50 mg, 150 mg and 200 mg hard capsules
nilotinib
What Tasigna is and what it is used for
What Tasigna is
Tasigna is a medicine that contains the active substance nilotinib.
What Tasigna is used for
Tasigna is used to treat a type of leukemia called Philadelphia chromosome-positive chronic myeloid leukemia ( Ph-positive CML). CML is a cancer of the blood, which 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 treatment that included imatinib. Tasigna is also used in adult and pediatric patients who have experienced serious side effects from previous treatment and therefore cannot continue with that medicine.
How Tasigna works
In patients with CML, a change occurs in the DNA (the genetic material), which triggers a signal to the body to produce abnormal white blood cells. Tasigna blocks this signal and thus stops the production of these cells.
Monitoring during treatment with Tasigna
Regular samples, including blood tests, will be taken during treatment. These samples check for:
- the number of blood cells ( white blood cells, red blood cells, and platelets ) in the body to see how Tasigna works.
- pancreas – and liver function in the body to see how Tasigna works.
- the electrolytes in the body ( potassium, magnesium ). These are important for the function of the heart.
- the level of sugar and fats in the blood.
The heart rate will also be checked using a machine that measures the electrical activity of the heart (a test called an “ECG”).
Your doctor will evaluate your treatment regularly and decide whether you should continue taking Tasigna. If you are told to stop taking this medicine, your doctor will continue to monitor your CML and may tell you to resume treatment with Tasigna if your condition indicates it is necessary.
Contact your doctor if you have any questions about how Tasigna works or why it has been prescribed for you or your child.
What you need to know before you take Tasigna
Follow your 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, ask your doctor for advice before taking Tasigna.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tasigna:
- if you previously had cardiovascular problems such as heart attack, angina, problems with the blood supply to your brain ( stroke ) or problems with the blood supply to your legs (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 (dyslipidemia).
- if you have a disturbance in heart function, such as an abnormal electrical signal, so-called “extended QT interval”.
- if you are being treated with medicines that lower your blood cholesterol levels (statins) or affect the heartbeat (medicines against rhythm disorders) or the liver (see under “ Other medicines and Tasigna ”).
- if you have a potassium or magnesium deficiency.
- if you have any disorder of liver function or pancreas.
- if you have symptoms such as easy bruising, feeling tired or short of breath, or have experienced recurrent infections.
- if you have undergone a surgical procedure in which the entire stomach has been removed (total gastrectomy).
- if you have ever had or may now have a hepatitis B infection. The reason for this is that Tasigna can cause your hepatitis B to become active again, which in some cases can be fatal. Patients will be closely monitored by their doctor for signs of this infection before starting treatment.
If any of these apply to you or your child, talk to a doctor.
During treatment with Tasigna
- if you faint (lose consciousness) or have an irregular heartbeat while taking this medicine, talk to your doctor immediately as this could be a sign of a serious heart condition. Prolongation of the QT interval et or an irregular heart rhythm can lead to sudden death. Sudden death has been uncommonly reported in patients taking Tasigna.
- if you experience sudden palpitations, severe muscle weakness or paralysis, convulsions, or sudden changes in your thoughts or level of alertness, talk to your doctor immediately as these may be signs 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, discoloration, or coldness in an arm or leg, talk to your doctor immediately as this may be a sign of an effect on the heart and blood vessels. Serious effects on the heart and blood vessels, including problems with blood flow to the bones ( peripheral arterial occlusive disease), ischemic heart disease, and problems with blood supply to the brain (ischemic cerebrovascular disease) have been reported in patients taking Tasigna. Your doctor should assess the level of fats ( lipids ) and sugar in the blood before starting treatment with Tasigna and during treatment.- talk to your doctor if you get swollen feet or hands, general swelling, or rapid weight gain, as this may be a sign of severe fluid retention. Severe fluid retention has been uncommonly reported in patients treated with Tasigna.
If you are the parent of a child being treated with Tasigna, contact your doctor if any of the above applies to your child.
Children and young people
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 newly diagnosed children under 10 years of age and limited experience in patients under 6 years of age who no longer benefit from previous treatment against CML.
