Zykadia

Package leaflet: Information for the patient

Zykadia 150 mg hard capsules

ceritinib
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Zykadia is and what it is used for

What Zykadia is
Zykadia is an anticancer medicine that contains the active substance ceritinib. It is used to treat
adults with advanced stages of a type of lung cancer called non-small cell lung cancer (NSCLC). Zykadia is given only to patients whose disease is caused by a
defect in a gene called ALK (anaplastic lymphoma kinase).
How Zykadia works
In patients with ALK defects, an abnormal protein is produced that stimulates the growth of
cancer cells. Zykadia blocks the action of this abnormal protein and thereby slows the growth and
spread of NSCLC.
If you have any questions about how Zykadia works or why this medicine has been prescribed for you,
ask your doctor or pharmacist.

2. What you need to know before taking Zykadia

Do not take Zykadia

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Zykadia:

• if you have liver problems.
• if you have lung problems or breathing difficulties.
• if you have heart problems, including a slow heart rate, or if an electrocardiogram (ECG) has shown that you have an abnormality in the heart's electrical activity called "QT prolongation".
• if you have diabetes (high blood sugar levels).
• if you have pancreatic problems.
• if you are currently taking steroids.

Immediately inform your doctor or pharmacist if you experience any of the following signs or symptoms during treatment with Zykadia:

• fatigue, itching, yellowing of the skin or whites of the eyes, nausea (feeling unwell) or vomiting, loss of appetite, pain in the right side of the abdomen (belly), dark or brown-colored urine, increased tendency to bleed or bruise. These may be signs or symptoms of liver problems.
• new or worsening cough with or without mucus, fever, chest pain, difficulty breathing or shortness of breath. These may be symptoms of lung problems.
• chest pain or discomfort, changes in heartbeat (fast or slow), feeling lightheaded, fainting, dizziness, blue-colored lips, shortness of breath, swelling in the lower limbs or skin. These may be signs or symptoms of heart problems.
• severe diarrhea, nausea or vomiting. These may be symptoms of digestive problems.
• excessive thirst or increased frequency of urination. These may be symptoms of high blood sugar levels. Your doctor may need to temporarily or permanently modify or discontinue Zykadia.

Blood tests during treatment with Zykadia
Your doctor will perform blood tests before starting treatment, every 2 weeks during the first 3 months of treatment, and then monthly thereafter. The purpose of these tests is to monitor liver function. Before starting treatment with Zykadia and regularly during treatment, your doctor should also perform blood tests to monitor pancreatic function and blood sugar levels.

Children and adolescents
Zykadia is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Zykadia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines such as vitamins or herbal supplements, as they may interact with Zykadia. It is particularly important that you inform your doctor about each of the following medicines.

Medicines that may increase the risk of side effects with Zykadia:

• medicines used to treat AIDS/HIV (e.g. ritonavir, saquinavir).
• medicines used to treat infections. These include antifungal medicines (such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines used to treat certain bacterial infections (antibiotics such as telithromycin).

The following medicines may reduce the effectiveness of Zykadia:

• St. John’s wort, a herbal medicine used to treat depression.
• medicines used to prevent epileptic seizures (antiepileptics such as phenytoin, carbamazepine, or phenobarbital).
• medicines used to treat tuberculosis (e.g. rifampicin, rifabutin).

Zykadia may increase the side effects associated with the following medicines:

• medicines used to treat irregular heartbeat or other heart problems (e.g. amiodarone, disopyramide, procainamide, quinidine, sotalol, dofetilide, ibutilide, and digoxin).
• medicines used to treat stomach problems (e.g. cisapride).
• medicines used to treat mental health conditions (e.g. haloperidol, droperidol, pimozide).
• medicines used to treat depression (e.g. nefazodone).
• midazolam, a medicine used to treat acute seizures or as a sedative before or during surgical procedures or medical interventions.
• warfarin and dabigatran, medicines used to prevent blood clots.
• diclofenac, a medicine used to treat pain and joint inflammation.
• alfentanil and fentanyl, medicines used to treat severe pain.
• ciclosporin, sirolimus, and tacrolimus, medicines used in organ transplants to prevent rejection of transplanted organs.
• dihydroergotamine and ergotamine, medicines used to treat migraine.
• domperidone, a medicine used to treat nausea and vomiting.
• moxifloxacin and clarithromycin, medicines used to treat bacterial infections.
• methadone, a medicine used to treat pain and opioid dependence.
• chloroquine and halofantrine, medicines used to treat malaria.
• topotecan, a medicine used to treat certain types of cancer.
• colchicine, a medicine used to treat gout.
• pravastatin and rosuvastatin, medicines used to lower cholesterol levels.
• sulfasalazine, a medicine used to treat inflammatory bowel diseases or rheumatoid arthritis.

