NILOTINIB ZENTIVA 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Nilotinib Zentiva 150mg hard capsules EFG

Nilotinib Zentiva 200mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Nilotinib Zentiva and what is it used for

What is Nilotinib Zentiva

Nilotinib Zentiva is a medicine that contains the active substance nilotinib.

What is Nilotinib Zentiva used for

Nilotinib is used to treat a type of leukaemia called Philadelphia chromosome-positive chronic myeloid leukaemia (CML). CML is a cancer of the blood that causes the body to produce too many abnormal white blood cells.

Nilotinib is used in adult and child patients with newly diagnosed CML or in patients with CML who are no longer benefiting from previous treatment, including imatinib. It is also used in adult and child patients who have experienced severe side effects with previous treatment and cannot continue taking it.

How Nilotinib Zentiva works

In patients with CML, a change in the DNA (genetic material) creates a signal that causes the body to produce abnormal white blood cells. Nilotinib blocks this signal and therefore interrupts the production of these cells.

Monitoring during treatment with Nilotinib Zentiva

During treatment, regular checks will be carried out, including blood tests. These tests will monitor:

• the number of blood cells in the body (white blood cells, red blood cells, and platelets) to check if nilotinib is being well tolerated.
• the function of the pancreas and liver to check if Nilotinib Zentiva is being well tolerated.
• the body's electrolytes (potassium, magnesium). These are important for the heart to work properly.
• the level of sugar and fats in the blood.
• The heart rate will also be checked using a machine that measures the heart's electrical activity (a test called an “ECG”).

Your doctor will regularly assess your treatment and decide if you should continue taking nilotinib. If they tell you to stop taking this medicine, they will continue to monitor your CML and, if necessary, may tell you to restart treatment with Nilotinib Zentiva.

If you have any questions about how Nilotinib Zentiva works or why it has been prescribed for you or your child, ask your doctor.

2. What you need to know before you take Nilotinib Zentiva

Follow carefully all instructions given by your doctor, even if they are different from the general information contained in this leaflet.

Do not take Nilotinib Zentiva

• if you are allergic to nilotinib or any of the other ingredients of this medicine (listed in section 6).
  • If you think you may be allergic, tell your doctor before taking Nilotinib Zentiva.

Warnings and precautions

Tell your doctor or pharmacist before starting treatment with Nilotinib Zentiva:

• if you have previously experienced cardiovascular events such as a heart attack, chest pain (angina), problems with blood flow to the brain (stroke) or problems with blood flow to the leg (peripheral arterial disease) or if you have risk factors for cardiovascular disease such as high blood pressure, diabetes, or problems with fat levels in the blood.
• if you have a heart condition, such as an abnormal electrical signal called “prolonged QT interval”.
• if you are taking treatment with medicinesthat lower cholesterol levels in the blood (statins) or that affect heart rhythm (anti-arrhythmics) or liver function (see Other medicines and Nilotinib Zentiva).
• if you have low levels of potassium or magnesium in the blood.
• if you have liver or pancreas problems.
• if you experience symptoms such as easy bruising, feeling tired, or difficulty breathing or have had repeated infections.
• if you have had surgery to remove the entire stomach (total gastrectomy).
• if you have ever had or may currently have a hepatitis B virus infection. This is because nilotinib could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor will carefully check for signs of this infection before starting treatment.

If any of these conditions apply to you or your child, tell your doctor.

During treatment with Nilotinib Zentiva

• if you experience fainting (loss of consciousness) or have an irregular heartbeat while taking this medicine, tell your doctor immediatelyas this may be a sign of a serious heart problem. Prolongation of the QT interval or an irregular heartbeat can cause sudden death. There have been reports of rare cases of sudden death in patients taking this medicine.
• if you experience sudden heart palpitations, severe muscle weakness, or paralysis, seizures, or sudden changes in behaviour or level of alertness, tell your doctor immediatelyas this may be a sign of a rapid breakdown of cancer cells called tumour lysis syndrome. There have been reports of rare cases of tumour lysis syndrome in patients treated with nilotinib.
• if you develop chest pain or discomfort, numbness or weakness, walking problems, or speech problems, pain, discolouration, or a feeling of coldness in a limb, tell your doctor immediatelyas this may be a sign of a cardiovascular event. There have been reports of serious cardiovascular events, including problems with blood flow to the leg (peripheral arterial disease), heart disease, and problems with blood flow to the brain (ischaemic cerebrovascular disease) in patients taking this medicine. Your doctor should check your fat and sugar levels in the blood before starting treatment with nilotinib and during treatment.
• if you develop swelling of the feet or hands, general swelling, or rapid weight gain, tell your doctor as these may be signs of serious fluid retention. There have been reports of rare cases of serious fluid retention in patients treated with nilotinib.

