Nilotinib zentiva: detailed information

Package leaflet: Information for the user

Nilotinib Zentiva, 150 mg, hard capsules
Nilotinib Zentiva, 200 mg, hard capsules
Nilotinibum
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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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 that contains the active substance called nilotinib.
Why Nilotinib Zentiva is used
Nilotinib Zentiva is used to treat a type of leukaemia called chronic myeloid leukaemia with the Philadelphia chromosome (Ph+ CML). CML is a blood cancer that causes the body to produce too many abnormal white blood cells.
Nilotinib Zentiva is used to treat adult patients and children and adolescents with newly diagnosed CML or in patients with CML who no longer benefit from prior therapy, including imatinib treatment, or in adult patients and children and adolescents who have experienced severe side effects that prevent continuation of prior therapy.
How Nilotinib Zentiva works
In patients with CML, a change in DNA (genetic material) leads to a signal that causes the body to produce abnormal white blood cells. Nilotinib Zentiva blocks this signal and thereby prevents the formation of these abnormal cells.
Monitoring treatment with Nilotinib Zentiva
During treatment, you will have regular tests, including blood tests. These tests will assess:

the number of blood cells (white blood cells, red blood cells and platelets) in your body, to evaluate how well you tolerate Nilotinib Zentiva.
the function of your pancreas and liver, to evaluate how well you tolerate Nilotinib Zentiva.
the levels of electrolytes in your body (potassium, magnesium), which are important for heart function.
the levels of sugar and fats in your blood.

Your heart rate will also be monitored using a device that measures the electrical activity of the heart (a test called an ECG).
Your doctor will regularly assess your treatment response and decide whether you should continue taking Nilotinib Zentiva. If you are told that you need to stop treatment with this medicine, your doctor will continue to monitor your CML status and may recommend restarting Nilotinib Zentiva treatment if your condition requires it.
If you have any questions about how Nilotinib Zentiva works or why it has been prescribed, please consult your doctor.

2. Important information before using Nilotinib Zentiva

You must strictly follow your doctor's instructions. They may differ from the general information contained in this leaflet.

When not to use Nilotinib Zentiva

if the patient is allergic to nilotinib or any of the other ingredients of this medicine (listed in section 6). If the patient suspects they may be allergic, they should inform their doctor before starting treatment with Nilotinib Zentiva.

Warnings and precautions

Before starting treatment with Nilotinib Zentiva, discuss the following with your doctor or pharmacist:

if the patient has previously experienced cardiovascular problems such as heart attack, chest pain (angina), impaired blood flow to the brain (stroke), or reduced blood flow to the legs (claudication), or if the patient has risk factors for cardiovascular disease, such as high blood pressure (hypertension), diabetes, or disorders of blood lipid levels (dyslipidaemia);
if the patient has heart disorders, such as abnormal electrical activity known as "prolongation of the QT interval";
if the patient is taking medicines that lower blood cholesterol levels (statins) or affect heart function (antiarrhythmics) or liver function (see Other medicines and Nilotinib Zentiva);
if the patient has low levels of potassium or magnesium;
if the patient has liver or pancreatic disorders;
if the patient experiences symptoms such as easy bruising, fatigue, shortness of breath, or recurrent infections;
if the patient has undergone surgery involving complete removal of the stomach (total gastrectomy);
if the patient has ever had or may currently have hepatitis B virus infection; this is because Nilotinib Zentiva may cause reactivation of hepatitis B virus, which in some cases can be fatal. Patients will be closely monitored by their doctor for signs of this infection before starting treatment. Inform your doctor if any of the above points apply.

