Nilotinib Zentiva 200 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nilotinib Zentiva 150 mg hard capsules EFG

Nilotinib Zentiva 200 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Nilotinib Zentiva is

Nilotinib Zentiva is a medicine that contains an active substance called nilotinib.

What Nilotinib Zentiva is used for

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

Nilotinib is used in adult and paediatric patients with newly diagnosed CML or in patients with CML who no longer benefit from prior therapy, including imatinib. It is also used in adult and paediatric patients who have experienced serious adverse effects with prior therapy and who cannot continue using it.

How Nilotinib Zentiva 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 Zentiva

During treatment, regular check-ups will be carried out, including blood tests. These tests will monitor:

the number of blood cells in the body (white blood cells, red blood cells, and platelets) to assess whether nilotinib is well tolerated.
the function of the pancreas and liver to assess whether Nilotinib Zentiva is well tolerated.
the body's electrolytes (potassium, magnesium). These 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, if necessary, may instruct you to restart treatment with Nilotinib Zentiva.

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

2. What you need to know before taking Nilotinib Zentiva

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

Do not take Nilotinib Zentiva

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nilotinib Zentiva:

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 condition, such as an abnormal electrical signal called "prolongation of the QT interval".
if you are receiving treatment with medications that lower cholesterol in the blood (statins) or affect heart rhythm (antiarrhythmics) or the liver (see Other medicines and Nilotinib Zentiva).
if you have low levels of potassium or magnesium.
if you have a liver or pancreas disorder.
if you experience 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 might currently have a hepatitis B virus infection. This is because nilotinib could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor 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 Zentiva

if you faint (lose consciousness) or experience irregular heartbeat while taking this medicine, contact your doctor immediately, as this may be a sign of a serious heart problem. QT interval prolongation or irregular heart rhythm can lead to sudden death. Rare cases of sudden death have been reported in patients taking this medicine.
if you experience sudden heart palpitations, severe muscle weakness or paralysis, seizures, or sudden changes in behavior or alertness, contact your doctor immediately, as this may indicate a 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 cold sensation in a limb, contact your doctor immediately, as this may be a sign of a cardiovascular event. Serious cardiovascular events have been reported in patients taking this medicine, including problems with blood flow to the leg (peripheral arterial occlusive disease), ischemic heart disease, and impaired blood supply to the brain (cerebrovascular ischemia). Your doctor should assess your blood fat (lipid) and sugar levels before starting and during treatment with nilotinib.
if you develop swelling in your hands or feet, 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 being treated with Nilotinib Zentiva, inform the doctor if any of the above conditions occur in your child.

Children and adolescents

Nilotinib Zentiva is used to treat children and adolescents with CML. There is no experience with 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.

Some children and adolescents receiving Nilotinib Zentiva may experience slower than normal growth. Your doctor will monitor growth during regular visits.

Other medicines and Nilotinib Zentiva

Nilotinib Zentiva may interfere 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" system and fight infections, frequently used to prevent rejection of transplanted organs such as liver, heart, or kidney;
dihydroergotamine and ergotamine – used to treat dementia;
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), talk to your doctor or pharmacist. Taking nilotinib with certain statins may increase the risk of muscle-related problems associated with statins, which in rare cases can lead to serious muscle breakdown (rhabdomyolysis) that may result in kidney damage.

Additionally, 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 and approximately 2 hours after taking nilotinib;
antacids such as those containing aluminium hydroxide, magnesium hydroxide, and simethicone, which neutralize high stomach acidity. These antacids should be taken approximately 2 hours before or approximately 2 hours after taking nilotinib.

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

Taking Nilotinib Zentiva with food and drink

Do not take Nilotinib Zentiva with food. Food can increase the absorption of this medicine and therefore increase the amount of nilotinib in the blood, possibly to a dangerous level. Do not drink grapefruit juice or eat grapefruit. 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, 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, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Nilotinib Zentiva contains lactose

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

Nilotinib Zentiva 200 mg hard capsules contain sodium and Allura Red AC aluminium lake

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

The azo dye Allura Red AC aluminium lake may cause allergic-type reactions.