If you are the parent of a child being treated with Nilotinib Zentiva, tell the doctor if any of the above conditions occur in your child.

Children and adolescents

Nilotinib Zentiva is used to treat children and adolescents with CML. There is no experience with the use of this medicine in children under 2 years of age. There is limited experience with the use of this medicine in children under 10 years of age with newly diagnosed CML and in children under 6 years of age who are not benefiting from previous treatment for CML.

Some children and adolescents taking Nilotinib Zentiva may experience slower than normal growth. Your doctor will monitor growth during regular check-ups.

Other medicines and Nilotinib Zentiva

Nilotinib Zentiva may interfere with some medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These include, in particular:

• anti-arrhythmics – used to treat irregular heartbeat;
• chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin – medicines that may have an unwanted effect on the heart's electrical activity;
• ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat infections;
• ritonavir – a protease inhibitor used to treat HIV;
• carbamazepine, phenobarbital, phenytoin – used to treat epilepsy;
• rifampicin – used to treat tuberculosis;
• St. John's Wort – a herbal product used to treat depression and other conditions (also known as Hypericum perforatum);
• midazolam – used to relieve anxiety before surgery;
• alfentanil and fentanyl – used to treat pain and as sedatives before or during surgery or medical procedures;
• cyclosporin, sirolimus, and tacrolimus – medicines that suppress the body's immune system and are used to prevent organ rejection in transplant patients;
• dihydroergotamine and ergotamine – used to treat dementia;
• lovastatin, simvastatin – used to treat high levels of fats in the blood;
• warfarin – used to treat blood clotting disorders;
• astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, or ergot alkaloids (ergotamine, dihydroergotamine).

These medicines should be avoided during treatment with nilotinib. If you are taking any of these medicines, your doctor may prescribe alternative medicines.

If you are taking statins (a type of medicine that lowers cholesterol levels in the blood), talk to your doctor or pharmacist. If you take nilotinib with certain statins, this may increase the risk of muscle problems associated with statins, which can rarely cause serious muscle damage (rhabdomyolysis) that can lead to kidney damage.

Also, tell your doctor or pharmacist before taking nilotinib if you are taking any antacids, which are medicines used to treat stomach acidity. These medicines should be taken separately from nilotinib:

• H2 blockers, which reduce stomach acid production. H2 blockers should be taken approximately 10 hours before and approximately 2 hours after taking nilotinib;
• antacids such as those containing aluminium hydroxide, magnesium hydroxide, and simethicone, which neutralize high stomach acidity. These antacids should be taken approximately 2 hours before or approximately 2 hours after taking nilotinib.

You should also tell your doctor if you are already taking Nilotinib Zentivaand are prescribed a new medicine that you have not taken before during treatment with nilotinib.

Taking Nilotinib Zentiva with food and drinks

Do not take Nilotinib Zentiva with food.Food can increase the absorption of this medicine and therefore increase the amount of nilotinib in the blood, possibly to a dangerous level. Do not drink grapefruit juice or eat grapefruit. It can increase the amount of nilotinib in the blood, possibly to a dangerous level.

Pregnancy and breast-feeding

• Nilotinib should not be used during pregnancyunless clearly necessary. If you are pregnant or think you may be pregnant, tell your doctor, who will discuss with you whether you can take this medicine during pregnancy.
• Women who can become pregnantmust use highly effective contraception during treatment and for up to 2 weeks after finishing treatment.
• Breast-feeding is not recommendedduring treatment with nilotinib and for 2 weeks after the last dose. Tell your doctor if you are 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.

Driving and using machines

If you experience side effects (such as dizziness or vision problems) that may affect your ability to drive safely or use tools or machines after taking this medicine, you should avoid these activities until the effect has stopped.

