Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - scemblix

Document Subject

Generated Narrative: MedicinalProductDefinition mp43a04579e02ef19c7380d883dba8b26f

identifier: http://ema.europa.eu/identifier/EU/1/22/1670/001-005

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Scemblix 20 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-43a04579e02ef19c7380d883dba8b26f

identifier: http://ema.europa.eu/identifier/EU/1/22/1670/001-005

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - scemblix

Attesters

What is in this leaflet

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

What Scemblix is Scemblix contains the active substance asciminib, which belongs to a group of medicines called protein kinase inhibitors.

What Scemblix is used for Scemblix is a cancer medicine used to treat adults with a type of blood cancer (leukaemia) called Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP). It is given to patients who were previously treated with two or more cancer medicines called tyrosine kinase inhibitors.

How Scemblix works In Ph+ CML, the body produces large numbers of abnormal white blood cells. Scemblix blocks the action of a protein (BCR::ABL1) that is produced by these abnormal white blood cells and stops their division and growth.

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

Do not take Scemblix

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

Warnings and precautions Talk to your doctor or pharmacist before taking Scemblix if any of the following applies to you:

• if you have or have ever had severe upper stomach pain that could be due to problems with your pancreas (inflamed pancreas, pancreatitis).
• if you have ever had or might now have a hepatitis B infection. This is because Scemblix could cause hepatitis B to become active again. You will be carefully checked by your doctor for signs of this infection before treatment is started.

Tell your doctor or pharmacist immediately if you get any of the following during treatment with Scemblix:

• if you experience weakness, spontaneous bleeding or bruising and frequent infections with signs such as fever, chills, sore throat or mouth ulcers. These can be signs of decreased bone marrow activity, resulting in myelosuppression (a reduction in the number of white blood cells, red blood cells and platelets).
• if blood tests show that you have high levels of enzymes called lipase and amylase (signs of damage to the pancreas, also known as pancreatic toxicity).
• if you have a heart disorder or a heart rhythm disorder, such as an irregular heartbeat or an abnormal electrical activity of the heart called QT interval prolongation that can be seen on an electrocardiogram (ECG).
• if blood tests show that you have a low level of potassium or magnesium (hypokalaemia or hypomagnesaemia).
• if you are being treated with medicines that may have an unwanted effect on the function of the heart (torsades de pointes) (see Other medicines and Scemblix ).
• if you experience headache, dizziness, chest pain or shortness of breath (possible signs of high blood pressure, also known as hypertension).

Monitoring during your treatment with Scemblix Your doctor will regularly monitor your condition to check that the treatment is having the desired effect. You will have regular tests including blood tests during treatment. These tests will monitor:

• the amount of blood cells (white blood cells, red blood cells and platelets).
• the levels of pancreas enzymes (amylase and lipase).
• the levels of electrolytes (potassium, magnesium).
• your heart rate and blood pressure.

Children and adolescents Do not give this medicine to children or adolescents aged under 18 years.

Other medicines and Scemblix Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are using:

• medicines usually used to treat seizures (fits), such as carbamazepine, phenobarbital or phenytoin.
• medicines used to treat pain and/or as sedatives before or during medical or surgical procedures, such as alfentanil or fentanyl.
• medicines used to treat migraine or dementia, such as dihydroergotamine or ergotamine.
• medicines that may have an unwanted effect on the electrical activity of the heart (torsades de pointes), such as bepridil, chloroquine, clarithromycin, halofantrine, haloperidol, methadone, moxifloxacin or pimozide.
• medicines used to reduce the blood s ability to clot, such as warfarin.
• medicines used to treat severe inflammation of the bowel or severe rheumatic joint inflammation, such as sulfasalazine.
• medicines used to treat cancer, severe rheumatic joint inflammation or psoriasis, such as methotrexate.
• medicines used to reduce blood cholesterol levels, such as pravastatin, atorvastatin, pitavastatin, rosuvastatin and simvastatin.
• St. John s wort (also known as Hypericum perforatum), a herbal medicine used to treat depression. If you are already taking Scemblix, you should tell your doctor if you are prescribed any new medicine.

Ask your doctor or pharmacist if you are not sure whether your medicine is one of the medicines listed above.

Scemblix with food and drink Do not take this medicine with food. Take it at least 2 hours after and 1 hour before any food. For more information, see When to take Scemblix in section 3. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy Scemblix may harm your unborn baby. If you are a woman who could become pregnant, your doctor will discuss with you the potential risks of taking it during pregnancy or breast-feeding.

If you are a woman who could become pregnant, your doctor may perform a pregnancy test before starting treatment with Scemblix.

If you do become pregnant, or think you may be pregnant, after starting treatment with Scemblix, tell your doctor straight away.

Contraceptive advice for women If you are a woman who could become pregnant, you should use an effective method of contraception during treatment with Scemblix and for at least 3 days after you stop taking it to avoid becoming pregnant. Ask your doctor about effective methods of contraception.

Breast-feeding It is not known if Scemblix passes into breast milk. Therefore, you should discontinue breast-feeding while you are taking it and for at least 3 days after you stop taking it.

Driving and using machines This medicine has no or negligible influence on the ability to drive and use machines. If you experience side effects (such as dizziness or visual disorders) with a potential impact on the ability to safely drive or use any tools or machines after taking this medicine, you should refrain from these activities until the effect has disappeared.