During treatment with Nilotinib Zentiva

if the patient experiences loss of consciousness (fainting) or irregular heartbeat, they must immediately inform their doctor, as these may be signs of a serious heart condition. QT interval prolongation or irregular heartbeat may lead to sudden death. Cases of sudden death have been reported, although not frequently, in patients receiving nilotinib.
if the patient develops: sudden rapid heartbeat, severe weakness or paralysis of muscles, seizures, or sudden changes in thinking or concentration, they must immediately inform their doctor, as these may be symptoms of tumour lysis syndrome caused by rapid breakdown of cancer cells. Tumour lysis syndrome has been reported rarely in patients treated with nilotinib.
if the patient experiences chest pain or discomfort, numbness or weakness, difficulty walking or speaking, or pain, discolouration, or coldness in a limb, they must immediately inform their doctor, as these may be symptoms of cardiovascular events. Serious cardiovascular events have been reported in patients receiving nilotinib, including impaired blood flow to the legs (peripheral arterial occlusive disease), ischaemic heart disease, and impaired blood flow to the brain (ischaemic stroke). Your doctor should measure blood lipid and blood sugar levels before starting treatment with Nilotinib Zentiva and during treatment.
if the patient develops swelling of the feet or hands, generalized oedema, or rapid weight gain, they should inform their doctor, as these may be signs of severe fluid retention. Cases of severe fluid retention have been reported, although not frequently, in patients treated with Nilotinib Zentiva. Parents of children treated with Nilotinib Zentiva should inform the doctor if any of the above situations apply to their child.

Children and adolescents

Nilotinib Zentiva is used in the treatment of 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 disease, and limited experience in patients under 6 years of age who have stopped responding to prior CML treatment.

Some children and adolescents taking Nilotinib Zentiva may grow more slowly than normal. The doctor will monitor growth during regular visits.

Nilotinib Zentiva and other medicines

Nilotinib Zentiva may affect the action of other medicines.

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. This is especially important for the following medicines:

antiarrhythmics – used to treat heart rhythm disorders;
chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin – medicines that may adversely affect the electrical activity of the heart;
ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat infections;
ritonavir – a "protease inhibitor" used to treat HIV infection;
carbamazepine, phenobarbital, and phenytoin – used to treat epilepsy;
rifampicin – used to treat tuberculosis;
St John’s wort (also known as Hypericum perforatum) – a herbal product used to treat depression and other conditions;
midazolam – used as a sedative before surgery;
alfentanil and fentanyl – used to treat pain and as sedatives before and during surgery or medical procedures;
cyclosporine, sirolimus, and tacrolimus – medicines used to suppress the body’s immune response and prevent rejection of transplanted organs such as liver, heart, and kidney;
dihydroergotamine and ergotamine – used to treat migraine;
lovastatin, simvastatin – used to treat high blood lipid levels;
warfarin – used to treat blood clotting disorders (such as thrombosis or thrombophilia);
astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, or ergot alkaloids (ergotamine, dihydroergotamine).

The use of the above-mentioned medicines should be avoided during treatment with Nilotinib Zentiva. If the patient is taking any of these medicines, the doctor may prescribe alternative treatments.

If the patient is taking a statin (a type of medicine that lowers blood cholesterol levels), they should speak with their doctor or pharmacist. Nilotinib Zentiva used together with certain statins may increase the risk of statin-related muscle problems, which in rare cases may lead to serious muscle breakdown (rhabdomyolysis) causing kidney damage.

Additionally, before taking Nilotinib Zentiva, inform your doctor or pharmacist if the patient is taking any medicines that neutralise stomach acid, i.e. antacids.

The following medicines should be taken separately from Nilotinib Zentiva:

H₂-receptor antagonists, which reduce stomach acid production. H₂-receptor antagonists should be taken approximately 10 hours before and approximately 2 hours after taking Nilotinib Zentiva;
antacids containing aluminium hydroxide, magnesium hydroxide, and simethicone, which neutralise stomach acidity. These medicines should be taken approximately 2 hours before or approximately 2 hours after taking Nilotinib Zentiva.

You should also inform your doctor if the patient is already taking Nilotinib Zentiva and has been prescribed a new medicine not previously taken together with Nilotinib Zentiva.

Taking Nilotinib Zentiva with food and drink

Do not take Nilotinib Zentiva with food. Food may significantly increase the absorption of Nilotinib Zentiva and raise its blood concentration, even to harmful levels. Do not drink grapefruit juice or eat grapefruit. These may increase the blood concentration of Nilotinib Zentiva, even to harmful levels.

Pregnancy and breastfeeding

Nilotinib Zentiva is not recommended during pregnancy, unless absolutely necessary. If the patient is pregnant or suspects she may be pregnant, she should inform her doctor, who will discuss with her the possibility of using this medicine.
Women who could become pregnant should be advised by their doctor to use highly effective contraception during treatment and for at least two weeks after stopping treatment.
Breastfeeding is not recommended during treatment with Nilotinib Zentiva and for two weeks after the last dose. If the patient is breastfeeding, she should inform her doctor. If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines

If the patient experiences adverse effects after taking this medicine (such as dizziness or visual disturbances) that may affect their ability to drive or operate machinery safely, they should stop performing these activities until the symptoms resolve.

