Nilotinib Stada

Package Leaflet: Information for the User

Nilotinib STADA, 50 mg, hard capsules

Nilotinib STADA, 150 mg, hard capsules

Nilotinib STADA, 200 mg, hard capsules

Nilotinib

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their 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 and other information

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

1. What Nilotinib is and what it is used for

What Nilotinib is

Nilotinib is a medicine that contains the active substance nilotinib.

What Nilotinib is used for

Nilotinib is used to treat a type of cancer called chronic myeloid leukaemia (CML) in adults and children. CML is a disease in which the bone marrow produces too many abnormal white blood cells.

How Nilotinib works

In patients with CML, there is a change in the DNA (genetic material) that leads to a signal that causes the bone marrow to produce too many abnormal white blood cells. Nilotinib blocks this signal and prevents the production of these abnormal cells.

Monitoring while taking Nilotinib

During treatment, regular blood tests will be performed to monitor:

• the number of blood cells (white blood cells, red blood cells, and platelets) in the body to assess how well Nilotinib is tolerated.
• the function of the pancreas and liver in the body to assess how well Nilotinib is tolerated.
• the level of electrolytes (potassium, magnesium) in the body, which are important for heart function.
• the level of sugar and fats in the blood.

The heart rate will also be monitored using a device that measures the electrical activity of the heart (a test called an ECG).

The doctor will regularly assess the results of the treatment and decide whether the patient should continue taking Nilotinib. If the patient is told to stop taking Nilotinib, the doctor will continue to monitor the patient's CML and may recommend that the patient restart Nilotinib if necessary.

2. What you need to know before you take Nilotinib

Follow the doctor's instructions carefully. They may differ from the general information in this leaflet.

When not to take Nilotinib

• 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

Before taking Nilotinib, tell your doctor or pharmacist:

• if you have ever had heart problems, such as a heart attack, angina, or stroke, or if you have risk factors for heart disease, such as high blood pressure, diabetes, or high levels of fats in the blood.
• if you have an irregular heartbeat or other heart problems.
• if you are taking medicines that lower cholesterol or affect the heart.
• 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, tiredness, or shortness of breath.
• if you have had surgery to remove your stomach.
• if you have ever had hepatitis B infection. This is because Nilotinib may cause the hepatitis B virus to become active again, which can be life-threatening.

While taking Nilotinib:

• if you experience fainting or irregular heartbeat, tell your doctor immediately, as this may be a sign of a serious heart problem.
• if you experience sudden pain, weakness, or paralysis, tell your doctor immediately, as this may be a sign of a serious condition called tumour lysis syndrome.

Tumour lysis syndrome is a condition that can occur when cancer cells die quickly. It can cause serious problems, such as kidney damage.

• if you experience pain or discomfort in the chest, numbness or weakness, difficulty walking or speaking, pain, discoloration, or coldness in a limb, tell your doctor immediately, as this may be a sign of a serious heart or blood vessel problem.
• if you experience swelling of the feet or hands, general swelling, or rapid weight gain, tell your doctor, as this may be a sign of a serious condition called fluid retention.

Children and adolescents

Nilotinib is used to treat CML in children and adolescents. There is limited experience with the use of Nilotinib in children under 2 years of age. There is also limited experience with the use of Nilotinib in children under 10 years of age with newly diagnosed CML and in children under 6 years of age who have stopped responding to previous CML treatment.

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

Nilotinib with other medicines

Nilotinib may affect the way other medicines work.

Tell your doctor or pharmacist about all the medicines you are taking, including those you have bought without a prescription.

• medicines for irregular heartbeat (anti-arrhythmics)
• medicines that may affect the heart, such as chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin
• medicines for infections, such as ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin
• ritonavir (a medicine for HIV infection)
• medicines for epilepsy, such as carbamazepine, phenobarbital, and phenytoin
• rifampicin (a medicine for tuberculosis)
• St. John's Wort (a herbal medicine for depression)
• midazolam (a medicine for sedation before surgery)
• alfentanil and fentanyl (medicines for pain relief and sedation before and during surgery or medical procedures)
• medicines that suppress the immune system, such as cyclosporin, sirolimus, and tacrolimus, which are used to prevent rejection of transplanted organs, such as liver, heart, and kidney
• medicines for dementia, such as dihydroergotamine and ergotamine
• medicines for high levels of fats in the blood, such as lovastatin and simvastatin
• warfarin (a medicine for blood clotting problems)
• astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, or ergot alkaloids (ergotamine, dihydroergotamine)

Do not take these medicines while taking Nilotinib. If you are taking any of these medicines, your doctor may prescribe different medicines.

