Patient Information Leaflet: Nilotinib Teva

Nilotinib Teva 150 mg Hard Capsules EFG

Nilotinib Teva 200 mg Hard Capsules EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Nilotinib Teva

3. How to take Nilotinib Teva

4. Possible side effects

5. Storage of Nilotinib Teva

6. Contents of the pack and additional information

What is Nilotinib Teva

Nilotinib Teva is a medication that contains an active ingredient called nilotinib.

What is Nilotinib Teva used for

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

Nilotinib is used in adult and pediatric patients with newly diagnosed CML or in patients with CML who no longer benefit from previous treatment, including imatinib. It is also used in adult and pediatric patients who have experienced severe adverse effects with previous treatment and cannot continue using it.

How Nilotinib Teva works

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

Monitoring during Nilotinib Teva treatment

Regular monitoring will be performed during treatment, including blood tests. These tests will control:

• the amount of blood cells in the body (white blood cells, red blood cells, and platelets) to check if nilotinib is well tolerated.
• the function of the pancreas and liver of the body to check if nilotinib is well tolerated.
• the body's electrolytes (potassium, magnesium). These are important for heart function.
• the level of sugar and fats in the blood.

Heart rate will also be monitored using a machine that measures the heart's electrical activity (an electrocardiogram, or ECG).

Your doctor will regularly evaluate your treatment and decide if you should continue taking nilotinib. If they instruct you to stop taking this medication, they will continue to monitor your CML and, if necessary, may instruct you to restart treatment with nilotinib.

If you have any questions about how nilotinib works or the reason why you or your child has been prescribed this medication, consult with your doctor.

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

Do not take Nilotinib Teva.

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

If you think you may be allergic, inform your doctor before taking Nilotinib Teva.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nilotinib Teva:

• if you have previously experienced cardiovascular events such as a heart attack, chest pain (angina), problems with blood supply to your brain (stroke) or problems with blood flow to your leg (claudication) or if you have risk factors for cardiovascular diseases such as high blood pressure (hypertension), diabetes or problems with the level of fats in your blood (lipid abnormalities).

• if you have a heart condition, such as an abnormal electrical signal called "prolongation of the QT interval".
• if you are receiving treatment with medicines that lower cholesterol in the blood (statins) or that affect heart rhythm (antiarrhythmics) or the liver (see Use of Nilotinib Teva with other medicines).
• if you have a lack of potassium or magnesium.
• if you have a liver or pancreas disorder.

• if you have symptoms such as easy bruising, feeling tired or difficulty breathing or have had repeated infections.

• if you have had a surgical procedure that involved the complete removal of your stomach (total gastrectomy).

• if you have ever had or may have hepatitis B virus infection at present. This is because Nilotinib Teva could make hepatitis B become active again, which can be fatal in some cases. Your doctor should carefully check for signs of this infection before starting treatment.

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

During treatment with Nilotinib Teva

• if you experience a fainting spell (loss of consciousness) or have an irregular heart rhythm while taking this medicine, inform your doctor immediately as this may be a sign of a serious heart problem. Prolongation of the QT interval or irregular heart rhythm can cause sudden death. There have been reports of rare cases of sudden death in patients taking nilotinib.

• if you experience sudden palpitations, severe muscle weakness or paralysis, convulsions or sudden changes in behaviour or level of alertness, inform your doctor immediately as this may be a sign of a rapid breakdown of cancer cells called tumour lysis syndrome. There have been reports of rare cases of tumour lysis syndrome in patients treated with nilotinib.

• if you develop chest pain or discomfort, numbness or weakness, walking or speech problems, pain, discoloration or coldness in a limb, inform your doctor immediately as this may be a sign of a cardiovascular event. There have been reports of serious cardiovascular events including peripheral arterial occlusive disease, coronary heart disease and cerebral ischaemia in patients taking nilotinib. Your doctor should evaluate your lipid and blood sugar levels before starting treatment with Nilotinib Teva and during treatment.

