Package leaflet: Information for the user

Nilotinib Zentiva 150 mg and 200 mg hard capsules

Equivalent medicine
Please read all of this leaflet carefully before you start 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, 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 side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Nilotinib Zentiva is and what it is used for
What you need to know before taking Nilotinib Zentiva
How to take Nilotinib Zentiva
Possible side effects
How to store Nilotinib Zentiva
Contents of the pack and other information

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

What Nilotinib Zentiva is
Nilotinib Zentiva is a medicine containing an active substance called nilotinib.

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

Nilotinib Zentiva is used in adult and paediatric patients with newly diagnosed CML or in patients with CML who no longer benefit from prior treatments, including imatinib. It is also used in adult and paediatric patients who have experienced severe side effects from previous treatments and are no longer able to continue taking them.

How Nilotinib Zentiva works
In patients with CML, a change in the DNA (genetic material) triggers a signal that causes the body to produce abnormal white blood cells. Nilotinib Zentiva blocks this signal, thereby stopping the production of these cells.

Monitoring during treatment with Nilotinib Zentiva
During treatment, you will have regular check-ups, including blood tests. These tests will monitor:

the number of blood cells (white blood cells, red blood cells, and platelets) to assess how well you are tolerating Nilotinib Zentiva;
pancreatic and liver function to assess how well you are tolerating Nilotinib Zentiva;
electrolytes in the body (potassium, magnesium). These electrolytes are important for heart function;
blood sugar and fat levels;
heart rate, which will also be monitored using a device that measures the heart's electrical activity (a test called "ECG").

Your doctor will regularly evaluate your treatment and decide whether you should continue taking Nilotinib Zentiva. If you are told to stop taking this medicine, your doctor will continue to monitor your CML and may advise you to restart Nilotinib Zentiva if your condition indicates that this is necessary.

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

2. What you should know before taking Nilotinib Zentiva

Follow carefully all instructions given by your doctor. These instructions may differ from the
general information contained in this leaflet.
Do not take Nilotinib Zentiva

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

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

if you have had previous 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 (claudication), or if you have risk factors for cardiovascular disease such as high blood pressure (hypertension), diabetes, or problems with blood lipid levels (dyslipidemia).
if you have heart problems, such as an abnormal electrical signal called “prolongation of the QT interval”.
if you are taking medicines that lower your blood cholesterol (statins) or affect your heart rhythm (antiarrhythmics) or affect the liver (see Other medicines and Nilotinib Zentiva).
if you have low levels of potassium or magnesium.
if you have liver or pancreatic disorders.
if you have symptoms such as tendency to bruise easily, feeling tired, shortness of breath, or have experienced repeated infections.
if you have had surgery involving removal of the entire stomach (total gastrectomy).
if you have ever had or may currently have hepatitis B infection. This is because Nilotinib Zentiva can cause reactivation of hepatitis B, which in some cases can be fatal. Patients will be closely monitored by their doctor for signs of this infection before starting treatment.

If any of these conditions apply to you or your child, inform your doctor.
During treatment with Nilotinib Zentiva

if you faint (lose consciousness) or experience an irregular heartbeat while taking this medicine, inform your doctor immediately as this may be a sign of a serious heart condition. Prolongation of the QT interval or an irregular heartbeat can lead to sudden death. Uncommon cases of sudden death have been reported in patients treated with Nilotinib Zentiva.
if you experience sudden palpitations, severe muscle weakness or paralysis, seizures, or sudden changes in thinking or alertness, inform your doctor immediately as this may be a sign of a rapid breakdown of tumor cells called tumor lysis syndrome. Rare cases of tumor lysis syndrome have been reported in patients treated with Nilotinib Zentiva.
if you experience chest pain or discomfort, numbness or weakness, difficulty walking or speaking, or pain, color change, or cold sensation in a limb, inform your doctor immediately as this may be a sign of a cardiovascular event. Serious cardiovascular events, including problems with blood flow to the leg (peripheral arterial occlusive disease), ischemic heart disease, and problems with blood flow to the brain (ischemic cerebrovascular disease), have been reported in patients treated with Nilotinib Zentiva. Your doctor should assess your blood lipid and blood sugar levels before starting treatment with Nilotinib Zentiva and during treatment.
if you experience swelling of the feet or hands, generalized swelling, or rapid weight gain, inform your doctor as these may be signs of severe fluid retention. Uncommon cases of severe fluid retention have been reported in patients treated with Nilotinib Zentiva.