Some children and adolescents taking Tasigna may grow more slowly than normal. The doctor will regularly check the growth.
Other medicines and Tasigna
Tasigna can affect or be affected by certain other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This applies in particular to the following medicines:
- antiarrhythmic drugs – used to treat irregular heartbeats
- chloroquine, halofantrine, clarithromycin, haloperidol, methadone, and moxifloxacin – drugs that may have an unwanted effect on the heart’s electrical activity
- ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat infection
- ritonavir – medicine from 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 natural remedy used to treat mild depression and mild anxiety (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 inhibit the body’s ability to ‘self-defense’ and fight infection and are commonly used to prevent rejection of transplanted organs such as the liver, heart, and kidneys;
- dihydroergotamine and ergotamine – used to treat dementia;
- lovastatin, simvastatin – used to treat high levels of blood fats;
- warfarin – is used to treat disorders of the blood’s ability to clot (e.g. blood clots or thrombosis )
- astemizole, terfenadine, cisapride, pimozide, quinidine , bepridil or ergot alkaloids ( ergotamine , dihydroergotamine)
These drugs should be avoided while being treated with Tasigna. If you are taking any of these medicines, your doctor may prescribe another alternative.
If you are taking a statin (a type of medicine that lowers blood cholesterol levels), talk to your doctor or pharmacist. If Tasigna is used together with certain statins, it may increase the risk of statin-related muscle problems which, in rare cases, can lead to severe muscle breakdown ( rhabdomyolysis ) and lead to kidney damage.
In addition, before taking Tasigna tell your doctor or pharmacist if you are using antacids, which are heartburn medicines. These medications need to be taken separately from Tasigna:
- H2 blockers, reduce the production of acid in the stomach. H2 blockers should be taken about 10 hours before and about 2 hours after you take Tasigna;
- antacids such as those containing aluminum hydroxide, magnesium hydroxide, and simethicone, which neutralize high acid levels in the stomach. These antacids should be taken about 2 hours before or about 2 hours after you take Tasigna.
If you are already taking Tasigna, and you have now been prescribed a new medicine that you did not take before during the Tasigna treatment, you must tell the doctor about it.
Tasigna with food and drink
Do not take Tasigna with a meal. Food can increase the absorption of Tasigna and thereby increase the amount of Tasigna in the blood, possibly so much that it can be harmful.
Do not drink grapefruit juice or eat grapefruit. This can increase the amount of Tasigna in the blood, possibly so much that it can be harmful.
Pregnancy and breastfeeding
- Tasigna is not recommended during pregnancy, unless necessary. If you are pregnant or think you may be, discuss with your doctor whether you can take this medicine during your pregnancy.
- Women of childbearing potential are advised to use highly effective contraception during treatment and up to two weeks after treatment.
- Breastfeeding is not recommended during treatment with Tasigna and for two weeks after the last dose. If you are breastfeeding, talk to your doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
If you experience side effects (such as dizziness or blurred vision) after taking this medicine, which may affect your ability to drive or use tools or machines safely, you should refrain from these activities until the effects have worn off.
Tasigna contains lactose
This medicine contains lactose (also known as milk sugar). If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to take Tasigna
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
How much Tasigna should you take?
Use for 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 daily. Patients who no longer benefit from previous treatment against CML: The recommended dose is 800 mg per day. This dose is achieved by taking two hard capsules of 200 mg twice daily.
Use for children and adolescents
- The dose given to your child depends on your child’s body weight and height. The doctor will calculate the correct dose and tell you which and how many capsules of Tasigna to give 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 the effect you get from the treatment.
Elderly people (65 years or older)
The same dose of Tasigna can be given to the elderly, 65 years of age or older, as to other adults.
When should Tasigna be taken?
Take the hard capsules:
- twice daily (about every 12 hours)
- at least 2 hours after a meal of any kind
- then wait 1 hour before eating again
If you have any questions about when to take this medicine, talk to your doctor or pharmacist. Take Tasigna at the same time each day, so it’s easier to remember to take the hard capsules.
