Prospect: information for the patient

Tasigna 50mg, 150mg and 200mg hard capsules

nilotinib

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

1.What is Tasigna and for what it is used

2.What you need to know before starting to take Tasigna

3.How to take Tasigna

4.Possible adverse effects

5.Storage ofTasigna

6.Contents of the package andadditional information

What is Tasigna

Tasigna is a medication that contains an active ingredient called nilotinib.

What is Tasigna used for

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

Tasigna 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 from previous treatment and cannot continue using it.

How Tasigna works

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

Monitoring during Tasigna 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 Tasigna is well tolerated.
• the function of the pancreas and liver of the body to check if Tasigna 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 Tasigna. 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 Tasigna.

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

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

Do not take Tasigna

-if you areallergicto nilotinib or to any of the other components of this medication (listed in section6).

If you think you may be allergic, inform your doctorbeforetaking Tasigna.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tasigna:

-if you have had previous 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 alterations).

-if you have aheart condition, such as an abnormal electrical signal called "prolongation of the QT interval".

-if you are receivingmedicationsthat lower cholesterol in the blood (statins) or that affect heart rhythm (antiarrhythmics) or the liver (seeUse of Tasigna withothermedicines).

-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, fatigue, or shortness of breath or have had repeated infections.

-if you have had a surgical procedure that involved the removal of the entire stomach (total gastrectomy).

-if you have ever had or may have hepatitis B virus infection at this time. This is because Tasigna could make hepatitis B 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 Tasigna

• if you experience a fainting spell (loss of consciousness) or have an irregular heart rhythm while taking this medication,inform your doctor immediatelyas 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 Tasigna.
• if you experience sudden heart palpitations, severe muscle weakness or paralysis, convulsions or sudden changes in behavior or level of alertness,inform your doctor immediatelyas this may be a sign of a rapid breakdown of cancer cells called tumor lysis syndrome. There have been reports of rare cases of tumor lysis syndrome in patients treated with Tasigna.
• if you develop chest pain or discomfort, numbness or weakness, walking or speech problems, pain, discoloration or coldness in a limb,inform your doctor immediatelyas this may be a sign of a cardiovascular event. There have been reports of serious cardiovascular events including peripheral artery disease, coronary artery disease, and stroke in patients taking Tasigna. Your doctor should evaluate your lipid and blood sugar levels before starting treatment with Tasigna and during treatment.
• if you develop swelling of the feet or hands, generalized 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 Tasigna.

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

Children and adolescents

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

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

Other medicines and Tasigna

Tasigna may interact with other medications.

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

• antiarrhythmics – used to treat irregular heart rhythm;
• chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin‑medicines that may have an undesirable effect on the heart's electrical activity;
• ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat infections;
• ritonavir – a medication 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 asHypericum 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– medications that suppress the body's "auto‑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);
• astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, or ergot alkaloids (ergotamine, dihydroergotamine).

You should avoid using these medications during treatment with Tasigna. If you are taking any of these medications, your doctor may prescribe alternative medications.

If you are taking statins (a type of medication that lowers cholesterol in the blood), talk to your doctor or pharmacist. If you use Tasigna 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 Tasigna if you are taking any antacids, which are medications for stomach acid. These medications should be taken separately from Tasigna:

• H2 blockers, which reduce stomach acid production. H2 blockers should be taken approximately 10 hours before and approximately 2 hours after taking Tasigna;
• antacids such as those containing aluminum hydroxide, magnesium hydroxide, and simethicone, which neutralize high stomach acidity. These antacids should be taken approximately 2 hours before or approximately 2 hours after taking Tasigna.

You should also inform your doctorif you are already taking Tasignaand are prescribed a new medication that you have not taken before during treatment with Tasigna.

Taking Tasigna with food and drinks

Do not take Tasigna with meals.The food may increase the absorption of Tasigna and therefore increase the amount of Tasigna in the blood, possibly to a dangerous level. Do not drink grapefruit juice or eat grapefruit. It may increase the amount of Tasigna in the blood, probably to a dangerous level.

Pregnancy and breastfeeding

• Tasigna is not recommended during pregnancyunless 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 medication during pregnancy.
• Women who may become pregnantshould use very effective contraception during treatment and for two weeks after stopping treatment.
• Breastfeeding is not recommendedduring treatment with Tasigna 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 medication.

Driving and operating 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 medication, you should avoid these activities until the effect has disappeared.

