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What Tasigna is and what it is used for
How does Tasigna work?
In CML patients, a change in DNA (genetic material) generates a signal that causes the body to produce abnormal white blood cells. Tasigna blocks this signal and stops the formation of these cells.
Follow your treatment with Tasigna
During the treatment you will be given regular examinations, including blood tests. They will be tracked through them:
- the amount of blood cells in your body (white blood cells, red blood cells and platelets) to determine how you are treated with Tasigna.
-the weight of the electrolytes in your body (potassium, magnesium). They are important to the functioning of the heart.
- the fat in your blood.
Your heart rate will also be checked using a machine that measures the electrical activity of the heart (the study is called "ECG").
If you have any questions about how Tasigna works or why you are prescribed, please contact your doctor.
2. What you need to know before taking Tasigna
Carefully observe all of the physician's instructions. These 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 this medicine
Warnings and precautions
Talk to your doctor or pharmacist before taking Tasigna
- if you have experienced a cardiovascular event such as a heart attack, chest pain (angina pectoris), problems with blood supply to the brain (stroke) or limb problems (claudication), or if you have risk factors for a cardiovascular event such as high Blood pressure (hypertension), diabetes, or problems with the level of fat in the blood (lipid disorders).
- if you have a heart condition, such as a changed electrical signal called "QT prolongation".
- if you are taking medicines that affect heart rhythm (antiarrhythmic) or affect the liver (see "Other medicines and Tasigna").
- If you suffer from a lack of potassium or magnesium.
- if you have liver or pancreas disease.
- if you have symptoms such as getting bruises, tiredness or shortness of breath, or if you are often ill with infections.
- if you have undergone a surgical operation involving total stomach removal (total gastrectomy).
If any of these conditions apply to you, tell your doctor.
During treatment with Tasigna
- If you become faint (lose consciousness) or have irregular heart rhythm while you are on Tasigna, tell your doctor immediately as this may indicate a serious heart condition. Prolonged QT interval or abnormal heart rhythm can cause sudden death. Uncommon cases of sudden death have been reported in patients treated with Tasigna.
- If you get sudden palpitations, severe muscle weakness or paralysis, convulsions or a sudden change in your way of thinking or consciousness, tell 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 Tasigna patients.
- If you experience chest pain or discomfort, stiffness or weakness, walking or speech problems, pain, loss of color or feeling cold in any limb, tell your doctor immediately as these may be signs of a cardiovascular event. There have been reports of serious cardiovascular events including problems with foot blood flow (peripheral arterial occlusive disease), coronary heart disease and cerebrovascular disorders (ischemic cerebrovascular disease) in patients taking Tasigna. Your doctor should check the level of fat (lipids) and sugar in your blood before initiating treatment with Tasigna
If you get swelling of the legs or arms, generalized edema or you quickly gain weight, tell your doctor as these may be signs of severe fluid retention. Uncommon cases of fluid retention have been reported in patients treated with Tasigna.
Other medicines and Tasigna
Tasigna may interact with some other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, this includes:
-antiatharithmic medicines - used to treat irregular heart rhythms;
Chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin - medicines that may have an adverse effect on heart function;
Ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin - used to treat infections;
-ritonavir - a medicine of the group of protease inhibitors used to treat AIDS virus;
Carbamazepine, phenobarbital, phenytoin - used to treat epilepsy;
- rifampicin - used to treat tuberculosis
Cyclosporine, sirolimus and tacrolimus - medicines that suppress the body's ability to fight infections; They are usually used to prevent rejection of transplanted organs such as liver, heart and kidney;
Dihydroergotamine and ergotamine - used to treat dementia;
-ostatstatin, simvastatin - used to treat elevated blood fat levels;
- warfarin - used to treat blood clotting disorders (such as blood clots or thrombosis);
-astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine).
These medicines should be avoided while taking Tasigna. If you are taking any of these, your doctor may prescribe other alternative medicines.
In addition, tell your doctor or pharmacist before taking Tasigna if you are taking any antacids, these are heartburn medicines. These medicines should be taken separately from Tasigna:
-H2 blockers, which reduce the formation of acid in the stomach. H2 blockers should be taken approximately 10 hours before and approximately 2 hours after ingestion
- antacids containing aluminum hydroxide, magnesium hydroxide and simethicone, which neutralize the high acidity of the stomach. These medicines should be taken approximately 2 hours before or approximately 2 hours after taking Tasigna.
Also, you should tell your doctor if you are already taking Tasigna and have been prescribed a new medicine that you have not previously taken during Tasigna treatment.
Tasigna with food and beverages
Do not take Tasigna with food. Food may increase the absorption of Tasigna and thus increase the amount of Tasigna in the blood to a level that may harm you. Do not drink grapefruit juice and do not eat grapefruit. This may increase the amount of Tasigna in the blood to a level that may harm you.
Older people (over / over 65)
Tasigna can be used by patients over 65 years of age at the same doses as other adults.
Pregnancy, breastfeeding and fertility
-Tasigna is not recommended during pregnancy unless clearly necessary. If you are pregnant or suspect that you may be pregnant, tell your doctor who will discuss with you whether you can continue to take Tasigna during pregnancy.
- Women who are likely to become pregnant are advised to use highly effective methods of contraception during treatment and for two weeks after stopping treatment.
-Training is not recommended during Tasigna treatment. If you are breast-feeding tell your doctor.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
If you experience side effects (such as dizziness and vision disturbances) with potentially affecting the ability to drive or use tools or machines after taking Tasigna, you should refrain from these activities until the reaction has passed.
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 product.
3. How to take Tasigna
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
How much Tasigna to take
The recommended dose is 600 mg daily. This dose is achieved by taking two hard capsules of 150 mg twice daily.