If you are taking a statin (a medicine to lower cholesterol), talk to your doctor or pharmacist. Nilotinib may increase the risk of muscle problems when taken with certain statins, which can rarely lead to serious muscle damage (rhabdomyolysis) that can cause kidney damage.

Also, tell your doctor or pharmacist if you are taking any medicines that reduce stomach acid, such as antacids.

The following medicines should be taken separately from Nilotinib:

• histamine H2-receptor antagonists, which reduce stomach acid production. Take these medicines about 10 hours before and about 2 hours after taking Nilotinib.
• antacids, which neutralize stomach acid. Take these medicines about 2 hours before or about 2 hours after taking Nilotinib.

Tell your doctor if you are already taking Nilotinib and a new medicine is prescribed that has not been taken with Nilotinib before.

Taking Nilotinib with food and drink

Do not take Nilotinib with food.Food can increase the absorption of Nilotinib and increase the risk of side effects.

Do not drink grapefruit juice or eat grapefruit. They can increase the level of Nilotinib in the blood, which can increase the risk of side effects.

Pregnancy and breast-feeding

• Do not take Nilotinib during pregnancyunless it is absolutely necessary. If you are pregnant or think you may be pregnant, tell your doctor, who will discuss the benefits and risks of taking Nilotinib with you.
• Women who may become pregnantshould use effective contraception during treatment with Nilotinib and for up to 2 weeks after stopping treatment.
• Do not breast-feedwhile taking Nilotinib and for 2 weeks after stopping treatment. If you are breast-feeding, tell your doctor, who will discuss the benefits and risks of taking Nilotinib with you.

Driving and using machines

If you experience side effects such as dizziness or blurred vision, do not drive or operate machinery until these effects have stopped.

Nilotinib contains lactose

This medicine contains lactose (a sugar found in milk). If you have been told that you have an intolerance to some sugars, contact your doctor before taking Nilotinib.

Nilotinib contains sodium

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

3. How to take Nilotinib

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

What dose of Nilotinib to take

Adult patients:

• Newly diagnosed CML patients:The recommended dose is 600 mg per day, taken as two 150 mg capsules twice a day.
• Patients who have stopped responding to previous CML treatment:The recommended dose is 800 mg per day, taken as two 200 mg capsules twice a day.

Children and adolescents:

• The dose is based on the child's weight and height. The doctor will calculate the correct dose and tell you which capsules to give to your child. The total daily dose should not exceed 800 mg.

The doctor may prescribe a lower dose depending on how well the patient tolerates the treatment.

Elderly patients (65 years and over)

Nilotinib can be taken by elderly patients at the same doses as for other adults.

When to take Nilotinib

Take the capsules:

• twice a day (about 12 hours apart)
• at least 2 hours after eating
• wait 1 hour after taking Nilotinib before eating. If you are unsure about when to take Nilotinib, talk to your doctor or pharmacist. Take Nilotinib at the same time every day to help you remember to take the capsules.

How to take Nilotinib

• Swallow the capsules whole with water.
• Do not take the capsules with food.
• Do not open the capsules. If you or your child cannot swallow the capsules whole, talk to your doctor or pharmacist, who may prescribe a different medicine.

How long to take Nilotinib

Take Nilotinib every day for as long as your doctor tells you to. The treatment is long-term. Your doctor will regularly monitor your condition to see if the treatment is working.

Your doctor may stop Nilotinib treatment based on certain criteria.

If you are unsure about the duration of treatment with Nilotinib, talk to your doctor.

If you take more Nilotinib than you should

If you take more Nilotinib than you should, contact your doctor or go to the hospital immediately. Take the package and this leaflet with you.

If you forget to take Nilotinib

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

Stopping Nilotinib treatment

Do not stop taking Nilotinib unless your doctor tells you to. Stopping Nilotinib treatment without talking to your doctor may worsen your condition, which can be life-threatening.

If you are considering stopping Nilotinib treatment, talk to your doctor, nurse, or pharmacist.

