NILOTINIB STADA 200 mg HARD CAPSULES

Introduction

Patient Information Leaflet

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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Nilotinib Stada and what is it used for
2. What you need to know before you take Nilotinib Stada
3. How to take Nilotinib Stada
4. Possible side effects
5. Storage of Nilotinib Stada
6. Contents of the pack and other information

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

What is Nilotinib Stada

Nilotinib Stada is a medicine that contains the active substance nilotinib.

What is Nilotinib Stada used for

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

Nilotinib is used in adult and child patients with CML who are newly diagnosed or in patients with CML who are no longer benefiting from previous treatment, including imatinib. It is also used in adult and child patients who have had serious side effects with previous treatment and cannot continue to take it.

How Nilotinib Stada works

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

Monitoring during treatment with Nilotinib Stada

During treatment, regular checks will be carried out, including blood tests. These tests will check:

• the number of blood cells in the body (white blood cells, red blood cells and platelets) to see if nilotinib is being tolerated.
• the function of the pancreas and liver to see if nilotinib is being tolerated.
• the body's electrolytes (potassium, magnesium). These are important for the heart to work properly.
• the level of sugar and fat in the blood.

Your heart rate will also be checked using a machine that measures the electrical activity of the heart (a test called an “ECG”).

Your doctor will regularly assess your treatment and decide if you should continue taking nilotinib. If they tell you to stop taking this medicine, they will continue to monitor your CML and may tell you to start taking nilotinib again if necessary.

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

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

Follow carefully all instructions given to you by your doctor, even if they are different from the general information contained in this leaflet.

Do not take Nilotinib Stada

• if you are allergic to nilotinib or any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic, tell your doctor before taking nilotinib.

Warnings and precautions

Tell your doctor or pharmacist before you start taking nilotinib:

• if you have had heart problems in the past, such as a heart attack, angina, stroke or poor circulation to your legs (peripheral arterial disease), or if you have risk factors for heart disease, such as high blood pressure, diabetes or high levels of fat in the blood.
• if you have a heart problem called “prolonged QT interval”.
• if you are taking medicines that lower cholesterol levels in the blood (statins) or affect heart rhythm (anti-arrhythmics) or liver function (see “Other medicines and Nilotinib Stada”).
• if you have low levels of potassium or magnesium in the blood.
• if you have liver or pancreas problems.
• if you have symptoms such as easy bruising, feeling tired or difficulty breathing, or if you have had repeated infections.
• if you have had surgery to remove your whole stomach (total gastrectomy).
• if you have ever had or might currently have a hepatitis B infection.

• This is because nilotinib could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor will check carefully for signs of this infection before starting treatment.

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

During treatment with nilotinib

• if you faint (lose consciousness) or have an irregular heart rhythm while taking this medicine, tell your doctor immediatelyas this could be a sign of a serious heart problem. A prolonged QT interval or irregular heart rhythm can cause sudden death. There have been rare reports of sudden death in patients taking nilotinib.
• if you experience sudden palpitations, severe muscle weakness or paralysis, seizures or sudden changes in behaviour or level of alertness, tell your doctor immediatelyas this could be a sign of a condition called “tumour lysis syndrome”. There have been rare reports of tumour lysis syndrome in patients treated with nilotinib.
• if you develop chest pain or discomfort, numbness or weakness, walking problems or speech problems, pain, discolouration or a feeling of coldness in a limb, tell your doctor immediatelyas this could be a sign of a cardiovascular event. There have been reports of serious cardiovascular events, including problems with blood flow to the legs (peripheral arterial occlusive disease), heart problems (ischaemic heart disease) and problems with blood flow to the brain (ischaemic cerebrovascular disease) in patients taking nilotinib. Your doctor should check your levels of fat and sugar in the blood before starting treatment with nilotinib and during treatment.
• if you develop swelling of the feet or hands, general swelling or rapid weight gain, tell your doctor as these could be signs of serious fluid retention. There have been rare reports of serious fluid retention in patients treated with nilotinib.

