Tasigna 200 mg hard capsules

Tasigna
200 mg hard capsules

Nilotinib

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Tasigna is and what it is used for


• 2. Before you take Tasigna


• 3. How to take Tasigna


• 4. Possible side effects


• 5. How to store Tasigna


• 6. Further information

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 patients with CML who are no longer benefiting from previous treatment including imatinib. It is also used in 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 your Tasigna treatment

You will have regular tests, including blood tests, during treatment. These will monitor the amount of blood cells (white blood cells, red blood cells and platelets) in your body to see how Tasigna is tolerated.

If you have any questions about how Tasigna works or why it has been prescribed for you, ask your doctor.

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 (hypersensitive) to nilotinib or any of the other ingredients of Tasigna listed at the end of this leaflet.

If you think you may be allergic, tell your doctor before taking Tasigna.

Take special care with Tasigna

• 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 Taking other medicines).


• if you suffer from lack of potassium or magnesium.


• if you have been treated with a medicine of the type called anthracyclines (frequently used in leukaemia therapy).


• if you have a liver or pancreas disorder.

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

During treatment with Tasigna

• if you faint (loss of consciousness) or have an irregular heart beat while taking Tasigna, 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.

Taking other medicines

Tasigna may interfere with some other medicines.

Tell your doctor or pharmacist before taking Tasigna if you are taking or have recently taken any –other medicines, including medicines obtained without a prescription. This includes in particular:

• antiarrhythmics – used to treat irregular heart beat;


• chloroquine, halofantrine, clarithromycin, haloperidol, methadone - medicines that may have an unwanted effect on the function of the heart;


• ketoconazole, itraconazole, voriconazole, moxifloxacin, 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;


• 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.

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.

Taking Tasigna with food and drink

• 
  Do not take Tasigna with food. Take the capsules at least 2 hours after any food and then wait at least 1 hour before eating again. For more information, see under "When to take Tasigna" in section 3.


• Do not drink grapefruit juice or eat grapefruit. It may increase the amount of Tasigna in the blood, possibly to a harmful level.

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.

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 Tasigna during your pregnancy.


• 
  Women who might get pregnant are advised to use effective contraception during treatment.


• 
  Breast-feeding is not recommended during treatment with Tasigna. Tell your doctor if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any 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 Tasigna, you should refrain from these activities until the effect has disappeared.

Important information about some of the ingredients of Tasigna

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.

How To Take Tasigna

Always take Tasigna exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much Tasigna to take

• The starting dose is 800 mg per day. This dose is achieved by taking two capsules of 200 mg twice a day.

When to take Tasigna

Take the 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 Tasigna, talk to your doctor or pharmacist. Taking Tasigna at the same time each day will help you remember when to take your capsules.

How to take Tasigna

• Swallow the capsules whole with water.


• Do not open the capsules.


• Do not take any food together with the capsules.

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.

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

If you stop taking Tasigna

Do not stop taking Tasigna unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Tasigna 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 common, uncommon or have been reported in very few patients.

• rapid weight gain, swelling of hands, ankles, feet or face


• chest pain, high blood pressure, irregular heart rhythm (signs of heart disorders)


• difficulty breathing, cough, wheezing, swelling of the feet or legs (signs of lung disorders)


• fever, sore throat, mouth sores, weakness, bruising, frequent infections (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 (signs of nervous system disorders)


• thirst, dry skin, irritability, dark urine, decreased urine output (signs of kidney disorders)


• blurred vision, loss of vision, visible bleeding in white of eye (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 stools, constipation, swollen abdomen (signs of gastrointestinal disorders)


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


• rash, painful red lumps, pain in joints and muscles (signs of skin disorders)


• excessive thirst, high urine output, increased appetite with weight loss, tiredness (signs of high level of sugar in the blood)

If you get any of these, tell your doctor straight away.

Some side effects are very common.

These effects may affect more than 10 in every 100 patients.

• nausea, constipation, diarrhoea


• headache


• tiredness


• itching, rash


• low level of white blood cells, red blood cells or platelets and high level of lipase in the blood (changes in blood test results)

If any of these affects you severely, tell your doctor.

Some side effects are common.

These effects may affect between 1 and 10 in every 100 patients.

• vomiting, abdominal pain, stomach discomfort after meals, flatulence


• bone pain, pain in joints, muscle spasms, muscle pain


• skin reddening, dry skin


• loss of appetite, weight decrease or increase


• hair loss


• insomnia


• night sweats, excessive sweating, hot flushes


• dizziness, generally feeling unwell; spinning sensation


• tingling or numbness


• voice disorder


• abnormal liver function tests and other changes in blood test results such as a high level of potassium or a low level of magnesium


• palpitations (sensation of rapid heart beat)

If any of these affects you severely, tell your doctor.

Some side effects are uncommon.

These effects may affect less than 1 in every 100 patients.

• decreased or increased skin sensitivity


• eye irritation, swelling, discharge, itching or redness, dry eye (signs of eye disorders)


• dry mouth


• heartburn, swelling or bloating of the abdomen


• breast pain


• nose bleed


• increased appetite


• anxiety


• depression


• difficulty and pain when urinating, exaggerated sense of needing to urinate


• inability to achieve or maintain an erection


• breast enlargement in men


• flu-like symptoms


• trembling


• decreased sharpness of vision


• frequent urine output


• abnormal kidney function test results


• severe headache often accompanied by nausea, vomiting and sensitivity to light

If any of these affects you severely, tell your doctor.

The following other side effects have been reported in very few patients treated with Tasigna:

• confusion, disorientation


• sensation of numbness or tingling in fingers and toes


• increased sensitivity of the eyes or the skin to light


• eye pain or redness, pain, swelling and itching of the eyelids


• difficulty hearing, ear pain


• joint stiffness, muscle weakness


• unconsciousness


• blood in urine


• weight gain, tiredness, hair loss, muscle weakness, feeling cold

If any of these affects you severely, tell your doctor.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Tasigna

• Keep out of the reach and sight of children.


• Do not use Tasigna after the expiry date which is stated on the carton and blister foil. 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 any pack that is damaged or shows signs of tampering.

Further Information

What Tasigna contains

• The active substance is nilotinib. Each capsule contains 200 mg nilotinib (as hydrochloride monohydrate).


• The other ingredients are lactose monohydrate, crospovidone, poloxamer 188, silica colloidal anhydrous, magnesium stearate. The capsule shell is composed of gelatin, titanium dioxide (E171), yellow iron oxide (E172) and, shellac, red iron oxide (E172) and soya lecithin (E322) for stamping of the imprint.

What Tasigna looks like and contents of the pack

Tasigna is supplied as hard capsules. The capsules are light yellow. A red imprint is stamped on each capsule ("NVR/TKI").

Tasigna is available in weekly and monthly packs:

• The weekly pack contains 28 capsules.


• The monthly pack contains 112 capsules (4x28). A monthly pack consists of 4 individual weekly packs.

Not all packs may be marketed in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

United Kingdom

Manufacturer

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:

United Kingdom

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

This leaflet was last approved in 12/2009