Nilotinib Stada 150 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Nilotinib Stada 50 mg hard capsules EFG

Nilotinib Stada 150 mg hard capsules EFG

Nilotinib Stada 200 mg hard capsules EFG

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

Keep this leaflet. You may need to read it again.
If you have any 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, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Nilotinib Stada is

Nilotinib Stada is a medicine containing an active substance called nilotinib.

What Nilotinib Stada is used for

Nilotinib is used to treat a type of leukemia called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). CML is a blood cancer that causes the body to produce an excessive number of abnormal white blood cells.

Nilotinib is used in adult and pediatric patients with newly diagnosed CML or in patients with CML who are no longer benefiting from prior therapy, including imatinib. It is also used in adult and pediatric patients who have experienced severe adverse reactions to prior therapy and who cannot continue using it.

How Nilotinib Stada works

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

Monitoring during treatment with Nilotinib Stada

During treatment, regular monitoring will be performed, including blood tests. These tests will monitor:

the number of blood cells in the body (white blood cells, red blood cells, and platelets) to check whether nilotinib is well tolerated.
the function of the pancreas and liver to check whether nilotinib is well tolerated.
body electrolytes (potassium, magnesium), which are important for heart function.
blood sugar and fat levels.

Heart rate will also be monitored using a machine that measures the heart's electrical activity (a test called an "ECG").

Your doctor will regularly evaluate your treatment and decide whether you should continue taking nilotinib. If your doctor advises you to stop this medicine, they will continue to monitor your CML and may instruct you to restart treatment with nilotinib if necessary.

If you have any questions about how nilotinib works or why you or your child has been prescribed this medicine, consult your doctor.

2. What you need to know before starting to take Nilotinib Stada

Carefully follow all instructions from your doctor, even if they differ from the general information contained in this leaflet.

Do not take Nilotinib Stada

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.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with nilotinib:

if you have previously experienced cardiovascular events such as a heart attack, chest pain (angina), problems with blood supply to your brain (stroke), or problems with blood flow to your leg (claudication), or if you have risk factors for cardiovascular disease such as high blood pressure (hypertension), diabetes, or problems with fat levels in your blood (lipid abnormalities).
if you have a heart disorder, such as an abnormal electrical signal called "prolongation of the QT interval".
if you are receiving treatment with medications that lower blood cholesterol (statins) or affect heart rhythm (antiarrhythmics) or the liver (see Other medicines and Nilotinib Stada).
if you have low levels of potassium or magnesium.
if you have a disorder of the liver or pancreas.
if you have symptoms such as easy bruising, feeling tired, difficulty breathing, or have had repeated infections.
if you have undergone surgery involving complete removal of the stomach (total gastrectomy).
if you have ever had or may currently have an infection with hepatitis virus.
This is because nilotinib could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor should carefully check for signs of this infection before starting treatment.

If any of these situations apply to you or your child, inform your doctor.

During treatment with nilotinib

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 problem. Prolongation of the QT interval or an irregular heartbeat can lead to sudden death. Rare cases of sudden death have been reported in patients taking nilotinib.
if you experience sudden heart palpitations, severe muscle weakness or paralysis, seizures, or sudden changes in behavior or level of alertness, inform your doctor immediately, as this may be a sign of rapid breakdown of cancer cells known as tumor lysis syndrome. Rare cases of tumor lysis syndrome have been reported in patients treated with nilotinib.
if you develop chest pain or discomfort, numbness or weakness, difficulty walking or speaking, pain, discoloration, or a 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 supply to the brain (cerebrovascular ischemic events), have been reported in patients taking nilotinib. Your doctor should assess your blood fat (lipid) and sugar levels before starting treatment with nilotinib and during treatment.
if you develop swelling of the feet or hands, generalized swelling, or rapid weight gain, inform your doctor, as these may be signs of severe fluid retention. Rare cases of severe fluid retention have been reported in patients treated with nilotinib.

If you are the parent of a child receiving treatment with nilotinib, inform the doctor if any of the conditions described above occur in your child.

Children and adolescents

Nilotinib is used to treat children and adolescents with CML. There is no experience with the use of this medicine in children under 2 years of age. There is no experience in children under 10 years of age with newly diagnosed disease, and limited experience in children under 6 years of age who did not benefit from prior treatment for CML, including imatinib.

Some children and adolescents receiving nilotinib may have slower than normal growth. Your doctor will monitor growth during regular visits.