• if you develop swelling of the feet or hands, generalised swelling or rapid weight gain, inform your doctor as these may be signs of severe fluid retention. There have been reports of rare cases of severe fluid retention in patients treated with nilotinib.

If you are the parents of a child being treated with Nilotinib Teva, inform your doctor if any of the conditions described above apply to your child.

Children and adolescents

Nilotinib Teva is used to treat children and adolescents with CML. There is no experience of the use of this medicine in children under 2 years of age. There is limited experience in children under 10 years of age with new diagnosis and limited experience in children under 6 years of age with patients who did not benefit from previous treatment for CML.

Some children and adolescents being treated with Nilotinib Teva may experience slower than normal growth. Your doctor will monitor growth at regular visits.

Other medicines and Nilotinib Teva

Nilotinib Teva may interact with other medicines.

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. These include, in particular:

• antiarrhythmics – used to treat irregular heart rhythm;
• chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacina – medicines that may have an undesirable effect on the heart's electrical activity;
• ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat infections;
• ritonavir – a medicine in the group of "protease inhibitors" used to treat HIV;
• carbamazepine, phenobarbital, phenytoin – used to treat epilepsy;
• rifampicin – used to treat tuberculosis;
• St. John's Wort – a product derived from plants used to treat depression and other conditions (also known as Hypericum perforatum);
• midazolam – used to alleviate 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 "defence" ability and fight infections and are often used to prevent organ transplant rejection such as the liver, heart or kidney;
• dihydroergotamine and ergotamine – used to treat dementia;
• lovastatin, simvastatin – used to treat high levels of fats in the blood;
• warfarin – used to treat blood clotting disorders (such as blood clots or thrombosis);
• astemizol, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine).

You should avoid using these medicines 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 in the blood), speak with your doctor or pharmacist. If you use Nilotinib Teva with certain statins, it may increase the risk of statin-related muscle problems, which in rare cases can cause severe muscle degeneration (rhabdomyolysis) that can lead to kidney damage.

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

• blockers of H2, 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 neutralise high stomach acidity. These antacids should be taken approximately 2 hours before or approximately 2 hours after taking Nilotinib Teva.

You should also inform 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 drinks

Do not take Nilotinib Teva with meals. Food may 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 may increase the amount of Nilotinib Teva in the blood, possibly to a dangerous level.

Pregnancy and breastfeeding

• Nilotinib Teva is not recommended during pregnancy unless clearly necessary. If you are pregnant or think you may be pregnant, inform your doctor, who will discuss with you whether you can take this medicine during pregnancy.

• Women who may become pregnant should use very effective contraception during treatment and for two weeks after stopping treatment.

• Nilotinib Teva is not recommended during breastfeeding and for two weeks after the last dose. Inform your doctor if you are breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

If you experience side effects (such as dizziness or vision problems) that may affect your ability to drive safely or use tools or machines after taking this medicine, you should avoid these activities until the effect has disappeared.

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 certain sugars, consult with him 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".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much Nilotinib Teva to take

Use in adults

• Patients with newly diagnosed LMC: The recommended dose is 600 mg per day. The dose is achieved by taking two hard capsules of 150 mg, twice a day.

• Patients with LMC who did not benefit from their previous treatment:The recommended dose is 800 mg per day. This dose is achieved by taking two capsules of 200 mg twice a day.

Use in children and adolescents

• The dose given to your child will depend on their body weight and height. Your doctor will calculate the correct dose to use and will indicate 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 you respond to treatment.

Patients aged 65 or older

Nilotinib Teva can be used by patients aged 65 or older at the same dose as the rest of adults.

When to take Nilotinib Teva

Take the hard capsules:

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

Consult with your doctor or pharmacist if you have doubts about when to take this medication. Taking Nilotinib Teva every day at the same time 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, use other medications with nilotinib instead of Nilotinib Teva.

For how long to take Nilotinib Teva

Take nilotinib every day for the time indicated by your doctor. This is a long-term treatment. Your doctor will monitor your situation periodically to check that the treatment is having the desired effect.

Your doctor may consider suspending your treatment with nilotinib based on specific criteria.

If you have doubts about how long you should take nilotinib, consult your doctor.