Doctor's advice to stop Nilotinib treatment

Your doctor will regularly assess the results of your treatment and decide whether you should continue taking Nilotinib. If you are told to stop taking Nilotinib, your doctor will continue to monitor your CML and may recommend that you restart Nilotinib if necessary.

If you have any further questions about taking Nilotinib, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nilotinib can cause side effects, although not everybody gets them.

Most side effects are mild to moderate and go away after a few days or weeks of treatment.

Some side effects can be serious.

• musculoskeletal pain: joint pain and muscle pain
• heart problems: chest pain, high or low blood pressure, irregular heartbeat, palpitations, fainting, blue discoloration of the lips, tongue, or skin
• arterial occlusion: pain, discomfort, weakness, or cramping in the legs, which may be caused by reduced blood flow, ulcers on the legs or arms that heal slowly or not at all, and noticeable changes in skin color (blue or pale) or temperature (cooling) of the legs or arms
• hypothyroidism: weight gain, tiredness, hair loss, muscle weakness, feeling cold
• hyperthyroidism: rapid heartbeat, bulging eyes, weight loss, swelling of the neck
• kidney or urinary problems: feeling thirsty, dry skin, irritability, dark urine, reduced urine output, painful or difficult urination, blood in the urine, abnormal urine color
• high blood sugar: excessive thirst, excessive urination, increased appetite, weight loss, tiredness
• vertigo: dizziness or feeling of spinning
• pancreatitis: severe abdominal pain
• skin problems: painful, red lumps, skin pain, redness, scaling, or blistering
• fluid retention: rapid weight gain, swelling of the hands, ankles, feet, or face
• migraine: severe headache, often with nausea, vomiting, and sensitivity to light
• blood problems: fever, easy bruising or bleeding, frequent infections, weakness for no reason
• blood clots: swelling and pain in one part of the body
• nervous system problems: weakness or paralysis of limbs or face, difficulty speaking, severe headache, seeing, feeling, or hearing things that are not there, changes in vision

loss of consciousness, confusion, disorientation, tremors, numbness or tingling, pain or numbness in the fingers or toes

• lung problems: difficulty breathing or pain when breathing, cough, wheezing, fever with or without cough
• gastrointestinal problems: abdominal pain, nausea, vomiting blood, black or bloody stools, constipation, heartburn, reflux
• liver problems: yellowing of the skin and eyes, nausea, loss of appetite, dark urine
• hepatitis B infection: reactivation of hepatitis B infection
• eye problems: vision changes, including blurred vision, double vision, or flashes of light, reduced vision or loss of vision, blood in the eyes, increased sensitivity of the eyes to light, eye pain, redness, itching, or swelling
• electrolyte imbalance: nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue, and joint problems due to abnormal blood test results (e.g., high levels of potassium, uric acid, and phosphorus, and low levels of calcium)

Some side effects are very common(may affect more than 1 in 10 people)

• diarrhea
• headache
• fatigue
• muscle pain
• itching, rash
• nausea
• constipation
• vomiting
• hair loss
• limb pain, bone pain, or back pain after stopping Nilotinib treatment
• slow growth in children and adolescents
• upper respiratory tract infections, including sore throat, runny nose, or stuffy nose, coughing
• low blood cell counts (red blood cells, platelets) or low hemoglobin levels
• high levels of lipase in the blood (pancreas function)
• high levels of bilirubin in the blood (liver function)
• high levels of alanine aminotransferase in the blood (liver enzymes)

Some side effects are common(may affect up to 1 in 10 people)