Nilotinib Zentiva contains lactose

This medicine contains lactose (also known as milk sugar). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Nilotinib Zentiva

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
What dose of Nilotinib Zentiva to take
Use in adult patients

Patients with newly diagnosed CML: The recommended dose is 600 mg per day. This dose is achieved by taking two 150 mg hard capsules twice daily.
Patients who have stopped benefiting from prior CML treatment: The recommended dose is 800 mg per day. This dose is achieved by taking two 200 mg hard capsules twice daily.

Use in children and adolescents

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

Your doctor may prescribe a lower dose depending on how the patient responds to treatment.
Elderly patients (aged 65 years and older)
Nilotinib Zentiva may be given to patients aged 65 years and older at the same doses as other adults.
When to take Nilotinib Zentiva
Hard capsules should be taken:

twice daily (approximately every 12 hours);
at least 2 hours after eating any food;
wait 1 hour after taking the medicine before eating a meal. If you have any doubts about when to take this medicine, you should contact your doctor or pharmacist. Nilotinib Zentiva should be taken at the same time each day, which will help you remember to take the hard capsules.

How to take Nilotinib Zentiva

Hard capsules must be swallowed whole with water.
Do not take hard capsules with food.
Do not open the hard capsules. If an adult or child is unable to swallow the entire capsule, an alternative medicine containing nilotinib should be used instead of Nilotinib Zentiva.

How long to take Nilotinib Zentiva
Nilotinib Zentiva should be taken every day for as long as your doctor recommends. Treatment is long-term. Your doctor will regularly monitor your condition to assess whether the treatment is having the desired effect.
Your treating doctor may consider stopping treatment with Nilotinib Zentiva based on specific criteria.
If you have any doubts about how long treatment with Nilotinib Zentiva should continue, consult your doctor.
Taking more than the recommended dose of Nilotinib Zentiva
If you take more than the recommended dose of Nilotinib Zentiva or take it by accident, you should contact your doctor immediately or go to hospital. Show the packaging and this leaflet to the doctor or hospital staff. Medical assistance may be required.
Missing a dose of Nilotinib Zentiva
If you miss a dose, take the next dose according to your regular schedule. Do not take a double dose to make up for the missed hard capsules.
Stopping Nilotinib Zentiva
This medicine should be taken until your doctor decides to stop treatment. Stopping Nilotinib Zentiva without consulting your doctor may worsen your condition, which could be life-threatening. If you are considering stopping Nilotinib Zentiva, remember to discuss this with your doctor, nurse, and (or) pharmacist.
Your doctor's recommendation to stop treatment with Nilotinib Zentiva
Your treating doctor will regularly evaluate the treatment results using specific diagnostic tests and decide whether you should continue taking this medicine. If you are instructed to stop treatment with Nilotinib Zentiva, your doctor will continue to closely monitor your CML condition before, during, and after stopping treatment with Nilotinib Zentiva and may recommend resuming Nilotinib Zentiva if necessary based on your condition.
If you have any further 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 in severity and resolve after a few days or weeks of treatment.
Some side effects may be severe.