3. How to take Nilotinib Zentiva

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

How much Nilotinib Zentiva to take

Use in adults

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 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 Zentiva capsules to give your child. The total daily dose given to your child must not exceed 800 mg.

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

Elderly patients (65 years or older)

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

When to take Nilotinib Zentiva

Take the hard capsules:

twice a day (approximately every 12 hours);
at least 2 hours after eating 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 Zentiva at the same time each day will help you remember when to take the hard capsules.

How to take Nilotinib Zentiva

Swallow the hard capsules whole with water.
Do not take any food together 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 Zentiva.

How long to take Nilotinib Zentiva

Take Nilotinib Zentiva every day for as long as your doctor tells you. This is a long-term treatment. Your doctor will monitor your condition periodically to ensure the treatment is having the desired effect.

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

If you take more Nilotinib Zentiva than you should

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

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

If you forget to take Nilotinib Zentiva

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

If you stop taking Nilotinib Zentiva

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 this medicine.

If your doctor advises you to stop treatment with Nilotinib Zentiva

Your doctor will regularly assess your treatment using a specific diagnostic test and will decide whether you should continue taking this medicine. If your doctor advises 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 marked 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, darkening of urine, reduced urine output, difficulty or pain when urinating, increased 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, redness of the skin, peeling or blisters
signs of water retention: rapid weight gain, swelling of hands, ankles, feet or face
signs of migraine: severe headache often accompanied by nausea, vomiting and sensitivity to light
signs of blood disorders: fever, 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 real, vision changes, loss of consciousness, confusion, disorientation, tremors, tingling, pain or numbness in fingers and 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, darkening of urine
signs of liver infection: recurrence (reactivation of hepatitis B infection)
signs of eye disorders: visual disturbances including blurred vision, double vision or perceived flashes of light, decreased 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 notice 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 when stopping treatment with nilotinib
slowed growth in children and adolescents
upper respiratory tract infection, including sore throat and nasal discharge or congestion, sneezing
low levels of blood cells (red blood cells, platelets) or hemoglobin
elevated levels of lipase in blood (pancreatic function)
elevated levels of bilirubin in blood (liver function)
elevated levels of alanine aminotransferase in blood (liver enzymes)

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

pneumonia
abdominal pain, stomach discomfort after meals, flatulence, bloating of the abdomen
bone pain, muscle spasms
pain (including neck pain)
dry skin, acne, decreased 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, which may be due to reduced blood flow, leg or arm ulcers that heal slowly or do not heal, and marked changes in color (bluish or pale) or temperature (cold) in legs or arms (possible signs of blockage in an artery of the leg, arm or affected toes or fingers)
difficulty breathing (also called dyspnea)
mouth sores with inflamed gums (also called stomatitis)
elevated levels of amylase in blood (pancreatic function)
elevated levels of creatinine in blood (kidney function)
elevated levels of alkaline phosphatase or creatine phosphokinase in blood
elevated levels of aspartate aminotransferase (liver enzymes) in blood
elevated levels of gamma-glutamyltransferase (liver enzymes) in blood
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 levels of uric acid in blood

