Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tepmetko

Document Subject

Generated Narrative: MedicinalProductDefinition mpbaea5a2972e0f05fd505526d61aba839

identifier: http://ema.europa.eu/identifier/EU/1/21/1596/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: TEPMETKO 225 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-baea5a2972e0f05fd505526d61aba839

identifier: http://ema.europa.eu/identifier/EU/1/21/1596/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - tepmetko

Attesters

What is in this leaflet

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

TEPMETKO contains the active substance tepotinib. It belongs to a group of medicines called protein kinase inhibitors which are 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 given, when the cancer cells have an alteration in the MET (mesenchymal-epithelial transition factor) gene and previous treatment has not helped to stop your disease.

An alteration in the MET gene can lead to production of an abnormal protein, which can then cause uncontrolled cell growth and cancer. By blocking the action of the abnormal protein, TEPMETKO may slow or stop the cancer from growing. It may also help to shrink the cancer.

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 taking this medicine if you have any questions.

Lung or breathing problems TEPMETKO can sometimes cause sudden breathing difficulties that may be associated with a fever and cough. Tell your doctor right away if you develop any new or worsening symptoms (see section 4) as these may be signs of a serious lung condition (interstitial lung disease) which needs immediate attention. Your doctor may need to treat you with other medicines and interrupt your TEPMETKO treatment.

Monitoring of liver function Your doctor will carry out blood tests to check how well your liver is working before you are treated with TEPMETKO, and as necessary during treatment.

Monitoring of heart function Your doctor may carry out ECG tests as necessary during treatment to check whether TEPMETKO affects your heart rhythm.

Contraception This medicine should not be used in pregnancy as it can harm the unborn baby. Men and women should use effective contraception during TEPMETKO treatment and for at least 1 week after the last dose. Your doctor will give you guidance on appropriate methods of contraception. See Pregnancy
below.

Children and adolescents This medicine has not been studied in patients below the age of 18 years.

Other medicines and TEPMETKO Tell your doctor if you are using, have recently used or might use any other medicines.

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

• dabigatran used to prevent stroke or venous thrombosis/pulmonary embolism
• digoxin used to treat irregular heart beat or other heart problems
• aliskiren used to treat high blood pressure
• everolimus used to treat cancer
• sirolimus used to prevent organ rejection in transplanted patients
• 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 suspect you are pregnant, unless advised by your doctor. This medicine may harm the unborn baby. Pregnancy testing is recommended prior to starting treatment with TEPMETKO.

Contraception in males and females If you are female and able to have children, you should use an effective method of contraception to avoid becoming pregnant during TEPMETKO treatment and for at least 1 week after the last dose. Talk to your doctor if you take hormonal contraceptives (e.g. the pill ) as you will need a second method of contraception during this time.

If you are male, you should use a barrier method of contraception to prevent your partner from getting pregnant, while you are treated with TEPMETKO and for at least 1 week after the last dose.

Your doctor will give you guidance on appropriate methods of contraception.

Breast-feeding It is not known whether TEPMETKO may pass to the baby via breast milk. Stop breast-feeding your baby while you are treated 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 or use machines.

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

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose is 2 tablets of TEPMETKO taken by mouth once daily. You may continue to take this medicine daily as long as you are benefitting from it and are not having intolerable side effects. In case of intolerable side effects, your doctor may advise you to reduce the dose to 1 tablet daily or interrupt the treatment for some days.

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

If you take more TEPMETKO than you should Experience with overdose of TEPMETKO is limited. Symptoms of overdose will most likely be similar to those mentioned under 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 miss a dose of TEPMETKO, take it as soon as you remember. If your next dose is due within 8 hours, skip the missed dose and take your next dose at your regular time. Do not take a double dose to make up for a missed dose.

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.

Serious side effects Lung or breathing problems Tell your doctor right away if you develop any new or worsening symptoms such as sudden breathing difficulties, cough or fever. These may be signs of a serious lung condition (interstitial lung disease) which needs immediate medical attention. This side effect is common (may affect up to 1 in 10 people).

Other side effects Talk to your doctor if you get any other side effects. These can include:

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

• Swelling caused by fluid build-up in the body (oedema)
• Feeling sick (nausea) or being sick (vomiting)
• Diarrhoea
• Raised levels of creatinine in blood (a sign of possible kidney problems)
• Raised levels of alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase in blood (a sign of possible liver problems)
• Raised levels of amylase or lipase in blood (a sign of possible digestive problems)
• Reduced levels of the protein albumin in blood

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

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

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.

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

This medicine does not require any special storage conditions.

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 TEPMETKO contains

• The active substance is tepotinib. Each film-coated tablet contains 225 mg 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.

What TEPMETKO looks like and contents of the pack TEPMETKO film-coated tablets are white-pink, oval, biconvex, approximately 18x9 mm in size and embossed with M on one side and plain on the other side. Each pack contains 60 tablets in a transparent blister, which consists of a multilayer composite form foil and an aluminium lidding.

Marketing Authorisation Holder Merck Europe B.V. Gustav Mahlerplein 1082 MA Amsterdam The Netherlands

Manufacturer Merck Healthcare KGaA Frankfurter Strasse 64293 Darmstadt Germany

This leaflet was last revised in

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