Musculoskeletal symptoms: joint and muscle pain
Heart-related symptoms: chest pain or discomfort, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (feeling of rapid heartbeat), fainting, blue discoloration of lips, tongue or skin
Symptoms of arterial blockage: pain, discomfort, weakness or muscle cramps in legs, which may be due to reduced blood flow, leg or hand ulcers that heal slowly or not at all, and noticeable changes in skin color (blue or pale) or temperature (cooling) of legs, hands, toes or fingers in affected limbs
Symptoms of hypothyroidism: weight gain, fatigue, hair loss, muscle weakness, feeling cold
Symptoms of hyperthyroidism: rapid heartbeat, bulging eyes, weight loss, swelling in the front of the neck
Symptoms of kidney or urinary tract dysfunction: feeling thirsty, dry skin, irritability, dark urine, reduced urine output, difficulty or pain when urinating, feeling of constant need to urinate, blood in urine, abnormal urine color
Symptoms of high blood sugar: excessive thirst, increased urine volume, increased appetite with weight loss, feeling tired
Dizziness symptoms: dizziness or sensation of spinning
Symptoms of pancreatitis: severe pain in the upper abdomen (middle or left side)
Skin disorder symptoms: painful red nodules, skin pain, skin redness, skin peeling or blistering
Fluid retention symptoms: rapid weight gain, swelling of hands, ankles, feet or face
Migraine symptoms: severe headache, often accompanied by nausea, vomiting and sensitivity to light
Blood disorder symptoms: fever, easy bruising or unexplained bleeding, severe or frequent infections, unexplained weakness
Symptoms of venous thrombosis: swelling and pain in one part of the body
Nervous system disorder symptoms: weakness or paralysis of limbs or face, difficulty speaking, severe headaches, seeing, hearing or feeling things that are not there, vision changes, loss of consciousness, confusion, disorientation, tremor, tingling, pain or numbness in fingers or toes of hands and feet
Lung disorder symptoms: difficulty breathing or pain when breathing, cough, wheezing with or without fever, swelling of feet or legs
Gastrointestinal disorder symptoms: abdominal pain, nausea, blood in vomit, black or bloody stools, constipation, heartburn, gastric reflux, abdominal swelling
Liver disorder symptoms: yellowing of skin and eyes, nausea, loss of appetite, dark urine
Liver infection symptoms: recurrence (reactivation) of hepatitis B virus infection
Eye disorder symptoms: vision disturbances, including blurred vision, double vision or seeing flashes of light, decreased visual acuity or vision loss, blood in the eye, increased eye sensitivity to light, eye pain, redness, itching or eye irritation, dry eyes, eyelid swelling or itching
Electrolyte imbalance symptoms: nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and (or) joint problems associated with abnormal blood test results (e.g. high potassium, uric acid and phosphate levels, and low calcium levels). If you notice any of the above side effects, contact your doctor immediately.

Some side effects occur very commonly (may affect more than 1 in 10 patients):

Diarrhea
Headache
Lack of energy
Muscle pain
Itching, rash
Nausea
Constipation
Vomiting
Hair loss
Limb pain, bone pain and spine pain after stopping treatment with Nilotinib Zentiva
Slowed growth rate in children and adolescents
Upper respiratory tract infections, including sore throat, watery nasal discharge or nasal congestion, sneezing
Low blood cell count (red blood cells, platelets) or low hemoglobin levels
High blood lipase activity (pancreatic function)
High bilirubin levels in blood (liver function)
High alanine aminotransferase activity in blood (liver enzymes)

Some side effects occur commonly (may affect less than 1 in 10 patients):

Pneumonia
Abdominal pain, stomach discomfort after meals, bloating, abdominal swelling or distension
Bone pain, muscle cramps
Pain (including neck pain)
Dry skin, acne, reduced skin sensitivity
Weight loss or weight gain
Insomnia, depression, anxiety
Night sweats, excessive sweating
General malaise
Nosebleeds
Gout symptoms: joint pain and swelling
Inability to achieve or maintain erection
Flu-like symptoms
Sore throat
Bronchitis
Ear pain, hearing sounds in the ears (e.g. ringing, buzzing) with no external source (also known as tinnitus)
Hemorrhagic nodules
Heavy menstrual periods
Itching of hair follicles
Vaginal or oral fungal infection
Conjunctivitis symptoms: eye discharge accompanied by itching, redness and swelling
Eye irritation, eye redness
Hypertension symptoms: high blood pressure, headache, dizziness
Facial flushing
Peripheral arterial disease symptoms: leg pain, discomfort, weakness or muscle cramps due to reduced blood flow, leg or hand ulcers that heal slowly or not at all, noticeable changes in skin color (blue or pale) or temperature (cooling) of legs or hands (these symptoms may indicate arterial blockage in the affected leg, arm, toes or fingers)
Dyspnea, oral ulceration with gingivitis (also known as oral mucositis)
Increased blood amylase activity (pancreatic function)
Increased creatinine levels in blood (kidney function)
Increased alkaline phosphatase or creatine kinase activity in blood
Increased aspartate aminotransferase activity in blood (liver enzymes)
Increased gamma-glutamyl transferase activity in blood (liver enzymes)
Leukopenia or neutropenia symptoms: low white blood cell count
Increased platelet or white blood cell count in blood
Decreased magnesium, potassium, sodium, calcium or phosphate levels in blood
Increased blood lipid levels (including cholesterol)
Increased uric acid levels in blood