Other medicines and Nilotinib Stada

Nilotinib may interact with certain medicines.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. These include, 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 medicine from the "protease inhibitor" group used to treat HIV;
carbamazepine, phenobarbital, phenytoin – used to treat epilepsy;
rifampicin – used to treat tuberculosis;
St. John’s wort – a plant-derived product used to treat depression and other conditions (also known as Hypericum perforatum);
midazolam – used to relieve anxiety before surgery;
alfentanil and fentanyl – used for pain treatment and as sedatives before or during surgery or medical procedures;
cyclosporine, sirolimus, and tacrolimus – medicines that suppress the body’s "self-defense" ability and fight infections, frequently used to prevent rejection of transplanted organs such as liver, heart, or kidney;
dihydroergotamine and ergotamine – used to treat migraine;
lovastatin, simvastatin – used to treat high blood fat levels;
warfarin – used to treat clotting disorders (such as blood clots or thrombosis);
astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, or ergot alkaloids (ergotamine, dihydroergotamine).

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

If you are taking statins (a type of medicine that lowers blood cholesterol), speak with your doctor or pharmacist. Taking nilotinib with certain statins may increase the risk of statin-related muscle problems, which in rare cases can lead to serious muscle breakdown (rhabdomyolysis) that may result in kidney damage.

In addition, inform your doctor or pharmacist before taking nilotinib if you are taking any antacids, which are medicines for stomach acidity. These medicines should be taken separately from nilotinib:

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

You should also inform your doctor if you are already taking nilotinib and are prescribed a new medicine that you have not taken previously during nilotinib treatment.

Taking Nilotinib Stada with food and drink

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

Pregnancy and breastfeeding

Nilotinib is not recommended during pregnancy unless clearly necessary. If you are pregnant or think you might be pregnant, inform your doctor, who will discuss with you whether you can take this medicine during pregnancy.
Women who can become pregnant should use highly effective contraception during treatment and for at least two weeks after stopping treatment.
Breastfeeding is not recommended during treatment with nilotinib and for two weeks after the last dose. Inform your doctor if you are breastfeeding.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

If you experience adverse effects (such as dizziness or vision problems) that may affect your ability to drive safely or operate tools or machines after taking this medicine, you should avoid these activities until the effects have subsided.

Nilotinib Stada contains lactose

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

Nilotinib Stada 50 mg and 150 mg contain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; hence, it is essentially "sodium-free".

3. How to take Nilotinib Stada

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How much nilotinib 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 with CML who did not benefit from prior treatment: The recommended dose is 800 mg daily. This dose is achieved by taking two 200 mg capsules twice daily.

Use in children and adolescents

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

Your doctor may prescribe a lower dose depending on how you or your child responds to treatment.

Elderly patients (65 years of age or older)

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

When to take nilotinib

Take the hard capsules:

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

Consult your doctor or pharmacist if you have any doubts about when to take this medicine. Taking nilotinib at the same time each day will help you remember when to take the capsules.

How to take Nilotinib Stada

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

How long to take Nilotinib Stada

Take nilotinib every day for as long as your doctor tells you to. This is a long-term treatment. Your doctor will monitor your condition regularly to check that the treatment is having the desired effect.

Your doctor may consider stopping your treatment with nilotinib based on specific criteria. If you have any doubts about how long you should take nilotinib, consult your doctor.

If you take more Nilotinib Stada than you should

If you have taken more nilotinib than you should, or if someone else accidentally takes your hard capsules, contact a doctor or hospital immediately. Show the capsule packaging and this leaflet. You may require medical treatment.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Nilotinib Stada

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

If you stop taking Nilotinib Stada

Do not stop treatment with this medicine unless your doctor tells you to. Stopping treatment with nilotinib without your doctor's recommendation puts you at risk of worsening of your disease, which could have fatal consequences. Be sure to discuss this with your doctor, nurse, and/or pharmacist if you are considering stopping treatment with nilotinib.