If you are the parent of a child taking nilotinib, tell your doctor if any of the above conditions apply to 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 limited experience in children under 10 years of age who are newly diagnosed and in children under 6 years of age who are not benefiting from previous treatment for CML, including imatinib.

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

Other medicines and Nilotinib Stada

Nilotinib may interfere with some medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. These include, in particular:

• anti-arrhythmics – used to treat irregular heart rhythm;
• chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin – medicines that may have an unwanted effect on the heart's electrical activity;
• ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat infections;
• ritonavir – a protease inhibitor used to treat HIV;
• carbamazepine, phenobarbital, phenytoin – used to treat epilepsy;
• rifampicin – used to treat tuberculosis;
• St John's Wort – a herbal product used to treat depression and other conditions (also known as Hypericum perforatum);
• midazolam – used to relieve anxiety before surgery;
• alfentanil and fentanyl – used to treat pain and as sedatives before or during surgery or medical procedures;
• ciclosporin, sirolimus and tacrolimus – medicines that suppress the body's immune system and are used to prevent organ rejection in patients who have had a liver, heart or kidney transplant;
• dihydroergotamine and ergotamine – used to treat dementia;
• lovastatin, simvastatin – used to treat high levels of fat in the blood;
• warfarin – used to treat blood clotting problems (such as blood clots or thrombosis);
• astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine).

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

If you are taking statins (a type of medicine that lowers cholesterol levels in the blood), talk to your doctor or pharmacist. If you take nilotinib with certain statins, this may increase the risk of muscle problems associated with statins, which can rarely cause a serious muscle condition (rhabdomyolysis) that can lead to kidney damage.

Also, tell your doctor or pharmacist before taking nilotinib if you are taking any antacids, which are medicines used to treat stomach acid. These medicines should be taken separately from nilotinib:

• H2 blockers, which reduce stomach acid production. 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 simeticone, which neutralise stomach acid. These antacids should be taken approximately 2 hours before or approximately 2 hours after taking nilotinib.

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

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. It can increase the amount of nilotinib in the blood, possibly to a dangerous level.

Pregnancy and breast-feeding

• If you are pregnant or think you may be pregnant, tell your doctor, who will discuss with you whether you can take this medicine during pregnancy.
• Women who may become pregnantmust use effective contraception during treatment and for up to 2 weeks after finishing treatment.
• Nilotinib is not recommended during breast-feedingand for up to 2 weeks after the last dose. Tell your doctor if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you experience side effects such as dizziness or vision problems that could affect your ability to drive or use tools or machines after taking this medicine, you should not drive or use machines until the effect has worn off.

Nilotinib Stada contains lactose

This medicine contains lactose (also known as milk sugar). If your doctor has told you that you have an intolerance to some sugars, contact them 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; this is essentially “sodium-free”.

3. How to take Nilotinib Stada

Follow carefully the instructions given to you by your doctor or pharmacist, even if they are different from the general information contained in this leaflet.

How much nilotinib to take

Adult use

• Patients with newly diagnosed CML:The recommended dose is 600 mg per day. The dose is achieved by taking two 150 mg hard capsules twice a day.
• Patients with CML who are not benefiting from previous treatment:The recommended dose is 800 mg per day. This dose is achieved by taking two 200 mg capsules twice a day.

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 to be used and will tell you which and how many nilotinib capsules to give to your child. The total daily dose given to your child should not exceed 800 mg.

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

Elderly patients (65 years or older)

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

When to take nilotinib

Take the hard capsules:

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

Ask your doctor or pharmacist if you have any doubts about when to take this medicine. Taking nilotinib at the same time every day will help you remember to take the hard 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 medicines instead of Nilotinib Stada.

How long to take Nilotinib Stada

Take nilotinib every day for as long as your doctor tells you. This is a long-term treatment. Your doctor will regularly check your condition to see if 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 to take nilotinib, ask your doctor.