How to take Tasigna
- Swallow the hard capsules whole with a glass of water.
- Do not eat food in any form while taking the hard capsules.
- Do not open the hard capsules unless you can swallow them. In this case, you can mix the contents of each hard capsule with 1 teaspoon of mashed apple and take it immediately. Do not take more than 1 teaspoon of pureed apple for each hard capsule and do not mix with anything other than pureed apple.
How long should Tasigna be taken?
Continue taking Tasigna every day for as long as your doctor tells you. This is a long-term treatment. The doctor will check you regularly, to see that the treatment is having the desired effect.
Your doctor may consider stopping your treatment with Tasigna based on specific criteria.
If you have any questions about how long to take Tasigna, talk to your doctor.
If you have taken too much Tasigna
If you have taken more Tasigna than you should, or if someone else has accidentally taken your hard capsules, contact your doctor or hospital immediately for advice. Show them the package with the hard capsules and this leaflet. Medical treatment may be necessary.
If you forget to take Tasigna
If you miss a dose, take the next dose as planned. 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. Stopping Tasigna without your doctor’s recommendation can lead to a worsening of your disease, which can have life-threatening consequences. Discuss with your doctor, nurse, and/or pharmacist if you are considering stopping Tasigna.
If your doctor recommends that you stop taking Tasigna
Your doctor will evaluate your treatment regularly with a specific diagnostic test and decide whether you should continue taking this medicine. If you are told to stop taking Tasigna, your doctor will continue to closely monitor your CML before, during, and after you stop treatment. Your doctor may tell you to resume treatment with Tasigna if your condition indicates this is necessary.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate and generally disappear after a few days to weeks.
Some side effects can be serious.
- signs of musculoskeletal pain: pain in joints and muscles
- signs of heart failure: chest pain or discomfort, high or low blood pressure, irregular heartbeat (fast or slow), palpitations (feeling of fast heartbeats), fainting, blue discoloration of lips, tongue, or skin
- signs of blocked artery: pain, discomfort, weakness, or cramps in the leg muscles that may be due to reduced blood flow, sores on the legs or arms that heal slowly or not at all, and noticeable changes in skin color (blueness or paleness) or body temperature (feeling cold) in the affected leg, arm, toes or fingers
- signs of an underactive thyroid: weight gain, fatigue, hair loss, muscle weakness, feeling cold
- signs of overactive thyroid: palpitations, protruding eyes, weight loss, swelling in the front of the neck
- signs of kidney or urinary tract dysfunction: thirst, dry skin, irritability, dark urine, decreased urine output, difficulty and pain when urinating, strong urge to urinate, blood in the urine, abnormal urine color
- signs of high blood sugar: severe thirst, large urine output, increased appetite with weight loss, fatigue
- signs of vertigo: dizziness or spinning sensation
- signs of pancreatitis: severe pain in the upper (middle or left) part of the abdomen
- signs of skin disease: painful red bumps, pain in the 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 disease: fever, easy bruising or bleeding of unknown cause, severe or frequent infections, weakness of the unknown cause
- signs of a blood clot in a vein: swelling and pain in any part of the body
- signs of a nervous system disorder: weakness or paralysis of the arms, legs, or face, difficulty speaking, severe headache, seeing, feeling, or hearing things that are not there, vision changes, loss of consciousness, confusion, disorientation, tremors, tingling sensations, pain or numbness in fingers and toes.