If you are the parent of a child being treated with Nilotinib Zentiva, inform your doctor if any of the above conditions apply.
Children and adolescents
Nilotinib Zentiva is a treatment for children and adolescents with CML. There is no experience with the use of this medicine in children under 2 years of age. There is no experience with the use of Nilotinib Zentiva in children under 10 years of age with newly diagnosed CML, and limited experience in patients under 6 years of age who no longer benefit from prior CML treatment.
Some children and adolescents taking Nilotinib Zentiva may experience slower than normal growth. Your doctor will monitor growth through regular check-ups.
Other medicines and Nilotinib Zentiva
Nilotinib Zentiva can interact with other medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This includes in particular:

antiarrhythmics – used to treat irregular heartbeat;
chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin – medicines that may have an undesirable effect on the heart's electrical activity;
ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat infections;
ritonavir – a “protease inhibitor” medicine 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;
cyclosporine, sirolimus, and tacrolimus – medicines that suppress the body’s ability to “defend itself” and fight infections, commonly used to prevent rejection of transplanted organs such as liver, heart, and kidneys;
dihydroergotamine and ergotamine – used to treat dementia;
lovastatin, simvastatin – used to treat high levels of blood fats;
warfarin – used to treat blood clotting disorders (such as blood clots or thrombosis);
astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, or ergot alkaloids (ergotamine, dihydroergotamine).

These medicines should be avoided during treatment with Nilotinib Zentiva. If you are taking any of these medicines, your doctor may prescribe alternative treatments.
If you are taking a statin (a medicine that lowers your blood cholesterol), talk to your doctor or pharmacist. When taken with certain statins, Nilotinib Zentiva may increase the risk of statin-related muscle problems, which in rare cases can lead to severe muscle damage (rhabdomyolysis) and subsequent kidney damage.
Also, inform your doctor or pharmacist before taking Nilotinib Zentiva if you are taking any antacid, i.e., a medicine for heartburn. These medicines must be taken separately from Nilotinib Zentiva:

H2 blockers, which reduce acid production in the stomach. H2 blockers should be taken approximately 10 hours before and approximately 2 hours after taking Nilotinib Zentiva;
Antacids such as those containing aluminium hydroxide, magnesium hydroxide, and simeticone, which neutralize high stomach acidity. These antacids should be taken approximately 2 hours before or approximately 2 hours after taking Nilotinib Zentiva.

You should also inform your doctor if you are already taking Nilotinib Zentiva and have been prescribed a new medicine not previously taken during treatment with Nilotinib Zentiva.
Nilotinib Zentiva with food and drink
Do not take Nilotinib Zentiva with food. Food can increase the absorption of Nilotinib Zentiva and thus increase the amount of Nilotinib Zentiva in the blood to a dangerous level.
Do not drink grapefruit juice or eat grapefruit. It may increase the amount of Nilotinib Zentiva in the blood to a dangerous level.
Pregnancy and breastfeeding

Nilotinib Zentiva is not recommended during pregnancy unless strictly necessary. If you are pregnant or think you may be pregnant, inform your doctor, who will discuss with you whether you can take this medicine during pregnancy.
Women who may become pregnant are advised to use a highly effective method of contraception during treatment and for two weeks after stopping treatment.
Breastfeeding is not recommended during treatment with Nilotinib Zentiva and for two weeks after the last dose. Inform your doctor if you are breastfeeding.

