Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Iressa (Gefitinib). If you are concerned about side effects, discuss the risks and benefits of Iressa (Gefitinib) with your doctor.

The following side effects have been reported by at least 1% of people taking Iressa (Gefitinib). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• red, itchy eye
• red, sore eyelid
• severe or long-lasting diarrhea, vomiting, nausea, or loss of appetite
• signs of allergic reaction (e.g., skin rash, itching, redness)
• ulcer on the surface of the eye (with or without ingrowing eyelashes)
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with Fever or discomfort)
• signs of bleeding (e.g., blood in urine, coughing blood, cuts that don't stop bleeding)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of severe breathing problems (e.g., chest pain, severe or worsening breathlessness with or without cough or fever)
• sudden severe headache

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Iressa (Gefitinib).

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:

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.