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Tasigna 200mg Capsules

15,275.00 SAR

Tasigna 200mg Capsules
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About Product

Product Description:



  • 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 myelogenous leukemia (Ph-positive CML). 

  • CML is cancer of the blood that causes the body to produce too many abnormal white blood cells.

  • Tasigna is used in adults and children who have recently been told they have CML, or in patients who have no longer benefited from previous treatment (including imatinib).

  • It is also used for adults and children who have had serious side effects from previous treatment, and therefore cannot continue with it.


How Tasigna works:



  • In patients with CML, a change in the DNA (hereditary material) will trigger a signal that tells the body to produce abnormal white blood cells. 

  • Tasigna blocks this signal and thus stops the production of these cells.


Check during treatment with Tasigna


Samples, including blood tests, will be taken regularly while the treatment is ongoing.


 These tests will check:



  • The amount of blood cells (white blood cells, red blood cells and platelets ) in the body to see how well Tasigna is tolerated.

  • The function of the pancreas and liver to see how well Tasigna is tolerated.

  • The amount of electrolytes in the body (potassium, magnesium). These are important for the heart to function.

  • The amount of sugar and fat in the blood.

  • The heart rhythm will also be examined using a machine that measures electrical activity in the heart (a test called "ECG").

  • Your doctor will regularly evaluate your treatment and decide whether you should continue taking Tasigna.

  • If you are told to stop using this medicine, your doctor will continue to monitor your disease.

  • You may be told to restart treatment with Tasigna, if your condition makes it necessary.

  • Ask your doctor if you have any questions about how Tasigna works or why it has been prescribed for you or your child.


How To Use



  • Always use this medicine exactly as your doctor or pharmacist has told you.

  • Contact a doctor or pharmacist if you are unsure.


How much Tasigna to take:


Use in adults:



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

  • This dose is achieved by taking 2 hard capsules of 150 mg twice a day.

  • Patients who no longer benefit from previous treatments for CML : The recommended dose is 800 mg daily. 

  • This dose is achieved by taking 2 hard capsules of 200 mg twice a day.


Use in children and adolescents:



  • The dose your child will receive will depend on the 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 to your child. 

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

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


Elderly people (65 years and over):



  • Tasigna can be used by people aged 65 and over with the same dose as for adults.


When should Tasigna be taken?


Take the hard capsules:



  • Twice daily (approximately every 12 hours)

  • At least 2 hours after any kind of food

  • Then wait 1 hour before eating again

  • Consult your doctor or pharmacist if you have any questions about when to take this medicine. 

  • Taking Tasigna at the same time each day will help you remember when to take the hard capsules.


How To Take Tasigna:



  • Swallow the hard capsules whole with water.

  • Do not eat any kind of food with the hard capsules.

  • Do not open the hard capsules unless you are unable to swallow them.

  • If you are unable to swallow the hard capsules, you can stir the contents of each hard capsule into one teaspoon of applesauce and take it immediately. 

  • Do not use more than one teaspoon of applesauce for each hard capsule, and do not use any food other than applesauce.


How long should Tasigna be taken for?



  • Continue to take Tasigna every day for as long as your doctor has told you.

  • This is a long-term treatment.

  • Your doctor will regularly check your condition to assess whether the treatment is having the desired effect.

  • The doctor may consider stopping treatment with Tasigna based on specific criteria. 

  • Talk to your doctor if you have any questions about how long to take Tasigna.


If you take too much Tasigna:



  • If you have taken too much Tasigna, or if someone has accidentally taken your hard capsules, contact your doctor or hospital immediately for advice. 

  • Show them the pack of hard capsules and this leaflet. Medical treatment may be necessary.


If you have forgotten to take Tasigna:



  • If you miss a dose, take your next dose at the usual time. 

  • You should not take a double dose to replace a forgotten hard capsule.


If you stop treatment with Tasigna:



  • Do not stop taking this medicine unless your doctor tells you to.

  • Discontinuing Tasigna without your doctor's advice exposes you to the risk of worsening your disease which could have life-threatening consequences. 