Scemblix contains lactose and sodium If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, 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.

How much Scemblix to take Your doctor will tell you exactly how many tablets you should take per day, and how to take them.

The recommended dose is 1 tablet of Scemblix 40 mg twice per day. Take 1 tablet, then take another one approximately 12 hours later. Depending on how you respond to treatment and on possible side effects, your doctor may ask you to change to a lower dose or to temporarily or permanently stop the treatment.

When to take Scemblix Take Scemblix:

• at least 2 hours after any food
• then wait at least 1 hour before eating again. Taking this medicine at the same time each day will help you to remember when to take it.

How to take Scemblix Swallow the tablets whole with a glass of water. Do not break, crush or chew them to ensure proper dosing.

How long to take Scemblix Continue taking this medicine for as long as your doctor tells you. This is a long-term treatment, possibly lasting for months or years. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect. If you have questions about how long to take this medicine, talk to your doctor or pharmacist.

If you take more Scemblix than you should If you have taken more tablets than you should have, or if someone else accidentally takes your medicine, contact a doctor for advice straight away. Show them the pack. Medical treatment may be necessary.

If you forget to take Scemblix If there are less than 6 hours until your next dose, skip the missed dose and then take the next one as planned. If there are more than 6 hours until your next dose, take the missed dose and then take the next one as planned.

If you stop taking Scemblix Do not stop taking this 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 experience any serious side effects, stop taking this medicine and tell your doctor immediately.

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

• spontaneous bleeding or bruising (signs of low level of platelets, thrombocytopenia)
• fever, sore throat, frequent infections (signs of low level of white blood cells, neutropenia)

Uncommon (may affect up to 1 in every 100 people)

• irregular heart-beat, change in the electrical activity of the heart (prolongation of the QT interval)
• fever above 38 C associated with a low level of white blood cells (febrile neutropenia)

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

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

• nose and throat infections (upper respiratory tract infection)
• tiredness, fatigue, pale skin (signs of low level of red blood cells, anaemia)
• headache, dizziness, chest pain, shortness of breath (signs of high blood pressure, hypertension)
• headache
• dizziness
• cough
• vomiting
• diarrhoea
• nausea
• abdominal (belly) pain
• rash
• pain in muscles, bones or joints (musculoskeletal pain)
• joint pain (arthralgia)
• tiredness (fatigue)
• itching (pruritus)

Common (may affect up to 1 in every 10 people)

• fever, coughing, difficulty breathing, wheezing (signs of lower respiratory tract infections)
• influenza
• loss of appetite
• blurred vision
• dry eyes
• palpitations
• chest pain, cough, hiccups, rapid breathing, fluid collection between the lungs and chest cavity which, if severe, could make you breathless (pleural effusion)
• shortness of breath, laboured breathing (signs of dyspnoea)
• chest pain (non-cardiac chest pain)
• severe upper stomach pain (sign of inflamed pancreas, pancreatitis)
• itchy rash (urticaria)
• fever (pyrexia)
• generalised swelling (oedema)

Uncommon (may affect up to 1 in every 100 people)

• allergic reaction which may include rash, hives, difficulty breathing or low blood pressure (hypersensitivity)

Abnormal blood test results During treatment, the results of blood tests may be abnormal, which can give your doctor information on the function of your organs. For example:

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

• high level of the enzymes lipase and amylase (pancreas function)
• high level of the enzymes transaminases, which include alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma-glutamyltransferase (GGT) (liver function)
• high level of fats/lipids

Common (may affect up to 1 in every 10 people)

• high level of the substance bilirubin (liver function)
• high level of the enzyme creatine phosphokinase (muscle function)
• high level of blood sugar

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

Do not store above 25 C.

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 Scemblix contains

• The active substance is asciminib. Each 20 mg film-coated tablet contains asciminib hydrochloride, equivalent to 20 mg asciminib. Each 40 mg film-coated tablet contains asciminib hydrochloride, equivalent to 40 mg asciminib.
• The other ingredients are: 20 mg and 40 mg film-coated tablets: lactose monohydrate, microcrystalline cellulose (E460i), hydroxypropylcellulose (E463), croscarmellose sodium (E468), polyvinyl alcohol (E1203), titanium dioxide (E171), magnesium stearate, talc (E553b), colloidal silicon dioxide, lecithin (E322), xanthan gum (E415), iron oxide red (E172). 20 mg film-coated tablets only: iron oxide yellow (E172) 40 mg film-coated tablets only: iron oxide black (E172). See Scemblix contains lactose and sodium in section 2. What Scemblix looks like and contents of the pack Scemblix 20 mg film-coated tablets (tablets): pale yellow, round, biconvex tablet with bevelled edges of approximately 6 mm diameter, debossed with company logo on one side and 20 on the other side.

Scemblix 40 mg film-coated tablets (tablets): violet white, round, biconvex tablet with bevelled edges of approximately 8 mm diameter, debossed with company logo on one side and 40 on the other side.

Scemblix is supplied in blisters containing 10 film-coated tablets.

The following pack sizes are available: Packs containing 20 or 60 film-coated tablets.

Scemblix 40 mg film-coated tablets are also available in multipacks containing 180 (3 packs of 60) 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 Farmac utica S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

Novartis Pharma GmbH Roonstrasse 90429 Nuremberg Germany

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: