NILOTINIB TEVA 150 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Nilotinib Teva 150 mg hard capsules EFG

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

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

What is Nilotinib Teva

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

What is Nilotinib Teva 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 taking it.

How Nilotinib Teva works

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

Monitoring during treatment with Nilotinib Teva

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.

Heart rate will also be checked using a machine that measures the heart's electrical activity (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 restart treatment with nilotinib 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 Teva

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

Do not take Nilotinib Teva

• 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 Teva.

Warnings and precautions

Tell your doctor or pharmacist before starting treatment with Nilotinib Teva:

• if you have had heart problems in the past, such as a heart attack, chest pain (angina), problems with blood flow to the brain (stroke), or problems with blood flow to the leg (claudication), or if you have risk factors for heart disease, such as high blood pressure, diabetes, or problems with fat levels in your blood.

• if you have a heart condition, such as an abnormal electrical signal called “prolonged QT interval”.
• if you are taking medicines that lower cholesterol (statins) or affect heart rhythm (anti-arrhythmics) or liver function (see Taking other medicines).
• if you have low potassium or magnesium levels.
• 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 entire stomach (total gastrectomy).

• if you have ever had or may currently have a hepatitis B virus infection. This is because Nilotinib Teva could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor will carefully check 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 Teva

• if you faint (lose consciousness) or have an irregular heart rhythm while taking this medicine, tell your doctor immediately, as this can be a sign of a serious heart problem. 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 have sudden heart palpitations, severe muscle weakness, or paralysis, seizures, or sudden changes in behaviour or level of alertness, tell your doctor immediately, as this can 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, tell your doctor immediately, as this can be a sign of a cardiovascular event. There have been reports of serious cardiovascular events, including problems with blood flow to the leg (peripheral arterial occlusive disease), heart disease (ischaemic heart disease), and problems with blood flow to the brain (ischaemic cerebrovascular disease) in patients taking nilotinib. Your doctor will check your fat and sugar levels before and during treatment with Nilotinib Teva.

• if you develop swelling of the feet or hands, general swelling, or rapid weight gain, tell your doctor, as these can 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 Teva, tell your doctor if any of the above conditions occur in your child.

Children and adolescents

Nilotinib Teva 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.

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

Other medicines and Nilotinib Teva

Nilotinib Teva 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 transplant, such as a liver, heart, or kidney;
• 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 disorders (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 Teva. 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), talk to your doctor or pharmacist. If you take Nilotinib Teva with certain statins, this may increase the risk of muscle problems associated with statins, which can rarely cause serious muscle damage (rhabdomyolysis) that can lead to kidney damage.

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

• H2 blockers, which reduce stomach acid production. H2 blockers should be taken approximately 10 hours before and approximately 2 hours after taking Nilotinib Teva;

• antacids such as those containing aluminium hydroxide, magnesium hydroxide, and simethicone, which neutralize high stomach acid. These antacids should be taken approximately 2 hours before or approximately 2 hours after taking Nilotinib Teva.

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

Taking Nilotinib Teva with food and drink

Do not take Nilotinib Teva with food. Food can increase the absorption of Nilotinib Teva and therefore increase the amount of Nilotinib Teva in the blood, possibly to a dangerous level. Do not drink grapefruit juice or eat grapefruit. It can increase the amount of Nilotinib Teva in the blood, possibly to a dangerous level.

Pregnancy and breast-feeding

• Nilotinib Teva should not be used during pregnancy unless clearly necessary. 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 can become pregnant should use highly effective contraception during treatment and for up to 2 weeks after finishing treatment.

• Nilotinib Teva should not be used during breast-feeding and for 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 may affect your ability to drive or use tools or machines safely after taking this medicine, you should avoid these activities until the effect has stopped.

Nilotinib Teva 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, consult your doctor before taking this medicine.

Nilotinib Teva 150 mg contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Nilotinib Teva

Follow exactly the instructions given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

How much Nilotinib Teva 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 Teva 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 your child responds to treatment.

Elderly patients (65 years or older)

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

When to take Nilotinib Teva

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 Teva at the same time every day will help you remember when to take the hard capsules.

How to take Nilotinib Teva

• Swallow the hard capsules whole with water.
• Do not take any food with the hard capsules.
• Do not open the capsules. If you or your child cannot swallow them, other nilotinib medicines should be used instead of Nilotinib Teva.

How long to take Nilotinib Teva

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 Teva than you should

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

If you forget to take Nilotinib Teva

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

If you stop taking Nilotinib Teva

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 to 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 Teva

Your doctor will regularly assess your treatment with a specific diagnostic test 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 restart treatment with nilotinib 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 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, exaggerated need to urinate, blood in the urine, abnormal urine color
• signs of high blood sugar levels: excessive thirst, high urine volume, 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, skin redness, scaling, or blisters
• signs of water retention: rapid weight gain, swelling of hands, ankles, feet, or face
• signs of migraine: severe headache often accompanied by nausea, vomiting, and sensitivity to light
• signs of blood disorders: fever, easy bruising or unexplained bleeding, severe or frequent infections, unexplained weakness
• signs of blood 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, tingling sensation, 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 visual acuity or loss of vision, blood in the eye, increased sensitivity of the eyes to light, eye pain, redness, itching, or irritation, dry 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 frequent(may affect more than 1 in 10 patients)