- signs of lung function disorder: difficulty breathing or painful breathing, cough, wheezing with or without fever, swelling of the feet or legs
- signs of gastrointestinal disease: abdominal pain, nausea, vomiting blood, black or bloody stools, constipation, heartburn, gastric acid reflux, swollen abdomen
- signs of liver dysfunction: yellow skin and eyes, nausea, loss of appetite, dark-colored urine
- signs of liver infection: recurrent (reactivation) hepatitis B infection
- signs of eye disease: visual disturbances including blurred vision, double vision, visual phenomena with flashes of light, reduced visual acuity or loss of vision, blood in the eye, increased sensitivity to light in the eyes, eye pain, red eyes, itching or irritation, dry eyes, swelling or itching of the eyelids
- signs of imbalance in electrolyte levels: nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue, and/or joint pain associated with abnormal blood levels (eg high levels of potassium, uric acid, and phosphorus, and low levels of calcium )
Contact a doctor immediately if you notice any of the side effects above
Some side effects are very common (may affect more than 1 in 10 users)
- diarrhea
- headache
- lack of energy
- muscle pain
- itching, rash
- nausea
- constipation
- vomiting
- hair loss
- pain in the extremities (arms and legs), bone pain, and back pain at the end of treatment with Tasigna
- slow growth in children and adolescents
- upper respiratory tract infection including sore throat and runny or stuffy nose, sneezing
- low levels of blood cells ( red blood cells, platelets ) or hemoglobin
- high levels of lipase in the blood (pancreatic dysfunction)
- high levels of bilirubin in the blood (liver function)
- high levels of alanine aminotransferase (liver enzyme)
Some side effects are common (may affect up to 1 in 10 users)
- pneumonia
- abdominal pain, upset stomach after you eat, gas, swollen or bloated abdomen
- bone pain, muscle twitching
- pain (including neck pain)
- dry skin, acne, reduced skin sensitivity
- weight loss or weight gain
- insomnia, depression, anxiety
- night sweats, profuse sweating
- general malaise
- nosebleed
- signs of gout: painful and swollen joints
- inability to get or keep an erection
- flu-like symptoms
- sore throat
- bronchial catarrh
- ear pain sounds in the ears (eg ringing, humming) that have no external source (also called tinnitus )
- hemorrhoids
- heavy periods
- itching in the hair follicles
- oral or vaginal yeast infection
- signs of conjunctivitis: watery eyes with itching, redness, and swelling
- eye irritation, red eyes
- signs of hypertension: high blood pressure, headache, dizziness
- redness
- signs of peripheral arterial occlusive disease: pain, discomfort, weakness, or cramps in the leg muscles that may be due to reduced blood flow, sores on the legs or arms that heal slowly or not at all, and noticeable changes in skin color (blueness or paleness) or body temperature (feeling cold) in the legs or arms (possible signs of a blocked artery in the affected leg, arm, toes or fingers)
- shortness of breath (also called dyspnoea)
- mouth ulcers with inflammation of the gums (also called stomatitis )
- high levels of amylase in the blood (pancreatic function)
- high levels of creatinine in the blood (kidney function)
- high levels of alkaline phosphatase or creatinine phosphokinase
- high levels of aspartate aminotransferase (liver enzyme)
- high levels of gamma-glutamyl transferase (liver enzyme)
- signs of leukopenia or neutropenia: low levels of white blood cells
- increased number of platelets or white blood cells
- low levels of magnesium, potassium, sodium, calcium, or phosphorus in the blood
- increased levels of potassium, calcium, or phosphorus in the blood
- high levels of fats in the blood (including cholesterol )
- high levels of uric acid in the blood
Some side effects are less common (may affect up to 1 in 100 users)
- allergy (hypersensitivity to Tasigna)
- dry mouth
- chest pain
- pain or discomfort in the side of the body
- increased appetite
- breast augmentation in men
- infection with herpes virus
- muscle and joint stiffness, swollen joints
- the sensation of body temperature changes (including hot sensation, cold sensation)
- altered sense of taste
- need to urinate frequently
- signs of inflammation of the stomach lining: abdominal pain, nausea, vomiting, diarrhea, swollen stomach
- memory loss
- skin cyst, thinning or thickening of the skin, thickening of the outermost layer of the skin, skin discoloration
- signs of psoriasis: thickened patches of red/silvery skin
- increased sensitivity to light in the skin
- hearing difficulties
- inflammation of the joints
- urinary incontinence