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

allergy (hypersensitivity to Nilotinib Zentiva)
dry mouth
breast pain
pain or discomfort in the side
increased appetite
breast enlargement in men
herpes virus infection
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 inflammation of the stomach lining: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
memory loss
skin cyst, thinning or thickening of the skin, thickening of the outermost skin layer, skin discoloration
signs of psoriasis: thickened red/silvery patches of skin
increased skin sensitivity to light
hearing difficulty
joint inflammation
urinary incontinence
intestinal inflammation (also called enterocolitis)
anal abscess
swelling of the nipple
symptoms of restless legs syndrome (an irresistible urge to move part of the body, 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 levels of parathyroid hormone in blood (a hormone regulating calcium and phosphorus levels)
elevated levels of lactate dehydrogenase in blood (an enzyme)
signs of low blood sugar levels: 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 and toes (also called peripheral neuropathy)
paralysis of any facial muscle
red spot on the white of the eye caused by broken blood vessels (also called conjunctival hemorrhage)
blood in the eyes (also called ocular hemorrhage)
eye irritation
signs of heart attack (also called myocardial infarction): sudden, 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 triggered by walking (also called intermittent claudication)
signs of arterial occlusion in limbs: possible high blood pressure, painful cramps in one or both hips, thighs or calf muscles after certain activities such as walking or climbing stairs, numbness or weakness in legs
bruising (when you have not injured yourself)
fat deposits in arteries that may cause blockage (also called atherosclerosis)
signs of low blood pressure (also called hypotension): lightheadedness, dizziness or fainting
signs of pulmonary edema: dyspnea
signs of pleural effusion: fluid accumulation between the layers of tissue covering 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
hoarseness
signs of pulmonary hypertension: high blood pressure in the arteries of the lungs
wheezing
tooth sensitivity
signs of inflammation (also called gingivitis): bleeding gums, tender or enlarged gums
elevated levels of urea in blood (kidney function)
changes in blood proteins (low globulin levels or presence of paraprotein)
elevated levels of unconjugated bilirubin in blood
elevated levels of troponins in blood

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

redness and/or swelling and possibly peeling of the palms of the hands and soles of the feet (called hand-foot syndrome)
mouth warts
feeling 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 status)
signs of optic neuritis: blurred vision, vision loss
signs of cardiac dysfunction (reduced ejection fraction): fatigue, chest discomfort, dizziness, pain, palpitations
low or high levels of insulin 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 with unknown frequency (cannot be estimated from available data):

signs of cardiac dysfunction (ventricular dysfunction): difficulty breathing, exertion 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30 °C.
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. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nilotinib Zentiva

The active substance is nilotinib.
Each 150 mg hard capsule contains 150 mg of nilotinib.
Other components are: Capsule contents: monohydrate lactose, crospovidone (E1202), polysorbate 80, magnesium aluminium silicate, anhydrous colloidal silica (E551), magnesium stearate (E5722); Capsule shell: gelatin (E441), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172); Printing ink: shellac (E904), black iron oxide (E172), potassium hydroxide (E525).
Each 200 mg hard capsule contains 200 mg of nilotinib.
Other components are: Capsule contents: monohydrate lactose, crospovidone, polysorbate 80, magnesium aluminium silicate, anhydrous colloidal silica (E551), magnesium stearate (E470b); Capsule shell: gelatin (E441), titanium dioxide (E171), iron oxide yellow (E172); Printing ink: shellac (E904), sodium hydroxide (E524), titanium dioxide (E171), povidone (E1201), aluminium lake of Allura red AC (E129).

Appearance of Nilotinib Zentiva and contents of the pack

Nilotinib Zentiva 150 mg hard capsules

Hard gelatin capsule (size 1) with an opaque red cap and opaque red body, printed with “SML” in black ink on the cap and “26” on the body, containing granular powder ranging from whitish to grey.

Nilotinib Zentiva 200 mg hard capsules

Hard gelatin capsule (size 0) with an opaque light yellow cap and opaque light yellow body, printed with “SML” in red ink on the cap and “27” on the body, containing granular powder ranging from whitish to grey.

Blister packs made of PVC/PVDC/Alu or perforated unit-dose blisters.

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Zentiva, k.s.
U kabelovny 130,
Dolní Mecholupy,
102 37 Prague 10,
Czech Republic

Manufacturer responsible for manufacturing

APIS Labor GmbH
Resslstraße 9
9065 Ebenthal in Kärnten, Austria.

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

Zentiva Spain S.L.U.
Avenida de Europa, 19, Edificio 3, Planta 1
28224 Pozuelo de Alarcón, Madrid
Spain

This medicine is authorized in the European Economic Area (EEA) member states under the following names:

Germany: Nilotinib Zentiva 50 mg Hartkapseln, Nilotinib Zentiva 150 mg Hartkapseln, Nilotinib Zentiva 200 mg Hartkapseln

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

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

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

Hungary: Nilotinib Zentiva k.s.

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

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