• 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
• slow 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 the blood (pancreatic function)
• high levels of bilirubin in the blood (hepatic function)
• high levels of alanine aminotransferases in the blood (hepatic enzymes)

Some adverse reactions are frequent(may affect up to 1 in 10 patients)

• pneumonia
• abdominal pain, stomach discomfort after meals, flatulence, swelling, or abdominal distension
• 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 arterial obstruction in the leg, arm, or toes or fingers)
• difficulty breathing (also called dyspnea)
• mouth sores with gum inflammation (also called stomatitis)
• high levels of amylase in the blood (pancreatic function)
• high levels of creatinine in the blood (renal function)
• high levels of alkaline phosphatase or creatine phosphokinase in the blood
• high levels of aspartate aminotransferases (hepatic enzymes) in the blood
• high levels of gamma-glutamyltransferase (hepatic enzymes) in the blood
• signs of leucopenia or neutropenia: low levels of white blood cells
• increased number of platelets or white blood cells in the blood
• low levels of magnesium, potassium, sodium, calcium, or phosphorus in the blood
• high levels of potassium, calcium, or phosphorus in the blood
• high levels of fats in the blood (including cholesterol)
• high levels of uric acid in the blood

Some adverse reactions are infrequent(may affect up to 1 in 100 patients)

• 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
• sensation of temperature change in the body (including sensation of heat, sensation 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 skin sensitivity 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, elevated heart rate/increased, difficulty breathing or rapid breathing
• skin infection (subcutaneous abscess)
• skin wart
• increased levels of a specific type of white blood cell (called eosinophils)
• signs of lymphopenia: low levels of white blood cells
• high levels of parathyroid hormone in the blood (a hormone that regulates calcium and phosphorus levels)
• high levels of lactate dehydrogenase in the 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)
• sensation 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 arterial occlusion: 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 pleurisy: chest pain, 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 the blood (renal function)
• change in blood proteins (low levels of globulins or presence of paraprotein)
• high levels of unconjugated bilirubin in the blood
• high levels of troponins in the blood

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

• 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
• sensation 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 cerebral artery occlusion: 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 the blood (a hormone that regulates blood sugar levels)
• low levels of C-peptide of insulin in the 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: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Nilotinib Teva

• 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 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 at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Container contents and additional information

Composition of Nilotinib Teva

• The active ingredient is Nilotinib.

Nilotinib Teva 150 mg: each hard capsule contains 150 mg of nilotinib (as dihydrochloride monohydrate).

The other ingredients are:

Capsule content: 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), 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 Teva 150 mg contains lactose and sodium.

Nilotinib Teva 200 mg: each hard capsule contains 200 mg of nilotinib (as dihydrochloride monohydrate).

The other ingredients are:

Capsule content: lactose monohydrate, crospovidone type A (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 Teva 200 mg contains lactose.

Product appearance and container contents

Nilotinib Teva 150 mg hard capsules are red, opaque capsules, size 1, with the printing of “150 mg” in black on the body. The contents of the hard capsules are a white to yellowish powder.

Nilotinib Teva 200 mg hard capsules are light yellow, opaque capsules, size 0, with the printing of “200 mg” in black on the body. The contents of the hard capsules are a white to yellowish powder.

Nilotinib Teva 150 mg hard capsules are available in PVC/PE/PVdC//Al or OPA/Al/PVC//Al blister packs: packs of 28, 30, and 40 hard capsules and multipacks of 112 (4 packs of 28), 120 (3 packs of 40), and 392 (14 packs of 28) hard capsules.

Nilotinib Teva 150 mg hard capsules are available in unit dose PVC/PE/PVdC//Al or OPA/Al/PVC//Al blister packs: packs of 28 unit dose hard capsules, 30 unit dose hard capsules, 40 unit dose hard capsules, and 112 unit dose hard capsules, and multipacks of 112 unit dose hard capsules (4 packs of 28 unit dose hard capsules), 120 unit dose hard capsules (3 packs of 40 unit dose hard capsules), and 392 unit dose hard capsules (14 packs of 28 unit dose hard capsules).

Nilotinib Teva 200 mg hard capsules are available in PVC/PE/PVdC//Al or OPA/Al/PVC//Al blister packs: packs of 28, 30, and 40 hard capsules and multipacks of 112 (4 packs of 28), 120 (3 packs of 40), and 392 (14 packs of 28) hard capsules.

Nilotinib Teva 200 mg hard capsules are available in unit dose PVC/PE/PVdC//Al or OPA/Al/PVC//Al blister packs: packs of 28 unit dose hard capsules, 30 unit dose hard capsules, 40 unit dose hard capsules, and 112 unit dose hard capsules, and multipacks of 112 unit dose hard capsules (4 packs of 28 unit dose hard capsules), 120 unit dose hard capsules (3 packs of 40 unit dose hard capsules), and 392 unit dose hard capsules (14 packs of 28 unit dose hard capsules).

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva GmbH

Graf-Arco-Str. 3

Ulm, 89079

Germany

Manufacturer

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000

Malta

PharOS Pharmaceutical Oriented

Services Ltd.

Lesvou Street End, Thesi Loggos Industrial Zone, Metamorfossi, 144 52

Greece

Local representative:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid)

Spain

Date of last revision of this leaflet: May 2024

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

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