If you take more Nilotinib Stada than you should

If you have taken more nilotinib than you should, or if someone else has taken your hard capsules by mistake, contact a doctor or hospital straight away. Show the pack of hard capsules and this leaflet. You may need medical treatment.

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

If you forget to take Nilotinib Stada

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

If you stop taking Nilotinib Stada

Do not stop taking this medicine unless your doctor tells you to. Stopping treatment with nilotinib without your doctor's advice may put you at risk of your disease getting worse, which could be fatal. Make sure you discuss this with your doctor, nurse and/or pharmacist if you are thinking of stopping treatment with nilotinib.

If your doctor tells you to stop taking Nilotinib Stada

Your doctor will regularly assess your treatment and decide if you should continue taking this medicine. If they tell you to stop taking nilotinib, they will continue to monitor your CML before, during and after stopping nilotinib and may tell you to start taking nilotinib again if necessary.

If you have any other 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 all people suffer from them. Most adverse reactions are mild to moderate and usually disappear after a few days or weeks of treatment.

Some adverse reactions can be serious

• signs of musculoskeletal pain: pain in the joints and muscles
• signs of cardiac disorders: pain or discomfort in the chest, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (feeling of rapid heartbeats), fainting, bluish discoloration of the lips, tongue, or skin
• signs of arterial obstruction: pain, discomfort, weakness, or cramps in the leg muscles, which may be due to decreased blood flow, ulcers on the legs or arms that heal more slowly or do not heal, and noticeable changes in color (bluish or pale) or temperature (cold) in the legs, arms, toes, or fingers
• signs of hypothyroidism: weight gain, fatigue, hair loss, muscle weakness, feeling of cold
• signs of hyperthyroidism: rapid heartbeats, bulging eyes, weight loss, swelling in the front of the neck
• signs of renal or urinary tract disorders: thirst, dry skin, irritability, darkening of urine, decreased urine output, difficulty and pain when urinating, excessive feeling of needing to urinate, blood in the urine, abnormal urine color
• signs of high blood sugar levels: excessive thirst, high urine output, increased appetite with weight loss, fatigue
• signs of vertigo: dizziness or feeling of spinning
• signs of pancreatitis: severe pain in the upper abdomen (middle or left)
• signs of skin disorders: painful red bumps, 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, ease of bruising or unexplained bleeding, severe or frequent infections, unexplained weakness
• signs of blood clotting in a vein: swelling and pain in a part of the body
• signs of nervous system disorders: weakness or paralysis of the limbs or face, difficulty speaking, severe headache, seeing, feeling, or hearing things that do not exist, changes in vision, loss of consciousness, confusion, disorientation, tremors, feeling of tingling, pain, or numbness in the fingers of the hands and feet
• signs of pulmonary disorders: difficulty breathing or pain when breathing, cough, wheezing with or without fever, swelling of the feet or legs
• signs of gastrointestinal disorders: abdominal pain, nausea, vomiting with blood, black or bloody stools, constipation, acidity, stomach reflux, swollen abdomen
• signs of hepatic disorders: yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine
• signs of hepatic infection: recurrence (reactivation of hepatitis B infection)
• signs of eye disorders: visual disturbances including blurred vision, double vision, or flashes of light, decreased sharpness or loss of vision, blood in the eye, increased sensitivity of the eyes to light, eye pain, redness, itching, or irritation, dryness of the eye, swelling or itching of the eyelids
• signs of electrolyte imbalance: nausea, difficulty breathing, irregular heartbeats, cloudy urine, fatigue, and/or joint pain 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 the 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 secretion or congestion, sneezing
• low levels of blood cells (red blood cells, platelets) or hemoglobin
• high levels of lipase in blood (pancreatic function)
• high levels of bilirubin in blood (hepatic function)
• high levels of alanine aminotransferases in blood (hepatic enzymes)