• pneumonia
• abdominal pain, discomfort in the stomach after eating, bloating, swelling, or gas in the stomach
• bone pain, muscle cramps
• pain (including neck pain)
• dry skin, acne, reduced skin sensitivity
• weight gain or loss
• insomnia, depression, anxiety
• night sweats, excessive sweating
• general feeling of being unwell
• nosebleeds
• gout: joint pain and swelling
• erectile dysfunction
• flu-like symptoms
• sore throat
• bronchitis
• ear pain, ringing in the ears (tinnitus), or other abnormal sounds
• petechiae (small red or purple spots on the skin)
• menstrual bleeding
• folliculitis (inflammation of the hair follicles)
• vaginal thrush (fungal infection)
• conjunctivitis: discharge from the eye, redness, itching, or swelling
• eye irritation, redness
• high blood pressure: high blood pressure, headache, dizziness
• flushing
• peripheral arterial disease: pain, discomfort, weakness, or cramping in the legs, which may be caused by reduced blood flow, ulcers on the legs or arms that heal slowly or not at all, and noticeable changes in skin color (blue or pale) or temperature (cooling) of the legs or arms
• shortness of breath
• mouth ulcers with gum inflammation (stomatitis)
• high levels of amylase in the blood (pancreas function)
• high levels of creatinine in the blood (kidney function)
• high levels of alkaline phosphatase or creatine phosphokinase in the blood
• high levels of aspartate aminotransferase in the blood (liver enzymes)
• high levels of gamma-glutamyltransferase in the blood (liver enzymes)
• leukopenia or neutropenia: low white blood cell count
• high platelet or white blood cell count
• low levels of magnesium, potassium, sodium, calcium, or phosphorus in the blood
• high levels of fats in the blood (including cholesterol)
• high levels of uric acid in the blood

Some side effects are uncommon(may affect up to 1 in 100 people)

• allergic reaction (hypersensitivity to Nilotinib)
• dry mouth
• chest pain
• side pain or discomfort
• increased appetite
• breast enlargement in men
• herpes virus infection
• stiffness or swelling of the joints
• feeling of temperature changes (including feeling hot or cold)
• taste disturbances
• frequent urination
• gastritis: stomach pain, nausea, vomiting, diarrhea, bloating
• memory loss
• skin cysts, skin thinning or thickening, skin discoloration
• psoriasis: thickened, red, silvery patches of skin
• increased sensitivity to light
• hearing difficulties
• arthritis
• urinary incontinence
• inflammation of the intestines (enterocolitis)
• anal abscess
• breast swelling
• restless legs syndrome: uncontrollable urge to move the legs, usually accompanied by uncomfortable sensations
• sepsis: fever, chest pain, rapid heartbeat, shortness of breath
• skin infection (subcutaneous abscess)
• skin warts
• high levels of eosinophils (a type of white blood cell) in the blood
• lymphopenia: low levels of lymphocytes (a type of white blood cell) in the blood
• high levels of parathyroid hormone in the blood (which regulates calcium and phosphorus levels)
• high levels of lactate dehydrogenase in the blood (an enzyme)
• low blood sugar: nausea, sweating, weakness, dizziness, trembling, headache
• dehydration
• abnormal levels of fats in the blood
• involuntary trembling
• difficulty concentrating
• unpleasant or abnormal sensations (including tingling or numbness)
• fatigue
• numbness or tingling in the fingers or toes (peripheral neuropathy)
• facial paralysis
• red spots in the white part of the eye due to broken blood vessels (subconjunctival hemorrhage)
• blood in the eyes (ocular hemorrhage)
• eye irritation
• heart attack (myocardial infarction): sudden and severe chest pain, fatigue, irregular heartbeat
• heart problems (cardiac arrhythmias): fatigue, discomfort in the chest, feeling of fainting, pain, palpitations
• athlete's foot (fungal infection)
• heart failure: shortness of breath, difficulty breathing when lying down, swelling of the feet or ankles
• pericarditis: chest pain (pericardial pain)
• hypertensive crisis: severe headache, dizziness, nausea
• intermittent claudication: pain and weakness in the legs when walking (claudication)
• peripheral artery disease: high blood pressure, pain, discomfort, weakness, or cramping in the legs, which may be caused by reduced blood flow, ulcers on the legs or arms that heal slowly or not at all, and noticeable changes in skin color (blue or pale) or temperature (cooling) of the legs or arms
• bruising (without any apparent reason such as bruising)
• fat deposits in the arteries, which can cause blockage (atherosclerosis)
• low blood pressure (hypotension): feeling of fainting, dizziness, or fainting
• pulmonary edema: shortness of breath
• pleural effusion: fluid accumulation between the layers of tissue surrounding the lungs and the chest cavity (which can reduce the heart's ability to pump blood in severe cases), chest pain, cough, hiccups, rapid breathing
• interstitial lung disease: cough, difficulty breathing, chest pain when breathing
• pleuritic pain: chest pain
• pleuritis: cough, chest pain when breathing
• hoarseness
• pulmonary hypertension: high blood pressure in the arteries of the lungs
• wheezing
• tooth sensitivity
• gingivitis: bleeding gums, tenderness, or swelling of the gums
• high levels of urea in the blood (kidney function)
• changes in blood protein levels (low globulin or presence of paraprotein)
• high levels of unconjugated bilirubin in the blood
• high levels of troponin in the blood

