TASIGNA 200 mg Hard Capsule

Зміст інструкції

1. Tasigna 50 mg, 150 mg and 200 mg hard capsules
   1. What is Tasigna and what is it 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. Package contents and other information

Tasigna 50 mg, 150 mg and 200 mg hard capsules

nilotinib

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Tasigna is and what it is used for
• 2. What you need to know before you take 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 is Tasigna and what is it used for

What is Tasigna
Tasigna is a medicine containing an active substance called nilotinib.

What is Tasigna used for
Tasigna is used for the treatment of a type of leukemia called chronic myeloid leukemia
Philadelphia chromosome positive (Ph+ CML). CML is a cancer of the blood that causes the
body to produce too many 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 treatments including imatinib. It is also used in
adult and pediatric patients who have experienced serious side effects following previous
treatments and are no longer able to continue taking them.

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

Monitoring during treatment with Tasigna
During treatment, regular checks will be performed, including blood tests. These tests will allow to check:

• the amount of blood cells (white blood cells, red blood cells and platelets) to see how Tasigna is tolerated.
• the function of the pancreas and liver to check how Tasigna is tolerated
• the electrolytes in the body (potassium, magnesium). These electrolytes are important for the functioning of the heart.
• the level of sugar and fats in the blood. The heart rate will also be checked using an instrument that measures the electrical activity of the heart (an examination called “ECG”).

The doctor will regularly evaluate the treatment and decide if you should continue to take Tasigna.
If you are told to stop this medicine, the doctor will continue to monitor the CML and may
tell you to resume Tasigna if your condition indicates that this is necessary.
If you have any questions about how Tasigna works or why it has been prescribed for you or for your child, please
ask your doctor.

2. What you need to know before taking Tasigna

Follow all of your doctor's instructions carefully. These instructions may be different from the

Do not take Tasigna

• if you are allergic to nilotinib or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, tell your doctor before takingTasigna.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tasigna:

• if you have had previous cardiovascular events such as a heart attack, chest pain (angina), problems with blood flow to the brain (stroke) or problems with blood flow to the leg (claudication) or if you have risk factors for cardiovascular disease such as high blood pressure (hypertension), diabetes or problems with blood fat levels (dyslipidemias).
• if you have heart problems, such as an abnormal electrical signal called “QT prolongation”.
• if you are taking medicinesthat lower your blood cholesterol or affect your heart rhythm (antiarrhythmics) or your liver (see Other medicines and Tasigna).
• if you suffer from low potassium or magnesium levels.
• if you have liver or pancreas problems.
• if you have symptoms such as a tendency to bruise, feeling tired or short of breath or have had repeated infections.
• if you have had surgery that involved the removal of your entire stomach (total gastrectomy).
• if you have ever had or may have an hepatitis B infection. This is because Tasigna can cause hepatitis B to reactivate, which can be fatal in some cases. Patients will be carefully examined by the doctor for signs of this infection before starting treatment. If any of these conditions apply to you or your child, tell your doctor.

During treatment with Tasigna

• if you faint (loss of consciousness) or have an irregular heartbeat during treatment with this medicine, tell your doctor immediatelyas this may be a sign of a serious heart condition. QT prolongation or an irregular heartbeat can lead to sudden death. Uncommon cases of sudden death have been reported in patients treated with Tasigna.
• if you have sudden palpitations, severe muscle weakness or paralysis, seizures or sudden changes in thinking or level of consciousness, tell your doctor immediatelyas this may be a sign of a rapid breakdown of cancer cells called tumor lysis syndrome. Rare cases of tumor lysis syndrome have been reported in patients treated with Tasigna.
• if you experience chest pain or discomfort, numbness or weakness, problems walking or speaking, pain, color change or coldness in a limb, tell your doctor immediatelyas this may be a sign of a cardiovascular event. Serious cardiovascular events, including problems with blood flow to the leg (obstructive peripheral arterial disease), ischemic heart disease and problems with blood flow to the brain (ischemic cerebrovascular disease) have been reported in patients treated with Tasigna. The doctor should check your fat (lipid) and blood sugar levels before starting treatment with Tasigna and during treatment.
• if you experience swelling of your feet or hands, generalized swelling or rapid weight gain, tell 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 who is being treated with Tasigna, tell the doctor if any of the above conditions apply to them.

Children and adolescents
Tasigna is a treatment for children and adolescents with CML. There is no experience with the use of this
medicine in children under 2 years of age. There is no experience with the use of Tasigna in children
newly diagnosed and under 10 years of age and there is limited experience in patients under
6 years of age who no longer benefit from previous treatment for CML.
Some children and adolescents taking Tasigna may experience slower than normal growth. The doctor will monitor growth with regular visits.