Nilotinib Zentiva contains lactose

This medicine contains lactose (also known as milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Nilotinib Zentiva 200 mg hard capsules contain sodium and red iron oxide (Allura AC)

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially “sodium-free”.

The colouring agent red iron oxide (Allura AC) may cause allergic reactions.

3. How to take Nilotinib Zentiva

Follow exactly the administration instructions given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

How much Nilotinib Zentiva to take

Adult use

• Patients with newly diagnosed CML:The recommended dose is 600 mg per day. The dose is achieved by taking two 150 mg hard capsules, twice a day.
• Patients with CML who are not benefiting from previous treatment:The recommended dose is 800 mg per day. This dose is achieved by taking two 200 mg capsules, twice a day.

Use in children and adolescents

• The dose given to your child will depend on their body weight and height. The doctor will calculate the correct dose to be used and tell you which and how many Nilotinib Zentiva capsules to give to your child. The total daily dose given to your child should not exceed 800 mg.

Your doctor may prescribe a lower dose depending on how you respond to treatment.

Elderly patients (65 years or older)

Nilotinib Zentiva can be used in patients 65 years or older at the same dose as other adults.

When to take Nilotinib Zentiva

Take the hard capsules:

• twice a day (approximately every 12 hours);
• at least 2 hours after eating;
• and then wait 1 hour before eating again.

Ask your doctor or pharmacist if you have any doubts about when to take this medicine. Taking Nilotinib Zentiva at the same time every day will help you remember when to take the hard capsules.

How to take Nilotinib Zentiva

• Swallow the hard capsules whole with water.
• Do not take any food with the hard capsules.
• Do not open the hard capsules. If you or your child have difficulty swallowing the capsule whole, you should use other nilotinib medicines instead of Nilotinib Zentiva.

How long to take Nilotinib Zentiva

Take Nilotinib Zentiva every day for as long as your doctor tells you. This is a long-term treatment. Your doctor will regularly check your condition to see if the treatment is having the desired effect.

Your doctor may consider stopping your treatment with this medicine based on specific criteria. If you have doubts about how long you should take Nilotinib Zentiva, ask your doctor.

If you take more Nilotinib Zentiva than you should

If you have taken more Nilotinib Zentiva than you should, or if someone else has taken your hard capsules by mistake, contact a doctor or hospital straight away. Show the pack of hard capsules and this leaflet. You may need medical treatment.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Nilotinib Zentiva

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed capsule.

If you stop taking Nilotinib Zentiva

Do not stop taking this medicine unless your doctor tells you to. Stopping treatment with nilotinib without your doctor's recommendation may put you at risk of your disease getting worse, which could have fatal consequences. Make sure to discuss this with your doctor, nurse, and/or pharmacist if you are thinking of stopping treatment with this medicine.

If your doctor recommends stopping treatment with Nilotinib Zentiva

Your doctor will regularly assess your treatment with a specific diagnostic test and decide if you should continue taking this medicine. If they tell you to stop taking nilotinib, they will continue to monitor your CML before, during, and after stopping nilotinib and, if necessary, may tell you to restart treatment with nilotinib.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Most adverse reactions are mild to moderate and usually disappear after a few days or weeks of treatment.

Some adverse reactions can be serious.