Some side effects are rare(may affect up to 1 in 1,000 people)

• redness and swelling of the palms of the hands and soles of the feet (palmar-plantar erythrodysesthesia syndrome)
• mouth warts
• feeling of hardness or thickening of the breasts
• thyroid inflammation
• mood changes or depression
• secondary hyperparathyroidism: bone and joint pain, frequent urination, abdominal pain, weakness, fatigue
• arterial stenosis in the brain: loss of vision in part or all of the visual field in both eyes, double vision, dizziness (feeling of spinning), numbness or tingling, loss of coordination, dizziness, or confusion
• brain edema (possible headache and/or changes in mental status)
• optic neuritis: blurred vision, loss of vision
• heart problems (reduced left ventricular ejection fraction): fatigue, discomfort in the chest, feeling of fainting, pain, palpitations
• low or high levels of insulin in the blood (a hormone that regulates blood sugar levels)
• low levels of C-peptide in the blood (a measure of pancreas function)
• sudden death

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

• heart problems (heart failure): shortness of breath, fatigue when resting, irregular heartbeat, discomfort in the chest, feeling of fainting, pain, palpitations, excessive urination, swelling of the feet, ankles, and abdomen.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nilotinib

• 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 carton and blister after EXP. The expiry date refers to the last day of that month.
• Nilotinib 50 mg hard capsules, packaged in PVC/PE/PVDC/Aluminium blisters: Do not store above 30°C.
• Nilotinib 150 mg and 200 mg hard capsules, packaged in PVC/PE/PVDC/Aluminium blisters and Nilotinib 50 mg, 150 mg, and 200 mg hard capsules, packaged in OPA/Aluminium/PVC/Aluminium blisters: No special storage precautions are required.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Nilotinib contains

• The active substance is nilotinib.

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

The other ingredients are:

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

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

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

See section 2, "Nilotinib contains lactose and sodium".

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

The other ingredients are:

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

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

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

See section 2, "Nilotinib contains lactose and sodium".

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

The other ingredients are:

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

Capsule shell: hypromellose (E464), purified water, carrageenan (E407), potassium chloride (E508), yellow iron oxide (E172), titanium dioxide (E171).

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

See section 2, "Nilotinib contains lactose and sodium".

How Nilotinib looks like and what the pack contains

Nilotinib 50 mg is available in the form of hard capsules (capsules) with a red, opaque cap and a light yellow, opaque body, size 4 (length approximately 14.4 mm), with a black horizontal print "50 mg" on the body. The hard capsules are filled with a powder of white to yellowish color.
Nilotinib 150 mg is available in the form of red, opaque hard capsules, size 1 (length approximately 19.3 mm), with a black horizontal print "150 mg" on the body. The hard capsules are filled with a powder of white to yellowish color.
Nilotinib 200 mg is available in the form of light yellow, opaque hard capsules (capsules) of size 0 (length approximately 21.4 mm), with a black horizontal print "200 mg" on the body. The hard capsules are filled with a powder of white to yellowish color.
Nilotinib hard capsules 50 mg are packaged in blisters of PVC/PE/PVDC/Aluminum or blisters of OPA/Aluminum/PVC/Aluminum:

• Single packs containing 40 hard capsules and collective packs containing 120 (3 packs of 40) hard capsules in a cardboard box.

Nilotinib hard capsules 50 mg are packaged in perforated single-dose blisters of PVC/PE/PVDC/Aluminum or blisters of OPA/Aluminum/PVC/Aluminum:

• Single packs containing 40 x 1 hard capsules and collective packs containing 120 x 1 (3 packs of 40 x 1) hard capsules in a cardboard box.

Nilotinib hard capsules 150 mg are packaged in blisters of PVC/PE/PVDC/Aluminum or blisters of OPA/Aluminum/PVC/Aluminum:

• Single packs containing 28, 40 hard capsules and collective packs containing 112 (4 packs of 28), 120 (3 packs of 40) and 392 (14 packs of 28) hard capsules in a cardboard box.