Ask your doctor or pharmacist if you are unsure whether a medicine you are taking is one of those listed above.
These medicines should be used with caution or may need to be avoided during treatment with Zykadia. If you are taking any of these medicines, your doctor may need to prescribe an alternative medicine.
If you are already taking Zykadia, inform your doctor whenever you are prescribed a new medicine that you have not previously taken together with Zykadia.

Oral contraceptives
If you are taking Zykadia while using oral contraceptives, the oral contraceptives may become ineffective.

Zykadia with food and drink
Do not eat grapefruit or drink grapefruit juice during treatment. It may increase the amount of Zykadia in your blood to a harmful level.

Pregnancy and breastfeeding
You must use an effective method of contraception during treatment with Zykadia and for 3 months after the end of treatment. Ask your doctor which contraceptive methods are most suitable for you.
Zykadia is not recommended during pregnancy unless the potential benefit outweighs the potential risk to the fetus. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine. Your doctor will discuss with you the potential risks of taking Zykadia during pregnancy.
Zykadia must not be used during breastfeeding. You and your doctor will decide whether you should breastfeed or take Zykadia. You must not do both.

Driving and using machines
Exercise great caution when driving or operating machinery while taking Zykadia, as this medicine may cause visual disturbances or fatigue.

Zykadia contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially "sodium-free".

3. How to take Zykadia

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.

How much to take

• The recommended dose is 450 mg (three capsules) taken once daily with food, although your doctor may adjust this recommendation if necessary. Your doctor will tell you exactly how many capsules you need to take. Do not change the dose without consulting your doctor.
• Take Zykadia once daily at the same time each day with food (for example, a snack or a full meal). If you are unable to eat when taking Zykadia, speak with your doctor.
• Swallow the capsules whole with water. Do not chew or crush them.
• If you vomit after swallowing the Zykadia capsules, do not take another dose until your next scheduled dose.

How long to take Zykadia

• Continue taking Zykadia for as long as your doctor tells you to.
• This is a long-term treatment that may last for months. Your doctor will monitor your condition and check that the treatment is having the desired effect.

If you have any doubts about how long to take Zykadia, ask your doctor or pharmacist.

If you take more Zykadia than you should
If you accidentally take too many capsules, or if someone else accidentally takes your medicine, contact a doctor or hospital immediately for advice. Medical treatment may be necessary.

If you forget to take Zykadia
What you should do if you miss a dose depends on how long it is until your next dose.

• If your next dose is 12 or more hours away, take the missed capsules as soon as you remember. Take the following doses at your usual time.
• If your next dose is less than 12 hours away, skip the missed capsules. Take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Zykadia
Do not stop taking this medicine without first talking to your doctor.
If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP taking Zykadia and contact your doctor immediately if you experience any of the
following side effects, which may be signs of an allergic reaction:

• Difficulty breathing or swallowing
• Swelling of the face, lips, tongue or throat
• Severe itching of the skin, with a red rash or swellings

Some side effects may be serious
If you experience any of the following side effects, inform your doctor or pharmacist immediately:

• Chest pain or discomfort, changes in heartbeat (fast or slow), feeling of dizziness, fainting, lightheadedness, bluish discoloration of the lips, shortness of breath, swelling of the lower limbs or skin (signs or symptoms of possible heart problems)
• New or worsening cough with or without mucus, fever, chest pain, difficulty breathing or shortness of breath (signs of possible lung problems)
• Fatigue, itching, yellowing of the skin or whites of the eyes, nausea or vomiting, loss of appetite, pain in the right side of the abdomen, dark or brown urine, increased tendency to bleed or bruise easily (potential signs or symptoms of liver problems)
• Severe diarrhoea, nausea or vomiting
• Excessive thirst, increased frequency of urination (symptoms of high blood sugar levels)
• Severe pain in the upper abdomen (sign of inflammation of the pancreas, also known as pancreatitis)