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

• pneumonia
• abdominal pain, stomach discomfort after meals, flatulence, abdominal swelling
• pain in the bones, muscle spasms
• pain (including neck pain)
• dry skin, acne, decreased skin sensitivity
• weight gain or loss
• insomnia, depression, anxiety
• night sweats, excessive sweating
• general feeling of discomfort
• nosebleeds
• signs of gout: pain and swelling in the joints
• inability to achieve or maintain an erection
• flu-like symptoms
• sore throat
• bronchitis
• ear pain, hearing noises (such as ringing, buzzing) that do not come from any external source (also called tinnitus)
• hemorrhoids
• heavy periods
• itching in the hair follicles
• oral or vaginal candidiasis
• signs of conjunctivitis: eye discharge with itching, redness, and swelling
• eye irritation, red eyes
• signs of hypertension: high blood pressure, headache, dizziness
• hot flashes
• signs of peripheral arterial occlusive disease: pain, discomfort, weakness, or cramps in the leg muscles, which may be due to decreased blood flow, ulcers on the legs or arms that heal slowly or do not heal, and noticeable changes in color (bluish or pale) or temperature (cold) in the legs or arms (possible signs of obstruction of an artery in the leg, arm, or toes and fingers)
• difficulty breathing (also called dyspnea)
• mouth sores with gum inflammation (also called stomatitis)
• high levels of amylase in blood (pancreatic function)
• high levels of creatinine in blood (renal function)
• high levels of alkaline phosphatase or creatine phosphokinase in blood
• high levels of aspartate aminotransferases (hepatic enzymes) in blood
• high levels of gamma-glutamyltransferase (hepatic enzymes) in blood
• signs of leucopenia or neutropenia: low level of white blood cells
• increase in the number of platelets or white blood cells in blood
• low levels of magnesium, potassium, sodium, calcium, or phosphorus in blood
• high levels of potassium, calcium, or phosphorus in blood
• high levels of fats in blood (including cholesterol)
• high levels of uric acid in blood

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

• allergy (hypersensitivity to nilotinib)
• dry mouth
• breast pain
• pain or discomfort in the side
• increased appetite
• breast enlargement in men
• herpes virus infection
• muscle and joint stiffness, joint swelling
• feeling of temperature change in the body (including feeling of heat, feeling of 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, thinning or thickening of the skin, thickening of the outer layer of the skin, skin discoloration
• signs of psoriasis: thickened patches of red/silver skin
• increased sensitivity of the skin to light
• difficulty hearing
• joint inflammation
• urinary incontinence
• intestinal inflammation (also called enterocolitis)
• anal abscess
• swelling in the nipple
• symptoms of restless legs syndrome (an irresistible urge to move a 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 levels of white blood cells
• high levels of parathyroid hormone in blood (a hormone that regulates calcium and phosphorus levels)
• high levels of lactate dehydrogenase in blood (an enzyme)
• signs of low blood sugar levels: nausea, sweating, weakness, dizziness, tremors, headache
• dehydration
• abnormal levels of fat in the blood
• involuntary movements (also called tremor)
• difficulty concentrating
• unpleasant and abnormal sensation when touching (also called dysesthesia)
• fatigue (also called exhaustion)
• feeling of numbness or tingling in the fingers of the hands and feet (also called peripheral neuropathy)
• paralysis of any facial muscle
• red spot in 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 and oppressive chest pain, fatigue, irregular heartbeats
• signs of heart murmur: fatigue, chest discomfort, dizziness, chest pain, palpitations
• fungal infection of the feet
• signs of heart failure: shortness of breath, difficulty breathing when lying down, swelling of the feet or legs
• pain behind the sternum (also called pericarditis)
• signs of hypertensive crisis: severe headache, dizziness, nausea
• pain in the legs and weakness caused by walking (also called intermittent claudication)
• signs of obstruction of the arteries of the limbs: possible high blood pressure, painful cramps in one or both hips, thighs, or calf muscles after performing certain activities such as walking or climbing stairs, numbness or weakness in the legs
• bruises (when you have not injured yourself)
• fat deposits in the arteries that can cause obstruction (also called arteriosclerosis)
• signs of low blood pressure (also called hypotension): dizziness, dizziness, or fainting
• signs of pulmonary edema: shortness of breath
• signs of pleural effusion: accumulation of fluid between the layers of tissue that cover the lungs and the thoracic cavity (which, if severe, can decrease 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 pleuritic pain: chest pain
• signs of pleurisy: cough, painful breathing
• hoarseness
• signs of pulmonary hypertension: high blood pressure in the pulmonary arteries
• wheezing
• sensitivity in the teeth
• signs of inflammation (also called gingivitis): bleeding gums, sensitive or swollen gums
• high levels of urea in blood (renal function)
• change in blood proteins (low level of globulins or presence of paraprotein)
• high levels of unconjugated bilirubin in blood
• high 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 the soles of the feet (called hand-foot syndrome)
• warts in the mouth
• feeling of hardening 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 obstruction of the cerebral arteries: loss of vision in part or all of both eyes, double vision, vertigo (feeling that everything is spinning), 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, loss of vision
• signs of cardiac dysfunction (reduced ejection fraction): fatigue, chest discomfort, dizziness, pain, palpitations
• low or high levels of insulin in blood (a hormone that regulates blood sugar levels)
• low levels of C-peptide of insulin in blood (pancreatic function)
• sudden death