Tasigna contains lactose

This medication contains lactose (also known as milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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 Tasigna to take

Use in adults

• Patients with newly diagnosed LMC:The recommended dose is 600mg per day. The dose is achieved by taking two hard capsules of 150mg, twice a day.
• Patients with LMC who did not benefit from their previous treatment:The recommended dose is 800mg per day. This dose is achieved by taking two capsules of 200mg 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 Tasigna capsules to give to your child. The total daily dose given to your child should not exceed 800mg.

Your doctor may prescribe a lower dose depending on how you respond to treatment.

Patients aged 65years or older

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

When to take Tasigna

Take the hard capsules:

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

Consult your doctor or pharmacist if you have any doubts about when to take this medication. Taking Tasigna every day at the same time will help you remember when to take the hard capsules.

How to take Tasigna

• Swallow the hard capsules whole with water.
• Do not take any food with the hard capsules.
• Do not open the hard capsules except if you cannot swallow them. In this case, you can sprinkle the contents of each hard capsule ononeteaspoon of apple sauce and take it immediately. Do not use more than one teaspoon of apple sauce for each hard capsule and do not use any other food apart from apple sauce.

For how long to take Tasigna

Take Tasigna every day for the time your doctor tells you. 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 stopping your treatment with Tasigna based on specific criteria.

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

If you take more Tasigna than you should

If you have taken more Tasigna 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 Tasigna

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

If you interrupt treatment with Tasigna

Do not stop treatment with this medication unless your doctor tells you to. Stopping treatment with Tasigna 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 stopping treatment with Tasigna.

If your doctor recommends stopping treatment with Tasigna

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

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 heartbeats), 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, ulcers on the legs or arms that heal slowly or not at all, and notable changes in color (blue or pale) or temperature (cold) in the legs, arms, affected fingers, or hands
• Subclinical hypothyroidism signs: weight gain, fatigue, hair loss, muscle weakness, feeling 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 volume, 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
• Reactivation of hepatitis B infection signs
• Ocular disorder signs: visual disturbances including 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, or swelling of the eyelids
• 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 10 patients)(may affect more than 1 in 10 patients)

-diarrhea

• headache
• lack of energy
• muscle pain
• itching, rash
• nausea
• constipation
• vomiting
• hair loss

• limb, bone, or back pain when stopping Tasigna treatment
• delayed growth in children and adolescents
• upper respiratory tract infection, including sore throat and nasal 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 (liver function)
• high levels of alanine aminotransferases in the blood (liver enzymes)

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

• neumonia
• abdominal pain, stomach discomfort after meals, flatulence, abdominal swelling
• bone pain, 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
• nasal bleeding
• gout signs: joint pain and swelling
• erectile dysfunction
• flu-like symptoms
• sore throat
• bronchitis
• ear pain, hearing ringing in the ears (tinnitus)
• hemorrhoids
• heavy 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, ulcers on the legs or arms that heal slowly or not at all, and notable changes in color (blue or pale) or temperature (cold) in the legs or arms (possible signs of peripheral artery obstruction)
• shortness of breath (also called dyspnea)
• mouth sores with inflammation of the gums (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 in the blood (liver enzymes)
• high levels of gamma-glutamyltransferases 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 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 patients)(may affect up to 1 in 100 patients)

• allergy (hypersensitivity to Tasigna)
• dry mouth
• breast pain
• side pain or discomfort
• increased appetite
• gynecomastia in men
• 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
• inflammation of the stomach lining signs: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
• memory loss
• skin cyst, skin thinning or thickening, skin thickening, skin discoloration
• psoriasis signs: thickened, red, or silvery patches on the skin
• increased skin sensitivity to light
• hearing difficulty
• joint inflammation
• urinary incontinence
• inflammation of the intestine (also called enterocolitis)
• anal abscess
• breast swelling
• restless leg syndrome signs: irresistible 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)
• skin warts
• increased eosinophils (a type of white blood cell)
• lymphopenia signs: 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)
• low blood sugar signs: nausea, sweating, weakness, dizziness, tremors, headache
• dehydration
• abnormal fat levels in the blood
• involuntary movements (also called tremor)
• difficulty concentrating
• unpleasant and abnormal sensation when touching (also called dysesthesia)
• fatigue (also called tiredness)
• numbness or tingling in the fingers of the hands or 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
• heart attack signs (also called myocardial infarction): sudden and oppressive chest pain, fatigue, irregular heartbeat
• heart murmur signs: fatigue, chest pain, dizziness, pain, palpitations
• foot fungal infection
• heart failure signs: shortness of breath, difficulty breathing when lying down, swelling of the feet or legs
• pain behind the sternum (also called pericarditis)
• hypertensive crisis signs: intense headache, dizziness, nausea
• leg pain and weakness caused by walking (also called intermittent claudication)
• peripheral artery obstruction signs: 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
• bruises (when you haven't been injured)
• deposits of fat in the arteries that can cause obstruction (also called arteriosclerosis)
• low blood pressure signs: dizziness, dizziness, or fainting
• pulmonary edema signs: shortness of breath
• pleural effusion signs: accumulation of fluid between the layers of tissue that surround the lungs and the chest cavity (which, if severe, can decrease the heart's ability to pump blood), chest pain, cough, hiccups, rapid breathing
• pulmonary interstitial disease signs: cough, difficulty breathing, chest pain
• pleurisy signs: cough, painful breathing
• hoarse voice
• pulmonary hypertension signs: high blood pressure in the arteries of the lungs
• wheezing
• tooth sensitivity
• inflammation signs (also called gingivitis): bleeding gums, sensitive or swollen gums
• high levels of urea in the blood (renal function)
• change 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 1,000 patients)(may affect up to 1 in 1,000 patients)

