Tasigna

Основна информация

  • Търговско наименование:
  • Tasigna
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Tasigna
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Antineoplastic agents,
  • Терапевтична област:
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Терапевтични показания:
  • Tasigna is indicated for the treatment of:adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib.Tasigna is indicated for the treatment of:adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
  • Каталог на резюме:
  • Revision: 36

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/000798
  • Дата Оторизация:
  • 19-11-2007
  • EMEA код:
  • EMEA/H/C/000798
  • Последна актуализация:
  • 03-04-2020

Доклад обществена оценка

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

EMA/278453/2017

EMEA/H/C/000798

EPAR summary for the public

Tasigna

nilotinib

This is a summary of the European public assessment report (EPAR) for Tasigna. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to recommend its

authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how

to use Tasigna.

For practical information about using Tasigna, patients should read the package leaflet or contact their

doctor or pharmacist.

What is Tasigna and what is it used for?

Tasigna is a medicine used to treat adults with chronic myelogenous leukaemia (CML), a type of cancer

of the white blood cells. It is used when the patient is ‘Philadelphia chromosome positive’ (Ph+), which

means that some of the patient’s genes have re-arranged themselves to form a special chromosome

called the Philadelphia chromosome. This chromosome produces an enzyme, called Bcr-Abl kinase,

that leads to the development of leukaemia.

Tasigna is used to treat the ‘chronic’ and ‘accelerated’ phases of CML, in patients who cannot tolerate

other treatments including imatinib (another cancer medicine), or when their disease is not responding

to them. There is no information available on its effectiveness in patients whose disease is in ‘blast

crisis’ (another phase of CML).

Tasigna is also used in newly diagnosed patients with CML in the chronic phase.

Because the number of patients with CML is low, the disease is considered ‘rare’, and Tasigna was

designated an ‘orphan medicine’ (a medicine used in rare diseases) on 22 May 2006.

How is Tasigna used?

Tasigna can only be obtained with a prescription and treatment should be started by a doctor who has

experience in the diagnosis and treatment of CML. The medicine is available as capsules (150 and

200 mg).

Tasigna

EMA/340855/2017

Page 2/3

In newly diagnosed patients with chronic phase CML, the recommended dose of Tasigna is 300 mg

twice a day. In patients with chronic or accelerated phase CML who cannot tolerate other treatments or

whose disease does not respond to them, the recommended dose is 400 mg twice a day.

Treatment should continue for as long as the patient continues to benefit. The dose should be reduced

or treatment interrupted if the patient has certain side effects affecting the blood. Stopping treatment

may be considered in patients in chronic phase after treatment with Tasigna for at least 3 years, whose

disease has been well controlled for at least 1 year.

The two doses of Tasigna should be taken around 12 hours apart. The capsules should be swallowed

whole with a glass of water, without eating anything for two hours before and one hour after each

dose. For patients who are unable to swallow capsules, the content of the capsules may be dispersed

in a teaspoon of apple puree and taken immediately. Tasigna can be given with certain other medicines

if appropriate.

During treatment with Tasigna, patients are to have regular blood tests, including tests for blood fat

levels. Increased blood cholesterol levels have been reported in patients receiving the medicine. If

treatment is stopped because disease has been well controlled, regular tests are required to ensure the

disease has not started to come back, and treatment must be restarted if this occurs.

How does Tasigna work?

The active substance in Tasigna, nilotinib, belongs to a group of medicines called ‘protein kinase

inhibitors’. These compounds act by blocking types of enzymes known as protein kinases. Nilotinib acts

by blocking the protein kinase called Bcr-Abl kinase. This enzyme is produced by leukaemia cells, and

causes them to multiply uncontrollably. By blocking Bcr-Abl kinase, Tasigna helps to control the spread

of leukaemia cells.

What benefits of Tasigna have been shown in studies?

Tasigna has been studied in two main studies involving a total of 439 patients with CML, who could not

tolerate imatinib or whose disease had stopped responding to it. In these studies, Tasigna was not

compared with any other treatment. The first study included a total of 320 patients whose disease was

in the ‘chronic phase’, three quarters of whom had stopped responding to imatinib. Its main measure

of effectiveness was the proportion of patients who had had a ‘major cytogenetic response’ (when the

proportion of white blood cells in the bone marrow that contained the Philadelphia chromosome had

fallen to below 35%). 156 (49%) of the 320 patients had a major cytogenetic response after having

received Tasigna for an average of 341 days (around eleven months).

The second study included a total of 119 patients whose disease was in the ‘accelerated phase’, four

fifths of whom had stopped responding to imatinib. Its main measure of effectiveness was the

proportion of patients who had had a ‘haematological response’ (a return to normal of the number of

white cells in the blood). This occurred in 50 (42%) of the 119 patients, after having received Tasigna

for an average of 202 days (around seven months).

In both studies, Tasigna had a similar effect in patients who could not tolerate imatinib and those

whose disease had stopped responding to it.

In a third main study in 846 newly diagnosed patients with chronic phase CML, Tasigna, either as

300 mg twice a day or as 400 mg twice a day, was compared with imatinib. The main measure of

effectiveness was the proportion of patients who had had a ‘major molecular response’ (when the

Tasigna

EMA/340855/2017

Page 3/3

proportion of the patient’s white blood cells that could produce the abnormal Bcr-Abl kinase had fallen

to below 0.1%) after 12 months of treatment.

In this study, Tasigna was more effective than imatinib at producing major molecular response: it was

seen in 125 (44.3%) of the 282 patients taking Tasigna 300 mg twice a day and 120 (42.7%) of the

281 patients taking Tasigna 400 mg twice a day compared with 63 (22.3%) of the 283 patients taking

imatinib.

Two further studies showed that the medicine’s benefits can be maintained after stopping treatment in

patients whose disease had been well controlled for at least a year. One study involved 190 patients in

whom initial treatment with Tasigna had resulted in a major molecular response; in 98 patients (52%)

the response remained 48 weeks after stopping treatment. The second study involved patients who

had switched to Tasigna after imatinib treatment: 73 out of 126 patients (58%) still had major

molecular response 48 weeks after stopping.

What are the risks associated with Tasigna?

The most common side effects with Tasigna (seen in more than 1 patient in 10) are thrombocytopenia

(low blood platelet counts), neutropenia (low white blood cell counts), headache, nausea (feeling sick),

rash, pruritus (itching), myalgia (muscle pain) and fatigue (tiredness). For the full list of all side effects

and restrictions with Tasigna, see the package leaflet.

Why is Tasigna approved?

The CHMP decided that Tasigna’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

What measures are being taken to ensure the safe and effective use of

Tasigna?

The company that makes Tasigna will provide an information pack for doctors and pharmacists who

will prescribe or dispense the medicine. The pack will remind them of how Tasigna should be used

safely in patients.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Tasigna have also been included in the summary of product characteristics and the

package leaflet.

Other information about Tasigna

The European Commission granted a marketing authorisation valid throughout the European Union for

Tasigna on 19 November 2007.

