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.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience 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. 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 body to produce abnormal white blood cells. Nilotinib blocks this signal and stops the production of these abnormal cells.

Monitoring of treatment with Nilotinib

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

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

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

Your doctor will regularly assess your response to 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 advise you to start taking Nilotinib again if your condition changes.

2. Before you take Nilotinib

Follow your 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 fat in the blood.
• if you have an irregular heartbeat or other heart problems.
• if you are taking medicines that lower cholesterol or affect heart function.
• 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 can cause the hepatitis B virus to become active again, which can be life-threatening.

During treatment with Nilotinib:

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

Tumour lysis syndrome is a condition that can occur when cancer cells are broken down quickly. It can cause kidney damage and other serious problems.

• if you experience pain or discomfort in your chest, numbness or weakness, difficulty walking or speaking, pain, discoloration, or coldness in your arms or legs, tell your doctor immediately, as this can be a sign of a serious heart or blood vessel problem.
• if you experience swelling of your feet or hands, or rapid weight gain, tell your doctor, as this can be a sign of 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. Some children and adolescents taking Nilotinib may grow more slowly than normal. Your doctor will monitor your growth during regular visits.

Nilotinib and other medicines

Nilotinib can 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 can affect the heart, such as chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin
• medicines for fungal 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
• medicines for migraine, such as dihydroergotamine and ergotamine
• medicines for high cholesterol, such as lovastatin and simvastatin
• warfarin (a medicine for blood clotting disorders)
• 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 alternative medicines.

If you are taking a statin (a medicine to lower cholesterol), you should talk to your doctor or pharmacist. Nilotinib can 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 to reduce stomach acid, such as antacids.

The following medicines should be taken separately from Nilotinib:

• histamine H2-receptor antagonists, which reduce stomach acid production. These medicines should be taken about 10 hours before and about 2 hours after taking Nilotinib.
• antacids, which neutralize stomach acid. These medicines should be taken 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 for you 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 its levels in the blood, which can be harmful. Do not drink grapefruit juice or eat grapefruit. They can increase the levels of Nilotinib in the blood, which can be harmful.

Pregnancy and breastfeeding

• 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 breastfeedwhile taking Nilotinib and for 2 weeks after stopping treatment. If you are breastfeeding, 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 resolved.

Nilotinib contains lactose

This medicine contains lactose (also known as milk sugar). 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

For adult patients:

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

For children and adolescents:

• The dose is based on the child's weight and height. Your 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.

Your doctor may prescribe a lower dose depending on how you respond to 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 about alternative medicines.

How long to take Nilotinib

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

Your doctor may consider stopping treatment with Nilotinib based on certain criteria.

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

What to do if you take too much Nilotinib

If you take too much Nilotinib or if someone else takes your medicine by mistake, contact your doctor or go to hospital immediately. Show the doctor or nurse the pack and this leaflet. Medical attention may be necessary.

What to do if you forget to take Nilotinib

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

Stopping treatment with Nilotinib

Do not stop taking Nilotinib unless your doctor tells you to. Stopping treatment with Nilotinib without consulting your doctor may put you at risk of your condition getting worse, which can be life-threatening.

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

What your doctor will do if you need to stop taking Nilotinib

Your doctor will regularly assess your response to 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 advise you to start taking Nilotinib again if your condition changes.

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.

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 can be caused by reduced blood flow
• 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, fatigue
• dizziness: dizziness or feeling of spinning
• pancreatitis: severe abdominal pain (in the middle or left side)
• skin problems: painful, red lumps, skin pain, redness, swelling, peeling, or blistering
• fluid retention: rapid weight gain, swelling of the hands, ankles, feet, or face
• migraine: severe headache, nausea, vomiting, sensitivity to light
• blood problems: fever, easy bruising or bleeding, frequent infections, weakness or fatigue
• blood clots: swelling and pain in one part of the body
• nervous system problems: weakness or paralysis of the arms or legs, difficulty speaking, severe headache, vision, hearing, or feeling 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