  • Always discuss with your doctor, nurse and/or pharmacist if you are considering stopping Tasigna.


If the doctor recommends that you discontinue treatment with Tasigna:



  • Your doctor will regularly evaluate your treatment using a specific diagnostic method and decide whether you should continue using this medicine. 

  • If you are told to stop using Tasigna, your doctor will continue to monitor your disease closely before, during and after you stop using Tasigna.

  • You may be told to restart treatment with Tasigna, if your condition makes it necessary.

  • Ask your doctor or pharmacist if you have any questions about the use of this medicine.


Warnings And Precautions:


Follow all instructions from your doctor carefully,


 even if they differ from the general information in this leaflet.


Do not use Tasigna:



  • If you are allergic to nilotinib or any of the other ingredients of this medicine .

  • If you think you may be allergic, consult your doctor before taking tasigna .


 


Talk to your doctor or pharmacist before using Tasigna:



  • If you have had previous cardiovascular events such as a heart attack , chest pain ( angina ), problems with the blood supply to the brain (stroke) or problems with the blood supply to the legs (claudication), or if you have risk factors for cardiovascular disease such as high blood pressure ( hypertension ), diabetes or problems with the amount of fat in your blood (lipid disorders).

  • If you have a heart condition , such as an abnormal electrical signal called "prolongation of the qt interval".

  • If you are treated with medicines that lower the cholesterol level in the blood ( statins ) or affect the heart rhythm ( antiarrhythmics ) or the liver (see other medicines and tasigna ).

  • If you are deficient in potassium or magnesium.

  • If you have a disease of the liver or pancreas.

  • If you have symptoms such as easily bruising, feeling tired or short of breath or you have experienced repeated infections .

  • If you have had an operation that involved removal of the entire stomach (total gastrectomy ).

  • If you have, or have ever had, a hepatitis b infection ( inflammation of the liver caused by infection with the hepatitis b virus). This is because tasigna can cause hepatitis b to become active again, which in some cases can be life-threatening. Before treatment is started, you will be carefully examined by your doctor for signs of such an infection .

  • Contact your doctor if any of this applies to you or your child.


During treatment with Tasigna:



  • If you faint (lose consciousness) or have an irregular heartbeat 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 irregular heartbeat can lead to sudden death.

  • uncommon cases of sudden death have been reported in patients taking tasigna.

  • If you suddenly experience palpitations, severe muscle weakness or paralysis, convulsions or a sudden change in mindset or level of alertness, contact your doctor immediately as this may be a sign of a rapid breakdown of cancer cells called tumor lysis syndrome.

  • rare cases of tumor lysis syndrome have been reported in patients treated with tasigna.

  • If you develop chest pain or discomfort, numbness or weakness, trouble walking or your ability to speak, pain, discoloration or a cold feeling in a leg or arm, tell your doctor immediately , as these may be symptoms of a cardiovascular event. Serious

  • Cardiovascular events including problems with blood supply to the leg (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 amount of fat (lipids) and sugar in your blood before you start treatment with tasigna and during treatment.

  • If you develop swelling of the feet or hands, general swelling or rapid weight gain, tell your doctor, as this may be a sign 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 being treated with tasigna, tell the doctor if your child has any of these conditions.


Children and youth:



  • Tasigna is a treatment for children and adolescents with CML. There is no experience with the use of this medicine in children under 2 years of age.

  • There is no experience with the use of Tasigna in children under 10 years of age with newly diagnosed CML. 

  • There is limited experience with use in patients under 6 years of age, who no longer benefit from previous treatments for CML.

  • Some children and adolescents taking Tasigna may grow more slowly than normal. 

  • The doctor will monitor the growth using regular examinations.


Other medicines and Tasigna:



  • Some other medicines affect or are affected by Tasigna.