The full EPAR for Tasigna can be found on the Agency’s website

ema.europa.eu/Find medicine/Human

medicines/European Public Assessment Reports. For more information about treatment with Tasigna,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The summary of opinion of the Committee for Orphan Medicinal Products for Tasigna can be found on

the Agency’s website ema.europa.eu/Find medicine/Human medicines/Rare disease designation

This summary was last updated in 05-2017.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Tasigna 50 mg hard capsules

nilotinib

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Tasigna is and what it is used for

What you need to know before you take Tasigna

How to take Tasigna

Possible side effects

How to store Tasigna

Contents of the pack and other information

1.

What Tasigna is and what it is used for

What Tasigna is

Tasigna is a medicine containing an active substance called nilotinib.

What Tasigna is used for

Tasigna is used to treat a type of leukaemia called Philadelphia chromosome positive chronic myeloid

leukaemia (Ph-positive CML). CML is a cancer of the blood which makes the body produce too many

abnormal white blood cells.

Tasigna is used in adult and paediatric patients with newly diagnosed CML or in patients with CML

who are no longer benefiting from previous treatment including imatinib. It is also used in adult and

paediatric patients who experienced serious side effects with previous treatment and are not able to

continue taking it.

How Tasigna works

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 thus stops the production of these

cells.

Monitoring during Tasigna treatment

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

the amount of blood cells (white blood cells, red blood cells and platelets) in the body to see

how Tasigna is tolerated.

pancreas and liver function in the body to see how Tasigna is tolerated.

the electrolytes in the body (potassium, magnesium). These are important in the functioning of

the heart.

the level of sugar and fats in the blood.

The heart rate will also be checked using a machine that measures electrical activity of the heart (a test

called an “ECG”).

Your doctor will regularly evaluate your treatment and decide whether you should continue to take

Tasigna. If you are told to discontinue this medicine, your doctor will continue to monitor your CML

and may tell you to re-start 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 your

child, ask your doctor.

2.

What you need to know before you take Tasigna

Follow all the doctor’s instructions carefully. They may differ from the general information contained

in this leaflet.

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 taking Tasigna.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tasigna:

if you have suffered prior cardiovascular events such as a heart attack, chest pain (angina),

problems with the blood supply to your brain (stroke) or problems with the 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 the level of fats in your blood (lipid

disorders).

if you have a heart disorder, such as an abnormal electrical signal called “prolongation of the

QT interval”.

if you are being treated with medicines that affect the heart beat (anti-arrhythmics) or the liver

(see Other medicines and Tasigna).

if you suffer from lack of potassium or magnesium.

if you have a liver or pancreas disorder.

if you have symptoms such as easy bruising, feeling tired or short of breath or have experienced

repeated infections.

if you have had a surgical procedure involving the removal of the entire stomach (total

gastrectomy).

if you have ever had or might now have a hepatitis B infection. This is because Tasigna could

cause hepatitis B to become active again, which can be fatal in some cases. Patients will be

carefully checked by their doctor for signs of this infection before treatment is started.

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

During treatment with Tasigna

if you faint (loss of consciousness) or have an irregular heart beat while taking this medicine,

tell your doctor immediately as this may be a sign of a serious heart condition. Prolongation of

the QT interval or an irregular heart beat may lead to sudden death. Uncommon cases of sudden

death have been reported in patients taking Tasigna.

if you have sudden heart palpitations, severe muscle weakness or paralysis, seizures or sudden

changes in your thinking or level of alertness, tell your doctor immediately as this may be a

sign of a fast breakdown of cancer cells called tumour lysis syndrome. Rare cases of tumour

lysis syndrome have been reported in patients treated with Tasigna.

if you develop chest pain or discomfort, numbness or weakness, problems with walking or with

your speech, pain, discolouration or a cool feeling in a limb, tell your doctor immediately as

this may be a sign of a cardiovascular event. Serious cardiovascular events including problems

with the blood flow to the leg (peripheral arterial occlusive disease), ischaemic heart disease and

problems with the blood supply to the brain (ischaemic cerebrovascular disease) have been

reported in patients taking Tasigna. Your doctor should assess the level of fats (lipids) and sugar

in your blood before initiating treatment with Tasigna and during treatment.

if you develop swelling of the feet or hands, generalised 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 your child.

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 below 2 years of age. There is no experience with the use of Tasigna in

newly diagnosed children below 10 years of age and limited experience in patients below 6 years of

age who are no longer benefiting from previous treatment for CML. The long-term effects of treating

children with Tasigna for long periods of time are not known.

Some children and adolescents taking Tasigna may have slower than normal growth. The doctor will

monitor growth at regular visits.

Other medicines and Tasigna

Tasigna may interfere with some other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This includes in particular:

anti-arrhythmics – used to treat irregular heart beat;

chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin - medicines

that may have an unwanted effect on the electrical activity of the heart;

ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat

infections;

ritonavir – a medicine from the class “ antiproteases” used to treat HIV;

carbamazepine, phenobarbital, phenytoin – used to treat epilepsy;

rifampicin – used to treat tuberculosis;

St. John’s Wort – a herbal product used to treat depression and other conditions (also known as

Hypericum perforatum);

midazolam – used to relieve anxiety before surgery;

alfentanil and fentanyl

used to treat pain and as a sedative before or during surgery or medical

procedures;

cyclosporine, sirolimus and tacrolimus – medicines that suppress the “self-defence” ability of

the body and fight infections and are commonly used to prevent the rejection of transplanted

organs such as the liver, heart and kidney;

dihydroergotamine and ergotamine – used to treat dementia;

lovastatin, simvastatin – used to treat high level of fats in blood;

warfarin – used to treat blood coagulation disorders (such as blood clots or thromboses);

astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine,

dihydroergotamine).

These medicines should be avoided during your treatment with Tasigna. If you are taking any of these,

your doctor might prescribe other alternative medicines.

In addition, tell your doctor or pharmacist before taking Tasigna if you are taking any antacids, which

are medicines against heartburn. These medicines need to be taken separately from Tasigna:

H2 blockers, which decrease the production of acid in the stomach. H2 blockers should be taken

approximately 10 hours before and approximately 2 hours after you take Tasigna;

antacids such as those containing aluminium hydroxide, magnesium hydroxide and simethicone,

which neutralise high acidity in the stomach. These antacids should be taken approximately

2 hours before or approximately 2 hours after you take Tasigna.

You should also tell your doctor if you are already taking Tasigna and you are prescribed a new

medicine that you have not taken previously during Tasigna treatment.

Tasigna with food and drink

Do not take Tasigna with food. Food may enhance the absorption of Tasigna and therefore increase

the amount of Tasigna in the blood, possibly to a harmful level

Do not drink grapefruit juice or eat

grapefruit. It may increase the amount of Tasigna in the blood, possibly to a harmful level.

Pregnancy and breast-feeding

Tasigna is not recommended during pregnancy unless clearly necessary. If you are pregnant

or think that you may be, tell your doctor who will discuss with you whether you can take this

medicine during your pregnancy.

Women who might get pregnant are advised to use highly effective contraception during

treatment and for up to two weeks after ending treatment.