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

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

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

• pneumonia
• abdominal pain, discomfort in the upper abdomen, bloating, swelling, or gas in the abdomen
• bone or muscle pain
• pain (including neck pain)
• dry skin, acne, decreased 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)
• petechiae (small red or purple spots on the skin)
• menstrual bleeding
• folliculitis (inflammation of the hair follicles)
• thrush (fungal infection of the vagina or mouth)
• conjunctivitis: eye discharge, redness, swelling, or itching
• eye irritation, redness, or itching
• high blood pressure: headache, dizziness, or blurred vision
• flushing
• peripheral arterial disease: pain, discomfort, weakness, or cramping in the legs, which can be caused by reduced blood flow
• shortness of breath
• mouth ulcers or gum inflammation (stomatitis)
• increased amylase activity in the blood (pancreas function)
• increased creatinine levels in the blood (kidney function)
• increased alkaline phosphatase or creatine kinase activity in the blood
• increased aspartate aminotransferase activity in the blood (liver enzymes)
• increased gamma-glutamyltransferase activity in the blood (liver enzymes)
• leukopenia or neutropenia: low white blood cell count
• increased platelet or white blood cell count
• low levels of magnesium, potassium, sodium, calcium, or phosphorus in the blood
• high levels of fat 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: abdominal pain, nausea, vomiting, diarrhoea, bloating
• memory loss
• skin cysts, thinning or thickening of the skin, skin discoloration
• psoriasis: thickened, red, silvery patches of skin
• increased sensitivity to sunlight
• hearing loss
• arthritis
• urinary incontinence
• inflammatory bowel disease (including colitis)
• anal abscess
• breast tenderness
• 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 (cellulitis)
• skin warts
• increased eosinophil count (a type of white blood cell)
• lymphopenia: low white blood cell count
• high levels of parathyroid hormone in the blood (which regulates calcium and phosphorus levels)
• increased lactate dehydrogenase activity (an enzyme)
• low blood sugar: nausea, sweating, weakness, dizziness, trembling, headache
• dehydration
• abnormal fat levels in the blood
• tremors
• difficulty concentrating
• 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 (subconjunctival haemorrhage)
• blood in the eyes (conjunctival haemorrhage)
• eye irritation
• heart attack: sudden, severe chest pain, fatigue, irregular heartbeat, discomfort in the chest, feeling of fainting, pain, palpitations
• heart problems: fatigue, discomfort in the chest, feeling of fainting, pain, palpitations, shortness of breath
• fungal infection of the feet
• heart failure: shortness of breath, fatigue, swelling of the feet, ankles, or abdomen
• pericarditis: chest pain (pericardial pain)
• hypertensive crisis: severe headache, dizziness, nausea
• intermittent claudication: pain or weakness in the legs when walking (which can be caused by reduced blood flow)
• arterial occlusion: pain, discomfort, weakness, or cramping in the legs, which can be caused by reduced blood flow
• bruising (without any apparent cause, such as injury)
• fat deposits in the arteries, which can cause them to narrow (atherosclerosis)
• low blood pressure: feeling faint, dizzy, or lightheaded
• pulmonary oedema: shortness of breath
• fluid accumulation in the lungs (pleural effusion): shortness of breath, chest pain, cough, hiccups, rapid breathing
• interstitial lung disease: cough, shortness of breath, chest pain when breathing
• pleuritic pain: chest pain
• pericarditis: cough, chest pain when breathing
• hoarseness
• hypertension: high blood pressure, headache, dizziness
• 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, swelling, and peeling of the skin on the hands and feet (palmar-plantar erythrodysesthesia syndrome)
• mouth warts
• breast tenderness or hardness
• thyroiditis: inflammation of the thyroid gland
• mood changes or depression
• hyperparathyroidism: bone or joint pain, frequent urination, abdominal pain, weakness, fatigue
• narrowing of the arteries in the brain: loss of vision, double vision, dizziness, numbness or tingling, loss of coordination, dizziness or confusion
• brain swelling (which can cause headache or changes in mental status)
• optic neuritis: blurred vision, loss of vision
• heart problems: fatigue, discomfort in the chest, feeling of fainting, pain, palpitations, shortness of breath
• low insulin levels in the blood (which regulates blood sugar levels)
• low C-peptide levels in the blood (which regulates blood sugar levels)
• sudden death

The following side effects have been reported with an unknown frequency:

• heart problems: shortness of breath, fatigue, irregular heartbeat, discomfort in the chest, feeling of fainting, pain, palpitations, excessive urination, swelling of the feet, ankles, or 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. This 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 (type A) (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b).

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

Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (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 (type A) (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b).

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

Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (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 (type A) (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b).

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

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

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

How the medicine Nilotinib looks like and what the pack contains

The Nilotinib 50 mg medicine is available in the form of hard capsules (capsules) with a red, opaque cap and a light yellow, opaque body, size 4 (length approx. 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.
The Nilotinib 150 mg medicine is available in the form of red, opaque hard capsules, size 1 (length approx. 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.
The Nilotinib 200 mg medicine is available in the form of light yellow, opaque hard capsules (capsules) of size 0 (length approx. 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.
The Nilotinib 50 mg hard capsules are packaged in PVC/PE/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters:

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

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

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

• 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.

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

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

• 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.

The Nilotinib 200 mg hard capsules are packaged in perforated single-dose blisters of PVC/PE/PVDC/Aluminum or 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 Authorization 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 medicine, please contact the local representative of the Marketing Authorization Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicine is authorized 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