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, a genetic change can lead to the production of a protein called BCR-ABL, which makes the leukemic cells grow and multiply. Nilotinib blocks this protein, reducing the growth and spread of cancer 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) to assess how well you tolerate Nilotinib.
• the function of your pancreas and liver to assess how well you tolerate Nilotinib.
• the levels of electrolytes (potassium, magnesium) in your blood, which are important for heart function.
• blood sugar and fat levels.

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

2. What you need to know 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 had heart problems, such as a heart attack, angina, stroke, or poor circulation in your legs.
• you have an irregular heartbeat or other heart problems.
• you are taking medicines that lower cholesterol or affect heart function.
• you have low levels of potassium or magnesium in your blood.
• you have liver or pancreas problems.
• you have symptoms such as easy bruising, tiredness, or shortness of breath.
• you have had your stomach completely removed.
• you have or have had hepatitis B infection.

During treatment with Nilotinib:

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

Tell your doctor if you experience any of the following symptoms:

• chest pain or discomfort, numbness or weakness, difficulty walking or speaking, pain, discoloration, or coldness in a limb.
• swelling of the feet or hands, or sudden weight gain.

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.

Nilotinib and other medicines

Nilotinib may affect the way other medicines work, and some medicines may affect the way Nilotinib works.

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

Do not take the following medicines with Nilotinib:

• medicines that lower cholesterol.
• certain antibiotics.
• medicines for fungal infections.
• medicines for HIV.
• medicines for epilepsy.
• medicines for tuberculosis.
• St. John's Wort (a herbal medicine).
• certain sedatives.
• certain painkillers.
• medicines that suppress the immune system.
• certain medicines for high blood pressure.
• warfarin (a medicine to prevent blood clots).

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.

Pregnancy and breastfeeding

• do not take Nilotinib if you are pregnant or think you may be pregnant, unless your doctor advises you to.
• women who may become pregnant should use effective contraception during treatment with Nilotinib and for up to 2 weeks after stopping treatment.
• do not breastfeed while taking Nilotinib and for up to 2 weeks after stopping treatment.

Driving and using machines

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

Nilotinib contains lactose and sodium

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

3. How to take Nilotinib

Take Nilotinib exactly as your doctor or pharmacist has told you.

How much Nilotinib to take

For adults:

• the recommended dose is 600 mg per day, taken as 2 capsules of 150 mg twice a day.
• if you have been previously treated for CML, the recommended dose is 800 mg per day, taken as 2 capsules of 200 mg twice a day.

For children and adolescents:

• the dose will depend on the child's weight and height. Your doctor will calculate the correct dose and tell you how many capsules to give to your child.

When to take Nilotinib

Take the capsules:

• twice a day (approximately 12 hours apart).
• at least 2 hours after a meal.
• wait 1 hour after taking Nilotinib before eating.

How to take Nilotinib

• swallow the capsules whole with water.
• do not take the capsules with food.
• do not open the capsules.

How long to take Nilotinib

Take Nilotinib every day for as long as your doctor tells you to.

If you take more Nilotinib than you should

If you take too much Nilotinib, contact your doctor or go to the hospital immediately.

If you forget to take Nilotinib

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

If you stop taking Nilotinib

Do not stop taking Nilotinib without talking to your doctor first.

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, muscle pain.
• cardiovascular events: chest pain, high or low blood pressure, irregular heartbeat, palpitations, fainting, blue discoloration of the lips, tongue, or skin.
• peripheral arterial occlusive disease: pain, discomfort, weakness, or cramping in the legs, which may be due to reduced blood flow.
• hypothyroidism: weight gain, tiredness, hair loss, muscle weakness, feeling cold.
• hyperthyroidism: rapid heartbeat, bulging eyes, weight loss, swelling of the neck.
• renal or urinary disorders: feeling thirsty, dark urine, reduced urine output, painful or difficult urination, blood in the urine.
• high blood sugar: excessive thirst, excessive urination, increased appetite, fatigue.
• vertigo: dizziness or a spinning sensation.
• pancreatitis: severe abdominal pain.
• skin disorders: painful red lumps, skin pain, redness, swelling, or blistering.
• fluid retention: rapid weight gain, swelling of the hands, feet, or face.
• migraine: severe headache, nausea, vomiting, sensitivity to light.
• blood disorders: fever, easy bruising or bleeding, frequent infections, weakness.
• deep vein thrombosis: swelling and pain in one part of the body.
• neurological disorders: weakness or paralysis of the face, arms, or legs, difficulty speaking, severe headache, changes in vision, hearing, or touch.
• respiratory disorders: difficulty breathing, chest pain, cough, wheezing, fever.
• gastrointestinal disorders: abdominal pain, nausea, vomiting, blood in the stool, constipation, heartburn, reflux.
• liver disorders: yellowing of the skin and eyes, nausea, loss of appetite, dark urine.
• hepatitis B reactivation: recurrence of hepatitis B infection.
• eye disorders: vision changes, including blurred vision, double vision, or flashes of light, eye pain, redness, swelling, or discharge.
• electrolyte imbalance: nausea, shortness of breath, irregular heartbeat, clouded urine, fatigue, and joint pain.