Breast-feeding is not recommended during treatment with Tasigna and for two weeks after the

last dose. Tell your doctor if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you experience side effects (such as dizziness or visual disorders) with a potential impact on the

ability to safely drive or use any tools or machines after taking this medicine, you should refrain from

these activities until the effect has disappeared.

Tasigna contains lactose

This medicine contains lactose (also known as milk sugar). If you have been told by your doctor that

you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.

How to take Tasigna

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

How much Tasigna to take

Use in adults

Patients newly diagnosed with CML: The recommended dose is 600 mg per day. This dose is

achieved by taking two hard capsules of 150 mg twice a day.

Patients who are no longer benefiting from previous treatment for CML: The

recommended dose is 800 mg per day. This dose is achieved by taking two hard capsules of

200 mg twice a day.

Use in children and adolescents

The dose given to your child will depend on your child’s body weight and height. The doctor

will calculate the correct dose to use and tell you which and how many capsules of Tasigna to

give to your child. The total daily dose you give to your child must not exceed 800 mg.

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

Older people (age 65 years and over)

Tasigna can be used by people aged 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 your hard capsules.

How to take Tasigna

Swallow the hard capsules whole with water.

Do not take any food together with the hard capsules.

Do not open the hard capsules unless you are unable to swallow them. If so, you may sprinkle

the content of each hard capsule in one teaspoon 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 food other

than apple sauce.

How long to take Tasigna

Continue taking Tasigna every day for as long as your doctor tells you. This is a long-term treatment.

Your doctor will regularly monitor your condition to check that the treatment is having the desired

effect.

Your doctor may consider discontinuing your 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 have, or if someone else accidentally takes your hard

capsules, contact a doctor or hospital for advice straight away. Show them the pack of hard capsules

and this package leaflet. Medical treatment may be necessary.

If you forget to take Tasigna

If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a

forgotten hard capsule.

If you stop taking Tasigna

Do not stop taking this medicine unless your doctor tells you to do so. Stopping Tasigna without your

doctor’s recommendation places you at risk for worsening of your disease which could have

life-threatening consequences. Be sure to discuss with your doctor, nurse, and/or pharmacist if you are

considering stopping Tasigna.

If your doctor recommends that you discontinue treatment with Tasigna

Your doctor will regularly evaluate your treatment with a specific diagnostic test and decide whether

you should continue to take this medicine. If you are told to discontinue Tasigna, your doctor will

continue to carefully monitor your CML before, during and after you have discontinued Tasigna and

may tell you to re-start Tasigna if your condition indicates that this is necessary.

If you have any further questions on 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 everybody gets them. Most of

the side effects are mild to moderate and will generally disappear after a few days to a few weeks of

treatment.

Some side effects could be serious.

These side effects are very common (may affect more than 1 in 10 people), common (may affect up to 1

in 10 people), uncommon (may affect up to 1 in 100 people) or have been reported with frequency not

known (cannot be estimated from the available data).

rapid weight gain, swelling of hands, ankles, feet or face (signs of water retention)

chest pain or discomfort, high or low blood pressure, irregular heart rhythm (fast or slow),

palpitations (sensation of rapid heartbeat), fainting, blue discolouration of the lips, tongue or

skin (signs of heart disorders)

difficulty breathing or painful breathing, cough, wheezing with or without fever, swelling of the

feet or legs (signs of lung disorders)

fever, easy bruising or unexplained bleeding, severe or frequent infections, unexplained

weakness (signs of blood disorders)

weakness or paralysis of the limbs or face, difficulty speaking, severe headache, seeing, feeling

or hearing things that are not there, changes in eyesight, loss of consciousness, confusion,

disorientation, trembling, sensation of tingling, pain or numbness in fingers and toes (signs of

nervous system disorders)

thirst, dry skin, irritability, dark urine, decreased urine output, difficulty and pain when

urinating, exaggerated sense of needing to urinate, blood in urine, abnormal urine colour (signs

of kidney or urinary tract disorders)

visual disturbances including blurred vision, double-vision or perceived flashes of light,

decreased sharpness or loss of vision, blood in eye, increased sensitivity of the eyes to light, eye

pain, redness, itching or irritation, dry eye, swelling or itching of the eyelids (signs of eye

disorders)

swelling and pain in one part of the body (signs of clotting within a vein)

abdominal pain, nausea, vomiting of blood, black or bloody stools, constipation, heartburn,

stomach acid reflux, swollen abdomen (signs of gastrointestinal disorders)

severe upper (middle or left) abdominal pain (sign of pancreatitis)

yellow skin and eyes, nausea, loss of appetite, dark-coloured urine (signs of liver disorders)

painful red lumps, skin pain, skin reddening, peeling or blisters (signs of skin disorders)

pain in joints and muscles (signs of musculoskeletal pain)

excessive thirst, high urine output, increased appetite with weight loss, tiredness (signs of high

level of sugar in the blood)

fast heartbeat, bulging eyes, weight loss, swelling at the front of the neck (signs of overactive

thyroid gland)

weight gain, tiredness, hair loss, muscle weakness, feeling cold (signs of underactive thyroid

gland)

severe headache often accompanied by nausea, vomiting and sensitivity to light (signs of

migraine)

dizziness or spinning sensation (signs of vertigo)

nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint

discomfort associated with abnormal results of blood tests (such as high levels of potassium,

uric acid and phosphorous and low levels of calcium)

pain, discomfort, weakness or cramping in the leg muscles, which may be due to decreased

blood flow, ulcers on the legs or arms that heal slowly or not at all and noticeable changes in

colour (blueness or paleness) or temperature (coolness) of the legs or arms, as these symptoms

could be signs of artery blockage in the affected limb (leg or arm) and digits (toes or fingers)

recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a

liver infection).

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

diarrhoea

headache

tiredness, lack of energy

muscle pain

itching, rash

nausea

abdominal pain

constipation

vomiting

hair loss

musculoskeletal pain, muscle pain, pain in extremity, pain in joints, bone pain and spinal pain

upon discontinuing treatment with Tasigna

slowing of growth in children and adolescents

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

upper respiratory tract infections

stomach discomfort after meals, flatulence, swelling or bloating of the abdomen

bone pain, pain in joints, muscle spasms, muscle weakness

pain including back pain, neck pain and pain in extremity, pain or discomfort in the side of the

body

dry skin, acne, wart, decreased skin sensitivity, hives

loss of appetite, disturbed sense of taste, weight decrease or increase

insomnia, depression, anxiety

night sweats, excessive sweating

generally feeling unwell

voice disorder

nose bleed

frequent urine output

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

increased skin sensitivity

dry mouth, sore throat, mouth sores

breast pain

painful and swollen joints (gout)

increased appetite

attention disorder

inability to achieve or maintain an erection

breast enlargement in men

flu-like symptoms

pneumonia, bronchitis

urinary tract infection

herpes virus infection

oral or vaginal thrush

muscle and joint stiffness, joint swelling

feeling body temperature change (including feeling hot, feeling cold)

sensitive teeth

The following other side effects have been reported with frequency not known (cannot be

estimated from the available data):

allergy (hypersensitivity to Tasigna)

memory loss, disturbed mood

skin cyst, thinning or thickening of the skin, thickening of the outermost layer of the skin, skin

discolouration, fungal infection of the feet

thickened patches of red/silver skin (signs of psoriasis)

bleeding, tender or enlarged gums

oral warts

reddening and/or swelling and possibly peeling on the palms and soles (so called hand-foot

syndrome)

increased sensitivity of the skin to light

difficulty hearing, ear pain, noises (ringing) in the ears

joint inflammation

urinary incontinence

enterocolitis (inflammation of the bowel)

haemorrhoids, anal abscess

feeling of hardening in the breasts, heavy periods, nipple swelling

symptoms of restless legs syndrome (an irresistable urge to move a part of the body, usually the

leg, accompanied by uncomfortable sensations)

