Nilotinib stada: detailed information

Package leaflet: Information for the user

Nilotinib STADA, 50 mg, hard capsules
Nilotinib STADA, 150 mg, hard capsules
Nilotinib STADA, 200 mg, hard capsules
Nilotinibum
Please read all of 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Nilotinib is and what it is used for

What Nilotinib is
Nilotinib is a medicine that contains an active substance called nilotinib.
What Nilotinib is used for
Nilotinib is used to treat a type of leukaemia called Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML). Chronic myeloid leukaemia (CML) is a cancer of the blood that causes the body to produce too many abnormal white blood cells.
Nilotinib is used to treat adult patients as well as children and adolescents with newly diagnosed CML, or patients with CML who no longer benefit from previous treatment, including treatment with imatinib. It is also used in adult patients as well as children and adolescents who have experienced severe side effects that make continuing previous treatment impossible.
How Nilotinib 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 blocks this signal and thereby prevents the formation of these abnormal cells.
Monitoring treatment with Nilotinib
During treatment, you will have regular tests, including blood tests. These tests will monitor:

blood cell counts (white blood cells, red blood cells, and platelets) to assess how well you tolerate Nilotinib.
pancreatic and liver function to assess how well you tolerate Nilotinib.
levels of electrolytes in the body (potassium, magnesium), which are important for heart function.
levels of blood sugar and fats (lipids).

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. 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 treatment if your condition requires it.
If you have any questions about how Nilotinib works or why it has been prescribed for an adult patient or a child, please speak to your doctor.

2. Important information before using Nilotinib

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

When not to use Nilotinib

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.

Warnings and precautions

Before starting treatment with Nilotinib, 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 supply to the brain (stroke), or reduced blood flow to the legs (intermittent claudication), or if the patient has risk factors for cardiovascular disease, such as high blood pressure (hypertension), diabetes, or disorders of blood lipid levels (dyslipidemia);
if the patient has heart rhythm disorders, such as abnormal electrical activity known as "QT interval prolongation";
if the patient is taking medications that lower blood cholesterol levels (statins), affect heart function (antiarrhythmic drugs), or affect liver function (see Other medicines and Nilotinib);
if the patient has low levels of potassium or magnesium;
if the patient has impaired liver or pancreas function;
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 may cause reactivation of hepatitis B virus, which in some cases may 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

if the patient experiences loss of consciousness (fainting) or irregular heartbeat during treatment with this medicine, they must immediately inform their doctor, as this may be a sign of serious heart disease. QT interval prolongation or irregular heartbeat may lead to sudden death. Cases of sudden death have been reported, not infrequently, in patients receiving nilotinib.
if the patient experiences: sudden palpitations, severe weakness or muscle paralysis, seizures, or sudden changes in thinking or concentration, they must immediately inform their doctor, as these may be symptoms of a rapid breakdown of cancer cells, known as tumor lysis syndrome. Tumor 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, discoloration, or coldness in a limb, they must immediately inform their doctor, as these may be symptoms of cardiovascular events. Serious cardiovascular events, including impaired blood flow to the legs (peripheral arterial occlusive disease), ischemic heart disease, and impaired blood supply to the brain (ischemic stroke), have been reported in patients receiving nilotinib. Your doctor should measure blood lipid and glucose levels before starting and during treatment with Nilotinib.
if the patient develops swelling of the feet or hands, generalized edema, or rapid weight gain, they should inform their doctor, as these may be signs of severe fluid retention. Severe fluid retention has been reported not infrequently in patients treated with nilotinib. Parents of children receiving Nilotinib should inform the doctor if any of the above situations apply to their child.

Children and adolescents

Nilotinib 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 limited experience with the use of Nilotinib in children under 10 years of age with newly diagnosed disease, and experience is limited in patients under 6 years of age who have stopped responding to prior CML treatment.

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

Nilotinib and other medicines

Nilotinib 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 the patient plans to take. This especially includes:

antiarrhythmic drugs – used to treat heart rhythm disorders;
chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin – medicines that may adversely affect the heart's electrical activity;
ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat infections;
ritonavir – a "protease inhibitor" used in the treatment of 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 medicine 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, often used to 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 thrombophlebitis);
astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, or ergot alkaloids (ergotamine, dihydroergotamine).