Some side effects occur less commonly (may affect less than 1 in 100 patients):

Allergic reaction (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
Sensation of body temperature changes (including feeling hot or cold)
Taste disturbances
Frequent urination
Gastritis symptoms: abdominal pain, nausea, vomiting, diarrhea, abdominal bloating
Memory loss
Skin cysts, skin thinning or thickening, thickening of the outer skin layer, skin discoloration
Psoriasis symptoms: thickened red/silvery skin patches
Increased skin sensitivity to light
Hearing difficulty
Arthritis
Urinary incontinence
Enteritis (also known as inflammation of the small intestine and colon)
Perianal abscess
Swelling of the nipple
Restless legs syndrome symptoms (irresistible urge to move part of the body, usually legs, accompanied by unpleasant sensations)
Sepsis symptoms: fever, chest pain, rapid heartbeat, shortness of breath or rapid breathing
Skin infection (subcutaneous abscess)
Skin warts
Increased number of a certain type of white blood cells (called eosinophils)
Lymphopenia symptoms: low white blood cell count
High parathyroid hormone levels (a hormone regulating calcium and phosphate levels) in blood
High lactate dehydrogenase levels (enzyme)
Low blood sugar symptoms: nausea, sweating, weakness, dizziness, tremor, headache
Dehydration
Abnormal blood lipid levels
Involuntary tremor
Difficulty concentrating
Unpleasant or abnormal touch sensation (also known as sensory disturbances)
Fatigue
Numbness or tingling in fingers or toes of hands and feet (also known as peripheral neuropathy)
Paralysis of any facial muscle
Red spots in the white of the eye due to blood vessel damage (also known as subconjunctival hemorrhage)
Blood in the eye (also known as eye hemorrhage)
Eye irritation
Heart attack symptoms (also known as myocardial infarction): sudden, crushing chest pain, fatigue, irregular heartbeat
Heart murmur symptoms: fatigue, chest discomfort, feeling faint, chest pain, palpitations
Fungal foot infection
Heart failure symptoms: shortness of breath, difficulty breathing when lying down, swelling of feet or legs
Pain behind the breastbone (also known as pericarditis)
Hypertensive crisis symptoms: severe headache, dizziness, nausea
Leg pain and weakness when walking (also known as intermittent claudication)
Symptoms of arterial narrowing in limbs: possible high blood pressure, painful muscle cramps in one or both hips, thighs or calves during certain activities such as walking or climbing stairs, numbness or weakness in legs
Bruising (without cause such as injury)
Fat deposits in arteries, which may cause blockage (also known as atherosclerosis)
Low blood pressure symptoms (also known as hypotension): feeling faint, dizziness or fainting
Pulmonary edema symptoms: shortness of breath
Pleural effusion symptoms: fluid accumulation between the layers of tissue lining the lungs and chest cavity (which in severe cases may reduce the heart's ability to pump blood), chest pain, cough, hiccups, rapid breathing
Interstitial lung disease symptoms: cough, difficulty breathing, pain when breathing
Pleuritic pain symptoms: chest pain
Pleurisy symptoms: cough, pain when breathing
Hoarseness
Pulmonary hypertension symptoms: high blood pressure in the pulmonary arteries
Wheezing
Tooth sensitivity
Inflammation symptoms (also known as gingivitis): bleeding gums, tenderness or swelling of gums
High urea levels in blood (kidney function)
Changes in blood protein levels (low globulin levels or presence of paraprotein)
High unconjugated bilirubin levels in blood
High troponin levels in blood

Some side effects occur rarely (may affect less than 1 in 1000 patients):

Redness and (or) swelling and possible peeling of palms and soles (known as hand-foot syndrome)
Oral warts
Feeling of breast hardening or stiffness
Thyroiditis
Mood disturbances or low mood
Secondary hyperparathyroidism symptoms: bone and joint pain, excessive urination, abdominal pain, weakness, fatigue
Cerebral arterial stenosis symptoms: vision loss affecting part or all of the visual field in both eyes, double vision, dizziness (spinning sensation), numbness or tingling, loss of coordination, dizziness or confusion
Brain edema (possible headache and (or) changes in mental state)
Optic neuritis symptoms: blurred vision, vision loss
Heart function disorder symptoms (reduced ejection fraction): fatigue, chest discomfort, feeling faint, pain, palpitations
Low or high insulin levels in blood (hormone regulating blood sugar levels)
Low C-peptide levels in blood (pancreatic function)
Sudden death