If you take more Nilotinib Teva than you should

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

If you forget to take Nilotinib Teva

If you have forgotten to take a dose, take the next dose at your usual time. Do not take a double dose to compensate for the missed capsule.

If you interrupt treatment with Nilotinib Teva

Do not interrupt treatment with this medication unless your doctor tells you to. Stopping treatment with nilotinib without your doctor's recommendation puts you at risk of worsening your disease, which could have fatal consequences. Make sure to discuss it with your doctor, nurse, and/or pharmacist if you are thinking of interrupting treatment with nilotinib.

If your doctor recommends suspending treatment with Nilotinib Teva

Your doctor will regularly evaluate your treatment with a specific diagnostic test and decide whether you should continue taking this medication. If they tell you to stop taking nilotinib, they will continue to monitor your LMC before, during, and after stopping nilotinib, and if necessary, may recommend that you restart treatment with nilotinib.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most side effects are mild to moderate and usually disappear after a few days or weeks of treatment.

Some side effects can be serious.

• Musculoskeletal pain signs: joint and muscle pain
• Cardiac disorder signs: chest pain or discomfort, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (sensation of rapid heartbeat), dizziness, blue discoloration of the lips, tongue, or skin
• Artery obstruction signs: pain, discomfort, weakness, or cramps in the muscles of the legs, which may be due to decreased blood flow, leg or arm ulcers that heal slowly or not at all, and notable changes in color (blue or pale) or temperature (cold) in the affected legs, arms, fingers, or hands
• Subclinical hypothyroidism signs: weight gain, fatigue, hair loss, muscle weakness, sensation of cold
• Hyperthyroidism signs: rapid heartbeat, bulging eyes, weight loss, swelling in the front of the neck
• Renal or urinary tract disorder signs: thirst, dry skin, irritability, dark urine, decreased urine output, difficulty and pain urinating, excessive need to urinate, blood in the urine, abnormal urine color
• High blood sugar signs: excessive thirst, high urine output, increased appetite with weight loss, fatigue
• Dizziness signs: dizziness or sensation of spinning
• Pancreatitis signs: intense pain in the upper abdomen (middle or left)
• Skin disorder signs: painful red bumps, skin pain, skin redness, peeling, or blisters
• Water retention signs: rapid weight gain, swelling of hands, ankles, feet, or face
• Migraine signs: intense headache often accompanied by nausea, vomiting, and sensitivity to light
• Blood disorder signs: fever, easy bruising or bleeding, unexplained infections, unexplained weakness
• Coagulation within a vein signs: swelling and pain in a part of the body
• Nervous system disorder signs: weakness or paralysis of the limbs or face, difficulty speaking, intense headache, seeing, feeling, or hearing things that do not exist, changes in vision, loss of consciousness, confusion, disorientation, tremors, numbness, pain, or tingling in the fingers of the hands or feet
• Pulmonary disorder signs: difficulty breathing or chest pain, cough, wheezing with or without fever, swelling of the feet or legs
• Gastrointestinal disorder signs: abdominal pain, nausea, vomiting with blood, black or bloody stools, constipation, heartburn, acid reflux, swollen abdomen
• Hepatic disorder signs: yellow skin and eyes, nausea, loss of appetite, dark urine
• Reactivated hepatitis B infection signs
• Ocular disorder signs: visual disturbances that include blurry vision, double vision, or flashes of light, decreased sharpness or loss of vision, blood in the eye, increased sensitivity of the eyes to light, eye pain, redness, itching, dryness, swelling, or irritation, eyelid swelling or itching
• Electrolyte imbalance signs: nausea, difficulty breathing, irregular heartbeat, cloudy urine, fatigue, and/or joint pain associated with abnormal blood test results (such as high potassium, uric acid, and phosphorus levels and low calcium levels)

Contact your doctor immediately if you notice any of the side effects described.