The above-mentioned medicines should not be taken during treatment with Nilotinib. 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), they should speak with their doctor or pharmacist. Nilotinib, when taken with certain statins, may increase the risk of statin-related muscle problems, which in rare cases may lead to severe muscle breakdown (rhabdomyolysis) causing kidney damage.

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

The following medicines should be taken separately from Nilotinib:

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

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

Taking Nilotinib with food and drink

Do not take Nilotinib with food. Food may significantly increase the absorption of Nilotinib 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, even to harmful levels.

Pregnancy and breastfeeding

Nilotinib 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 the possibility of using this medicine.
Women who can become pregnant should be advised by their doctor to use highly effective contraception during treatment and for at least two weeks after treatment ends.
Breastfeeding is not recommended during treatment with Nilotinib 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 plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery

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

Nilotinib 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 contact their doctor before taking this medicine.

Nilotinib contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Nilotinib

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
What dose of Nilotinib should be taken?
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. The doctor will calculate the correct dose to use and will inform you which capsules and how many capsules of Nilotinib 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 you respond to treatment.
Patients of advanced age (aged 65 years and older)
Nilotinib may be administered to patients aged 65 years and older at the same doses as other adults.
When to take Nilotinib
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 food. If you have any doubts about when to take this medicine, you should contact your doctor or pharmacist. Nilotinib should be taken at the same time each day, which will help you remember to take the hard capsules.

How to take Nilotinib

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

How long to take Nilotinib

Nilotinib should be taken daily for as long as directed by your doctor. Treatment is long-term. Your doctor will monitor your condition regularly to assess whether the treatment is achieving the desired effects.
Your doctor may consider discontinuing treatment with Nilotinib based on specific criteria.
If you have any doubts about the duration of treatment with Nilotinib, you should contact your doctor.
Taking more than the recommended dose of Nilotinib
If you take more than the recommended dose of Nilotinib, or if the medicine is taken accidentally, you should contact your doctor immediately or go to hospital. Show the packaging and the patient information leaflet to the doctor or healthcare professional. Medical assistance may be required.
Missed dose of Nilotinib
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 treatment with Nilotinib
This medicine should be taken until your doctor decides to stop treatment. Stopping treatment with Nilotinib without consulting your doctor may worsen your condition and could be life-threatening. If you are considering stopping treatment with Nilotinib, you should discuss this with your doctor, nurse, and (or) pharmacist.
Doctor's recommendation to stop treatment with Nilotinib
Your doctor will regularly evaluate the treatment results using specific diagnostic tests and will decide whether you should continue taking this medicine. If you are instructed to stop treatment with Nilotinib, your doctor will continue to closely monitor the course of your disease (CML) before, during, and after stopping treatment with Nilotinib, and may recommend that you resume taking Nilotinib if necessary based on your condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Most adverse reactions are mild to moderate in severity and resolve within a few days
or weeks of treatment.
Some adverse symptoms may be severe.

musculoskeletal symptoms: joint and muscle pain
cardiac disorders: chest pain or discomfort, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (sensation of rapid heartbeat), fainting, blue discoloration of lips, tongue or skin
symptoms of arterial occlusion: pain, discomfort, weakness or cramps in legs, possibly due to reduced blood flow, leg or hand ulcers healing 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: thirst, dry skin, irritability, dark urine color, reduced urine output, difficult or painful urination, persistent urge to urinate, blood in urine, abnormal urine color
symptoms of high blood sugar levels: excessive thirst, increased urine volume, increased appetite with weight loss, feeling tired
vestibular dizziness symptoms: dizziness or spinning sensation
symptoms of pancreatitis: severe pain in the upper abdomen (middle or left side)
skin disorders: 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 light sensitivity
blood disorders: fever, easy bruising or unexplained bleeding, severe or frequent infections, unexplained weakness
symptoms of venous thrombosis: swelling and pain in one body part
nervous system disorders: weakness or paralysis of limbs or face, difficulty speaking, severe headaches, seeing, hearing or sensing things that are not real, visual disturbances, loss of consciousness, confusion, disorientation, tremor, tingling sensation, pain or
numbness in fingers of hands and feet
lung disorders: difficulty breathing or pain during breathing, cough, wheezing with or without fever, swelling of feet or legs
gastrointestinal disorders: abdominal pain, nausea, blood in vomit, black or bloody stools, constipation, heartburn, gastric reflux, abdominal swelling
liver function disorders: yellowing of skin and eyes, nausea, loss of appetite, dark urine
liver infection symptoms: reactivation of hepatitis B virus infection
eye disorders: vision disturbances, including blurred vision, double vision or flashes of light, decreased visual acuity or vision loss, blood in the eye, increased sensitivity of eyes to light, eye pain, redness, itching or eye irritation, dry eyes, eyelid swelling or itching
electrolyte imbalance symptoms: nausea, shortness of breath, irregular pulse, cloudy urine, fatigue and (or) joint complaints associated with abnormal blood test results (e.g. high potassium, uric acid and phosphate levels, low calcium levels)
You should contact your doctor immediately if you notice any of the above adverse reactions.