Other possible side effects
Other side effects are listed below. If any of these side effects become severe, inform your doctor or pharmacist.
Very common (may affect more than 1 in 10 people):

• Fatigue (tiredness and asthenia)
• Abnormal blood test results to monitor liver function (elevated levels of enzymes called alanine aminotransferase and/or aspartate aminotransferase and/or gamma-glutamyl transferase and/or alkaline phosphatase in the blood, elevated bilirubin levels)
• Abdominal pain
• Decreased appetite
• Weight loss
• Constipation
• Rash
• Abnormal blood test results to monitor kidney function (elevated creatinine levels)
• Heartburn (potential sign of a gastrointestinal disorder)
• Reduction in red blood cell count, a condition known as anaemia

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

• Vision problems
• Low levels of phosphate in the blood (this may be detected during blood tests)
• Increased blood levels of enzymes called lipase and/or amylase (which may be detected by blood tests)
• Markedly reduced urine output (potential sign of kidney problems)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zykadia

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister pack after (Exp./EXP). The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice any damage to the packaging or signs of tampering.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zykadia contains

• The active substance in Zykadia is ceritinib. Each hard capsule contains 150 mg of ceritinib.
• The other components are:
• Capsule contents: colloidal anhydrous silica; low-substituted hydroxypropylcellulose; sodium starch glycolate (type A) (see “Zykadia contains sodium” in section 2); magnesium stearate; microcrystalline cellulose.
• Capsule shell: gelatin, indigo carmine (E132), and titanium dioxide (E171).
• Printing ink: Shellac 45% glaze (bleached, de-waxed), iron oxide black (E172), propylene glycol, and 28% ammonium hydroxide.

Description of the appearance of Zykadia and contents of the pack
Zykadia hard capsules have an opaque white body and an opaque blue cap, approximately 23.3 mm in length, with “LDK 150MG” printed on the cap and “NVR” on the body. They contain a white to almost white powder.
The capsules are supplied in blisters and available in packs containing 40, 90 or 150 (3 packs of 50) capsules. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharmaceuticals S.R.L.
Str. Livezeni nr. 7A
540472 Targu Mures
Romania

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:
België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50
България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11
Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00
Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872
Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 555
Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00
Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570
España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888
France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600
Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01
Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50
Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439
Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200
Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00
Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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

Package leaflet: Information for the patient

Zykadia 150 mg film-coated tablets

ceritinib
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Zykadia is and what it is used for

What Zykadia is
Zykadia is an anticancer medicine containing the active substance ceritinib. It is used to treat
adult patients with advanced stages of a type of lung cancer called non-small cell lung cancer (NSCLC).
Zykadia is given only to patients whose disease is caused by a defect in a gene called ALK (anaplastic lymphoma kinase).
How Zykadia works
In patients with ALK defects, an abnormal protein is produced that stimulates the growth of cancer cells.
Zykadia blocks the action of this abnormal protein, thereby slowing the growth and spread of NSCLC.
If you have any questions about how Zykadia works or why this medicine has been prescribed for you,
please consult your doctor or pharmacist.

2. What you need to know before taking Zykadia

Do not take Zykadia

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Zykadia:

• if you have liver problems.
• if you have lung problems or breathing difficulties.
• if you have heart problems, including a slow heart rate, or if the results of an electrocardiogram (ECG) have shown that you have an electrical heart abnormality called "QT interval prolongation".
• if you have diabetes (high blood sugar levels).
• if you have pancreatic problems.
• if you are currently taking steroids.

Inform your doctor or pharmacist immediately if you experience any of the following signs or symptoms during treatment with Zykadia:

• fatigue, itching, yellowing of the skin or whites of the eyes, nausea (feeling unwell) or vomiting, loss of appetite, pain in the right side of the abdomen (stomach), dark or brown urine, increased tendency to bleed or bruise. These may be signs or symptoms of liver problems.
• onset or worsening of cough with or without mucus, fever, chest pain, difficulty breathing or shortness of breath. These may be symptoms of lung problems.
• chest pain or discomfort, changes in heartbeat (fast or slow), feeling lightheaded, fainting, dizziness, blue-colored lips, shortness of breath, swelling in the lower limbs or skin. These may be signs or symptoms of heart problems.
• severe diarrhea, nausea or vomiting. These may be symptoms of digestive problems.
• excessive thirst or increased frequency of urination. These may be symptoms of high blood sugar levels. Your doctor may need to temporarily or permanently modify or discontinue Zykadia.

