Iressa

The recommended dose is one 250 mg tablet once a day. Try to take it at the same time each day.

Iressa (Gefitinib) may be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Iressa (Gefitinib) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Iressa (Gefitinib) at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each brown, round, biconvex, film-coated tablet, impressed with "IRESSA 250" on one side and plain on the other, contains Iressa (Gefitinib) 250 mg. Nonmedicinal ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, macrogol 300, magnesium stearate, microcrystalline cellulose, povidone, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.

Iressa (Gefitinib) should not be taken by anyone who:

• is allergic to Iressa (Gefitinib) or to any of the ingredients of the medication
• has an EGFR expression negative tumour

There may be an interaction between Iressa (Gefitinib) and any of the following:

• azole antifungals (e.g., itraconazole, ketoconazole)
• barbiturates (e.g., mephobarbital, pentobarbital, secobarbital)
• Carbamazepine
• echinacea
• histamine H2-receptor antagonists (e.g., Cimetidine, Ranitidine)
• imatinib
• isoniazid
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Phenytoin
• picrolimus

• protease inhibitors (e.g., atazanavir, nelfinavir, ritonavir)
• proton pump inhibitors (PPIs; e.g., Esomeprazole, Lansoprazole, Pantoprazole)
• quinidine
• rifabutin
• rifampicin
• rifampin
• St. John's wort
• Tacrolimus
• Topotecan
• live vaccines
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Iressa (Gefitinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Iressa (Gefitinib).

Abnormal bleeding: The use of Iressa (Gefitinib) may increase the risk of bleeding. If you have signs of unusual bleeding, such as passing black tarry stools, have bloody diarrhea, vomit or cough up blood, or have unusual bruising, contact your doctor right away. People with bleeding disorders should discuss with their doctor how Iressa (Gefitinib) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Iressa (Gefitinib), and whether and special monitoring is needed. People taking blood thinners such as Warfarin should have regular blood tests to check how quickly their blood is clotting.

Dehydration: Gefitinb commonly causes diarrhea, nausea, and vomiting, which can contribute to dehydration and additional ill effects. If you experience severe diarrhea or diarrhea and vomiting for several days in a row, contact your doctor as soon as possible.

Grapefruit juice: Grapefruit juice prevents Iressa (Gefitinib) from leaving the body as it should, causing the medication to build up in the body and result in side effects. People should not drink grapefruit juice while taking Iressa (Gefitinib).

Heart rhythm: Iressa (Gefitinib) may cause abnormal changes in electrocardiograms (ECGs). People who have any heart rhythm disorder should be monitored by their doctor while taking Iressa (Gefitinib).

Interstitial lung disease (ILD): This is a rare but serious complication. People who are over 55, those with other lung or heart conditions, and people who smoke have an increased risk of death from ILD. Iressa (Gefitinib) should be stopped if ILD develops. Contact your doctor if you develop symptoms of ILD, such as shortness of breath, cough, and fever.

Kidney function: Iressa (Gefitinib) may cause kidney damage or decreased kidney function as a result of dehydration. People with reduced kidney function or Kidney Disease should discuss with their doctor how Iressa (Gefitinib) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Iressa (Gefitinib), and whether any special monitoring is needed.

Liver function: Iressa (Gefitinib) may cause liver damage or decreased liver function. People with reduced liver function or liver disease should discuss with their doctor how Iressa (Gefitinib) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Iressa (Gefitinib), and whether any special monitoring is needed. Your doctor will monitor your liver function with blood tests while you are taking Iressa (Gefitinib).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Weakness or impairment: Iressa (Gefitinib) usually does not make you drowsy or impair your ability to drive or operate machinery. However, it may make some people feel weak. Do not drive or operate machinery if you feel weak.

Pregnancy: There are no adequate studies of use of Iressa (Gefitinib) by pregnant women. Iressa (Gefitinib) may cause harm to an unborn baby if it is taken during pregnancy. If you become pregnant while taking Iressa (Gefitinib), contact your doctor immediately.

Breast-feeding: It is not known if Iressa (Gefitinib) passes into breast milk. If you are a breast-feeding mother and are taking Iressa (Gefitinib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Iressa (Gefitinib) have not been established for children under 16 years of age.