If your doctor advises you to stop treatment with Nilotinib Stada

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

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

4. Possible adverse effects

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

Some adverse reactions may be serious

signs of musculoskeletal pain: joint and muscle pain
signs of cardiac disorders: 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 heal slowly or do not heal; and noticeable changes in color (bluish or pale) or temperature (cold) in legs, arms, toes, or fingers
signs of underactive thyroid gland: weight gain, fatigue, hair loss, muscle weakness, feeling cold
signs of overactive thyroid gland: rapid heartbeat, bulging eyes, weight loss, swelling in the front of the neck
signs of kidney or urinary tract disorders: thirst, dry skin, irritability, dark urine, reduced urine output, difficulty or pain when urinating, excessive urge to urinate, blood in urine, abnormal urine color
signs of high blood sugar levels: excessive thirst, increased urine volume, increased appetite with weight loss, fatigue
signs of dizziness: dizziness or spinning sensation
signs of pancreatitis: severe pain in the upper abdomen (middle or left side)
signs of skin disorders: painful red lumps, skin pain, skin redness, 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, easy bruising or unexplained bleeding, severe or frequent infections, unexplained weakness
signs of blood clot in a vein: 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, feeling, or hearing things that are not there, vision changes, loss of consciousness, confusion, disorientation, tremors, tingling, pain, or numbness in fingers or toes
signs of lung disorders: difficulty breathing or pain when breathing, cough, wheezing with or without fever, swelling of feet or legs
signs of gastrointestinal disorders: abdominal pain, nausea, vomiting blood, black or bloody stools, constipation, heartburn, stomach reflux, bloated abdomen
signs of liver disorders: yellowing of skin and eyes, nausea, loss of appetite, dark urine
signs of liver infection: recurrence (reactivation of hepatitis B infection)
signs of eye disorders: visual disturbances including blurred vision, double vision, or perception of flashes of light, reduced sharpness or loss of vision, 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, difficulty breathing, irregular heartbeat, cloudy urine, fatigue and/or joint discomfort 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 experience any of the adverse effects described.

Some adverse reactions 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
pain in limbs, bone pain, and spinal pain upon stopping nilotinib treatment
slowed growth in children and adolescents
upper respiratory tract infection, including sore throat, nasal discharge or congestion, sneezing
low blood cell counts (red blood cells, platelets) or hemoglobin
elevated blood lipase levels (pancreatic function)
elevated blood bilirubin levels (liver function)
elevated blood alanine aminotransferase levels (liver enzymes)

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

pneumonia
abdominal pain, stomach discomfort after meals, flatulence, abdominal swelling
bone pain, muscle spasms
pain (including neck pain)
dry skin, acne, reduced skin sensitivity
weight gain or weight loss
insomnia, depression, anxiety
night sweats, excessive sweating
general feeling of discomfort
nosebleeds
signs of gout: joint pain and swelling
inability to achieve or maintain an erection
flu-like symptoms
sore throat
bronchitis
ear pain, hearing noises (e.g., ringing, buzzing) not coming from an external source (also called tinnitus)
hemorrhoids
heavy menstrual periods
itching in hair follicles
oral or vaginal candidiasis
signs of conjunctivitis: itchy eye discharge, redness, and swelling
eye irritation, red eyes
signs of hypertension: high blood pressure, headache, dizziness
hot flashes
signs of peripheral arterial occlusive disease: pain, discomfort, weakness, or cramps in leg muscles due to reduced blood flow; leg or arm ulcers that heal slowly or not at all; and noticeable changes in color (bluish or pale) or temperature (cold) in legs, arms, toes, or fingers (possible signs of blockage in an artery of the leg, arm, or affected fingers or toes)
difficulty breathing (also called dyspnea)
mouth sores with inflamed gums (also called stomatitis)
elevated blood amylase levels (pancreatic function)
elevated blood creatinine levels (kidney function)
elevated blood alkaline phosphatase or creatine phosphokinase levels
elevated blood aspartate aminotransferase levels (liver enzymes)
elevated blood gamma-glutamyltransferase levels (liver enzymes)
signs of leukopenia or neutropenia: low white blood cell count
increased number of platelets or white blood cells in blood
low levels of magnesium, potassium, sodium, calcium, or phosphorus in blood
increased levels of potassium, calcium, or phosphorus in blood
elevated blood fat levels (including cholesterol)
elevated blood uric acid levels