Other medicines and Tasigna
Tasigna can interact with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes in particular:

• antiarrhythmics - used to treat irregular heartbeat;
• chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin - medicines that can have an undesirable effect on the electrical activity of the heart;
• ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin - used to treat infections;
• ritonavir - a medicine in the “protease inhibitor” class 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 for anxiety relief before surgery;
• alfentanil and fentanyl - used to treat pain and as sedatives before or during surgery or medical procedures;
• cyclosporine, sirolimus and tacrolimus - drugs that suppress the body's “defense” capabilities and fight infections and are commonly used to prevent rejection of transplanted organs, such as liver, heart and kidneys;
• 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).

These medicines must be avoided during treatment with Tasigna. If you are taking any
of these medicines, your doctor may prescribe other medicines as an alternative.
If you are taking a statin (a medicine that lowers your cholesterol), talk to
your doctor or pharmacist. When taken with certain statins, Tasigna may increase the risk of muscle problems related to statins, which in rare cases can lead to severe muscle injury
(rhabdomyolysis) with subsequent kidney damage.
Also, tell your doctor or pharmacist before taking Tasigna if you are taking any
antacid, that is, a medicine for heartburn. These medicines should be taken separately from Tasigna:

• H2 blockers, which decrease acid production in the stomach. H2 blockers should be taken about 10 hours before and about 2 hours after taking Tasigna;
• antacids containing aluminum hydroxide, magnesium hydroxide and simethicone, which neutralize high acidity in the stomach. These antacids should be taken about 2 hours before or about 2 hours after taking Tasigna.

You should also tell your doctor if you are already takingTasignaand you have been prescribed a new
medicine that you were not taking before during treatment with Tasigna.

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

Pregnancy and breastfeeding

• Tasigna is not recommended during pregnancyunless strictly necessary.If you are pregnant or think you may be, tell your doctor who will discuss with you whether you can take this medicine during pregnancy.
• Women who can become pregnantare advised to use a very effective method of contraception during treatment and for two weeks after the end of treatment.
• Breastfeeding is not recommendedduring treatment with Tasigna and for two weeks after the last dose. Tell your doctor if you are breastfeeding. If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
If you experience side effects (such as dizziness or vision problems) with a potential impact on
your ability to drive safely vehicles or use tools or machinery after taking
this medicine, you should stop these activities until the effect has disappeared.

Tasigna contains lactose
This medicine contains lactose (also known as milk sugar). If your doctor has
diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take Tasigna

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

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 a day.
• Patients who no longer benefit from previous treatment for CML: The recommended dose is 800 mg per day. This dose is achieved by taking two 200 mg hard capsules twice a day.

Use in children and adolescents

• The dose given to your child will depend on the child's weight and height. The doctor will calculate the correct dose to use and tell you which and how many Tasigna capsules to give to your child. The total daily dose to be given to your child must not exceed 800 mg.

The doctor may prescribe a lower dosage depending on how you respond to treatment.

Elderly people (65 years and over)
Tasigna can be used by people 65 years and over at the same dose as for other adults.

When to take Tasigna
Take the hard capsules:

• twice a day (approximately every 12 hours);
• at least 2 hours after any food;
• then wait 1 hour before eating again. If you have questions about when to take this medicine, talk to your doctor or pharmacist. 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 food together with the hard capsules.
• Do not open the hard capsules unless you are unable to swallow them. In this case, you can sprinkle the contents of each hard capsule into oneteaspoonful of applesauce and take it immediately. Do not use more than one teaspoonful of applesauce per hard capsule and do not use any other food besides applesauce.

How long to take Tasigna
Continue to take Tasigna every day for as long as it has been prescribed for you by your doctor.
This is a long-term treatment. The doctor will regularly check your condition to
verify that the treatment is having the desired effect.
The doctor may consider stopping treatment with Tasigna based on specific criteria.
If you have questions about how long to take Tasigna, talk to your doctor.

If you take more Tasigna than you should
If you have taken more Tasigna than you should, or if someone else has accidentally taken your capsules
hard capsules, contact a doctor or hospital immediately for advice. Show them the packaging of the

If you forget to take Tasigna
If you forget to take a dose, take the next dose as scheduled. Do not take a
double dose to make up for the forgotten hard capsule.

If you stop taking Tasigna
Do not stop treatment with this medicine unless your doctor tells you to do so.
Stopping Tasigna without your doctor's recommendation puts you at risk of worsening
of the disease which may have life-threatening consequences. Make sure you discuss with your doctor,
nurse, and/or pharmacist if you are considering stopping Tasigna.