Nilotinib hard capsules 150 mg are packaged in perforated single-dose blisters of PVC/PE/PVDC/Aluminum or blisters of OPA/Aluminum/PVC/Aluminum:

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

Nilotinib hard capsules 200 mg are packaged in blisters of PVC/PE/PVDC/Aluminum or blisters of OPA/Aluminum/PVC/Aluminum:

• Single packs containing 28, 40 hard capsules and collective packs containing 112 (4 packs of 28), 120 (3 packs of 40) and 392 (14 packs of 28) hard capsules in a cardboard box.

Nilotinib hard capsules 200 mg are packaged in perforated single-dose blisters of PVC/PE/PVDC/Aluminum or blisters of OPA/Aluminum/PVC/Aluminum:

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

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

Manufacturer

Clonmel Healthcare Ltd.,
Waterford Road,
E91 D768 County Tipperary,
Ireland
STADA Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany
STADA Arzneimittel GmbH,
Muthgasse 36/2
1190 Vienna,
Austria
PharOS Pharmaceutical Oriented Services Ltd.
Lesvou Street End, Thesi Loggos Industrial Zone,
Metamorfossi, 144 52,
Greece
To obtain more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Countries:

Austria
Nilotinib STADA 50 mg hard capsules
Nilotinib STADA 150 mg hard capsules
Nilotinib STADA 200 mg hard capsules
Belgium
Nilotinib EG 50 mg hard capsules
Nilotinib EG 150 mg hard capsules
Nilotinib EG 200 mg hard capsules
Croatia
Nilotinib STADA 50 mg hard capsules
Nilotinib STADA 150 mg hard capsules
Cyprus
Nilotinib Stada 50mg hard capsule
Nilotinib Stada 150mg hard capsule
Nilotinib Stada 200mg hard capsule
Denmark
Nilotinib STADA
Estonia
Nilotinib STADA
Finland
Nilotinib STADA 50 mg hard capsules
Nilotinib STADA 150 mg hard capsules
France
NILOTINIB EG 50 mg, hard capsules
NILOTINIB EG 150 mg, hard capsules
NILOTINIB EG 200 mg, hard capsules
Greece
Nilotinib Stada
Spain
Nilotinib STADA 150 mg hard capsules EFG
Nilotinib STADA 200 mg hard capsules EFG
Netherlands
Nilotinib CF 50 mg, hard capsules
Nilotinib CF 150 mg, hard capsules
Nilotinib CF 200 mg, hard capsules
Ireland
Nilotinib Clonmel 50 mg hard capsules
Nilotinib Clonmel 150 mg hard capsules
Nilotinib Clonmel 200 mg hard capsules
Iceland
Nilotinib STADA 50 mg hard capsules
Nilotinib STADA 150 mg hard capsules
Nilotinib STADA 200 mg hard capsules
Lithuania
Nilotinib STADA 50 mg hard capsules
Nilotinib STADA 100 mg hard capsules
Nilotinib STADA 200 mg hard capsules
Latvia
Nilotinib STADA 50 mg hard capsules
Nilotinib STADA 100 mg hard capsules
Nilotinib STADA 200 mg hard capsules
Luxembourg
Nilotinib EG 50 mg hard capsules
Nilotinib EG 150 mg hard capsules
Nilotinib EG 200 mg hard capsules
Malta
Nilotinib Clonmel 50 mg hard capsules
Nilotinib Clonmel 150 mg hard capsules
Nilotinib Clonmel 200 mg hard capsules
Germany
Nilotinib AL 50 mg hard capsules Nilotinib AL 150 mg hard capsules
Nilotinib AL 200 mg hard capsules
Norway
Nilotinib STADA
Portugal
Nilotinib Stada
Sweden
Nilotinib STADA 50 mg hard capsules
Nilotinib STADA 150 mg hard capsules
Nilotinib STADA 200 mg hard capsules
Slovenia
Nilotinib STADA 50 mg hard capsules
Nilotinib STADA 150 mg hard capsules
Nilotinib STADA 200 mg hard capsules
Slovakia
Nilotinib STADA 50 mg hard capsules
Nilotinib STADA 150 mg hard capsules
Nilotinib STADA 200 mg hard capsules
Hungary
Nilotinib STADA 50 mg hard capsules
Nilotinib STADA 150 mg hard capsules
Nilotinib STADA 200 mg hard capsules
Italy
NILOTINIB EG
Date of last revision of the leaflet:October 2024