During Tasigna treatment, you may also have some abnormal blood test results such as:

low level of blood cells (white cells, red cells, platelets) or haemoglobin

increase in the number of platelets or white cells, or specific types of white cells (eosinophils) in

the blood

high blood level of lipase or amylase (pancreas function)

high blood level of bilirubin or liver enzymes (liver function)

high blood level of creatinine or urea (kidney function)

low or high blood level of insulin (a hormone regulating blood sugar level)

low or high level of sugar, or high level of fats (including cholesterol) in the blood

high blood level of parathyroid hormone (a hormone regulating calcium and phosphorus level)

change in blood proteins (low level of globulins or presence of paraprotein)

high blood levels of enzymes (alkaline phosphatase, lactate dehydrogenase or creatine

phosphokinase)

high blood level of potassium, calcium, phosphorus or uric acid

low blood level of magnesium, potassium, sodium, calcium, or phosphorus

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help 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 carton and blister. The

expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from moisture.

Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help protect the

environment.

6.

Contents of the pack and other information

What Tasigna contains

The active substance is nilotinib. Each hard capsule contains 50 mg nilotinib (as hydrochloride

monohydrate).

The other ingredients are lactose monohydrate, crospovidone type A, poloxamer 188, colloidal

anhydrous silica, magnesium stearate. The hard capsule shell is composed of gelatin, titanium

dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) and, shellac, black iron oxide

(E172), propylene glycol and ammonium hydroxide for stamping of the imprint.

What Tasigna looks like and contents of the pack

Tasigna is supplied as hard capsules. The hard capsules are red/light yellow. A black imprint is

stamped on each hard capsule (“NVR/ABL”).

Tasigna is available in a pack containing 120 hard capsules (3 packs of 40 hard capsules).

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farmacéutica SA

Ronda de Santa Maria, 158

08210 Barberà del Vallès (Barcelona)

Spain

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

For any information about this medicine, please 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 52 555

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

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/. There are also links to other websites about rare diseases and treatments.

Package leaflet: Information for the user

Tasigna 150 mg hard capsules

nilotinib

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Tasigna is and what it is used for

What you need to know before you take Tasigna

How to take Tasigna

Possible side effects

How to store Tasigna

Contents of the pack and other information

1.

What Tasigna is and what it is used for

What Tasigna is

Tasigna is a medicine containing an active substance called nilotinib.

What Tasigna is used for

Tasigna is used to treat a type of leukaemia called Philadelphia chromosome positive chronic myeloid

leukaemia (Ph-positive CML). CML is a cancer of the blood which makes the body produce too many

abnormal white blood cells.

Tasigna is used in adult and paediatric patients with newly diagnosed CML. It is also used in

paediatric patients with CML who are no longer benefiting from previous treatment including imatinib

or who experienced serious side effects with previous treatment and are not able to continue taking it.

How Tasigna works

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 thus stops the production of these

cells.

Monitoring during Tasigna treatment

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

the amount of blood cells (white blood cells, red blood cells and platelets) in the body to see

how Tasigna is tolerated.

pancreas and liver function in the body to see how Tasigna is tolerated.

the electrolytes in the body (potassium, magnesium). These are important in the functioning of

the heart.

the level of sugar and fats in the blood.

The heart rate will also be checked using a machine that measures electrical activity of the heart (a test

called an “ECG”).

Your doctor will regularly evaluate your treatment and decide whether you should continue to take

Tasigna. If you are told to discontinue this medicine, your doctor will continue to monitor your CML

and may tell you to re-start 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 your

child, ask your doctor.

2.

What you need to know before you take Tasigna

Follow all the doctor’s instructions carefully. They may differ from the general information contained

in this leaflet.

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 taking Tasigna.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tasigna:

if you have suffered prior cardiovascular events such as a heart attack, chest pain (angina),

problems with the blood supply to your brain (stroke) or problems with the 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 the level of fats in your blood (lipid

disorders).

if you have a heart disorder, such as an abnormal electrical signal called “prolongation of the

QT interval”.

if you are being treated with medicines that affect the heart beat (anti-arrhythmics) or the liver

(see Other medicines and Tasigna).

if you suffer from lack of potassium or magnesium.

if you have a liver or pancreas disorder.

if you have symptoms such as easy bruising, feeling tired or short of breath or have experienced

repeated infections.

if you have had a surgical procedure involving the removal of the entire stomach (total

gastrectomy).

if you have ever had or might now have a hepatitis B infection. This is because Tasigna could

cause hepatitis B to become active again, which can be fatal in some cases. Patients will be

carefully checked by their doctor for signs of this infection before treatment is started.

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

During treatment with Tasigna

if you faint (loss of consciousness) or have an irregular heart beat while taking this medicine,

tell your doctor immediately as this may be a sign of a serious heart condition. Prolongation of

the QT interval or an irregular heart beat may lead to sudden death. Uncommon cases of sudden

death have been reported in patients taking Tasigna.

if you have sudden heart palpitations, severe muscle weakness or paralysis, seizures or sudden

changes in your thinking or level of alertness, tell your doctor immediately as this may be a

sign of a fast breakdown of cancer cells called tumour lysis syndrome. Rare cases of tumour

lysis syndrome have been reported in patients treated with Tasigna.

if you develop chest pain or discomfort, numbness or weakness, problems with walking or with

your speech, pain, discolouration or a cool feeling in a limb, tell your doctor immediately as

this may be a sign of a cardiovascular event. Serious cardiovascular events including problems

with the blood flow to the leg (peripheral arterial occlusive disease), ischaemic heart disease and

problems with the blood supply to the brain (ischaemic cerebrovascular disease) have been

reported in patients taking Tasigna. Your doctor should assess the level of fats (lipids) and sugar

in your blood before initiating treatment with Tasigna and during treatment.

if you develop swelling of the feet or hands, generalised 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 your child.

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 below 2 years of age. There is no experience with the use of Tasigna in

newly diagnosed children below 10 years of age and limited experience in patients below 6 years of

age who are no longer benefiting from previous treatment for CML. The long-term effects of treating

children with Tasigna for long periods of time are not known.

Some children and adolescents taking Tasigna may have slower than normal growth. The doctor will

monitor growth at regular visits.