Some adverse reactions occur very commonly (may occur in 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 back pain after completion of Nilotinib treatment
growth retardation in children and adolescents
upper respiratory tract infection, including sore throat, watery nasal discharge or nasal congestion, sneezing
low blood cell count (red blood cells, platelets) or low hemoglobin concentration
increased blood lipase activity (pancreatic function)
increased blood bilirubin concentration (liver function)
increased alanine aminotransferase activity in blood (liver enzymes)

Some adverse reactions occur commonly (may occur in no more 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 (e.g. ringing, buzzing) without 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 cramps possibly due to reduced blood flow, leg or hand ulcers healing slowly or not at all, noticeable skin color changes (pale or blue) or temperature changes (cooling) in legs or hands (these symptoms may indicate arterial occlusion in affected leg, arm, toes or fingers)
shortness of breath
oral ulcers with gingivitis (also known as oral mucositis)
increased blood amylase activity (pancreatic function)
increased blood creatinine concentration (kidney function)
increased blood alkaline phosphatase or creatine kinase activity
increased blood aspartate aminotransferase activity (liver enzymes)
increased blood gamma-glutamyl transferase activity (liver enzymes)
leukopenia or neutropenia symptoms: low white blood cell count
increased platelet or white blood cell count in blood
decreased blood magnesium, potassium, sodium, calcium or phosphorus levels
increased blood lipid levels (including cholesterol)
increased blood uric acid concentration

Some adverse reactions occur uncommonly (may occur in no more than 1 in 100
patients):

hypersensitivity (allergic reaction to Nilotinib)
dry mouth
chest 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
nipple swelling
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 concentration (hormone regulating calcium and phosphorus levels) in blood
increased lactate dehydrogenase activity (enzyme)
symptoms of low blood sugar: nausea, sweating, weakness, dizziness, tremor, headache
dehydration
abnormal blood fat concentration
involuntary tremor
difficulty concentrating
unpleasant or abnormal touch sensation (also known as sensory disturbances)
fatigue
sensation of numbness or tingling in fingers of hands and feet (also known as peripheral neuropathy)
facial muscle paralysis
red spots in the white of the eye due to blood vessel damage (also known as subconjunctival hemorrhage)
blood in the eyes (also known as intraocular hemorrhage)
eye irritation
myocardial infarction symptoms (also known as heart attack): sudden, crushing chest pain, fatigue, irregular heartbeat
heart murmur symptoms: fatigue, chest discomfort, dizziness, chest pain, palpitations
fungal foot infection
heart failure symptoms: shortness of breath, difficulty breathing when lying down, swelling of feet or legs
retrosternal pain (also known as pericarditis)
hypertensive crisis symptoms: severe headache, dizziness, nausea
leg pain and weakness while walking (also known as intermittent claudication)
symptoms of arterial narrowing in limbs: possible high blood pressure, painful cramps in one or both hips, thighs or calves during certain activities such as walking or climbing stairs, leg numbness or weakness
bruising (without cause such as injury)
fat deposits in arteries that may cause blockage (also known as atherosclerosis)
low blood pressure symptoms (also known as hypotension): dizziness, lightheadedness 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 during breathing
pleuritic pain symptoms: chest pain
pleuritis symptoms: cough, pain during 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 blood urea concentration (kidney function)
changes in blood protein levels (low globulin concentration or presence of paraprotein)
increased unconjugated bilirubin concentration in blood
high troponin concentration in blood