• signs of musculoskeletal pain: pain in the joints and muscles
• signs of cardiac disorders: pain or discomfort in the chest, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (feeling of rapid heartbeats), fainting, bluish discoloration of the lips, tongue, or skin
• signs of arterial obstruction: pain, discomfort, weakness, or cramps in the leg muscles, which may be due to decreased blood flow, ulcers on the legs or arms that heal more slowly or do not heal, and noticeable changes in color (bluish or pale) or temperature (cold) in the legs, arms, toes, or fingers
• signs of hypothyroidism: weight gain, fatigue, hair loss, muscle weakness, feeling of cold
• signs of hyperthyroidism: rapid heartbeats, bulging eyes, weight loss, swelling in the front of the neck
• signs of renal or urinary tract disorders: thirst, dry skin, irritability, darkening of urine, decreased urine output, difficulty and pain when urinating, exaggerated feeling of need to urinate, blood in urine, abnormal urine color
• signs of high blood sugar levels: excessive thirst, high urine volume, increased appetite with weight loss, fatigue
• signs of vertigo: dizziness or feeling of spinning
• signs of pancreatitis: severe pain in the upper abdomen (middle or left)
• signs of skin disorders: painful red lumps, skin pain, skin redness, scaling, or blisters
• signs of water retention: rapid weight gain, swelling of hands, ankles, feet, or face
• signs of migraine: severe headache often accompanied by nausea, vomiting, and sensitivity to light
• signs of blood disorders: fever, ease of bruising or unexplained bleeding, severe or frequent infections, unexplained weakness
• signs of blood clotting within a vein: swelling and pain in a part of the body
• signs of nervous system disorders: weakness or paralysis of the limbs or face, difficulty speaking, severe headache, seeing, feeling, or hearing things that do not exist, changes in vision, loss of consciousness, confusion, disorientation, tremors, feeling of tingling, pain, or numbness in the fingers of the hands and feet
• signs of pulmonary disorders: difficulty breathing or pain when breathing, cough, wheezing with or without fever, swelling of feet or legs
• signs of gastrointestinal disorders: abdominal pain, nausea, vomiting with blood, black or bloody stools, constipation, acidity, stomach reflux, swollen abdomen
• signs of liver disorders: yellowish skin and eyes, nausea, loss of appetite, darkening of urine
• signs of liver infection: recurrence (reactivation of hepatitis B infection)
• signs of eye disorders: visual disturbances including blurred vision, double vision, or flashes of light perceived, decreased sharpness or loss of vision, blood in the eye, increased sensitivity of the eyes to light, eye pain, redness, itching, or irritation, dry eye, swelling, or itching of the eyelids
• signs of electrolyte imbalance: nausea, difficulty breathing, irregular heartbeats, cloudy urine, fatigue, and/or discomfort in the joints associated with abnormal blood test results (such as high levels of potassium, uric acid, and phosphorus and low levels of calcium)

Contact your doctor immediately if you notice any of the adverse effects described.

Some adverse reactions are very frequent(may affect more than 1 in 10 people)

• diarrhea
  • headache
  • lack of energy
  • muscle pain
  • itching, rash
  • nausea
  • constipation
  • vomiting
  • hair loss

• pain in the extremities, bone pain, and spinal pain when stopping treatment with nilotinib
• slowed growth in children and adolescents
• upper respiratory tract infection, including sore throat and nasal secretion or congestion, sneezing
• low levels of blood cells (red blood cells, platelets) or hemoglobin
• high levels of lipase in blood (pancreatic function)
• high levels of bilirubin in blood (liver function)
• high levels of alanine aminotransferases in blood (liver enzymes)

Some adverse reactions are frequent(may affect up to 1 in 10 people)

• pneumonia
• abdominal pain, stomach discomfort after meals, flatulence, abdominal swelling
• pain in the bones, muscle spasms
• pain (including pain in the neck)
• dry skin, acne, decreased skin sensitivity
• weight gain or loss
• insomnia, depression, anxiety
• night sweats, excessive sweating
• general feeling of discomfort
• nosebleeds
• signs of gout: pain and swelling in the joints
• inability to achieve or maintain an erection
• flu-like symptoms
• sore throat
• bronchitis
• ear pain, hearing noises (e.g., ringing, buzzing) that do not come from any external source (also called tinnitus)
• hemorrhoids
• heavy periods
• itching in the hair follicles
• oral or vaginal candidiasis
• signs of conjunctivitis: eye discharge with itching, redness, and swelling
• eye irritation, red eyes
• signs of hypertension: high blood pressure, headache, dizziness
• hot flashes
• signs of peripheral arterial occlusive disease: pain, discomfort, weakness, or cramps in the leg muscles, which may be due to decreased blood flow, ulcers on the legs or arms that heal slowly or do not heal, and noticeable changes in color (bluish or pale) or temperature (cold) in the legs or arms
• difficulty breathing (also called dyspnea)
• mouth sores with gum inflammation (also called stomatitis)
• high levels of amylase in blood (pancreatic function)
• high levels of creatinine in blood (renal function)
• high levels of alkaline phosphatase or creatine phosphokinase in blood
• high levels of aspartate aminotransferases (liver enzymes) in blood
• high levels of gamma-glutamyltransferase (liver enzymes) in blood
• signs of leukopenia or neutropenia: low level of white blood cells
• increase in the number of platelets or white blood cells in blood
• low levels of magnesium, potassium, sodium, calcium, or phosphorus in blood
• high levels of potassium, calcium, or phosphorus in blood
• high levels of fats in blood (including cholesterol)
• high levels of uric acid in blood