- inflammation of the intestine (also called enterocolitis)
- anal abscess
- swollen nipples
- symptoms of restless legs (an irresistible need to move a body part, usually the leg, accompanied by an uncomfortable feeling)
- signs of blood poisoning: fever, chest pain, elevated/increased heart rate, labored breathing or rapid breathing
- skin infection (bruising under the skin)
- skin wart
- increase in specific types of white blood cells (called eosinophils )
- signs of lymphopenia: low levels of white blood cells
- high levels of parathyroid hormone in the blood (a hormone that regulates calcium and phosphorus levels)
- high levels of lactate dehydrogenase (an enzyme )
- signs of low blood sugar: nausea, sweating, weakness, dizziness, tremors, headache
- dehydration
- abnormal fat content in the blood
- involuntary shaking (also called tremor )
- concentration difficulties
- discomfort and abnormal sensation to touch (also called dysaesthesia)
- fatigue (also called fatigue)
- numbness or tingling sensation in fingers and toes (also called peripheral neuropathy )
- paralysis of a muscle in the face
- red spot in the white of the eye caused by burst blood vessels (also called conjunctival hemorrhage)
- blood in the eyes (ocular hemorrhage)
- eye irritation
- signs of heart attack (also called myocardial infarction ): sudden and pressing chest pain, fatigue, irregular heartbeat
- signs of heart murmur: tiredness, chest discomfort, unsteadiness, chest pain, palpitations
- fungal infection of the feet
- signs of heart failure: shortness of breath, difficulty breathing when lying down, swollen feet or legs
- pain behind the sternum (also called pericarditis)
- signs of hypertensive crisis: severe headache, dizziness, nausea
- painful and weak legs when walking (also called intermittent claudication )
- signs of narrowing of the arteries in the extremities: possible high blood pressure, painful cramps in one or both hips, thighs, or calf muscles after certain activities such as walking or climbing stairs, numbness or weakness in the legs
- bruises (without injury)
- fatty deposits in the arteries that can cause blockage (also called arteriosclerosis )
- signs of low blood pressure (also called hypotension ), unsteadiness, dizziness, or fainting
- signs of pulmonary edema: shortness of breath
- signs of pleural effusion: accumulation of fluid between the layers of tissue surrounding the lungs and chest cavity (which if severe can reduce the heart’s ability to pump blood), chest pain, coughing, hiccups, rapid breathing
- signs of interstitial lung disease: cough, difficulty breathing, painful breathing
- signs of pleural pain: chest pain
- signs of pleurisy: cough painful breathing
- huskiness
- signs of pulmonary hypertension: high blood pressure in the pulmonary arteries
- wheezing
- sensitivity in the teeth
- signs of inflammation: (also called gingivitis ): bleeding gums, sore or swollen gums
- high levels of urea in the blood (kidney function)
- change in blood proteins (low levels of globulins or presence of paraprotein)
- high levels of unconjugated bilirubin in the blood
- high levels of troponins in the blood
Some side effects are rare (may affect up to 1 in 1,000 users)
- redness and/or swelling, possible peeling of the palms of the hands and soles of the feet (also called hand-foot syndrome)
- warts in the mouth
- the feeling of hardness or stiffness in the breasts
- inflammation of the thyroid gland (also called thyroiditis )
- affect mood or low mood
- signs of secondary hyperparathyroidism: bone and joint pain, heavy urination, abdominal pain, weakness, fatigue
- signs of narrowing of the arteries in the brain: partial or complete loss of vision in both eyes, double vision, vertigo (spinning sensation), numbness or tingling, loss of coordination, dizziness or confusion
- swelling of the brain (possibly headache and/or change in mental status
- signs of inflammation of the optic nerve: blurred vision, vision loss
- signs of heart failure (decreased ejection fraction ): fatigue, chest discomfort, unsteadiness, pain, palpitations
- low or high levels of insulin (a hormone that regulates blood sugar levels)
- low levels of insulin C-peptide (a measure of pancreatic function)
- sudden death
The following other side effects have been reported (occurring in an unknown number of users):
- signs of heart failure (ventricular dysfunction): shortness of breath, feeling of exertion at rest, irregular heartbeat, chest discomfort, unsteadiness, pain, palpitations, heavy urination, swollen feet, ankles, and swollen abdomen.
How to store Tasigna
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
- Store at a maximum of 30°C.
- Store in the original packaging. Moisture sensitive.