Some adverse reactions occur rarely (may occur in no more than 1 in 1000
patients):

redness and (or) swelling and possible peeling of palms and soles (known as hand-foot syndrome)
oral warts
sensation of breast hardening or stiffness
thyroiditis
mood disturbances or depression
secondary hyperparathyroidism symptoms: bone and joint pain, excessive urination, abdominal pain, weakness, fatigue
cerebral artery 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) mental status changes)
optic neuritis symptoms: blurred vision, vision loss
cardiac function disorder symptoms (reduced ejection fraction): fatigue, chest discomfort, dizziness, pain, palpitations
low or high insulin concentration in blood (hormone regulating blood sugar levels)
low C-peptide concentration in blood (pancreatic function)
sudden death

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

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

Reporting of adverse reactions
If you experience any adverse reactions, including any not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nilotinib STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP. The expiry date refers to the last day of the stated month.
Nilotinib 50 mg hard capsules, packed in blisters made of PVC/PE/PVDC/Aluminium: Do not store above 30°C.
Nilotinib 150 mg and 200 mg hard capsules, packed in blisters made of PVC/PE/PVDC/Aluminium, and Nilotinib 50 mg, 150 mg and 200 mg hard capsules, packed in blisters made of OPA/Aluminium/PVC/Aluminium: No special storage conditions apply.
Do not use this medicine if you notice that the packaging is damaged or shows signs of prior opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Nilotinib contains

The active substance is nilotinib.

Each 50 mg hard capsule contains 50 mg of nilotinib (as nilotinib monohydrochloride dihydrate).
The other ingredients are:
Capsule contents: monohydrate lactose, crospovidone type A (E1202), anhydrous colloidal silica (E551), magnesium stearate (E470b).
Capsule shell: hypromellose (E464), purified water, carrageenan (E407), potassium chloride (E508), erythrosine (E127), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).
Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172).
See section 2, "Nilotinib contains lactose and sodium".

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

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

What Nilotinib looks like and contents of the pack
Nilotinib 50 mg is available as hard capsules (capsules) with a red, opaque cap and a light yellow, opaque body, size 4 (approx. 14.4 mm in length), with a black horizontal print "50 mg" on the body. The hard capsules are filled with powder ranging from white to yellowish.

Nilotinib 150 mg is available as red, opaque hard capsules of size 1 (approx. 19.3 mm in length), with a black horizontal print "150 mg" on the body. The hard capsules are filled with powder ranging from white to yellowish.

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

Nilotinib 50 mg hard capsules are packed in blisters made of PVC/PE/PVDC/Aluminium or in blisters made of OPA/Aluminium/PVC/Aluminium:

Unit packs containing 40 hard capsules and multipacks containing 120 (3 packs of 40) hard capsules in a cardboard box.

Nilotinib 50 mg hard capsules are also packed in perforated single-dose blisters made of PVC/PE/PVDC/Aluminium or in blisters made of OPA/Aluminium/PVC/Aluminium:

Unit packs containing 40 x 1 hard capsules and multipacks containing 120 x 1 (3 packs of 40 x 1) hard capsules in a cardboard box.

Nilotinib 150 mg hard capsules are packed in blisters made of PVC/PE/PVDC/Aluminium or in blisters made of OPA/Aluminium/PVC/Aluminium:

Unit packs containing 28 or 40 hard capsules and multipacks containing 112 (4 packs of 28), 120 (3 packs of 40) or 392 (14 packs of 28) hard capsules in a cardboard box.

Nilotinib 150 mg hard capsules are also packed in perforated single-dose blisters made of PVC/PE/PVDC/Aluminium or in blisters made of OPA/Aluminium/PVC/Aluminium:

Unit packs containing 28 x 1 or 40 x 1 hard capsules and multipacks containing 112 x 1 (4 packs of 28 x 1), 120 x 1 (3 packs of 40 x 1) or 392 x 1 (14 packs of 28 x 1) hard capsules in a cardboard box.

Nilotinib 200 mg hard capsules are packed in blisters made of PVC/PE/PVDC/Aluminium or in blisters made of OPA/Aluminium/PVC/Aluminium:

Unit packs containing 28 or 40 hard capsules and multipacks containing 112 (4 packs of 28), 120 (3 packs of 40) or 392 (14 packs of 28) hard capsules in a cardboard box.

