Iressa (Gefitinib)

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Gefitinib 250mg

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Manufactured by: Cipla Ltd
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Gefitinib 250mg
Product of Australia
Manufactured by Cipla Ltd
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Iressa 250mg

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Manufactured by: AstraZeneca
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Iressa 250mg
Product of Canada
Manufactured by AstraZeneca
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Gefitinib 250mg

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Manufactured by: Apotex Inc
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Gefitinib 250mg
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Manufactured by Apotex Inc
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Gefitinib 250mg

Product of India
Manufactured by: Natco Pharma Ltd.
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Gefitinib 250mg
Product of India
Manufactured by Natco Pharma Ltd.
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Iressa (Gefitinib) Dosage and Side Effects

IRESSA is a cancer medication that interferes with the growth and spread of cancer cells in the body.  IRESSA is used to treat non-small cell lung cancer.  IRESSA is sometimes used to treat cancer that has spread to other parts of the body.

Proper Use of this medication

Usual dose:

Take one 250 mg tablet, once a day, every day, at about the same time. You can take IRESSA with or without food.

This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you forget to take a dose, take the last missed dose as soon as you remember, as long as it is at least 12 hours before the next dose is due.

If it is less than 12 hours until the next dose, do not take the dose you have missed.

Side Effects

Like all medicines, IRESSA can have side effects. These are usually mild to moderate in intensity, and reversible. Side effects often start during the first month of taking IRESSA.

Talk to your doctor if any of the following happens to you. You may need further examinations or treatment:

Very common side effects (Greater than or equal to 10 of every 100 patients):

  • Diarrhoea, nausea, vomiting, stomatitis (red and sore mouth)

  • Loss of appetite

  • Skin reactions such as rash, itching dry and/or cracked skin

  • Weakness (asthenia)

Common side effects (Greater than or equal to 1 every 100 patients, but less than 10 of every 100 patients):

  • Dry mouth

  • Nosebleed or blood in the urine

  • Protein in your urine (shown in a urine test)

  • Burning sensations during urination and frequent, urgent need to urinate (cystitis)

  • Nail problems

  • Loss of hair

  • Eye problems (dry, red, itchy eye or red and sore eyelid)

  • Fever

Uncommon side effects (Greater than or equal to 1 of every 1000 patients, but less than 1 of every 100 patients):

  • Unexpected bleeding if you are taking warfarin.

The following side effects can also occur with IRESSA, and they are seen when a blood test is taken:

Very common (Greater than or equal to 10 of every 100 patients):

  • Changes to the level of one liver enzyme known as alanine aminotransferase (ALT).

Common (Greater than or equal to 1 every 100 patients, but less than 10 of every 100 patients):

  • Changes to the level of bilirubin and the other liver enzyme known as aspartate aminotransferase (AST).

  • Changes to the level of creatinine in your blood, which shows how well your kidneys are working. This is often a consequence of diarrhoea or vomiting, which may lead to severe dehydration.

Uncommon (Greater than or equal to 1 of every 1000 patients, but less than 1 of every 100 patients):

  • Changes to the way your blood clots, if you are taking warfarin (medicine to prevent blood-clotting).

This is not a complete list of side effects. For any unexpected effects while taking IRESSA, contact your doctor or pharmacist.

Warnings and Precautions

Serious Warnings and Precautions

IRESSA should be prescribed by a health care professional experienced in the treatment and management of patients with cancer.

IRESSA should not be used in patients with EGFR mutation negative tumours.

IRESSA has not been studied in patients with severely reduced kidney function.

Isolated cases of liver failure have been reported in patients taking IRESSA, and some patients have died from this.

Gastrointestinal perforation (a hole through the wall of the stomach or intestine), including fatal cases, was reported in patients taking IRESSA.

BEFORE you use IRESSA, talk to your doctor or pharmacist if:

  • You have, or have had, lung diseases other than lung cancer. Some of them may worsen during treatment with IRESSA.

  • You are pregnant, or plan to become pregnant.

  • You are breastfeeding.

  • You have a disorder affecting the liver.

  • You have eye problems or wear contact lenses.

  • You have kidney problems.

  • You smoke, are at an advanced age, have a history of gastrointestinal ulceration, have cancer that has spread to the bowel, or are taking steroids or non-steroidal anti-inflammatory drugs.

Bleeding has been reported with the use of IRESSA such as nosebleed, blood in the urine, coughing up of blood and bleeding from the lungs.

IRESSA is not expected to impair your ability to drive or use machines. However, some patients may occasionally feel weak. If this happens, you should not drive or operate machinery.

IRESSA is not recommended for use in patients under 16 years of age.

Interactions with this medication

Please inform your doctor if you are taking or have taken any medicines (including medicines taken some time ago), even those available over the counter. Your doctor especially needs to know if:

  • You take any of the following medicines: phenytoin, carbamazepine, rifampicin, barbiturates, St John's Wort, itraconazole, ketoconazole, protease inhibitors (drugs to treat HIV/AIDS) or macrolide antibiotics such as erythromycin or clarithromycin. These medicines may affect the way IRESSA works. Your doctor should also know if you drink grapefruit juice.

  • You take warfarin (to prevent blood-clots), as IRESSA may affect it. Your doctor may need to check your blood more often.

  • You take any medicines which are used to help reduce stomach acid (e.g., ranitidine, sodium bicarbonate, proton-pump inhibitors).

Other related products

The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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