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.
• limb pain, bone pain, or back pain after stopping treatment.
• 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 (pancreatic 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, or swelling of the abdomen.
• muscle spasms, muscle pain.
• pain (including neck pain).
• dry skin, acne, reduced skin sensitivity.
• weight gain or loss.
• insomnia, depression, anxiety.
• night sweats, excessive sweating.
• general malaise.
• nosebleeds.
• gout: joint pain and swelling.
• erectile dysfunction.
• flu-like symptoms.
• sore throat.
• bronchitis.
• ear pain, ringing in the ears, or other abnormal sounds.
• petechiae (small red or purple spots on the skin).
• menstrual disorders.
• vaginal thrush or oral thrush.
• conjunctivitis: eye discharge, redness, or swelling.
• eye irritation, redness.
• hypertension: high blood pressure, headache, dizziness.
• flushing.
• peripheral arterial occlusive disease: pain, discomfort, weakness, or cramping in the legs.
• shortness of breath.
• mouth ulcers or gum inflammation.
• increased amylase activity in the blood (pancreatic 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 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 reactions (hypersensitivity).
• dry mouth.
• chest pain.
• side pain or discomfort.
• increased appetite.
• breast enlargement in men.
• herpes virus infections.
• muscle stiffness or joint swelling.
• feeling hot or cold.
• taste disorders.
• frequent urination.
• gastritis: stomach pain, nausea, vomiting, diarrhoea, or bloating.
• memory loss.
• skin cysts, skin thinning, or skin thickening.
• psoriasis: thickened, red, and scaly skin patches.
• increased sensitivity to sunlight.
• hearing loss.
• arthritis.
• urinary incontinence.
• enteritis: inflammation of the small intestine or colon.
• anal abscess.
• breast tenderness.
• restless legs syndrome: uncontrollable urge to move the legs.
• sepsis: fever, chest pain, rapid heartbeat, shortness of breath.
• skin infections.
• warts.
• increased eosinophil count (a type of white blood cell).
• lymphopenia: low lymphocyte count.
• high levels of parathyroid hormone in the blood.
• increased lactate dehydrogenase activity (an enzyme).
• low blood sugar: nausea, sweating, weakness, dizziness, shakiness, or headache.
• dehydration.
• abnormal fat levels in the blood.
• tremors.
• difficulty concentrating.
• abnormal sensations (such as tingling or numbness).
• fatigue.
• numbness or tingling in the hands or feet (peripheral neuropathy).
• facial paralysis.
• eye bleeding or redness.
• heart attack: severe chest pain, fatigue, shortness of breath.
• heart failure: shortness of breath, fatigue, swelling of the feet, ankles, or abdomen.
• pericarditis: chest pain.
• hypertensive crisis: severe headache, dizziness, nausea.
• intermittent claudication: leg pain when walking.
• arterial occlusive disease: poor circulation in the legs.
• bruising (without any known cause such as injury).
• atherosclerosis: fatty deposits in the arteries.
• low blood pressure: dizziness, lightheadedness, or fainting.
• pulmonary oedema: shortness of breath.
• pleural effusion: fluid accumulation in the lungs.
• interstitial lung disease: cough, shortness of breath, chest pain.
• pleuritic pain: chest pain.
• pericarditis: chest pain.
• hoarseness.
• pulmonary hypertension: high blood pressure in the lungs.
• wheezing.
• tooth sensitivity.
• gum inflammation or mouth ulcers.
• kidney function disorders: high levels of urea in the blood.
• abnormal protein levels in the blood.
• 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 1000 people)

• palmar-plantar erythrodysesthesia: redness, swelling, and peeling of the skin on the palms and soles.
• oral warts.
• breast tenderness or hardness.
• thyroiditis: inflammation of the thyroid gland.
• mood disorders or depression.
• hyperparathyroidism: high levels of parathyroid hormone in the blood.
• arterial occlusive disease in the brain: vision loss, double vision, dizziness, numbness or tingling.
• brain oedema: headache, changes in mental status.
• optic neuritis: blurred vision, loss of vision.
• heart failure: shortness of breath, fatigue, swelling of the feet, ankles, or abdomen.
• low insulin levels in the blood.
• low C-peptide levels in the blood.
• sudden death.

Side effects with unknown frequency

• heart failure: shortness of breath, fatigue, swelling of the feet, ankles, or abdomen.

Reporting of side effects

If you experience any side effects, tell your doctor or pharmacist. You can also report side effects directly to the regulatory agency in your country.

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.
• 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.

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 content: lactose monohydrate, crospovidone (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 content: lactose monohydrate, crospovidone (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 content: lactose monohydrate, crospovidone (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 of about 14.4 mm), with a black horizontal print "50 mg" on the body. The hard capsules are filled with a powder of a color from white to yellowish.
The Nilotinib 150 mg medicine is available in the form of red, opaque hard capsules, size 1 (length of about 19.3 mm), with a black horizontal print "150 mg" on the body. The hard capsules are filled with a powder of a color from white to yellowish.
The Nilotinib 200 mg medicine is available in the form of light yellow, opaque hard capsules (capsules) of size 0 (length of about 21.4 mm), with a black horizontal print "200 mg" on the body. The hard capsules are filled with a powder of a color from white to yellowish.
Nilotinib hard capsules 50 mg 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.

Nilotinib hard capsules 50 mg 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.

Nilotinib hard capsules 150 mg 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.

Nilotinib hard capsules 150 mg 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.

Nilotinib hard capsules 200 mg 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.

Nilotinib hard capsules 200 mg 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