- Do not use this medicine if you see that the packaging is damaged or shows signs of tampering.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is nilotinib.
- Each 50 mg hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate).
Other ingredients are:
Capsule content: lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172)
Printing ink: shellac (E904), black iron oxide (E172), propylene glycol, ammonium hydroxide - Each 150 mg hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate).
Other ingredients are:
Capsule content: lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172)
Printing ink: shellac (E904), black iron oxide (E172), n-butyl alcohol, propylene glycol, anhydrous ethanol, isopropyl alcohol, ammonium hydroxide - Each 200 mg hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).
Other ingredients are:
Capsule content: lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172)
Printing ink: shellac (E904), anhydrous alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, red iron oxide (E172)
Appearance and package sizes of the medicine
Tasigna 50 mg is supplied as hard capsules. The hard capsules are red/light yellow. Each hard capsule is embossed in black (“NVR/ABL”).
Tasigna 150 mg is supplied as hard capsules. The hard capsules are red. Each hard capsule is embossed in black (“NVR/BCR”).
Tasigna 200 mg is supplied as hard capsules. The hard capsules are light yellow. Each hard capsule is imprinted in red (“NVR/TKI”).
Tasigna 50 mg is supplied in packs of 120 hard capsules (3 packs of 40 hard capsules).
Tasigna 150 mg is supplied in packs containing 28 or 40 hard capsules and in multipacks containing 112 hard capsules (consisting of 4 cartons, each containing 28 hard capsules), 120 hard capsules (consisting of 3 cartons, each containing 40 hard capsules), or 392 hard capsules (consisting of 14 cartons, each containing 28 hard capsules).
Tasigna 200 mg is supplied in wallet packs of 28 hard capsules and carton packs of 28 or 40 hard capsules. Tasigna is also supplied in multipacks of 112 hard capsules (consisting of 4 wallet packs, each containing 28 hard capsules), 112 hard capsules (consisting of 4 cartons, each containing 28 capsules), 120 hard capsules (consisting of 3 cartons, each containing 40 hard capsules) or 392 hard capsules (consisting of 14 cartons, each containing 28 hard capsules).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Farmacéutica SA
Gran Via de Les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Lek dd, PE PROIZVODNJA LENDAVA
Trimline 2D
Lendava, 9220
Slovenia
For further information about this medicine, contact the representative of the marketing authorization holder:
| België/Belgique/BelgienNovartis Pharma NVTél/Tel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lietuvos filialasPhone: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel.: +359 2 489 98 28 | Luxembourg/LuxembourgNovartis Pharma NVTél/Tel: +32 2 246 16 11 |
| Czech RepublicNovartis s.r.oPhone: +420 225 775 111 | MagyarországNovartis Hungária Kft.Tel.: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A/SPhone: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Phone: +356 2122 2872 |
| DeutschlandNovartis Pharma GmbHPhone: +49 911 273 0 | The NetherlandsNovartis Pharma BVPhone: +31 88 04 52 555 |
| EstoniaSIA Novartis Baltics Eesti branchPhone: +372 66 30 810 | NorwayNovartis Norway iPhone: +47 23 05 20 00 |
| GreeceNovartis (Greece) AEBEPhone: +30 210 281 17 12 | AustriaNovartis Pharma GmbHPhone: +43 1 86 6570 |
| SpainNovartis Farmacéutica, SAPhone: +34 93 306 42 00 | PolishNovartis Poland Sp. z o. iPhone: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Produtos Farmacêuticos, SAPhone: +351 21 000 8600 |
| HrvatskaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLPhone: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedPhone: +353 1 260 12 55 | Slovenija Novartis Pharma Services Inc.Phone: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovenian RepublicNovartis Slovakia s.r.oPhone: +421 2 5542 5439 |
| ItalyNovartis Pharma SpAPhone: +39 02 96 54 1 | Finland/FinlandNovartis Finland OyTel: +358 (0)10 6133 200 |
| CyprusNovartis Pharma Services Inc.Phone: +357 22 690 690 | SwedenNovartis Sweden ABPhone: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsPhone: +371 67 887 070 | United Kingdom (Northern Ireland) |