If your doctor recommends stopping treatment with Tasigna
The doctor will regularly assess the treatment with a specific diagnostic test and decide whether you should
continue to take this medicine. If you are told to stop Tasigna, the doctor
will continue to carefully monitor the CML before, during and after stopping Tasigna and may
tell you to restart Tasigna if your condition indicates that this is necessary.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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 period of treatment between a few days and a few weeks.

Some side effects can be serious.

• signs of musculoskeletal pain: joint and muscle pain
• signs of heart disorders: chest pain or discomfort, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (feeling of rapid heartbeat) fainting, bluish discoloration of the lips, tongue or skin
• signs of artery blockage: pain, discomfort, weakness or cramps in the leg muscles, which may be due to reduced blood flow, ulcers on the legs or arms that do not heal or heal slowly and obvious changes in color (bluish or paleness) or temperature (coldness) of the affected leg, arm, toes or hands
• signs of thyroid gland underactivity: weight gain, fatigue, hair loss, muscle weakness, feeling cold
• signs of thyroid gland overactivity: fast heartbeat, bulging eyes, weight loss, swelling in the front of the neck
• signs of kidney or urinary tract disorders: thirst, dry skin, irritability, dark urine, decreased amount of urine, difficulty and pain when urinating, urgent need to urinate, blood in the urine, abnormal urine color
• signs of a high level of sugar in the blood: excessive thirst, increased amount of urine, increased appetite with weight loss, fatigue
• signs of dizziness: dizziness or a spinning sensation
• signs of pancreatitis: severe upper abdominal pain (in the center or on the left)
• signs of skin disorders: painful red nodules, skin pain, skin redness, scaling or blisters
• signs of fluid retention: rapid weight gain, swelling of the hands, ankles, feet or face
• signs of migraine: severe headache often accompanied by nausea, vomiting and sensitivity to light
• signs of blood disorders: fever, tendency to bruise or unexplained bleeding, serious or frequent infections, unexplained weakness
• signs of venous thrombosis: swelling and pain in a part of the body
• signs of nervous system disorders: weakness or paralysis of the limbs or face, difficulty speaking, severe headache, seeing, hearing, or sensing things that are not there, changes in vision, loss of consciousness, confusion, disorientation, tremors, tingling, pain or numbness in the fingers of the hands and feet
• signs of lung disorders: difficulty breathing or painful breathing, cough, wheezing with or without fever, swelling of the feet or legs
• signs of gastrointestinal disorders: abdominal pain, nausea, vomiting blood, black or bloody stools, constipation, heartburn, acid reflux, bloated abdomen
• signs of liver disorders: yellowing of the skin and eyes, nausea, loss of appetite, dark urine
• signs of liver infection: recurrence (reactivation of hepatitis B infection)
• signs of eye disorders: vision disturbances including blurred vision, double vision or perception of flashes of light, decreased visual acuity or vision loss, blood in the eye, increased sensitivity of the eyes to light, eye pain, redness, itching or irritation, dry eyes, swelling or itching of the eyelids
• signs of electrolyte imbalance: nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and/or joint disorders associated with abnormal blood test results (such as high levels of potassium, uric acid and phosphorus and low levels of calcium) Contact your doctor immediately if you notice any of the above side effects.

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

• diarrhea
• headache
• lack of energy
• muscle pain
• itching, rash
• nausea
• constipation
• vomiting
• hair loss
• pain in the limbs, bone pain and spinal pain after stopping treatment with Tasigna
• slowed growth in children and adolescents
• upper respiratory tract infection including sore throat and runny or stuffy nose, sneezing
• low level of blood cells (red blood cells, platelets) or hemoglobin
• high level of lipase in the blood (pancreas function)
• high level of bilirubin in the blood (liver function)
• high level of alanine aminotransferase in the blood (liver enzymes)