If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
If you experience side effects (such as dizziness or vision problems) that could potentially affect your ability to drive safely or operate tools or machinery after taking this medicine, you must stop such activities until the effects have disappeared.
Nilotinib Zentiva contains lactose
This medicine contains lactose (also known as milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Nilotinib Zentiva 200 mg hard capsules contain sodium and Allura AC red aluminium lake
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.
The azo dye Allura AC red aluminium lake may cause allergic reactions.

3. How to take Nilotinib Zentiva

Take this medicine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
How much Nilotinib Zentiva to take
Use in adults

Patients with newly diagnosed CML: The recommended dose is 600 mg daily. This dose is achieved by taking two 150 mg hard capsules twice daily.
Patients who no longer benefit from prior CML treatment: The recommended dose is 800 mg daily. This dose is achieved by taking two 200 mg hard capsules twice daily.

Use in children and adolescents

The dose given to your child will depend on the child's weight and height. Your doctor will calculate the correct dose and will tell you which and how many capsules of Nilotinib Zentiva should be given to your child. The total daily dose administered to your child must not exceed 800 mg.

Your doctor may prescribe a lower dose depending on your response to treatment.
Elderly patients (65 years and older)
Nilotinib Zentiva may be used in patients aged 65 years and older at the same dose as in other adults.
When to take Nilotinib Zentiva
Take the hard capsules:

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

If you have any questions about when to take this medicine, speak with your doctor or pharmacist.
Taking Nilotinib Zentiva at the same time each 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 food together with the hard capsules.
Do not open the hard capsules unless you are unable to swallow them. In this case, you may sprinkle the contents of each hard capsule onto one teaspoon of apple sauce and take it immediately. Do not use more than one teaspoon of apple sauce per hard capsule, and do not use any other food except apple sauce.

How long to take Nilotinib Zentiva
Continue taking Nilotinib Zentiva every day for as long as your doctor has prescribed it. This is a long-term treatment. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Your doctor may consider stopping treatment with Nilotinib Zentiva based on specific criteria. If you have any questions about how long to take Nilotinib Zentiva, speak with 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 accidentally taken your hard capsules, contact a doctor or hospital immediately for advice. Show them the packaging of the capsules and this leaflet. Medical treatment may be necessary.
If you forget to take Nilotinib Zentiva
If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the forgotten capsule.
If you stop taking Nilotinib Zentiva
Do not stop treatment with this medicine unless your doctor tells you to. Stopping Nilotinib Zentiva without medical advice may put you at risk of worsening disease, which could be life-threatening. Make sure to discuss with your doctor, nurse, and/or pharmacist if you are considering stopping Nilotinib Zentiva.
If your doctor recommends stopping treatment with Nilotinib Zentiva
Your doctor will regularly assess your treatment with a specific diagnostic test and decide whether you should continue taking this medicine. If you are told to stop Nilotinib Zentiva, your doctor will continue to monitor your CML closely before, during, and after stopping Nilotinib Zentiva, and may instruct you to restart Nilotinib Zentiva if your condition indicates that this is necessary.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate and usually disappear after a period of treatment ranging from a few days to a few weeks.
Some side effects may be serious.