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

allergy (hypersensitivity to nilotinib)
dry mouth
breast pain
side pain or discomfort
increased appetite
breast enlargement in men
herpes virus infection
stiffness of muscles and joints, joint swelling
sensation of temperature change in the body (including feeling hot or cold)
altered sense of taste
increased frequency of urination
signs of stomach lining inflammation: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
memory loss
skin cyst, skin thinning or thickening, thickening of the outermost skin layer, skin discoloration
signs of psoriasis: thickened red/silvery skin patches
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 body part, usually the leg, accompanied by uncomfortable sensations)
signs of sepsis: fever, chest pain, increased heart rate, difficulty breathing or rapid breathing
skin infection (subcutaneous abscess)
skin wart
increase in a specific type of white blood cell (called eosinophils)
signs of lymphopenia: low white blood cell count
elevated blood parathyroid hormone levels (a hormone regulating calcium and phosphorus levels)
elevated blood lactate dehydrogenase levels (an enzyme)
signs of low blood sugar: nausea, sweating, weakness, dizziness, tremors, headache
dehydration
abnormal blood fat levels
involuntary movements (also called tremor)
difficulty concentrating
unpleasant or abnormal sensation upon touch (also called dysesthesia)
tiredness (also called fatigue)
numbness or tingling in fingers or toes (also called peripheral neuropathy)
facial muscle paralysis
red spot on the white of the eye due to broken blood vessels (also called conjunctival hemorrhage)
blood in the eyes (also called ocular hemorrhage)
eye irritation
signs of heart attack (also called myocardial infarction): sudden, crushing chest pain, fatigue, irregular heartbeat
signs of heart murmur: fatigue, chest discomfort, dizziness, chest pain, palpitations
fungal foot infection
signs of heart failure: dyspnea, 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 when walking (also called intermittent claudication)
signs of arterial blockage in limbs: possible high blood pressure, painful cramps in one or both hips, thighs, or calf muscles after certain activities like walking or climbing stairs, numbness or weakness in legs
bruising (when not injured)
fat deposits in arteries that may cause blockage (also called atherosclerosis)
signs of low blood pressure (also called hypotension): lightheadedness, dizziness, or fainting
signs of pulmonary edema: dyspnea
signs of pleural effusion: fluid buildup 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, pain when breathing
signs of pleural pain: chest pain
signs of pleurisy: cough, painful breathing
hoarse voice
signs of pulmonary hypertension: high blood pressure in the lung arteries
wheezing
tooth sensitivity
signs of inflammation (also called gingivitis): bleeding gums, tender or enlarged gums
elevated blood urea levels (kidney function)
changes in blood proteins (low globulin levels or presence of paraprotein)
elevated levels of unconjugated bilirubin in blood
elevated blood troponin levels

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

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

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nilotinib Stada

Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.
- This medicine does not require any special storage conditions.
- Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nilotinib Stada

The active substance is nilotinib.
Each 50 mg hard capsule contains 50 mg of nilotinib (as dihydrochloride monohydrate).

The other components are:

Capsule contents: lactose monohydrate, crospovidone type A (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b).

Hard capsule shell: hypromellose (E464), purified water, carrageenan (E407), potassium chloride (E508), erythrosine (E127), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171).

Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172).

See section 2, Nilotinib Stada 50 mg contains lactose and sodium.

Each 150 mg hard capsule contains 150 mg of nilotinib (as dihydrochloride monohydrate).

The other components are:

Capsule contents: lactose monohydrate, crospovidone type A (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b).

Hard capsule shell: hypromellose (E464), purified water, carrageenan (E407), potassium chloride (E508), erythrosine (E127), yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171).

Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172).

See section 2, Nilotinib Stada 150 mg contains lactose and sodium.

Each 200 mg hard capsule contains 200 mg of nilotinib (as dihydrochloride monohydrate).

The other components are:

Capsule contents: lactose monohydrate, crospovidone type A (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b).

Hard 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 Stada 200 mg contains lactose.

Appearance of Nilotinib Stada and contents of the pack

Nilotinib 50 mg is presented as opaque hard capsules with a red cap and light yellow body, size 4 (approximately 14.4 mm long), printed horizontally in black with "50 mg" on the body. The hard capsules contain white to yellowish powder.

Nilotinib 150 mg is presented as opaque red hard capsules, size 1 (approximately 19.3 mm long), printed horizontally in black with "150 mg" on the body. The hard capsules contain white to yellowish powder.

Nilotinib 200 mg is presented as opaque light yellow hard capsules, size 0 (approximately 21.4 mm long), printed horizontally in black with "200 mg" on the body. The hard capsules contain white to yellowish powder.

Nilotinib 50 mg is packaged in PVC/PE/PVdC//Al or OPA/Al/PVC//Al blisters or pre-cut unit-dose blisters in:

Pack containing 40 capsules and multipack containing 120 capsules (3 packs of 40).