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

• pneumonia
• abdominal pain, stomach discomfort after meals, gas, bloating or abdominal distension
• bone pains, muscle spasms
• pain (including neck pain)
• dry skin, acne, decreased skin sensitivity
• weight loss or gain
• insomnia, depression, anxiety
• night sweats, excessive sweating
• general feeling of being unwell
• nosebleeds
• signs of gout: painful and swollen joints
• inability to achieve or maintain an erection
• flu-like symptoms
• sore throat
• bronchitis
• ear pain, hearing noises (e.g. ringing, buzzing) in the ears that have no external source (also called tinnitus)
• hemorrhoids
• heavy menstrual bleeding
• itching of hair follicles
• oral or vaginal candidiasis
• signs of conjunctivitis: eye discharge with itching, redness and swelling
• eye irritation, red eyes
• signs of hypertension: high blood pressure, headache, dizziness
• flushing
• signs of occlusive peripheral artery disease: pain, discomfort, weakness or cramps in the leg muscles, which may be due to reduced blood flow, ulcers on the legs or arms that do not heal or heal slowly and obvious changes in color (bluish or paleness) or temperature (coldness) of the legs or arms (possible signs of blockage of an artery in the leg, arm, toes or hands)
• shortness of breath (also called dyspnea)
• mouth ulcers with inflammation of the gums (also called stomatitis)
• high level of amylase in the blood (pancreas function)
• high level of creatinine in the blood (kidney function)
• high level of alkaline phosphatase or creatine phosphokinase in the blood
• high level of aspartate aminotransferase in the blood (liver enzymes)
• high level of gamma-glutamyl transferase in the blood (liver enzymes)
• signs of leukopenia or neutropenia: low level of white blood cells
• increased number of platelets or white blood cells in the blood
• low levels in the blood of magnesium, potassium, sodium, calcium or phosphorus
• increased level of potassium, calcium and phosphorus in the blood
• high level of fats (including cholesterol) in the blood
• high level of uric acid in the blood

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

• allergy (hypersensitivity to Tasigna)
• dry mouth
• breast pain
• pain or discomfort in the side
• increased appetite
• enlargement of the breast gland in men
• herpes virus infection
• stiffness of muscles and joints, swelling of the joints
• feeling of change in body temperature (including feeling hot, feeling cold)
• taste disorder
• frequent urge to urinate
• signs of inflammation of the stomach lining: abdominal pain, nausea, vomiting, diarrhea, abdominal distension
• memory loss
• skin cysts, thinning or thickening of the skin, thickening of the outermost layer of the skin, change in skin color
• signs of psoriasis: thickened areas of red/silver skin
• increased skin sensitivity to light
• difficulty hearing
• joint inflammation
• urinary incontinence
• inflammation of the intestine (also called enterocolitis)
• anal abscess
• nipple swelling
• symptoms of restless legs syndrome (an irresistible urge to move a part of the body, usually the legs, associated with uncomfortable sensations)
• signs of sepsis: fever, chest pain, rapid/increased heart rate, shortness of breath or rapid breathing
• skin infection (subcutaneous abscess)
• skin wart
• increase in specific types of white blood cells (called eosinophils) in the blood
• signs of lymphopenia: low level of white blood cells
• high level of parathyroid hormone in the blood (a hormone that regulates calcium and phosphorus levels)
• high level of lactate dehydrogenase in the blood (an enzyme)
• signs of low blood sugar: nausea, sweating, weakness, dizziness, tremor, headache
• dehydration
• abnormal level of fats in the blood
• involuntary tremor (also called tremor)
• difficulty concentrating
• unpleasant and abnormal sensation to the touch (also called dysesthesia)
• fatigue (also called asthenia)
• feeling of numbness or tingling in the fingers of the hands and feet (also called peripheral neuropathy)
• paralysis of any muscle of the face
• red spot in the white of the eye caused by rupture of blood vessels (also called subconjunctival hemorrhage)
• blood in the eyes (also called eye hemorrhage)
• eye irritation
• signs of heart attack (also called myocardial infarction): sudden and crushing chest pain, fatigue, irregular heartbeat
• signs of heart murmur: fatigue, chest discomfort, dizziness, chest pain, palpitations
• fungal infection of the feet
• signs of heart failure: shortness of breath, difficulty breathing when lying down, swelling of the feet or legs
• pain behind the 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 narrowing of the arteries in the limbs: possible high blood pressure, painful cramps in one or both leg muscles after some activity such as walking or climbing stairs, numbness or weakness in the legs
• bruising (when you haven't hurt yourself)
• deposits of fat in the arteries that can cause blockage (also called arteriosclerosis)
• signs of low blood pressure (also called hypotension): dizziness, lightheadedness or fainting
• signs of pulmonary edema: shortness of breath
• signs of pleural effusion: accumulation of fluid between the layers of tissue lining the lungs and the chest cavity (which, if severe, can reduce the heart's ability to pump blood), cough with chest pain, hiccups, rapid breathing
• signs of interstitial lung disease: cough, difficulty breathing, painful breathing
• signs of pleuritic pain: chest pain
• signs of pleurisy: cough, painful breathing
• hoarse voice
• signs of pulmonary hypertension: high blood pressure in the arteries of the lungs
• wheezing
• sensitive teeth
• signs of inflammation (also called gingivitis): bleeding gums, sensitive or swollen gums
• high level of urea in the blood (kidney function)
• change in blood proteins (low level of globulins or presence of paraprotein)
• high level of unconjugated bilirubin in the blood
• high level of troponin in the blood