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

Heart function disorder symptoms (ventricular dysfunction): shortness of breath, fatigue at rest, irregular heartbeat, chest discomfort, feeling faint, pain, palpitations, excessive urination, swelling of feet, ankles and abdomen.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Nilotinib Zentiva

Keep this medicine out of 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 the stated month.
This medicine does not require any special storage conditions.
Do not use this medicine if the packaging is damaged or if there are signs of prior opening.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nilotinib Zentiva contains

The active substance is nilotinib.

Each hard capsule contains 150 mg of nilotinib (as nilotinib dihydrochloride dihydrate).
Other ingredients are:
Capsule contents: lactose monohydrate, crospovidone type A (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b)
Capsule shell: hypromellose (E464), carrageenan (E407), potassium chloride (E508), erythrosine (E127), iron oxide yellow (E172), iron oxide red (E172), titanium dioxide (E171), purified water.
Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (E172)
See section 2, Nilotinib Zentiva contains lactose.

Each hard capsule contains 200 mg of nilotinib (as nilotinib dihydrochloride dihydrate).
Other ingredients are:
Capsule contents: lactose monohydrate, crospovidone type A (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b)
Capsule shell: hypromellose (E464), carrageenan (E407), potassium chloride (E508), iron oxide yellow (E172), titanium dioxide (E171), purified water.
Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (E172)
See section 2, Nilotinib Zentiva contains lactose.

What Nilotinib Zentiva looks like and contents of the pack
Nilotinib Zentiva 150 mg is supplied as red, opaque hard capsules (size 1, approximate length 19.3 mm) with a black horizontal print "150 mg" on the body. The hard capsules are filled with a powder ranging from white to yellowish.

Nilotinib Zentiva 200 mg is supplied as light yellow, opaque hard capsules (size 0, approximate length 21.4 mm) with a black horizontal print "200 mg" on the body. The hard capsules are filled with a powder ranging from white to yellowish.

Nilotinib Zentiva is available in the following pack sizes:
Nilotinib Zentiva 150 mg hard capsules
PVC/PE/PVdC/Aluminium or OPA/Aluminium/PVC/Aluminium foil blisters

Unit packs containing 28 or 112 hard capsules in blisters, in a cardboard box.
Multipack containers containing 112 (4 packs of 28) hard capsules or 120 (3 packs of 40) hard capsules, in a cardboard box.

Nilotinib Zentiva 200 mg hard capsules
PVC/PE/PVdC/Aluminium or OPA/Aluminium/PVC/Aluminium foil blisters

Unit packs containing 28 or 112 hard capsules in blisters, in a cardboard box.
Multipack containers containing 112 (4 packs of 28) hard capsules or 120 (3 packs of 40) hard capsules, in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate,
Birzebbugia BBG3000,
Malta
PharOS Pharmaceutical Oriented Services Ltd.
Lesvou Street End, Thesi Loggos Industrial Zone,
Metamorfossi, 144 52,
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Hungary: Nilotinib Zentiva 50mg kemény kapszula, Nilotinib Zentiva 150mg kemény kapszula, Nilotinib Zentiva 200mg kemény kapszula
Austria: Nilotinib Zentiva 150 mg Hartkapseln, Nilotinib Zentiva 200 mg Hartkapseln
Bulgaria: Нилотиниб Зентива 150 mg твърди капсули, Нилотиниб Зентива 200 mg твърди капсули
Croatia: Nilotinib Zentiva 150 mg tvrde kapsule, Nilotinib Zentiva 200 mg tvrde kapsule
Estonia, Czech Republic, Poland, Portugal: Nilotinib Zentiva
Lithuania: Nilotinib Zentiva 150 mg kietosios kapsulės, Nilotinib Zentiva 200 mg kietosios kapsulės
Latvia: Nilotinib Zentiva 150 mg tvrde kapsules, Nilotinib Zentiva 200 mg tvrde kapsules
Romania: Nilotinib Zentiva 150 mg capsule, Nilotinib Zentiva 200 mg capsule
Slovakia: Nilotinib Zentiva 150 mg, Nilotinib Zentiva 200 mg

To obtain more detailed information about this medicinal product, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00