Tasigna 200 mg hard capsules

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Tasigna 50 mg, 150 mg and 200 mg hard capsules

nilotinib

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Tasigna is and what it is used for

What Tasigna is

Tasigna is a medicine that contains an active substance called nilotinib.

What Tasigna is used for

Tasigna is used to treat a type of leukemia called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). CML is a blood cancer that causes the body to produce an excessive number 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 prior therapy, including imatinib. It is also used in adult and pediatric patients who have experienced severe adverse reactions to prior therapy and who are unable to continue taking 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 thereby interrupts the production of these cells.

Monitoring during treatment with Tasigna

During treatment, regular monitoring will be performed, including blood tests. These tests will monitor:

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

Your heart rate will also be monitored using a machine that measures the heart's electrical activity (a test called an "ECG").

Your doctor will regularly evaluate your treatment and decide whether you should continue taking Tasigna. If your doctor advises you to stop taking this medicine, 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 why you or your child has been prescribed this medicine, please consult your doctor.

2. What you need to know before taking Tasigna

Carefully follow all instructions from your doctor, even if they differ from the general information contained in this leaflet.

Do not take Tasigna

• 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 Tasigna.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Tasigna:

• 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 disease such as high blood pressure (hypertension), diabetes, or problems with fat levels 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 being treated with medications that lower blood cholesterol (statins), affect heart rhythm (antiarrhythmics), or affect the liver (see Use of Tasigna with other medicines).
• if you have low levels of potassium or magnesium.
• if you have liver or pancreatic disorders.
• if you experience symptoms such as easy bruising, feeling tired, shortness of breath, or have had repeated infections.
• if you have had surgery involving complete removal of the stomach (total gastrectomy).
• if you have ever had, or may currently have, hepatitis B virus infection. This is because Tasigna could cause hepatitis B to become active again, which may be fatal in some cases. Your doctor should carefully check for signs of this infection before starting treatment.

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

During treatment with Tasigna

• if you faint (lose consciousness) or experience irregular heartbeat 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 lead to sudden death. Rare cases of sudden death have been reported in patients taking Tasigna.
• if you develop sudden heart palpitations, severe muscle weakness or paralysis, seizures, or sudden changes in behavior or alertness, inform your doctor immediately, as this may be a sign of rapid breakdown of cancer cells known as tumor lysis syndrome. Rare cases of tumor lysis syndrome have been reported in patients treated with Tasigna.
• if you develop chest pain or discomfort, numbness or weakness, difficulty walking or speaking, pain, discoloration, or cold sensation in a limb, inform your doctor immediately, as this may be a sign of a cardiovascular event. Serious cardiovascular events including problems with blood flow to the leg (peripheral arterial occlusive disease), ischemic heart disease, and impaired blood supply to the brain (cerebrovascular ischemia) have been reported in patients taking Tasigna. Your doctor should monitor your blood fat (lipid) and blood sugar levels before starting Tasigna and during treatment.
• if you develop swelling in your hands or feet, generalized swelling, or rapid weight gain, inform your doctor, as these may be signs of severe fluid retention. Uncommon cases of severe fluid retention have been reported in patients treated with Tasigna.

If you are the parent of a child receiving Tasigna, inform the doctor if any of the conditions described above occur in your child.

Children and adolescents

Tasigna is used to treat children and adolescents with CML. There is no experience with this medicine in children under 2 years of age. There is no experience in children under 10 years of age with newly diagnosed disease, and limited experience in children under 6 years of age who did not benefit from prior treatment for CML, including imatinib.

Some children and adolescents receiving Tasigna may have slower than normal growth. Your doctor will monitor growth during regular visits.

Other medicines and Tasigna

Tasigna may interact with certain medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. These include, in particular:

• antiarrhythmics – used to treat irregular heartbeat;
• 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 medicine from the "protease inhibitor" group 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 for pain treatment and as sedatives before or during surgery or medical procedures;
• cyclosporine, sirolimus, and tacrolimus – medicines that suppress the body’s "self-defense" ability and fight infections, often used to prevent rejection of transplanted organs such as liver, heart, or kidney;
• dihydroergotamine and ergotamine – used to treat dementia;
• lovastatin, simvastatin – used to treat high blood fat levels;
• warfarin – used to treat clotting disorders (such as blood clots or thrombosis);
• astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, or ergot alkaloids (ergotamine, dihydroergotamine).