signs of musculoskeletal pain: joint and muscle pain
signs of heart problems: chest pain or discomfort, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (feeling of rapid heartbeat), fainting, bluish discoloration of lips, tongue or skin
signs of arterial blockage: pain, discomfort, weakness or cramps in leg muscles, which may be due to reduced blood flow, leg or arm ulcers that do not heal or heal slowly, and noticeable changes in color (bluish or pale) or temperature (coldness) of the affected leg, arm, toes or fingers
signs of underactive thyroid gland: weight gain, tiredness, hair loss, muscle weakness, feeling cold
signs of overactive thyroid gland: fast heartbeat, protruding eyes, weight loss, swelling in the front of the neck
signs of kidney or urinary tract problems: thirst, dry skin, irritability, dark urine, decreased amount of urine, difficulty and pain when urinating, urgent need to urinate, blood in urine, abnormal urine color
signs of high blood sugar levels: excessive thirst, increased amount of urine, increased appetite with weight loss, tiredness
signs of dizziness: dizziness or sensation of spinning
signs of pancreatitis: severe upper abdominal pain (in the center or on the left)
signs of skin problems: painful red lumps, skin pain, redness of the skin, peeling or blisters
signs of fluid 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, tendency to bruise or unexplained bleeding, severe or frequent infections, unexplained weakness
signs of venous thrombosis: swelling and pain in one part of the body
signs of nervous system disorders: weakness or paralysis of limbs or face, difficulty

speaking, severe headache, seeing, hearing, or sensing things that are not there, changes
in vision, loss of consciousness, confusion, disorientation, tremors,
tingling, pain or numbness in fingers of hands and feet

signs of lung problems: difficulty breathing or painful breathing, cough, wheezing with or without fever, swelling in feet or legs
signs of gastrointestinal problems: abdominal pain, nausea, vomiting blood, black stools or blood in stools, constipation, heartburn, gastric reflux, bloated abdomen
signs of liver problems: yellowing of skin and eyes, nausea, loss of appetite, dark-colored urine
signs of liver infection: recurrence (reactivation of hepatitis B infection)
signs of eye problems: vision disturbances including blurred vision, double vision or perception of flashes of light, decreased visual acuity or vision loss, blood in the eye, increased sensitivity of eyes to light, eye pain, redness, itching or irritation, dry eyes, swelling or itching of eyelids
signs of electrolyte imbalance: nausea, shortness of breath, irregular heartbeat, cloudy urine, tiredness and/or joint problems 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 above side effects.
Some side effects are very common (may affect more than 1 in 10 people)

diarrhea
headache
lack of energy
muscle pain
itching, rash
nausea
constipation
vomiting
hair loss
limb pain, bone pain and spinal pain after stopping treatment with Nilotinib Zentiva
slowed growth in children and adolescents
upper respiratory tract infection including sore throat, runny or blocked nose, sneezing
low levels of blood cells (red blood cells, platelets) or hemoglobin
high level of lipase in blood (pancreatic function)
high level of bilirubin in blood (liver function)
high level of alanine aminotransferase in blood (liver enzymes)

Some side effects are common (may affect up to 1 in 10 people)

pneumonia
abdominal pain, stomach discomfort after meals, intestinal gas, bloating or abdominal distension
bone pain, muscle spasms
pain (including neck pain)
dry skin, acne, decreased skin sensitivity
weight decrease or increase
insomnia, depression, anxiety
night sweats, excessive sweating
general feeling of malaise
nosebleeds
signs of gout: painful and swollen joints
inability to achieve or maintain an erection
flu-like symptoms
sore throat
bronchitis
ear pain, hearing noises (e.g. ringing, buzzing) in the ears that have no external source (also called tinnitus)
hemorrhoids
heavy menstrual periods
itching of 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
redness
signs of occlusive peripheral arterial disease: pain, discomfort, weakness or cramps in leg muscles, which may be due to reduced blood flow, leg or arm ulcers that do not heal or heal slowly, and noticeable changes in color (bluish or pale) or temperature (coldness) of legs or arms (possible signs of arterial blockage in leg, arm, toes or fingers)
shortness of breath (also called dyspnea)
mouth ulcers with inflammation of the gums (also called stomatitis)
high level of amylase in blood (pancreatic function)
high level of creatinine in blood (kidney function)
high level of alkaline phosphatase or creatine phosphokinase in blood
high level of aspartate aminotransferase in blood (liver enzymes)
high level of gamma-glutamyl transferase in blood (liver enzymes)
signs of leucopenia or neutropenia: low white blood cell count
increased number of platelets or white blood cells in blood
low blood levels of magnesium, potassium, sodium, calcium or phosphorus
increased levels of potassium, calcium and phosphorus in blood
high level of fats in blood (including cholesterol)
high level of uric acid in blood