Talk to your doctor or pharmacist if you use, have recently used or plan to use other medicines. This applies in particular to:



  • Antiarrhythmics – used to treat irregular heart rhythms

  • Chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin - medicines that can have an unwanted effect on the heart's electrical activity

  • Ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat infections

  • Ritonavir - a medicine in the class "antiproteases", which is used in the treatment of hiv

  • Carbamazepine, phenobarbital, phenytoin – used to treat epilepsy

  • Rifampicin – used to treat tuberculosis

  • John's wort – a natural remedy used to treat depression and other conditions (also known as hypericum perforatum )

  • Midazolam – used as an anxiolytic before surgical interventions

  • Alfentanil and fentanyl – used to treat pain and as a sedative before or during surgery or medical treatment

  • Cyclosporine, sirolimus and tacrolimus – medicines that reduce the body's ability to defend itself and fight infections and are usually used to prevent rejection of transplanted organs such as the liver, heart and kidney

  • Dihydroergotamine and ergotamine – used to treat dementia

  • Lovastatin, simvastatin – used to treat high levels of fat in the blood

  • Warfarin – used to treat blood clotting disorders (such as blood clots and thrombosis )

  • Astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil eller ergotalkaloider (ergotamin, dihydroergotamin).

  • These medicines must be avoided while being treated with tasigna. 


If you take any of these, it is possible that your doctor will prescribe other alternative medicines:



  • Talk to your doctor or pharmacist if you are using a statin (a type of medicine that lowers cholesterol levels in the blood). 

  • If Tasigna is used together with certain statins , the risk of getting muscle problems from statins may increase. 

  • In rare cases, this can lead to severe muscle breakdown ( rhabdomyolysis ), which can cause kidney damage.

  • Also inform the doctor or pharmacist before taking Tasigna if you use antacids used for heartburn . 


These medicines must be taken separately from Tasigna:



  • H2 receptor blockers that reduce the production of acid in the stomach. H2 blockers should be taken approx.
    10 hours before and approx. 2 hours after taking Tasigna.

  • Antacids containing aluminum hydroxide, magnesium hydroxide and simethicone which neutralize high acid content in the stomach. These antacids should be taken approx. 2 hours before or approx. 2 hours after taking Tasigna.

  • You must also inform your doctor if you are already taking Tasigna and you are prescribed a new medicine that you have not previously used during treatment with Tasigna.

  • Taking Tasigna together with food and drink

  • Do not take Tasigna with food. Food can enhance the absorption of Tasigna and thus increase the amount of Tasigna in the blood to a potentially harmful level. 

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


Pregnancy And Breastfeeding:



  • Tasigna is not recommended during pregnancy unless strictly necessary.

  • If you are pregnant or think you may be, tell your doctor who will discuss with you whether you can take this medicine during pregnancy.

  • Women who may become pregnant are advised to use very safe contraception during treatment and up to two weeks after treatment ends.

  • 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.

  • Talk to your doctor or pharmacist before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant.


Driving And Using Machines:



  • If after taking this medicine you experience side effects (such as dizziness or visual disturbances) that could potentially affect your ability to drive, use tools or machines in a safe manner, you should avoid these activities until the effect has disappeared.

  • Tasigna contains lactose

  • This medicine contains lactose (also known as milk sugar). 

  • If your doctor has told you that you have an intolerance to some types of sugar, you should contact your doctor before taking this medicine.


How to store Tasigna:



  • Keep out of reach of children.

  • Do not use this medicine after the expiry date which is stated on the carton and blister pack after EXP. 

  • The expiration date is the last day of the specified month.

  • Store at a maximum of 30ºc.

  • Store in the original packaging to protect against moisture.

  • Do not use this medicine if you notice that the packaging is broken or shows signs of being damaged.

  • Medicines must not be thrown into waste water or together with household waste.

  • Ask the pharmacy how to dispose of medicines that you no longer use. 

  • These measures will help to protect the environment.


Ingredients:


The active substance is NILOTINIB.



  • Each 150 mg hard capsule contains 150 mg NILOTINIB (as hydrochloride monohydrate).

  • Each 200 mg hard capsule contains 200 mg NILOTINIB (as hydrochloride monohydrate).

Product Details:

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