• hand-foot syndrome signs: redness, swelling, and possible peeling of the palms of the hands and soles of the feet
• mouth warts
• sensation of breast hardness or stiffness
• thyroiditis signs: inflammation of the thyroid gland
• altered mood or depression
• secondary hyperparathyroidism signs: bone and joint pain, excessive urination, abdominal pain, weakness, fatigue
• peripheral artery occlusion signs: loss of vision in one or both eyes, double vision, dizziness (sensation of spinning), numbness or tingling, loss of coordination, dizziness, or confusion
• brain swelling (possible headache and/or changes in mental state)
• optic neuritis signs: blurry vision, loss of vision
• heart dysfunction signs (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):

• heart dysfunction signs (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 national notification system included in theAppendix V. 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, and on the blister after EXP. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C.
• Store in the original packaging to protect it from moisture.
• Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.
• Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Tasigna

• The active ingredient is nilotinib.

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

The other components are:

Hard capsule content: lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.

Hard capsule coating: gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

Printing ink: shellac (E904), iron oxide black (E172), propylene glycol, and ammonium hydroxide.

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

The other components are:

Hard capsule content: lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.

Hard capsule coating: gelatin, titanium dioxide (E171), iron oxide red and yellow (E172).

Printing ink: shellac (E904), iron oxide black (E172), n-butanol, propylene glycol, anhydrous ethanol, isopropanol, and ammonium hydroxide.

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

The other components are:

Hard capsule content: lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.

Hard capsule coating: gelatin, titanium dioxide (E171), iron oxide yellow (E172).

Printing ink: shellac (E904), anhydrous ethanol, isopropanol, butanol, propylene glycol, strong ammonia solution, potassium hydroxide, and iron oxide red (E172).

Appearance of Tasigna and packaging contents

Tasigna 50 mg is presented as hard capsules. The hard capsules are red and yellowish in color. Each hard capsule has a black imprint (‘NVR/ABL’).

Tasigna 150 mg is presented as hard capsules. The hard capsules are red in color. Each hard capsule has a black imprint (‘NVR/BCR’).

Tasigna 200 mg is presented as hard capsules. The hard capsules are yellowish in color. Each hard capsule has a red imprint (‘NVR/TKI’).

Tasigna 50 mg is available in packs containing 120 hard capsules (3 packs of 40 hard capsules).

Tasigna 150 mg is available in packs containing 28 or 40 hard capsules and in multiple packs of 112 hard capsules (containing 4 boxes, each containing 28 hard capsules), 120 hard capsules (containing 3 boxes, each containing 40 hard capsules), or 392 hard capsules (containing 14 boxes, each containing 28 hard capsules).

Tasigna 200 mg is available in a box containing 28 hard capsules and in a pack containing 28 or 40 hard capsules. Tasigna is also available in multiple packs of 112 hard capsules (containing 4 boxes, each containing 28 hard capsules), 112 hard capsules (containing 4 boxes, each containing 28 hard capsules), 120 hard capsules (containing 3 boxes of 40 hard capsules), or 392 hard capsules (containing 14 boxes of 28 hard capsules).

Only some pack sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Irlanda

Responsible Person

Novartis Pharmaceutical Manufacturing LLC

Verovškova ulica 57

1000 Ljubljana

Eslovenia

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

España

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Alemania

Lek d.d., PE PROIZVODNJA LENDAVA

Trimlini 2D

Lendava, 9220

Eslovenia

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Alemania

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/. There are also links to other websites on rare diseases and orphan medicinal products.