Some side effects are uncommon (may affect up to 1 in 100 people)

allergy (hypersensitivity to Nilotinib Zentiva)
dry mouth
breast pain
pain or discomfort in the flank
increased appetite
enlargement of breast gland in men
herpes virus infection
stiffness of muscles and joints, joint swelling
sensation of body temperature change (including feeling hot, feeling cold)
taste disturbance
frequent urge to urinate
signs of inflammation of gastric mucosa: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
memory loss
skin cysts, thinning or thickening of skin, thickening of the outer layer of skin, skin color changes
signs of psoriasis: thickened areas of red/silvery skin
increased skin sensitivity to light
hearing difficulty
joint inflammation
urinary incontinence
intestinal inflammation (also called enterocolitis)
anal abscess
swelling of the nipple
symptoms of restless legs syndrome (an irresistible urge to move a part of the body, usually legs, associated with uncomfortable sensations)
signs of sepsis: fever, chest pain, increased heart rate, shortness of breath or rapid breathing
skin infection (subcutaneous abscess)
skin wart
increased levels of specific types of white blood cells (called eosinophils) in blood
signs of lymphopenia: low white blood cell count
high level of parathyroid hormone in blood (a hormone regulating calcium and phosphorus levels)
high level of lactate dehydrogenase in blood (an enzyme)
signs of low blood sugar: nausea, sweating, weakness, dizziness, tremor, headache
dehydration
abnormal blood fat levels
involuntary tremor (also called tremor)
difficulty concentrating
unpleasant or abnormal sensation to touch (also called dysesthesia)
tiredness (also called fatigue)
numbness or tingling in fingers of hands and feet (also called peripheral neuropathy)
paralysis of any facial muscle
red spot in the white of the eye caused by rupture of blood vessels (also called conjunctival hemorrhage)
blood in the eyes (also called eye hemorrhage)
eye irritation
signs of heart attack (also called myocardial infarction): sudden crushing chest pain, tiredness, irregular heartbeat
signs of heart murmur: tiredness, chest discomfort, dizziness, chest pain, palpitations
fungal foot infection
signs of heart failure: breathlessness, difficulty breathing when lying down, swelling of feet or legs
pain behind the breastbone (also called pericarditis)
signs of hypertensive crisis: severe headache, dizziness, nausea
leg pain and weakness caused by walking (also called intermittent claudication)
signs of narrowing of arteries in limbs: possible high blood pressure, painful cramps in one or both hips, thighs or calves after certain activities such as walking or climbing stairs, numbness or weakness in legs
bruising (when you have not injured yourself)
fat deposits in arteries that may cause blockage (also called arteriosclerosis)
signs of low blood pressure (also called hypotension): dizziness, lightheadedness or fainting
signs of pulmonary edema: breathlessness
signs of pleural effusion: accumulation of fluid between the layers of tissue lining the lungs and chest cavity (which, if severe, may reduce the heart's ability to pump blood), chest pain cough, hiccups, rapid breathing
signs of interstitial lung disease: cough, difficulty breathing, painful breathing
signs of pleural pain: chest pain
signs of pleuritis: cough, painful breathing
hoarseness
signs of pulmonary hypertension: high blood pressure in the lung arteries
wheezing
sensitive teeth
signs of inflammation (also called gingivitis): bleeding gums, sensitive or swollen gums
high level of urea in blood (kidney function)
changes in blood proteins (low globulin levels or presence of paraprotein)
high level of unconjugated bilirubin in blood
high level of troponin in blood