Other medicines and Tasigna

Tasigna may interfere with some other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This includes in particular:

anti-arrhythmics – used to treat irregular heart beat;

chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin - medicines

that may have an unwanted effect on the electrical activity of the heart;

ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat

infections;

ritonavir – a medicine from the class “ antiproteases” used to treat HIV;

carbamazepine, phenobarbital, phenytoin – used to treat epilepsy;

rifampicin – used to treat tuberculosis;

St. John’s Wort – a herbal product used to treat depression and other conditions (also known as

Hypericum perforatum);

midazolam – used to relieve anxiety before surgery;

alfentanil and fentanyl – used to treat pain and as a sedative before or during surgery or medical

procedures;

cyclosporine, sirolimus and tacrolimus – medicines that suppress the “self-defence” ability of

the body and fight infections and are commonly used to prevent the rejection of transplanted

organs such as the liver, heart and kidney;

dihydroergotamine and ergotamine – used to treat dementia;

lovastatin, simvastatin – used to treat high level of fats in blood;

warfarin – used to treat blood coagulation disorders (such as blood clots or thromboses);

astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine,

dihydroergotamine).

These medicines should be avoided during your treatment with Tasigna. If you are taking any of these,

your doctor might prescribe other alternative medicines.

In addition, tell your doctor or pharmacist before taking Tasigna if you are taking any antacids, which

are medicines against heartburn. These medicines need to be taken separately from Tasigna:

H2 blockers, which decrease the production of acid in the stomach. H2 blockers should be taken

approximately 10 hours before and approximately 2 hours after you take Tasigna;

antacids such as those containing aluminium hydroxide, magnesium hydroxide and simethicone,

which neutralise high acidity in the stomach. These antacids should be taken approximately

2 hours before or approximately 2 hours after you take Tasigna.

You should also tell your doctor if you are already taking Tasigna and you are prescribed a new

medicine that you have not taken previously during Tasigna treatment.

Tasigna with food and drink

Do not take Tasigna with food. Food may enhance the absorption of Tasigna and therefore increase

the amount of Tasigna in the blood, possibly to a harmful level

Do not drink grapefruit juice or eat

grapefruit. It may increase the amount of Tasigna in the blood, possibly to a harmful level.

Pregnancy and breast-feeding

Tasigna is not recommended during pregnancy unless clearly necessary. If you are pregnant

or think that you may be, tell your doctor who will discuss with you whether you can take this

medicine during your pregnancy.

Women who might get pregnant are advised to use highly effective contraception during

treatment and for up to two weeks after ending treatment.

Breast-feeding is not recommended during treatment with Tasigna and for two weeks after the

last dose. Tell your doctor if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you experience side effects (such as dizziness or visual disorders) with a potential impact on the

ability to safely drive or use any tools or machines after taking this medicine, you should refrain from

these activities until the effect has disappeared.

Tasigna contains lactose

This medicine contains lactose (also known as milk sugar). If you have been told by your doctor that

you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.

How to take Tasigna

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

How much Tasigna to take

Use in adults

The recommended dose is 600 mg per day. This dose is achieved by taking two hard capsules of

150 mg twice a day.

Use in children and adolescents

The dose given to your child will depend on your child’s body weight and height. The doctor

will calculate the correct dose to use and tell you which and how many capsules of Tasigna to

give to your child. The total daily dose you give to your child must not exceed 800 mg.

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

Older people (age 65 years and over)

Tasigna can be used by people aged 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 your hard capsules.

How to take Tasigna

Swallow the hard capsules whole with water.

Do not take any food together with the hard capsules.

Do not open the hard capsules unless you are unable to swallow them. If so, you may sprinkle

the content of each hard capsule in one teaspoon 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 food other

than apple sauce.

How long to take Tasigna

Continue taking Tasigna every day for as long as your doctor tells you. This is a long-term treatment.

Your doctor will regularly monitor your condition to check that the treatment is having the desired

effect.

Your doctor may consider discontinuing your 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 have, or if someone else accidentally takes your hard

capsules, contact a doctor or hospital for advice straight away. Show them the pack of hard capsules

and this package leaflet. Medical treatment may be necessary.

If you forget to take Tasigna

If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a

forgotten hard capsule.

If you stop taking Tasigna

Do not stop taking this medicine unless your doctor tells you to do so. Stopping Tasigna without your

doctor’s recommendation places you at risk for worsening of your disease which could have

life-threatening consequences. Be sure to discuss with your doctor, nurse, and/or pharmacist if you are

considering stopping Tasigna.

If your doctor recommends that you discontinue treatment with Tasigna

Your doctor will regularly evaluate your treatment with a specific diagnostic test and decide whether

you should continue to take this medicine. If you are told to discontinue Tasigna, your doctor will

continue to carefully monitor your CML before, during and after you have discontinued Tasigna and

may tell you to re-start Tasigna if your condition indicates that this is necessary.

If you have any further questions on 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 everybody gets them. Most of

the side effects are mild to moderate and will generally disappear after a few days to a few weeks of

treatment.

Some side effects could be serious.

These side effects are very common (may affect more than 1 in 10 people), common (may affect up to 1

in 10 people), uncommon (may affect up to 1 in 100 people) or have been reported with frequency not

known (cannot be estimated from the available data).

rapid weight gain, swelling of hands, ankles, feet or face (signs of water retention)

chest pain or discomfort, high blood pressure, irregular heart rhythm (fast or slow), palpitations

(sensation of rapid heartbeat), fainting, blue discolouration of the lips, tongue or skin (signs of

heart disorders)

difficulty or painful breathing, cough, wheezing with or without fever, swelling of the feet or

legs (signs of lung disorders)

fever, easy bruising or unexplained bleeding, frequent infections, unexplained weakness (signs

of blood disorders)

weakness or paralysis of the limbs or face, difficulty speaking, severe headache, seeing, feeling

or hearing things that are not there, loss of consciousness, confusion, disorientation, trembling,

sensation of tingling, pain or numbness in fingers and toes (signs of nervous system disorders)

difficulty and pain when passing urine, abnormal urine colour (signs of kidney or urinary tract

disorders)

visual disturbances including blurred vision, perceived flashes of light, loss of vision, blood in

eye, eye pain, redness, itching or irritation, dry eye, swelling or itching of the eyelids (signs of

eye disorders)

abdominal pain, nausea, vomiting of blood, bloody stools, constipation, heartburn, stomach acid

reflux, swollen abdomen (signs of gastrointestinal disorders)

severe upper (middle or left) abdominal pain (sign of pancreatitis)

yellow skin and eyes, nausea, loss of appetite, dark-coloured urine (signs of liver disorders)

painful red lumps, skin pain, skin reddening, peeling or blisters (signs of skin disorders)

pain in joints and muscles (signs of musculoskeletal pain)

excessive thirst, high urine output, increased appetite with weight loss, tiredness (signs of high

level of sugar in the blood)

severe headache often accompanied by nausea, vomiting and sensitivity to light (signs of

migraine)

dizziness or spinning sensation (signs of vertigo)

nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint

discomfort associated with abnormal results of blood tests (such as high levels of potassium,

uric acid and phosphorous and low levels of calcium)

pain, discomfort, weakness or cramping in the leg muscles, which may be due to decreased

blood flow, ulcers on the legs or arms that heal slowly or not at all and noticeable changes in

colour (blueness or paleness) or temperature (coolness) of the legs or arms, as these symptoms

could be signs of artery blockage in the affected limb (leg or arm) and digits (toes or fingers)

recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a

liver infection).