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

• redness and/or swelling and possible peeling of the palms of the hands and soles of the feet (so-called hand-foot syndrome)
• warts in the mouth
• feeling of hardening or stiffness of the breast
• inflammation of the thyroid gland (also called thyroiditis)
• disturbed or depressed mood
• signs of secondary hyperparathyroidism: bone and joint pain, excessive urination, abdominal pain, weakness, fatigue
• signs of narrowing of the arteries in the brain: partial or total loss of vision in both eyes, double vision, dizziness (feeling dizzy), 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 heart failure (reduced ejection fraction): fatigue, discomfort in the chest, dizziness, pain, palpitations
• low or high level of insulin in the blood (a hormone that regulates blood sugar levels)
• low level of C-peptide in the blood (pancreas function)
• sudden death

The following other side effects have been reported with unknown frequency (cannot be
defined based on available data):

• signs of heart failure (ventricular dysfunction): shortness of breath, exertion at rest, irregular heartbeat, chest discomfort, dizziness, pain, palpitations, excessive urination, swelling of the feet, ankles and abdomen.

Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, please contact
your doctor or pharmacist. You can also report undesirable effects directly through the national
reporting system indicated in Annex V. Reporting undesirable effects can help
to provide more information on the safety of this medicine.

5. How to store Tasigna

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the package and on the blister after EXP. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.
• Store in the original package to protect the medicine from moisture.
• Do not use this medicine if you notice that the package is damaged or tampered with.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Tasigna contains

• The active ingredient is nilotinib.
• Each 50 mg hard capsule contains 50 mg of nilotinib (as monohydrate hydrochloride). The other components are: Capsule content: Monohydrate lactose, crospovidone type A, poloxamer 188, anhydrous colloidal silica, magnesium stearate Capsule shell: Gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) Ink for printing: Gum lac (E904), black iron oxide (E172), propylene glycol, ammonium hydroxide
• Each 150 mg hard capsule contains 150 mg of nilotinib (as monohydrate hydrochloride). The other components are: Capsule content: Monohydrate lactose, crospovidone type A, poloxamer 188, anhydrous colloidal silica, magnesium stearate Capsule shell: Gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) Ink for printing: Gum lac (E904), black iron oxide (E172), n-butyl alcohol, propylene glycol, dehydrated alcohol, isopropyl alcohol, ammonium hydroxide
• Each 200 mg hard capsule contains 200 mg of nilotinib (as monohydrate hydrochloride). The other components are: Capsule content: Monohydrate lactose, crospovidone type A, poloxamer 188, anhydrous colloidal silica, magnesium stearate Capsule shell: Gelatin, titanium dioxide (E171), yellow iron oxide (E172) Ink for printing: Gum lac (E904), dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, red iron oxide (E172)

Description of the appearance of Tasigna and package contents
Tasigna 50 mg is supplied as hard capsules. The hard capsules are light red/yellow in color. A
black inscription is printed on each hard capsule (“NVR/ABL”).
Tasigna 150 mg is supplied as hard capsules. The hard capsules are red in color. A black inscription
is printed on each hard capsule (“NVR/BCR”).
Tasigna 200 mg is supplied as hard capsules. The hard capsules are light yellow in color. A
red inscription is printed on each hard capsule (“NVR/TKI”).
Tasigna 50 mg hard capsules are available in a package containing 120 hard capsules
(3 packs of 40 hard capsules).
Tasigna 150 mg hard capsules are available in packs containing 28 or 40 hard capsules and in
multipacks of 112 hard capsules (comprising 4 blisters, each containing 28 hard capsules), 120 hard capsules (comprising 3 blisters, each containing 40 hard capsules) or
392 hard capsules (comprising 14 blisters, each containing 28 hard capsules).
Tasigna 200 mg hard capsules are available in a wallet pack of 28 hard capsules and
in a blister pack containing 28 or 40 hard capsules. Tasigna is also available in multipacks of
112 hard capsules (comprising 4 blisters, each containing 28 hard capsules), 120 hard capsules
(comprising 3 blisters, each containing 40 hard capsules) or 392 hard capsules (comprising 14 blisters, each containing 28 hard capsules).
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
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
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
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

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu/. Also, links to other websites on rare diseases and related therapeutic treatments are provided.