The use of these medicines should be avoided during treatment with Tasigna. If you are taking any of these drugs, your doctor may prescribe alternative medicines.

If you are taking statins (a type of medicine that lowers blood cholesterol), talk to your doctor or pharmacist. Taking Tasigna with certain statins may increase the risk of muscle-related problems associated with statins, which in rare cases can lead to severe muscle breakdown (rhabdomyolysis) that may result in kidney damage.

Additionally, inform your doctor or pharmacist before taking Tasigna if you are taking any antacids, which are medicines for stomach acidity. These medicines should be taken separately from Tasigna:

• H2 blockers, which reduce acid production in the stomach. H2 blockers should be taken approximately 10 hours before or approximately 2 hours after taking Tasigna;
• antacids such as those containing aluminium 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 doctor if you are already taking Tasigna and are prescribed a new medicine you have not taken before during treatment with Tasigna.

Taking Tasigna with food and drink

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

Pregnancy and breastfeeding

• Tasigna is not recommended during pregnancy unless clearly necessary. If you are pregnant or think you might be, inform your doctor, who will discuss with you whether you can take this medicine during pregnancy.
• Women who could become pregnant should use highly effective contraception during treatment and for at least two weeks after stopping treatment.
• Breastfeeding is not recommended during treatment with Tasigna and for the following 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 plan 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 operate tools or machines after taking this medicine, you should avoid these activities until the effect has passed.

Tasigna contains lactose

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

3. How to take Tasigna

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much Tasigna to take

Use in adults

• Patients with newly diagnosed CML: The recommended dose is 600 mg per day. This dose is achieved by taking two 150 mg hard capsules twice daily.
• Patients with CML who did not benefit from prior treatment: The recommended dose is 800 mg daily. This dose is achieved by taking two 200 mg hard capsules twice daily.

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 and will tell you which Tasigna capsules and how many to give your child. The total daily dose given to your child must not exceed 800 mg.

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

Elderly patients (65 years or older)

Tasigna may be used in patients aged 65 years or older at the same dose as other adults.

When to take Tasigna

Take the hard capsules:

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

Consult your doctor or pharmacist if you have any doubts about when to take this medicine. Taking Tasigna at the same time each day 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 unless you are unable to swallow them. In this case, you may sprinkle the contents of each hard capsule onto one teaspoon of apple sauce and take it immediately. Use no more than one teaspoon of apple sauce per hard capsule, and do not use any other food except apple sauce.

How long to take Tasigna

Take Tasigna every day for as long as your doctor tells you. This is a long-term treatment. Your doctor will monitor your condition 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 accidentally takes your hard capsules, contact a doctor or hospital immediately. Show the pack of capsules and this leaflet. You may require 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 hard capsule.

If you interrupt treatment with Tasigna

Do not interrupt treatment with this medicine unless instructed by your doctor. Interrupting treatment with Tasigna without medical advice puts you at risk of worsening of your disease, which could have fatal consequences. Be sure to discuss this with your doctor, nurse, and/or pharmacist if you are considering stopping treatment with Tasigna.

If your doctor recommends stopping treatment with Tasigna

Your doctor will regularly assess your treatment using a specific diagnostic test and will decide whether you should continue taking this medicine. If you are instructed to stop Tasigna, your doctor will continue to monitor your CML before, during, and after stopping Tasigna, and may, if necessary, instruct you to restart treatment with Tasigna.

If you have any further 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 everyone gets them. Most adverse reactions are mild to moderate and usually disappear after a few days or weeks of treatment.

Some adverse reactions may be serious.

