (interstitial lung disease) that needs immediate attention. Your doctor may need to treat you with other medicines and interrupt your treatment with TEPMETKO.

Liver function monitoring

Your doctor will do blood tests to check how well your liver is working before treatment with TEPMETKO and when necessary during treatment.

Heart function monitoring

Your doctor will do electrocardiograms (ECG) when necessary during treatment to check if TEPMETKO affects your heart rhythm.

Contraception

This medicine must not be used during pregnancy, as it may harm the baby. Men and women must use effective contraceptive methods during treatment with TEPMETKO and for at least 1 week after the last dose. Your doctor will tell you which contraceptive methods are appropriate. See "Pregnancy" below.

Children and adolescents

This medicine has not been studied in patients under 18 years of age.

Other medicines and TEPMETKO

Tell your doctor if you are taking, have recently taken or might take any other medicines.

TEPMETKO may affect how the following medicines work and/or increase the side effects of these medicines:

• dabigatran, used to prevent stroke or venous thromboembolism
• 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 rejection after transplantation
• rosuvastatin, used to treat high blood fat levels
• methotrexate, used to treat inflammatory diseases or cancer
• topotecan, used to treat cancer
• metformin, used to treat diabetes

Pregnancy and breast-feeding

Pregnancy

Do not take TEPMETKO if you are pregnant or think you may be pregnant, unless your doctor tells you to. This medicine may harm the baby. A pregnancy test is recommended before starting treatment with TEPMETKO.

Contraception in men and women

If you are a woman who can become pregnant, you must use an effective contraceptive method to avoid becoming pregnant during treatment with TEPMETKO and for at least 1 week after the last dose. Tell your doctor if you are taking hormonal contraceptives (e.g. "the pill"), as you will need to use a second contraceptive method during this period.

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

Your doctor will tell you which contraceptive methods are appropriate.

Breast-feeding

It is not known whether TEPMETKO can pass into breast milk. Stop breast-feeding during treatment with this medicine and for at least 1 week after the last dose.

Driving and using machines

TEPMETKO has no influence on the ability to drive and use machines.

TEPMETKO contains lactose

TEPMETKO contains 4.4 mg of lactose monohydrate in each tablet. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take TEPMETKO

Take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor.

The recommended dose is 2 TEPMETKO tablets orally once a day. You can keep taking this medicine every day as long as it is beneficial for you and you do not have unacceptable side effects. If you have unacceptable side effects, your doctor may tell you to reduce the dose to 1 tablet a day or 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 full dose.

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

• Put the tablets in a glass without crushing them.
• Add 30 ml (equivalent to two tablespoons) of non-carbonated water: do not use any other liquid.
• Stir the water until the tablets break up into very small pieces, which may take a few minutes: the tablets will not dissolve completely.
• Drink the liquid within 1 hour.
• To make sure you take all the medicine, rinse the glass well with another 30 ml of water and drink the contents immediately.

If you have a nasogastric tube (NG) with a diameter of 8 French or more:

• Follow the same instructions to mix the tablets in 30 ml of non-carbonated water as described above.
• Administer the liquid within 1 hour according to the NG tube manufacturer's instructions.
• To make sure you take all the medicine, rinse the glass and syringe twice with another 30 ml of water each to ensure that no medicine residue remains in the glass or syringe and that the full dose is administered.

If you take more TEPMETKO than you should

Experience with overdose of TEPMETKO is limited. The symptoms of overdose are likely to be similar to those mentioned in "Possible side effects" (see section 4). If you have taken more TEPMETKO than you should, talk to your doctor.

If you forget to take TEPMETKO

If you forget to take a dose of TEPMETKO, take it as soon as you remember. If it is less than 8 hours until the next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Lung or breathing problems

Tell your doctor immediately if you get new symptoms or if your symptoms get worse, such as sudden difficulty breathing, cough or fever, as this could be a sign of a serious lung disorder (interstitial lung disease) that needs immediate attention. This side effect is common (may affect up to 1 in 10 people).

Other side effects

Tell your doctor if you get any other side effects. These may include:

Very common side effects (may affect more than 1 in 10 people)

• swelling due to fluid accumulation in the body (oedema)
• feeling sick (nausea) or vomiting
• diarrhoea
• high levels of creatinine in the blood (a sign of possible kidney problems)
• high levels of alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase in the blood (a sign of possible liver problems)
• high levels of amylase or lipase in the blood (a sign of possible digestive problems)
• low levels of albumin in the blood

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

• change in heart electrical activity seen on the ECG (prolongation of the QT interval)

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.

5. Storage of TEPMETKO

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 blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What TEPMETKO contains

• The active substance is tepotinib. Each tablet contains 225 mg of tepotinib (as hydrochloride hydrate).
• The other ingredients are mannitol, colloidal anhydrous silica, crospovidone, magnesium stearate and microcrystalline cellulose in the tablet core and hypromellose, lactose monohydrate (see section 2, "TEPMETKO contains lactose"), macrogol, triacetin, red iron oxide (E172) and titanium dioxide (E171) in the film coating.

Appearance and packaging

TEPMETKO film-coated tablets are white-pink, oval and biconvex, approximately 18 x 9 mm in size, with the inscription "M" on one side and no inscription on the other side. Each pack contains 60 tablets in a transparent blister, consisting of a multi-layer composite film and an aluminium lidding foil.

Marketing authorisation holder

Merck Europe B.V.

Gustav Mahlerplein 102

1082 MA Amsterdam

Netherlands

Manufacturer

Merck Healthcare KGaA

Frankfurter Strasse 250

64293 Darmstadt

Germany

Date of last revision of this leaflet

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.