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

headache

tiredness

muscle pain

itching, rash

nausea

hair loss

musculoskeletal pain, muscle pain, pain in extremity, pain in joints, bone pain and spinal pain

upon discontinuing treatment with Tasigna

slowing of growth in children and adolescents

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

diarrhoea, vomiting, abdominal pain, stomach discomfort after meals, flatulence, swelling or

bloating of the abdomen, constipation

bone pain, pain in joints, muscle spasms, muscle weakness, pain in extremity, back pain, pain or

discomfort in the side of the body

upper respiratory tract infections

dry skin, acne, wart, decreased skin sensitivity

loss of appetite, disturbed sense of taste, weight increase

insomnia, anxiety, depression

night sweats, excessive sweating

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

generally feeling unwell

painful and swollen joints (gout)

inability to achieve or maintain an erection

feeling body temperature change (including feeling hot, feeling cold)

sensitive teeth

The following other side effects have been reported with frequency not known (cannot be

estimated from the available data):

allergy (hypersensitivity to Tasigna)

memory loss, disturbed or depressed mood, lack of energy

oral thrush

skin cyst, thinning or thickening of the skin, thickening of the outermost layer of the skin, skin

discolouration, hives, fungal infection of the feet

thickened patches of red/silver skin (signs of psoriasis)

increased skin sensitivity

bleeding, tender or enlarged gums

nose bleed

dry mouth, sore throat, mouth sores

frequent urine output

haemorrhoids, anal abscess

enterocolitis (inflammation of the bowel)

herpes virus infection

feeling of hardening in the breasts, heavy periods, nipple swelling

appetite disorder, weight decreased

breast enlargement in men

symptoms of restless legs syndrome (an irresistable urge to move a part of the body, usually the

leg, accompanied by uncomfortable sensations)

During Tasigna treatment, you may also have some abnormal blood test results such as:

low level of blood cells (white cells, red cells, platelets) or haemoglobin

increase in the number of platelets or white cells, or specific types of white cells (eosinophils) in

the blood

high blood level of lipase or amylase (pancreas function)

high blood level of bilirubin or liver enzymes (liver function)

low or high blood level of insulin (a hormone regulating blood sugar level)

low or high level of sugar, or high level of fats (including cholesterol) in the blood

high blood level of parathyroid hormone (a hormone regulating calcium and phosphorus level)

change in blood proteins (low level of globulins or presence of paraprotein)

high blood level of alkaline phosphatase

high blood level of potassium, calcium, phosphorus or uric acid

low blood level of potassium or calcium

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help 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 carton and blister. The

expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from moisture.

Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help protect the

environment.

6.

Contents of the pack and other information

What Tasigna contains

The active substance is nilotinib. Each hard capsule contains 150 mg nilotinib (as hydrochloride

monohydrate).

The other ingredients are lactose monohydrate, crospovidone type A, poloxamer 188, colloidal

anhydrous silica, magnesium stearate. The hard capsule shell is composed of gelatin, titanium

dioxide (E171), red and yellow iron oxide (E172) and, shellac, black iron oxide (E172), n-butyl

alcohol, propylene glycol, dehydrated ethanol, isopropylalcohol and ammoniumhydroxide for

stamping of the imprint.

What Tasigna looks like and contents of the pack

Tasigna is supplied as hard capsules. The hard capsules are red. A black imprint is stamped on each

hard capsule (“NVR/BCR”).

Tasigna is available in packs containing 28 or 40 hard capsules and in multipacks of 112 hard capsules

(comprising 4 cartons, each containing 28 hard capsules), 120 hard capsules (comprising 3 cartons,

each containing 40 hard capsules) or 392 hard capsules (comprising 14 cartons, each containing

28 hard capsules).

Not all packs may be marketed in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Lek d.d., PE PROIZVODNJA LENDAVA

Trimlini 2D

Lendava, 9220

Slovenia

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

For any information about this medicine, please 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 52 555

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

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/. There are also links to other websites about rare diseases and treatments.

Package leaflet: Information for the user

Tasigna 200 mg hard capsules

nilotinib

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Tasigna is and what it is used for

What you need to know before you take Tasigna

How to take Tasigna

Possible side effects

How to store Tasigna

Contents of the pack and other information

1.

What Tasigna is and what it is used for

What Tasigna is

Tasigna is a medicine containing an active substance called nilotinib.

What Tasigna is used for

Tasigna is used to treat a type of leukaemia called Philadelphia chromosome positive chronic myeloid

leukaemia (Ph-positive CML). CML is a cancer of the blood which makes the body produce too many

abnormal white blood cells.

Tasigna is used in adult and paediatric patients with newly diagnosed CML or in patients with CML

who are no longer benefiting from previous treatment including imatinib. It is also used in adult and

paediatric patients who experienced serious side effects with previous treatment and are not able to

continue taking it.

How Tasigna works

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 thus stops the production of these

cells.

Monitoring during Tasigna treatment

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

the amount of blood cells (white blood cells, red blood cells and platelets) in the body to see

how Tasigna is tolerated.

pancreas and liver function in the body to see how Tasigna is tolerated.

the electrolytes in the body (potassium, magnesium). These are important in the functioning of

the heart.

the level of sugar and fats in the blood.

The heart rate will also be checked using a machine that measures electrical activity of the heart (a test

called an “ECG”).

Your doctor will regularly evaluate your treatment and decide whether you should continue to take

Tasigna. If you are told to discontinue this medicine, your doctor will continue to monitor your CML

and may tell you to re-start 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 your

child, ask your doctor.

2.

What you need to know before you take Tasigna

Follow all the doctor’s instructions carefully. They may differ from the general information contained

in this leaflet.

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 taking Tasigna.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tasigna:

if you have suffered prior cardiovascular events such as a heart attack, chest pain (angina),

problems with the blood supply to your brain (stroke) or problems with the 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 the level of fats in your blood (lipid

disorders).

if you have a heart disorder, such as an abnormal electrical signal called “prolongation of the

QT interval”.

if you are being treated with medicines that affect the heart beat (anti-arrhythmics) or the liver

(see Other medicines and Tasigna).

if you suffer from lack of potassium or magnesium.

if you have a liver or pancreas disorder.

if you have symptoms such as easy bruising, feeling tired or short of breath or have experienced

repeated infections.

if you have had a surgical procedure involving the removal of the entire stomach (total

gastrectomy).

if you have ever had or might now have a hepatitis B infection. This is because Tasigna could

cause hepatitis B to become active again, which can be fatal in some cases. Patients will be

carefully checked by their doctor for signs of this infection before treatment is started.