• signs of musculoskeletal pain: joint and muscle pain
• signs of cardiac disorders: chest pain or discomfort, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (sensation of rapid heartbeat), fainting, bluish discoloration of the lips, tongue, or skin
• signs of arterial blockage: pain, discomfort, weakness, or cramps in the leg muscles, which may be due to reduced blood flow, leg ulcers or arms healing slowly or not healing, and noticeable changes in color (bluish or pale) or temperature (cold) in the legs, arms, toes, or fingers affected
• signs of underactive thyroid gland: weight gain, fatigue, hair loss, muscle weakness, feeling cold
• signs of overactive thyroid gland: rapid heartbeat, bulging eyes, weight loss, swelling in the front of the neck
• signs of kidney or urinary tract disorders: thirst, dry skin, irritability, darkening of urine, decreased urine volume, difficulty and pain when urinating, increased urgency to urinate, blood in urine, abnormal urine color
• signs of high blood sugar levels: excessive thirst, high urine volume, increased appetite with weight loss, fatigue
• signs of dizziness: dizziness or spinning sensation
• signs of pancreatitis: severe pain in the upper abdomen (middle or left side)
• signs of skin disorders: painful red lumps, skin pain, skin redness, skin peeling or blisters
• signs of fluid retention: rapid weight gain, swelling of hands, ankles, feet, or face
• signs of migraine: severe headache often accompanied by nausea, vomiting, and light sensitivity
• signs of blood disorders: fever, easy bruising or unexplained bleeding, severe or frequent infections, unexplained weakness
• signs of blood clot in a vein: swelling and pain in one part of the body
• signs of nervous system disorders: weakness or paralysis of limbs or face, difficulty speaking, severe headache, seeing, feeling, or hearing things that are not real, vision changes, loss of consciousness, confusion, disorientation, tremors, tingling, pain, or numbness in fingers or toes
• signs of lung disorders: difficulty breathing or pain when breathing, cough, wheezing with or without fever, swelling of feet or legs
• signs of gastrointestinal disorders: abdominal pain, nausea, vomiting blood, black or bloody stools, constipation, heartburn, stomach reflux, bloated abdomen
• signs of liver disorders: yellowing of skin and eyes, nausea, loss of appetite, darkening of urine
• signs of liver infection: recurrence (reactivation of hepatitis B infection)
• signs of eye disorders: vision disturbances including blurred vision, double vision or perceived flashes of light, reduced sharpness or loss of vision, blood in the eye, increased eye sensitivity to light, eye pain, redness, itching or irritation, dry eyes, swelling or itching of eyelids
• signs of electrolyte imbalance: nausea, difficulty breathing, irregular heartbeat, cloudy urine, fatigue and/or joint discomfort 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 experience any of the adverse effects described.

Some adverse reactions are very common (may affect more than 1 in 10 patients)

• diarrhea

• headache

• lack of energy

• muscle pain

• itching, rash

• nausea

• constipation

• vomiting

• hair loss

• pain in limbs, bone pain, and spinal pain upon discontinuation of Tasigna treatment

• slowed growth in children and adolescents

• upper respiratory tract infection, including sore throat and nasal discharge or congestion, sneezing

• low blood cell counts (red blood cells, platelets) or hemoglobin

• elevated lipase levels in blood (pancreatic function)

• elevated bilirubin levels in blood (liver function)

• elevated alanine aminotransferase levels in blood (liver enzymes)