Nilotinib 200 mg hard capsules are also packed in perforated single-dose blisters made of PVC/PE/PVDC/Aluminium or in blisters made of OPA/Aluminium/PVC/Aluminium:

Unit packs containing 28 x 1 or 40 x 1 hard capsules and multipacks containing 112 x 1 (4 packs of 28 x 1), 120 x 1 (3 packs of 40 x 1) or 392 x 1 (14 packs of 28 x 1) hard capsules in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany

Manufacturer
Clonmel Healthcare Ltd.,
Waterford Road,
E91 D768 County Tipperary,
Ireland
Stada Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany
Stada Arzneimittel GmbH,
Muthgasse 36/2
1190 Vienna,
Austria
PharOS Pharmaceutical Oriented Services Ltd.
Lesvou Street End, Thesi Loggos Industrial Zone,
Metamorfossi, 144 52,
Greece

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Nilotinib STADA 50 mg Hartkapseln
Nilotinib STADA 150 mg Hartkapseln
Nilotinib STADA 200 mg Hartkapseln
Belgium Nilotinib EG 50 mg harde capsules
Nilotinib EG 150 mg harde capsules
Nilotinib EG 200 mg harde capsules
Croatia Nilotinib STADA 50 mg tvrde kapsule
Nilotinib STADA 150 mg tvrde kapsule
Cyprus Nilotinib Stada 50mg σκληρό καψάκιο
Nilotinib Stada 150mg σκληρό καψάκιο
Nilotinib Stada 200mg σκληρό καψάκιο
Denmark Nilotinib STADA
Estonia Nilotinib STADA
Finland Nilotinib STADA 50 mg kapseli, kova
Nilotinib STADA 150 mg kapseli, kova
France NILOTINIB EG 50 mg, gélule
NILOTINIB EG 150 mg, gélule
NILOTINIB EG 200 mg, gélule
Greece Nilotinib Stada
Spain Nilotinib STADA 150 mg cápsulas duras EFG
Nilotinib STADA 200 mg cápsulas duras EFG
Netherlands Nilotinib CF 50 mg, harde capsules
Nilotinib CF 150 mg, harde capsules
Nilotinib CF 200 mg, harde capsules
Ireland Nilotinib Clonmel 50 mg hard capsules
Nilotinib Clonmel 150 mg hard capsules
Nilotinib Clonmel 200 mg hard capsules
Iceland Nilotinib STADA 50 mg hörð hylki
Nilotinib STADA 150 mg hörð hylki
Nilotinib STADA 200 mg hörð hylki
Lithuania Nilotinib STADA 50 mg kietosios kapsulės
Nilotinib STADA 100 mg kietosios kapsulės
Nilotinib STADA 200 mg kietosios kapsulės
Latvia Nilotinib STADA 50 mg cietās kapsulas
Nilotinib STADA 100 mg cietās kapsulas
Nilotinib STADA 200 mg cietās kapsulas
Luxembourg Nilotinib EG 50 mg gélules
Nilotinib EG 150 mg gélules
Nilotinib EG 200 mg gélules
Malta Nilotinib Clonmel 50 mg hard capsules
Nilotinib Clonmel 150 mg hard capsules
Nilotinib Clonmel 200 mg hard capsules
Germany Nilotinib AL 50 mg Hartkapseln
Nilotinib AL 150 mg Hartkapseln
Nilotinib AL 200 mg Hartkapseln
Norway Nilotinib STADA
Portugal Nilotinib Stada
Sweden Nilotinib STADA 50 mg hårda kapslar
Nilotinib STADA 150 mg hårda kapslar
Nilotinib STADA 200 mg hårda kapslar
Slovenia Nilotinib STADA 50 mg trde kapsule
Nilotinib STADA 150 mg trde kapsule
Nilotinib STADA 200 mg trde kapsule
Slovakia Nilotinib STADA 50 mg tvrdé kapsuly
Nilotinib STADA 150 mg tvrdé kapsuly
Nilotinib STADA 200 mg tvrdé kapsuly
Hungary Nilotinib STADA 50 mg kemény kapszula
Nilotinib STADA 150 mg kemény kapszula
Nilotinib STADA 200 mg kemény kapszula
Italy NILOTINIB EG