Blood tests during treatment with Zykadia
Your doctor must perform blood tests before starting treatment, every 2 weeks during the first three months of treatment, and then monthly. The purpose of these tests is to monitor liver function. Before starting treatment with Zykadia and regularly during treatment, your doctor should also perform blood tests to monitor pancreatic function and blood sugar levels.

Children and adolescents
Zykadia is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Zykadia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription such as vitamins or herbal supplements, as they may interact with Zykadia. It is particularly important that you list each of the following medicines.

Medicines that may increase the risk of side effects with Zykadia:

• medicines used to treat AIDS/HIV (e.g., ritonavir, saquinavir).
• medicines used to treat infections. These include antifungal medicines for fungal infections (antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines for treating certain types of bacterial infections (antibiotics such as telithromycin).

The following medicines may reduce the effectiveness of Zykadia:

• St. John’s wort, an herbal medicine used to treat depression.
• medicines used to prevent epileptic seizures (antiepileptics such as phenytoin, carbamazepine, or phenobarbital).
• medicines used to treat tuberculosis (e.g., rifampicin, rifabutin).

Zykadia may increase the side effects associated with the following medicines:

• medicines used to treat irregular heartbeat or other heart problems (e.g., amiodarone, disopyramide, procainamide, quinidine, sotalol, dofetilide, ibutilide, and digoxin).
• medicines used to treat stomach problems (e.g., cisapride).
• medicines used to treat mental health disorders (e.g., haloperidol, droperidol, pimozide).
• medicines used to treat depression (e.g., nefazodone).
• midazolam, a medicine used to treat acute seizures or as a sedative before or during surgery or medical procedures.
• warfarin and dabigatran, medicines used to prevent blood clots.
• diclofenac, a medicine used to treat pain and joint inflammation.
• alfentanil and fentanyl, medicines used to treat severe pain.
• cyclosporine, sirolimus, and tacrolimus, medicines used in organ transplants to prevent rejection of transplanted organs.
• dihydroergotamine and ergotamine, medicines used to treat migraine.
• domperidone, a medicine used to treat nausea and vomiting.
• moxifloxacin and clarithromycin, medicines used to treat bacterial infections.
• methadone, a medicine used to treat pain and opioid dependence.
• chloroquine and halofantrine, medicines used to treat malaria.
• topotecan, a medicine used to treat certain types of cancer.
• colchicine, a medicine used to treat gout.
• pravastatin and rosuvastatin, medicines used to lower cholesterol levels.
• sulfasalazine, a medicine used to treat inflammatory bowel diseases or rheumatoid arthritis.

Ask your doctor or pharmacist if you are unsure whether the medicine you are taking is one of those listed above.
These medicines should be used with caution or may need to be avoided during treatment with Zykadia. If you are taking any of these medicines, your doctor may need to prescribe an alternative.
If you are already taking Zykadia, inform your doctor whenever you are prescribed a new medicine that you have not previously taken concurrently with Zykadia.

Oral contraceptives
If you are taking Zykadia while using oral contraceptives, the oral contraceptives may become ineffective.

Zykadia with food and drink
Do not eat grapefruit or drink grapefruit juice during treatment. It may increase the amount of Zykadia in your blood to a harmful level.

Pregnancy and breastfeeding
You must use an effective method of contraception during treatment with Zykadia and for 3 months after the end of treatment. Ask your doctor which contraceptive methods are most suitable for you.
Zykadia is not recommended during pregnancy unless the potential benefit outweighs the potential risk to the unborn child. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine. Your doctor will discuss with you the potential risks of taking Zykadia during pregnancy.
Zykadia must not be used during breastfeeding. You and your doctor will decide whether you should breastfeed or take Zykadia. You must not do both.

Driving and using machines
Exercise caution when driving or operating machinery while taking Zykadia, as this medicine may cause visual disturbances or fatigue.

Zykadia contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Zykadia

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.

How much to take

• The recommended dose is 450 mg (three tablets) taken once daily with food, although your doctor may adjust this recommendation if necessary. Your doctor will tell you exactly how many tablets you need to take. Do not change the dose without consulting your doctor.
• Take Zykadia once daily at the same time each day with food (for example, a snack or a full meal). If you are unable to eat when taking Zykadia, speak with your doctor.
• Swallow the tablets whole with water. Do not chew or crush them.
• If you vomit after swallowing Zykadia tablets, do not take another dose until your next scheduled dose.