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

• pneumonia
• abdominal pain, stomach discomfort after meals, flatulence, abdominal swelling
• bone pain, muscle spasms
• pain (including neck pain)
• dry skin, acne, reduced skin sensitivity
• weight gain or weight loss
• insomnia, depression, anxiety
• night sweats, excessive sweating
• general feeling of malaise
• nosebleeds
• signs of gout: joint pain and swelling
• inability to achieve or maintain an erection
• flu-like symptoms
• sore throat
• bronchitis
• ear pain, hearing noises (e.g., ringing, buzzing) not from an external source (also called tinnitus)
• hemorrhoids
• heavy menstrual periods
• itching in hair follicles
• oral or vaginal candidiasis
• signs of conjunctivitis: itchy eye discharge, 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 leg muscles, possibly due to reduced blood flow, leg or arm ulcers healing slowly or not healing, and noticeable changes in color (bluish or pale) or temperature (cold) in legs or arms (possible signs of blockage in an artery of the leg, arm, or affected toes or fingers)
• difficulty breathing (also called dyspnea)
• mouth sores with inflamed gums (also called stomatitis)
• elevated amylase levels in blood (pancreatic function)
• elevated creatinine levels in blood (kidney function)
• elevated alkaline phosphatase or creatine phosphokinase levels in blood
• elevated aspartate aminotransferase levels (liver enzymes) in blood
• elevated gamma-glutamyltransferase levels (liver enzymes) in blood
• signs of leukopenia or neutropenia: low white blood cell count
• increased platelet or white blood cell count in blood
• low blood levels of magnesium, potassium, sodium, calcium, or phosphorus
• increased blood levels of potassium, calcium, or phosphorus
• elevated blood fat levels (including cholesterol)
• elevated blood uric acid levels

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

• allergy (hypersensitivity to Tasigna)
• dry mouth
• breast pain
• pain or discomfort in the side
• increased appetite
• breast enlargement in men
• herpes virus infection
• stiffness of muscles and joints, joint swelling
• sensation of temperature change in the body (including feeling hot or 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, skin thinning or thickening, thickening of the outermost skin layer, skin discoloration
• signs of psoriasis: thickened red/silvery skin patches
• increased skin sensitivity to light
• hearing difficulty
• joint inflammation
• urinary incontinence
• intestinal inflammation (also called enterocolitis)
• anal abscess
• swelling of the nipple
• symptoms of restless legs syndrome (an irresistible urge to move a body part, usually the leg, accompanied by uncomfortable sensations)
• signs of sepsis: fever, chest pain, increased heart rate, difficulty breathing or rapid breathing
• skin infection (subcutaneous abscess)
• skin wart
• increase in a specific type of white blood cell (called eosinophils)
• signs of lymphopenia: low white blood cell count
• elevated parathyroid hormone levels in blood (a hormone regulating calcium and phosphorus levels)
• elevated lactate dehydrogenase levels in blood (an enzyme)
• signs of low blood sugar: nausea, sweating, weakness, dizziness, tremors, headache
• dehydration
• abnormal blood fat levels
• involuntary movements (also called tremor)
• difficulty concentrating
• unpleasant or abnormal sensation upon touch (also called dysesthesia)
• fatigue (also called tiredness)
• numbness or tingling in fingers or toes (also called peripheral neuropathy)
• facial muscle paralysis
• 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, crushing chest pain, fatigue, irregular heartbeat
• signs of heart murmur: fatigue, chest discomfort, dizziness, chest pain, palpitations
• fungal foot infection
• signs of heart failure: dyspnea, difficulty breathing when lying down, swelling of feet or legs
• pain behind the breastbone (also called pericarditis)
• signs of hypertensive crisis: severe headache, dizziness, nausea
• leg pain and weakness caused by walking (also called intermittent claudication)
• signs of arterial occlusion in limbs: possible high blood pressure, painful cramps in one or both hips, thighs, or calf muscles after certain activities like walking or climbing stairs, numbness or weakness in legs
• bruising (when not injured)
• fat deposits in arteries that may cause blockage (also called arteriosclerosis)
• signs of low blood pressure (also called hypotension): lightheadedness, dizziness, or fainting
• signs of pulmonary edema: dyspnea
• signs of pleural effusion: fluid accumulation between the layers of tissue lining the lungs and chest cavity (which, if severe, may reduce the heart's ability to pump blood), chest pain, cough, hiccups, rapid breathing
• signs of interstitial lung disease: cough, difficulty breathing, painful breathing
• signs of pleural pain: chest pain
• signs of pleurisy: cough, painful breathing
• hoarseness
• signs of pulmonary hypertension: high blood pressure in the lung arteries
• wheezing
• tooth sensitivity
• signs of gum inflammation (also called gingivitis): bleeding gums, tender or enlarged gums
• elevated blood urea levels (kidney function)
• changes in blood proteins (low globulin levels or presence of paraprotein)
• elevated unconjugated bilirubin levels in blood
• elevated troponin levels in 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 soles of the feet (called hand-foot syndrome)
• mouth warts
• sensation of hardness or stiffness in the breasts
• inflammation of the thyroid gland (also called thyroiditis)
• mood changes or depression
• signs of secondary hyperparathyroidism: bone and joint pain, excessive urination, abdominal pain, weakness, fatigue
• signs of brain artery blockage: loss of vision in part or all of both eyes, double vision, vertigo (spinning sensation), 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, vision loss
• signs of cardiac dysfunction (reduced ejection fraction): fatigue, chest discomfort, dizziness, pain, palpitations
• low or high insulin levels in blood (a hormone regulating blood sugar levels)
• low C-peptide insulin levels in blood (pancreatic function)
• sudden death