Pack containing 40 capsules in unit-dose blisters and multipack containing 120 capsules (3 packs of 40) in unit-dose blisters.

Nilotinib 150 mg is packaged in PVC/PE/PVdC//Al or OPA/Al/PVC//Al blisters or pre-cut unit-dose blisters in:

Pack containing 28, 40 capsules and multipack containing 112 (4 packs of 28), 120 (3 packs of 40) and 392 capsules (14 packs of 28).

Pack containing 28, 40 capsules in unit-dose blisters and multipack containing 112 (4 packs of 28), 120 (3 packs of 40) and 392 capsules (14 packs of 28) in unit-dose blisters.

Nilotinib 200 mg is packaged in PVC/PE/PVdC//Al or OPA/Al/PVC//Al blisters or pre-cut unit-dose blisters in:

Pack containing 28, 40 capsules and multipack containing 112 (4 packs of 28), 120 (3 packs of 40) and 392 capsules (14 packs of 28).

Pack containing 28, 40 capsules in unit-dose blisters and multipack containing 112 (4 packs of 28), 120 (3 packs of 40) and 392 capsules (14 packs of 28) in unit-dose blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

PharOS Pharmaceutical Oriented Services Ltd.

Lesvou Street End, Thesi Loggos Industrial Zone,

Metamorfossi, 144 52,

Greece

STADA Arzneimittel AG

Stadastrasse 2 – 18, 61118 Bad Vilbel

Germany

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary,

Ireland

STADA Arzneimittel GmbH

Muthgasse 36/2, 1190 Wien

Austria

This medicinal product is authorized in the European Economic Area Member States 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

Cyprus: Nilotinib Stada 50mg σκληρή κάψουλα
Nilotinib Stada 150mg σκληρή κάψουλα
Nilotinib Stada 200mg σκληρή κάψουλα

Czech Republic: Nilotinib STADA

Germany: Nilotinib AL 50 mg Hartkapseln
Nilotinib AL 150 mg Hartkapseln
Nilotinib AL 200 mg Hartkapseln

Denmark: Nilotinib STADA

Estonia: Nilotinib STADA

Greece: Nilotinib Stada

Spain: Nilotinib STADA 50 mg cápsulas duras EFG
Nilotinib STADA 150 mg cápsulas duras EFG
Nilotinib STADA 200 mg cápsulas duras EFG

Finland: Nilotinib STADA 50 mg kapseli, kova
Nilotinib STADA 150 mg kapseli, kova
Nilotinib STADA 200 mg kapseli, kova

France: NILOTINIB EG 50 mg, gélule
NILOTINIB EG 150 mg, gélule
NILOTINIB EG 200 mg, gélule

Croatia: Nilotinib STADA 50 mg tvrde kapsule
Nilotinib STADA 150 mg tvrde kapsule
Nilotinib STADA 200 mg tvrde kapsule

Hungary: Nilotinib STADA 50 mg kemény kapszula
Nilotinib STADA 150 mg kemény kapszula
Nilotinib STADA 200 mg kemény kapszula

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

Italy: NILOTINIB EG

Lithuania: Nilotinib STADA 50 mg kietosios kapsulės
Nilotinib STADA 100 mg kietosios kapsulės
Nilotinib STADA 200 mg kietosios kapsulės

Luxembourg: Nilotinib EG 50 mg gélules
Nilotinib EG 150 mg gélules
Nilotinib EG 200 mg gélules

Latvia: Nilotinib STADA 50 mg cietas kapsulas
Nilotinib STADA 100 mg cietas kapsulas
Nilotinib STADA 200 mg cietas kapsulas

Malta: Nilotinib Clonmel 50 mg hard capsules
Nilotinib Clonmel 150 mg hard capsules
Nilotinib Clonmel 200 mg hard capsules

Netherlands: Nilotinib CF 50 mg, harde capsules
Nilotinib CF 150 mg, harde capsules
Nilotinib CF 200 mg, harde capsules

Norway: Nilotinib STADA

Poland: Nilotinib STADA

Portugal: Nilotinib Stada

Romania: Nilotinib Stada 50 mg capsule
Nilotinib Stada 150 mg capsule
Nilotinib Stada 200 mg capsule

Sweden: Nilotinib STADA

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

Date of the most recent review of this leaflet: May 2024

Other sources of information

You can access the approved summary of product characteristics for this medicine by scanning the QR code on the outer packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html

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