Some adverse reactions are infrequent(may affect up to 1 in 100 people)

• allergy (hypersensitivity to Nilotinib Zentiva)
• dry mouth
• breast pain
• pain or discomfort in the side
• increased appetite
• breast enlargement in men
• herpes virus infection
• muscle and joint stiffness, joint swelling
• feeling of temperature change in the body (including feeling of heat, feeling of cold)
• altered sense of taste
• increased frequency of urination
• signs of stomach lining inflammation: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
• memory loss
• skin cyst, skin thinning or thickening, skin discoloration
• signs of psoriasis: thickened patches of red/silver skin
• increased sensitivity of the skin to light
• difficulty hearing
• joint inflammation
• urinary incontinence
• inflammation of the intestine (also called enterocolitis)
• anal abscess
• swelling in the nipple
• symptoms of restless legs syndrome (an irresistible urge to move a part of the body, usually the leg, accompanied by uncomfortable sensations)
• signs of sepsis: fever, chest pain, elevated heart rate/increased, difficulty breathing or rapid breathing
• skin infection (subcutaneous abscess)
• skin wart
• increase in a specific type of white blood cell (called eosinophils)
• signs of lymphopenia: low levels of white blood cells
• high levels of parathyroid hormone in blood (a hormone that regulates calcium and phosphorus levels)
• high levels of lactate dehydrogenase in blood (an enzyme)
• signs of low blood sugar levels: nausea, sweating, weakness, dizziness, tremors, headache
• dehydration
• abnormal levels of fat in the blood
• involuntary movements (also called tremor)
• difficulty concentrating
• unpleasant and abnormal sensation when touched (also called dysesthesia)
• fatigue (also called tiredness)
• feeling of numbness or tingling in the fingers of the hands and feet (also called peripheral neuropathy)
• paralysis of any facial muscle
• red spot on the white of the eye caused by broken blood vessels (also called conjunctival hemorrhage)
• blood in the eyes (also called ocular hemorrhage)
• eye irritation
• signs of heart attack (also called myocardial infarction): sudden and oppressive chest pain, fatigue, irregular heartbeats
• signs of heart murmur: fatigue, chest discomfort, dizziness, chest pain, palpitations
• fungal infection of the feet
• signs of heart failure: dyspnea, difficulty breathing when lying down, swelling of the feet or legs
• pain behind the sternum (also called pericarditis)
• signs of hypertensive crisis: severe headache, dizziness, nausea
• pain in the legs and weakness caused by walking (also called intermittent claudication)
• signs of occlusion of the arteries of the limbs: possible high blood pressure, painful cramps in one or both hips, thighs, or calf muscles after performing certain activities such as walking or climbing stairs, numbness or weakness in the legs
• bruises (when you have not injured yourself)
• fat deposits in the arteries that can cause obstruction (also called arteriosclerosis)
• signs of low blood pressure (also called hypotension): dizziness, dizziness, or fainting
• signs of pulmonary edema: dyspnea
• signs of pleural effusion: accumulation of fluid between the layers of tissue that cover the lungs and the thoracic cavity (which, if severe, can decrease the heart's ability to pump blood), chest pain, cough, hiccups, rapid breathing
• signs of interstitial lung disease: cough, difficulty breathing, pain when breathing
• signs of pleurisy: chest pain
• signs of pleuritis: cough, painful breathing
• hoarseness
• signs of pulmonary hypertension: high blood pressure in the arteries of the lungs
• wheezing
• sensitivity in the teeth
• signs of inflammation (also called gingivitis): bleeding gums, sensitive or enlarged gums
• high levels of urea in blood (renal function)
• change in blood proteins (low level of globulins or presence of paraprotein)
• high levels of unconjugated bilirubin in blood
• high levels of troponins in blood