Your doctor may prescribe a lower dose depending on how you respond to treatment.
When to take Tasigna
Take the hard capsules:
- once a day (approximately every 12 hours);
At least 2 hours after any meal;
- Then wait 1 hour before eating again.
If you have any questions about when to take Tasigna, ask your doctor or pharmacist. Taking Tasigna at the same time each day will help you remember when to take the pound capsules.
How to take Tasigna
- Swallow hard capsules whole with water.
Do not take any food at the same time as hard capsules.
Do not open hard capsules unless it is impossible to swallow them whole. In this case, you can dissolve the contents of each hard capsule in one teaspoon of apple puree and take it immediately. Do not use more than one teaspoon of apple puree for each hard capsule and do not use any food other than apple puree.
How long to take Tasigna
Continue to take 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 see if the treatment has the desired effect.
If you have any questions about how long to take Tasigna, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. Most side effects are mild to moderate and usually disappear after a few days to a few weeks of treatment.
Some side effects may be serious.
These side effects are common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people) or have been reported in very few patients.
- rapid increase in body weight, swelling of the hands, ankles, feet or face (signs of water retention)
- chest pain, high blood pressure, abnormal heart rhythm, blue lips, tongue or skin (signs of heart disease)
- difficulty breathing, cough, wheezing with or without fever, swelling of the feet or feet (signs of lung disease)
- high temperature, easy bruising, frequent infections (signs of blood disorders)
Blurred vision, loss of vision, haemorrhage in the eye (signs of eye disease)
Swelling and pain in one part of the body (signs of formation of a thrombus in a vein)
- nausea, nausea, constipation, abdominal swelling (signs of gastrointestinal disease)
- severe upper abdominal pain (a sign of pancreatitis)
- yellowing of the skin and eyes, nausea, lack of appetite, dark urine coloring (signs of liver disease)
-bear, painful red lumps, pain in the joints and muscles (signs of skin diseases)
- very strong thirst, excessive urine output, increased appetite for weight loss, tiredness (signs of high blood sugar)
(Eg high levels of potassium, uric acid and phosphorus and low levels of calcium), heartburn, urinary incontinence, tiredness and / or discomfort in the joints associated with abnormal blood tests (eg, high levels of potassium, uric acid and phosphorus and low levels of calcium)
- pain, discomfort, weakness or spasms in the leg muscles, which may be due to reduced blood flow, foot or hand sores that heal slowly or not at all, visible changes in color (bluish or pale) or temperature (cold ) On the legs or arms, as these symptoms may be signs of blockage of the arteries of the affected limb (foot or hand) or fingers (toes and hands)
If you get any of the side effects listed, tell your doctor immediately.
Some side effects are very common (may affect more than 1 in 10 people)
- rash, rash, urticaria
- high level of bilirubin in the blood (hepatic function)
- high level of lipase in the blood (pancreatic function)
If any of these side effects affect you severely, tell your doctor.
Some side effects are common (may affect up to 1 in 10 people)
- diarrhea, vomiting, abdominal discomfort, stomach discomfort after feeding, gas, swelling or ballooning of the abdomen
- chest pain, joint pain, muscle cramps, pain in the limbs, back pain, pain or discomfort in one half of the body
- eye inflammation, swelling, secretion, itching or redness, dry eye (signs of eye disease)
- skin redness, dry skin, acne, warts, decreased skin sensitivity
Loss of appetite, change in taste, weight gain
Night sweats, increased sweating, hot flashes
- dizziness, vertigo
Palpitations (feeling palpitations)
If any of these side effects affect you severely, tell your doctor.
Some side effects are uncommon (may affect up to 1 in 100 people)
- skin pain
- swelling of the eyelids
- Bloody nose
- numbness or stiffness
- feeling change in body temperature (including feeling of heat, feeling cold)
- bluish plaques from red / silver skin (signs of psoriasis)
If any of these side effects affect you severely, tell your doctor.
The following other side effects have been reported in very few patients treated with Tasigna:
- loss of memory, mood disorders or depressed mood, lack of energy, general malaise
-leaf, bacterial skin infection
Blistering, skin cyst, oily skin, thinning of the skin, dark spots on the skin, discoloration of the skin
- increased sensitivity of the skin
- Bleeding, sensitivity or growth of the gums
-hreams or stuffy nose, sneezing
-dishness in the mouth, sore throat, mouths in the mouth
- pain or redness of the eyes, pain, itching of the eyelids
- painful and swollen joints (gout), muscle weakness
- difficulty and painful urination, increased urinating urgency
Frequent urination, abnormal urine color
- Feeling of chest tightness, severe menstruation, swelling of the nipples
- appetite disorders, weight loss
- severe headache often accompanied by nausea,
How to store Tasigna
-Due to keep out of reach of children.
-Do not use this medicine after the expiry date which is stated on the carton and the 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 packaging is damaged or shows signs of tampering.
-Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Tasigna contains
The active substance is nilotinib. Each hard capsule contains 150 mg of nilotinib (as hydrochloride monohydrate).
- The other ingredients are: lactose monohydrate, crospovidone, poloxamer 188, colloidal anhydrous silica and magnesium stearate. The hard capsule consists of gelatin, titanium dioxide (E171), red and yellow iron oxide (E172) and shellac and black iron oxide (E172) for printing the inscription.
What Tasigna looks like and contents of the pack
Tasigna is available as hard capsules. Hard capsules are red. Each hard capsule has a black label ("NVR / BCR").
Tasigna is available in packs containing 28 or 40 hard capsules and in group packs containing 112 hard capsules (including 4 cartons each containing 28 hard capsules) or 120 hard capsules (including 3 cartons each containing 40 hard capsules ).
Not all packs may be marketed in your country.
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