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

• Diarrhea
• Headache
• Lack of energy
• Muscle pain
• Itching, rash
• Nausea
• Constipation
• Vomiting
• Hair loss
• Pain in the limbs, bone pain, and back pain when stopping nilotinib treatment
• Slowed growth in children and adolescents
• Upper respiratory tract infection, including sore throat and nasal congestion, sneezing
• Low levels of red blood cells, white blood cells, or platelets
• High levels of lipase in the blood (pancreatic 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 10patients)

• Pneumonia
• Abdominal pain, stomach discomfort after meals, flatulence, abdominal swelling or distension
• Bone pain, muscle spasms
• Pain (including neck pain)
• Dry skin, acne, decreased skin sensitivity
• Weight gain or loss
• Insomnia, depression, anxiety
• Nocturnal sweating, excessive sweating
• General feeling of discomfort
• Nasal bleeding
• Gout signs: joint pain and swelling
• Impotence
• Flu-like symptoms
• Sore throat
• Bronchitis
• Ear pain, hearing ringing sounds (such as tinnitus)
• Hemorrhoids
• Heavy menstrual periods
• Itching on hair follicles
• Oral or vaginal candidiasis
• Conjunctivitis signs: eye discharge with itching, redness, and swelling
• Eye irritation, red eyes
• Hypertension signs: high blood pressure, headache, dizziness
• Angina
• Peripheral artery disease signs: pain, discomfort, weakness, or cramps in the muscles of the legs, which may be due to decreased blood flow, leg or arm ulcers that heal slowly or not at all, and notable changes in color (blue or pale) or temperature (cold) in the affected legs, arms, fingers, or hands
• Dyspnea (difficulty breathing)
• Mouth sores with inflamed gums (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 aminotransferase in the blood (liver enzymes)
• High levels of gamma-glutamyltransferase in the blood (liver enzymes)
• Leukopenia or neutropenia signs: low white blood cell count
• Increased platelet or white blood cell count 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 lipids in the blood (including cholesterol)
• High levels of uric acid in the blood

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

• Allergy (hypersensitivity to nilotinib)
• Dry mouth
• Breast pain
• Pain or discomfort in the side
• Increased appetite
• Male breast enlargement
• Herpes virus infection
• Muscle stiffness and joint swelling, joint pain
• Sensation of body temperature change (including feeling hot or cold)
• Altered sense of taste
• Increased frequency of urination
• Signs of gastric mucosal inflammation: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
• Memory loss
• Cutaneous cyst, skin thinning or thickening, skin thickening, skin discoloration
• Psoriasis signs: thickened, red, or silvery patches on the skin
• Increased skin sensitivity to light
• Difficulty hearing
• Joint inflammation
• Urinary incontinence
• Enterocolitis (inflammation of the intestine)
• Anal abscess
• Nipple swelling
• Restless leg syndrome symptoms (a strong urge to move a part of the body, usually the leg, accompanied by uncomfortable sensations)
• Sepsis signs: fever, chest pain, rapid heartbeat, difficulty breathing or rapid breathing
• Skin infection (subcutaneous abscess)
• Wart on the skin
• Increased eosinophils (a type of white blood cell)
• Signs of lymphopenia: low white blood cell count
• 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: nausea, sweating, weakness, dizziness, tremors, headache
• Dehydration
• Abnormal lipid levels in the blood
• Involuntary movements (tremors)
• Difficulty concentrating
• Unpleasant and abnormal sensation when touching (dysesthesia)
• Fatigue (also called tiredness)
• Numbness or tingling in the fingers of the hands or feet (peripheral neuropathy)
• Paralysis of any facial muscle
• Red spot in the white of the eye caused by broken blood vessels (conjunctival hemorrhage)
• Blood in the eyes (ocular hemorrhage)
• Eye irritation
• Signs of myocardial infarction (heart attack): sudden and oppressive chest pain, fatigue, irregular heartbeat
• Signs of cardiac murmur: fatigue, chest pain, dizziness, pain, palpitations
• Fungal infection of the feet
• Signs of heart failure: dyspnea, difficulty breathing when lying down, swelling of the feet or legs
• Pain behind the sternum (pericarditis)
• Signs of hypertensive crisis: intense headache, dizziness, nausea
• Pain in the legs and weakness caused by walking (intermittent claudication)
• Signs of extremity artery occlusion: possible high blood pressure, painful cramps in one or both hips, thighs, or calf muscles after certain activities such as walking or climbing stairs, numbness or weakness in the legs
• Hematomas (when you haven't been injured)
• Deposits of fat in the arteries that can cause obstruction (arteriosclerosis)
• Signs of low blood pressure (hypotension): dizziness, dizziness, or fainting
• Signs of pulmonary edema: dyspnea
• Signs of pleural effusion: accumulation of fluid between the layers of tissue that cover the lungs and the chest cavity (which, if severe, can reduce the heart's ability to pump blood), chest pain, cough, hiccups, rapid breathing
• Signs of interstitial lung disease: cough, difficulty breathing, chest pain
• Signs of pleurisy: cough, painful breathing
• Hoarse voice
• Signs of pulmonary hypertension: high blood pressure in the pulmonary arteries
• Wheezing
• Teeth sensitivity
• Signs of gingivitis: bleeding gums, sensitive or swollen gums
• High levels of urea in the blood (renal function)
• Changes in blood proteins (low globulin levels or presence of paraprotein)
• High levels of unconjugated bilirubin in the blood
• High levels of troponins in the blood