How long to take Zykadia

• Continue taking Zykadia for as long as your doctor tells you to.
• This is a long-term treatment, which may last for months. Your doctor will monitor your condition and check that the treatment is having the desired effect.

If you have any questions about how long to take Zykadia, ask your doctor or pharmacist.

If you take more Zykadia than you should
If you accidentally take too many tablets, or if someone else accidentally takes your medicine, contact a doctor or hospital immediately for advice. Medical treatment may be necessary.

If you forget to take Zykadia
What you should do if you forget a dose depends on how long it is until your next scheduled dose.

• If your next dose is 12 hours or more away, take the missed tablets as soon as you remember. Take the next dose at your usual time.
• If your next dose is less than 12 hours away, skip the missed tablets. Take the next dose at your usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Zykadia
Do not stop taking this medicine without first talking to your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
STOP taking Zykadia and contact your doctor immediately if you experience any of the following
side effects, which may be signs of an allergic reaction:

• Difficulty breathing or swallowing
• Swelling of the face, lips, tongue, or throat
• Severe itching of the skin, with a red rash or swellings

Some side effects may be serious
If you experience any of the following side effects, inform your doctor or pharmacist immediately:

• Chest pain or discomfort, changes in heartbeat (fast or slow), feeling of dizziness, fainting, lightheadedness, bluish discoloration of the lips, shortness of breath, swelling of the lower limbs or skin (signs or symptoms of possible heart problems)
• New or worsening cough with or without mucus, fever, chest pain, difficulty breathing or shortness of breath (signs of possible lung problems)
• Fatigue, itching, yellowing of the skin or whites of the eyes, nausea or vomiting, loss of appetite, pain in the right side of the abdomen (stomach), dark or brown-colored urine, increased tendency to bleed or bruise (potential signs or symptoms of liver problems)
• Severe diarrhoea, nausea, or vomiting
• Excessive thirst, increased frequency of urination (symptoms of high blood sugar levels)
• Severe pain in the upper abdomen (sign of inflammation of the pancreas, also known as pancreatitis)

Other possible side effects
Other possible side effects are listed below. If any of these side effects become severe, inform your doctor or pharmacist.
Very common (may affect more than 1 in 10 users):

• Fatigue (tiredness and asthenia)
• Abnormal blood test results used to monitor liver function (elevated levels of enzymes called alanine aminotransferase and/or aspartate aminotransferase and/or gamma-glutamyl transferase and/or alkaline phosphatase, elevated bilirubin levels)
• Abdominal pain
• Decreased appetite
• Weight loss
• Constipation
• Rash
• Abnormal blood test results used to monitor kidney function (elevated creatinine levels)
• Heartburn (potential sign of a gastrointestinal disorder)
• Reduction in red blood cell count, a condition known as anaemia

Common (may affect up to 1 in 10 users):

• Vision problems
• Low levels of phosphate in the blood (this may be detected during blood tests)
• Increased blood levels of enzymes called lipase and/or amylase (which may be detected by blood tests)
• Markedly reduced urine flow (potential sign of kidney problems)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zykadia

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after (Exp./EXP). The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice damage to the packaging or any signs of tampering.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zykadia contains

• The active substance in Zykadia is ceritinib. Each film-coated tablet contains 150 mg of ceritinib.
• The other components are:
• Tablet core: microcrystalline cellulose; low-substituted hydroxypropylcellulose; povidone; sodium croscarmellose (see “Zykadia contains sodium” in section 2); magnesium stearate, anhydrous colloidal silicon dioxide.
• Film coating: hypromellose, titanium dioxide (E171), macrogol, talc, indigo carmine aluminium lake (E132).

Description of the appearance of Zykadia and the contents of the pack
The film-coated tablets (tablets) of Zykadia are light blue, round (approximate diameter: 9.1 mm), biconvex with bevelled edges, without sharp corners, printed with "NVR" on one side and "ZY1" on the other side.
The tablets are supplied in blisters and are available in a pack containing 84 tablets (4 blisters of 21 tablets each).

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Pharmaceutical Manufacturing LLC
Verovškova ulica 57
1000 Ljubljana
Slovenia
Lek farmacevtska družba d.d., Poslovna enota PROIZVODNJA LENDAVA
Trimlini 2D
9220 Lendava
Slovenia
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 555

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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