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

During treatment with Tasigna

if you faint (loss of consciousness) or have an irregular heart beat while taking this medicine,

tell your doctor immediately as this may be a sign of a serious heart condition. Prolongation of

the QT interval or an irregular heart beat may lead to sudden death. Uncommon cases of sudden

death have been reported in patients taking Tasigna.

if you have sudden heart palpitations, severe muscle weakness or paralysis, seizures or sudden

changes in your thinking or level of alertness, tell your doctor immediately as this may be a

sign of a fast breakdown of cancer cells called tumour lysis syndrome. Rare cases of tumour

lysis syndrome have been reported in patients treated with Tasigna.

if you develop chest pain or discomfort, numbness or weakness, problems with walking or with

your speech, pain, discolouration or a cool feeling in a limb, tell your doctor immediately as

this may be a sign of a cardiovascular event. Serious cardiovascular events including problems

with the blood flow to the leg (peripheral arterial occlusive disease), ischaemic heart disease and

problems with the blood supply to the brain (ischaemic cerebrovascular disease) have been

reported in patients taking Tasigna. Your doctor should assess the level of fats (lipids) and sugar

in your blood before initiating treatment with Tasigna and during treatment.

if you develop swelling of the feet or hands, generalised 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 your child.

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 below 2 years of age. There is no experience with the use of Tasigna in

newly diagnosed children below 10 years of age and limited experience in patients below 6 years of

age who are no longer benefiting from previous treatment for CML. The long-term effects of treating

children with Tasigna for long periods of time are not known.

Some children and adolescents taking Tasigna may have slower than normal growth. The doctor will

monitor growth at regular visits.

Other medicines and Tasigna

Tasigna may interfere with some other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This includes in particular:

anti-arrhythmics – used to treat irregular heart beat;

chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin - medicines

that may have an unwanted effect on the electrical activity of the heart;

ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat

infections;

ritonavir – a medicine from the class “ antiproteases” used to treat HIV;

carbamazepine, phenobarbital, phenytoin – used to treat epilepsy;

rifampicin – used to treat tuberculosis;

St. John’s Wort – a herbal product used to treat depression and other conditions (also known as

Hypericum perforatum);

midazolam – used to relieve anxiety before surgery;

alfentanil and fentanyl

used to treat pain and as a sedative before or during surgery or medical

procedures;

cyclosporine, sirolimus and tacrolimus – medicines that suppress the “self-defence” ability of

the body and fight infections and are commonly used to prevent the rejection of transplanted

organs such as the liver, heart and kidney;

dihydroergotamine and ergotamine – used to treat dementia;

lovastatin, simvastatin – used to treat high level of fats in blood;

warfarin – used to treat blood coagulation disorders (such as blood clots or thromboses);

astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine,

dihydroergotamine).

These medicines should be avoided during your treatment with Tasigna. If you are taking any of these,

your doctor might prescribe other alternative medicines.

In addition, tell your doctor or pharmacist before taking Tasigna if you are taking any antacids, which

are medicines against heartburn. These medicines need to be taken separately from Tasigna:

H2 blockers, which decrease the production of acid in the stomach. H2 blockers should be taken

approximately 10 hours before and approximately 2 hours after you take Tasigna;

antacids such as those containing aluminium hydroxide, magnesium hydroxide and simethicone,

which neutralise high acidity in the stomach. These antacids should be taken approximately

2 hours before or approximately 2 hours after you take Tasigna.

You should also tell your doctor if you are already taking Tasigna and you are prescribed a new

medicine that you have not taken previously during Tasigna treatment.

Tasigna with food and drink

Do not take Tasigna with food. Food may enhance the absorption of Tasigna and therefore increase

the amount of Tasigna in the blood, possibly to a harmful level

Do not drink grapefruit juice or eat

grapefruit. It may increase the amount of Tasigna in the blood, possibly to a harmful level.

Pregnancy and breast-feeding

Tasigna is not recommended during pregnancy unless clearly necessary. If you are pregnant

or think that you may be, tell your doctor who will discuss with you whether you can take this

medicine during your pregnancy.

Women who might get pregnant are advised to use highly effective contraception during

treatment and for up to two weeks after ending treatment.

Breast-feeding is not recommended during treatment with Tasigna and for two weeks after the

last dose. Tell your doctor if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you experience side effects (such as dizziness or visual disorders) with a potential impact on the

ability to safely drive or use any tools or machines after taking this medicine, you should refrain from

these activities until the effect has disappeared.

Tasigna contains lactose

This medicine contains lactose (also known as milk sugar). If you have been told by your doctor that

you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.

How to take Tasigna

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

How much Tasigna to take

Use in adults

The recommended dose is 800 mg per day. This dose is achieved by taking two hard capsules of

200 mg twice a day.

Use in children and adolescents

The dose given to your child will depend on your child’s body weight and height. The doctor

will calculate the correct dose to use and tell you which and how many capsules of Tasigna to

give to your child. The total daily dose you give to your child must not exceed 800 mg.

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

Older people (age 65 years and over)

Tasigna can be used by people aged 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 your hard capsules.

How to take Tasigna

Swallow the hard capsules whole with water.

Do not take any food together with the hard capsules.

Do not open the hard capsules unless you are unable to swallow them. If so, you may sprinkle

the content of each hard capsule in one teaspoon 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 food other

than apple sauce.

How long to take Tasigna

Continue taking Tasigna every day for as long as your doctor tells you. This is a long-term treatment.

Your doctor will regularly monitor your condition to check that the treatment is having the desired

effect.

Your doctor may consider discontinuing your 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 have, or if someone else accidentally takes your hard

capsules, contact a doctor or hospital for advice straight away. Show them the pack of hard capsules

and this package leaflet. Medical treatment may be necessary.

If you forget to take Tasigna

If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a

forgotten hard capsule.

If you stop taking Tasigna

Do not stop taking this medicine unless your doctor tells you to do so. Stopping Tasigna without your

doctor’s recommendation places you at risk for worsening of your disease which could have

life-threatening consequences. Be sure to discuss with your doctor, nurse, and/or pharmacist if you are

considering stopping Tasigna.

If your doctor recommends that you discontinue treatment with Tasigna

Your doctor will regularly evaluate your treatment with a specific diagnostic test and decide whether

you should continue to take this medicine. If you are told to discontinue Tasigna, your doctor will

continue to carefully monitor your CML before, during and after you have discontinued Tasigna and

may tell you to re-start Tasigna if your condition indicates that this is necessary.

If you have any further questions on 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 everybody gets them. Most of

the side effects are mild to moderate and will generally disappear after a few days to a few weeks of

treatment.

Some side effects could be serious.