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

• Redness and/or swelling and possibly peeling of the palms of the hands and soles of the feet (hand-foot syndrome)
• Warts in the mouth
• Sensation of breast hardness or stiffness
• Thyroid gland inflammation (thyroiditis)
• Altered mood or depression
• 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, dizziness (sensation of spinning), numbness or tingling, loss of coordination, dizziness or confusion
• Swelling of the brain (possible headache and/or changes in mental state)
• Signs of optic neuritis: blurry vision, vision loss
• Signs of cardiac dysfunction (reduced ejection fraction): fatigue, chest pain, dizziness, pain, palpitations
• Low or high insulin levels in the blood (a hormone that regulates blood sugar levels)
• Low levels of proinsulin C-peptide in the blood (pancreatic function)
• Sudden death

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

• Signs of cardiac dysfunction (ventricular dysfunction): difficulty breathing, exertion at rest, irregular heartbeat, chest pain, dizziness, pain, palpitations, excessive urination, swelling of the feet, ankles, and abdomen.

Reporting of adverse reactions

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

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.

• Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

• Medications should not be thrown down the drain or in the trash.Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Nilotinib Teva

• The active ingredient is Nilotinib.

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

The other components are:

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

Capsule coating: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 hydrate).

The other components are:

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

Capsule coating: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.

Appearance of the product and packaging contents

Nilotinib Teva 150 mg hard capsules are red, opaque, size 1 capsules with the imprint 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 yellowish clear, opaque, size 0 capsules with the imprint 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 blistersPVC/PE/PVdC//Al u OPA/Al/PVC//Al: Packs of 28, 30 and 40 hard capsules and multi-packs 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 single-dose blistersPVC/PE/PVdC//Al u OPA/Al/PVC//Al: Packs of 28 hard capsules, 30 hard capsules, 40 hard capsules and 112 hard capsules and multi-packs of 112 hard capsules (4 packs of 28 hard capsules), 120 hard capsules (3 packs of 40 hard capsules) and 392 hard capsules (14 packs of 28 hard capsules).

Nilotinib Teva 200 mg hard capsules are available in blistersPVC/PE/PVdC//Al u OPA/Al/PVC//Al: Packs of 28, 30 and 40 hard capsules and multi-packs 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 single-dose blistersPVC/PE/PVdC//Al u OPA/Al/PVC//Al: Packs of 28 hard capsules, 30 hard capsules, 40 hard capsules and 112 hard capsules and multi-packs of 112 hard capsules (4 packs of 28 hard capsules), 120 hard capsules (3 packs of 40 hard capsules) and 392 hard capsules (14 packs of 28 hard capsules).

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Teva GmbH

Graf-Arco-Str. 3

Ulm, 89079

Germany

Manufacturer responsible

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

Last review date of this leaflet: May 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

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