Some adverse reactions are rare(may affect up to 1 in 1,000 people)

• redness and/or swelling and possibly peeling of the palms of the hands and soles of the feet (called hand-foot syndrome)
• warts in the mouth
• feeling of hardening or stiffness in the breasts
• inflammation of the thyroid gland (also called thyroiditis)
• altered or depressed mood
• signs of secondary hyperparathyroidism: bone and joint pain, excessive urination, abdominal pain, weakness, fatigue
• signs of cerebral artery occlusion: partial or total loss of vision in one or both eyes, double vision, vertigo (feeling of spinning), numbness or tingling, loss of coordination, dizziness, or confusion
• brain swelling (possible headache and/or changes in mental state)
• signs of optic neuritis: blurred vision, loss of vision
• signs of cardiac dysfunction (reduced ejection fraction): fatigue, chest discomfort, dizziness, pain, palpitations
• low or high levels of insulin in blood (a hormone that regulates blood sugar levels)
• low levels of C-peptide in blood (pancreatic function)
• sudden death

The following adverse reactions have been reported with an unknown frequency (cannot be estimated from the available data):

• signs of cardiac dysfunction (ventricular dysfunction): difficulty breathing, effort at rest, irregular heartbeats, chest discomfort, dizziness, pain, palpitations, excessive urination, swelling in the feet, ankles, and abdomen.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Nilotinib Zentiva

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C.
• Do not use this medicine if you observe that the packaging is damaged or shows signs of tampering.
• Medicines should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Nilotinib Zentiva

• The active ingredient is nilotinib.

• Each 150 mg hard capsule contains 150 mg of nilotinib.
• The other ingredients are: Capsule content: lactose monohydrate, crospovidone (E1202), polysorbate 80, aluminum and magnesium silicate, anhydrous colloidal silica (E551), magnesium stearate (E5722); Capsule shell: gelatin (E441), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172); Printing ink: shellac (E904), black iron oxide (E172), potassium hydroxide (E525).

• Each 200 mg hard capsule contains 200 mg of nilotinib.
• The other ingredients are: Capsule content: lactose monohydrate, crospovidone, polysorbate 80, aluminum and magnesium silicate, anhydrous colloidal silica (E551), magnesium stearate (E470b); Capsule shell: gelatin (E441), titanium dioxide (E171), yellow iron oxide (E172); Printing ink: shellac (E904), sodium hydroxide (E524), titanium dioxide (E171), povidone (E1201), aluminum red Allura AC lacquer (E129).

Appearance of Nilotinib Zentiva and Package Contents

Nilotinib Zentiva 150 mg hard capsules

Hard gelatin capsule (size 1) with opaque red cap and opaque red body with "SML" printed in black ink on the cap and "26" on the body, containing white to gray granular powder.

Nilotinib Zentiva 200 mg hard capsules

Hard gelatin capsule (size 0) with opaque light yellow cap and opaque light yellow body with "SML" printed in red ink on the cap and "27" on the body, containing white to gray granular powder.

PVC/PVDC/Alu blisters or perforated unit doses.

• Package containing 28 hard capsules in blisters.
• Package containing 28 hard capsules in perforated unit dose blisters.
• Multiple packages containing 112 (4 packages of 28) hard capsules or 392 (14 packages of 28) hard capsules in blisters.
• Multiple packages containing 112 (4 packages of 28) hard capsules or 392 (14 packages of 28) hard capsules in perforated unit dose blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder

Zentiva, k.s.

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10,

Czech Republic

Manufacturer

APIS Labor GmbH

Resslstraße 9

9065 Ebenthal in Kärnten, Austria.

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Nilotinib Zentiva 50 mg hard capsules, Nilotinib Zentiva 150 mg hard capsules, Nilotinib Zentiva 200 mg hard capsules

France: Nilotinib Zentiva 150 mg, capsule, Nilotinib Zentiva 200 mg, capsule

Italy, Denmark, Iceland, Finland, Norway, Sweden: Nilotinib Zentiva

Spain: Nilotinib Zentiva 150 mg hard capsules EFG, Nilotinib Zentiva 200 mg hard capsules EFG

Hungary: Nilotinib Zentiva k.s.

Date of the last revision of this prospectus:November 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).