These side effects are very common (may affect more than 1 in 10 people), common (may affect up to 1

in 10 people), uncommon (may affect up to 1 in 100 people) or have been reported with frequency not

known (cannot be estimated from the available data).

rapid weight gain, swelling of hands, ankles, feet or face (signs of water retention)

chest pain or discomfort, high or low blood pressure, irregular heart rhythm (fast or slow),

palpitations (sensation of rapid heartbeat), fainting, blue discolouration of the lips, tongue or

skin (signs of heart disorders)

difficulty breathing or painful breathing, cough, wheezing with or without fever, swelling of the

feet or legs (signs of lung disorders)

fever, easy bruising or unexplained bleeding, severe or frequent infections, unexplained

weakness (signs of blood disorders)

weakness or paralysis of the limbs or face, difficulty speaking, severe headache, seeing, feeling

or hearing things that are not there, changes in eyesight, loss of consciousness, confusion,

disorientation, trembling, sensation of tingling, pain or numbness in fingers and toes (signs of

nervous system disorders)

thirst, dry skin, irritability, dark urine, decreased urine output, difficulty and pain when

urinating, exaggerated sense of needing to urinate, blood in urine, abnormal urine colour (signs

of kidney or urinary tract disorders)

visual disturbances including blurred vision, double-vision or perceived flashes of light,

decreased sharpness or loss of vision, blood in eye, increased sensitivity of the eyes to light, eye

pain, redness, itching or irritation, dry eye, swelling or itching of the eyelids (signs of eye

disorders)

swelling and pain in one part of the body (signs of clotting within a vein)

abdominal pain, nausea, vomiting of blood, black or bloody stools, constipation, heartburn,

stomach acid reflux, swollen abdomen (signs of gastrointestinal disorders)

severe upper (middle or left) abdominal pain (sign of pancreatitis)

yellow skin and eyes, nausea, loss of appetite, dark-coloured urine (signs of liver disorders)

painful red lumps, skin pain, skin reddening, peeling or blisters (signs of skin disorders)

pain in joints and muscles (signs of musculoskeletal pain)

excessive thirst, high urine output, increased appetite with weight loss, tiredness (signs of high

level of sugar in the blood)

fast heartbeat, bulging eyes, weight loss, swelling at the front of the neck (signs of overactive

thyroid gland)

weight gain, tiredness, hair loss, muscle weakness, feeling cold (signs of underactive thyroid

gland)

severe headache often accompanied by nausea, vomiting and sensitivity to light (signs of

migraine)

dizziness or spinning sensation (signs of vertigo)

nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint

discomfort associated with abnormal results of blood tests (such as high levels of potassium,

uric acid and phosphorous and low levels of calcium)

pain, discomfort, weakness or cramping in the leg muscles, which may be due to decreased

blood flow, ulcers on the legs or arms that heal slowly or not at all and noticeable changes in

colour (blueness or paleness) or temperature (coolness) of the legs or arms, as these symptoms

could be signs of artery blockage in the affected limb (leg or arm) and digits (toes or fingers)

recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a

liver infection).

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

diarrhoea

headache

tiredness, lack of energy

muscle pain

itching, rash

nausea

abdominal pain

constipation

vomiting

hair loss

musculoskeletal pain, muscle pain, pain in extremity, pain in joints, bone pain and spinal pain

upon discontinuing treatment with Tasigna

slowing of growth in children and adolescents

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

upper respiratory tract infections

stomach discomfort after meals, flatulence, swelling or bloating of the abdomen

bone pain, pain in joints, muscle spasms, muscle weakness

pain including back pain, neck pain and pain in extremity, pain or discomfort in the side of the

body

dry skin, acne, wart, decreased skin sensitivity, hives

loss of appetite, disturbed sense of taste, weight decrease or increase

insomnia, depression, anxiety

night sweats, excessive sweating

generally feeling unwell

voice disorder

nose bleed

frequent urine output

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

increased skin sensitivity

dry mouth, sore throat, mouth sores

breast pain

painful and swollen joints (gout)

increased appetite

attention disorder

inability to achieve or maintain an erection

breast enlargement in men

flu-like symptoms

pneumonia, bronchitis

urinary tract infection

herpes virus infection

oral or vaginal thrush

muscle and joint stiffness, joint swelling

feeling body temperature change (including feeling hot, feeling cold)

sensitive teeth

The following other side effects have been reported with frequency not known (cannot be

estimated from the available data):

allergy (hypersensitivity to Tasigna)

memory loss, disturbed mood

skin cyst, thinning or thickening of the skin, thickening of the outermost layer of the skin, skin

discolouration, fungal infection of the feet

thickened patches of red/silver skin (signs of psoriasis)

bleeding, tender or enlarged gums

oral warts

reddening and/or swelling and possibly peeling on the palms and soles (so called hand-foot

syndrome)

increased sensitivity of the skin to light

difficulty hearing, ear pain, noises (ringing) in the ears

joint inflammation

urinary incontinence

enterocolitis (inflammation of the bowel)

haemorrhoids, anal abscess

feeling of hardening in the breasts, heavy periods, nipple swelling

symptoms of restless legs syndrome (an irresistable urge to move a part of the body, usually the

leg, accompanied by uncomfortable sensations)

During Tasigna treatment, you may also have some abnormal blood test results such as:

low level of blood cells (white cells, red cells, platelets) or haemoglobin

increase in the number of platelets or white cells, or specific types of white cells (eosinophils) in

the blood

high blood level of lipase or amylase (pancreas function)

high blood level of bilirubin or liver enzymes (liver function)

high blood level of creatinine or urea (kidney function)

low or high blood level of insulin (a hormone regulating blood sugar level)

low or high level of sugar, or high level of fats (including cholesterol) in the blood

high blood level of parathyroid hormone (a hormone regulating calcium and phosphorus level)

change in blood proteins (low level of globulins or presence of paraprotein)

high blood levels of enzymes (alkaline phosphatase, lactate dehydrogenase or creatine

phosphokinase)

high blood level of potassium, calcium, phosphorus or uric acid

low blood level of magnesium, potassium, sodium, calcium, or phosphorus

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help 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 carton and blister. The

expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from moisture.

Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help protect the

environment.

6.

Contents of the pack and other information

What Tasigna contains

The active substance is nilotinib. Each hard capsule contains 200 mg nilotinib (as hydrochloride

monohydrate).

The other ingredients are lactose monohydrate, crospovidone type A, poloxamer 188, colloidal

anhydrous silica, magnesium stearate. The hard capsule shell is composed of gelatin, titanium

dioxide (E171), yellow iron oxide (E172) and, shellac (E904), dehydrated alcohol, isopropyl

alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and red

iron oxide (E172) for stamping of the imprint.

What Tasigna looks like and contents of the pack

Tasigna is supplied as hard capsules. The hard capsules are light yellow. A red imprint is stamped on

each hard capsule (“NVR/TKI”).

Tasigna is available in a wallet containing 28 hard capsules and in a carton containing 28 or 40 hard

capsules.

Tasigna is also available in multipacks of:

112 (4 wallets of 28) hard capsules.

112 (4 packs of 28) hard capsules.

120 (3 packs of 40) hard capsules.

392 (14 packs of 28) hard capsules.

Not all packs may be marketed in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Lek d.d., PE PROIZVODNJA LENDAVA

Trimlini 2D

Lendava, 9220

Slovenia

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

For any information about this medicine, please 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 52 555

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

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/. There are also links to other websites about rare diseases and treatments.