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

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Nilotinib Stada

• Keep this medicine out of the sight and reach of children.
• • Do not use this medicine after the expiration date that appears on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.
  • This medicine does not require special storage conditions.
  • Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Container Contents and Additional Information

Composition of Nilotinib Stada

• The active ingredient is nilotinib.

• Each 50 mg hard capsule contains 50 mg of nilotinib (as hydrochloride dihydrate).

The other components are:

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

The 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 hydrochloride dihydrate).

The other components are:

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

The 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 hydrochloride dihydrate).

The other components are:

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

The 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 Container Contents

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

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

Nilotinib 200 mg is presented as hard capsules (capsules) opaque, light yellow, size 0 (approximately 21.4 mm long) with the printing in horizontal “200 mg” in black 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 unit dose blisters in:

A container containing 40 capsules and a multiple container containing 120 capsules (3 containers of 40).

A container containing 40 capsules in unit dose blisters and a multiple container containing 120 capsules (3 containers of 40) in unit dose blisters.

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

A container containing 28, 40 capsules and a multiple container containing 112 (4 containers of 28), 120 (3 containers of 40) and 392 capsules (14 containers of 28).

A container containing 28, 40 capsules in unit dose blisters and a multiple container containing 112 (4 containers of 28), 120 (3 containers of 40) and 392 capsules (14 containers of 28) in unit dose blisters.

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

A container containing 28, 40 capsules and a multiple container containing 112 (4 containers of 28), 120 (3 containers of 40) and 392 capsules (14 containers of 28).

A container containing 28, 40 capsules in unit dose blisters and a multiple container containing 112 (4 containers of 28), 120 (3 containers of 40) and 392 capsules (14 containers of 28) in unit dose blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

PharOS Pharmaceutical Oriented Services Ltd.

Lesvou Street End, Thesi Loggos Industrial Zone,

Metamorfossi, 144 52,

Greece

or

STADA Arzneimittel AG

Stadastrasse 2 – 18, 61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary,

Ireland

or

STADA Arzneimittel GmbH

Muthgasse 36/2, 1190 Wien

Austria

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

Nilotinib EG 150 mg hard capsules

Nilotinib EG 200 mg hard capsules

Cyprus: Nilotinib Stada 50mg σκληρ? καψ?κιο

Nilotinib Stada 150mg σκληρ? καψ?κιο

Nilotinib Stada 200mg σκληρ? καψ?κιο

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 hard capsules EFG

Nilotinib STADA 150 mg hard capsules EFG

Nilotinib STADA 200 mg hard capsules 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 kapsules

Nilotinib STADA 100 mg kietosios kapsules

Nilotinib STADA 200 mg kietosios kapsules

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 last revision of this leaflet:May 2024

Other sources of information

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

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