Some side effects are rare (may affect up to 1 in 1,000 people)

redness and/or swelling and possible peeling of palms of hands and soles of feet (so-called hand-foot syndrome)
warts in the mouth
sensation of hardness or stiffness in the breast
inflammation of the thyroid (also called thyroiditis)
disturbed or depressed mood
signs of secondary hyperparathyroidism: bone and joint pain, excessive urination, abdominal pain, weakness, tiredness
signs of narrowing of arteries in the brain: partial or complete vision loss in both eyes, double vision, vertigo (sensation of dizziness), numbness or tingling, loss of coordination, dizziness or confusion
brain swelling (possible headache and/or changes in mental status)
signs of optic neuritis: blurred vision, vision loss
signs of cardiac dysfunction (reduced ejection fraction): tiredness, chest discomfort, dizziness, pain, palpitations
low or high level of insulin in blood (a hormone regulating blood sugar levels)
low level of insulin C-peptide in blood (pancreatic function)
sudden death

The following other side effects have been reported with unknown frequency (cannot be estimated
from the available data):

signs of cardiac dysfunction (ventricular dysfunction): shortness of breath, exertion at rest, irregular heartbeat, chest discomfort, dizziness, pain, palpitations, excessive urination, swelling of feet, ankles and abdomen.

Reporting of side effects
If you get any side effects, 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Nilotinib Zentiva

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. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if you notice that the packaging is damaged or tampered with.
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 Nilotinib Zentiva contains

Each 150 mg hard capsule contains 150 mg of nilotinib.
The other ingredients are: Capsule contents: monohydrate lactose, crospovidone (E1202), polysorbate 80, magnesium aluminometasilicate, colloidal silicon dioxide (E551), magnesium stearate (E572); 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 contents: monohydrate lactose, crospovidone (E1202), polysorbate 80, magnesium aluminometasilicate, colloidal silicon dioxide (E551), magnesium stearate (E572); Capsule shell: gelatin (E441), titanium dioxide (E171), yellow iron oxide (E172); Printing ink: shellac (E904), sodium hydroxide (E524), titanium dioxide (E171), povidone (E1201), red aluminium lake Allura AC (E129).

Description of the appearance of Nilotinib Zentiva and the contents of the pack
Nilotinib Zentiva 150 mg hard capsules
Hard gelatin capsule (size 1) with an opaque red cap and an opaque red body, printed in black ink with "SML" on the cap and "26" on the body, containing granular powder ranging from off-white to grey.
Nilotinib Zentiva 200 mg hard capsules
Hard gelatin capsule (size 0) with an opaque light yellow cap and an opaque light yellow body, printed in red ink with "SML" on the cap and "27" on the body, containing granular powder ranging from off-white to grey.
Nilotinib Zentiva is available in the following pack sizes:
Nilotinib Zentiva 150 mg and 200 mg hard capsules
PVC/PVDC/aluminium blisters or unit-dose divisible blisters.

Packs containing 28 hard capsules.
Packs containing 28x1 hard capsules in unit-dose divisible blisters.
Multiple packs containing 112 (4 packs of 28 hard capsules) or 392 (14 packs of 28 hard capsules) hard capsules in blisters.
Multiple packs containing 112x1 (4 packs of 28x1) or 392x1 (14 packs of 28x1) hard capsules in unit-dose divisible blisters.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan, Italy
Manufacturer
APIS Labor GmbH
Resslstraße 9
9065 Ebenthal in Kärnten, Austria
This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Nilotinib Zentiva 150 mg Hartkapseln, Nilotinib Zentiva 200 mg Hartkapseln
France: Nilotinib Zentiva 150 mg, gélule, Nilotinib Zentiva 200 mg, gélule
Italy, Denmark, Iceland, Finland, Norway, Sweden: Nilotinib Zentiva
Spain: Nilotinib Zentiva 150 mg/200 mg cápsulas duras EFG
Hungary: Nilotinib Zentiva k.s.