The following adverse reactions have been reported at an unknown frequency (cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tasigna

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer packaging after EXP and on the blister after EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 30 °C.
• Store in the original packaging to protect from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tasigna

• The active substance is nilotinib.

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

The other components are:

Capsule contents: lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.

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

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

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

The other components are:

Capsule contents: lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.

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

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

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

The other components are:

Capsule contents: lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.

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

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

Appearance of Tasigna and contents of the pack

Tasigna 50 mg is presented as hard capsules. The hard capsules are red and light yellow in colour. Each hard capsule has a black print («NVR/ABL»).

Tasigna 150 mg is presented as hard capsules. The hard capsules are red in colour. Each hard capsule has a black print («NVR/BCR»).

Tasigna 200 mg is presented as hard capsules. The hard capsules are light yellow in colour. Each hard capsule has a red print («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 packs, each with 28 hard capsules), 120 hard capsules (containing 3 packs, each with 40 hard capsules) or 392 hard capsules (containing 14 packs, each with 28 hard capsules).

Tasigna 200 mg is available in a carton containing 28 hard capsules and in a box containing 28 or 40 hard capsules. Tasigna is also available in multiple packs of 112 hard capsules (containing 4 cartons, each with 28 hard capsules), 112 hard capsules (containing 4 boxes, each with 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 certain pack sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer responsible for manufacturing

Novartis Pharmaceutical Manufacturing LLC

Verovškova ulica 57

1000 Ljubljana

Slovenia

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Lek d.d., PE PROIZVODNJA LENDAVA

Trimlini 2D

Lendava, 9220

Slovenia

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

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

Belgium/Belgium/Belgium Novartis Pharma N.V. Tel/Tel: +32 2 246 16 11	Lithuania SIA Novartis Baltics Lithuania branch Tel: +370 5 269 16 50
Bulgaria Novartis Bulgaria EOOD Tel.: +359 2 489 98 28	Luxembourg/Luxembourg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11
Czech Republic Novartis s.r.o. Tel: +420 225 775 111	Hungary Novartis Hungária Kft. Tel.: +36 1 457 65 00
Denmark Novartis Healthcare A/S Tlf: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Germany Novartis Pharma GmbH Tel: +49 911 273 0	Netherlands Novartis Pharma B.V. Tel: +31 88 04 52 111
Estonia SIA Novartis Baltics Estonia branch Tel: +372 66 30 810	Norway Novartis Norge AS Tlf: +47 23 05 20 00
Greece Novartis (Hellas) S.A. Tel: +30 210 281 17 12	Austria Novartis Pharma GmbH Tel: +43 1 86 6570
Spain Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00	Poland Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00	Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Croatia Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	Romania Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55	Slovenia Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Iceland Vistor hf. Tel: +354 535 7000	Slovakia Novartis Slovakia s.r.o. Tel: +421 2 5542 5439
Italy Novartis Farma S.p.A. Tel: +39 02 96 54 1	Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
Cyprus Novartis Pharma Services Inc. Tel: +357 22 690 690	Sweden Novartis Sverige AB Tel: +46 8 732 32 00
Latvia SIA Novartis Baltics Tel: +371 67 887 070

Date of the latest revision of this leaflet:

Other sources of information

Detailed information on this medicine 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.