Iressa 250mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What IRESSA is and what it is used for
2. What you need to know before you take IRESSA
3. How to take IRESSA
4. Possible side effects
5. How to store IRESSA
6. Contents of the pack and other information

Do not take IRESSA

• if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section 6, ‘What IRESSA contains’).
• if you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking IRESSA.

• if you have ever had any other lung problems. Some lung problems may get worse during treatment with IRESSA.
• if you have ever had problems with your liver.

Children and adolescents

IRESSA is not indicated in children and adolescents under 18 years.

Other medicines and IRESSA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Phenytoin or carbamazepine (for epilepsy).
• Rifampicin (for tuberculosis).
• Itraconazole (for fungal infections).
• Barbiturates (a type of medicine used for sleeping problems).
• Herbal remedies containing St John’s wort (Hypericum perforatum, used for depression and anxiety).
• Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).

These medicines may affect the way IRESSA works.

• Warfarin (a so-called oral anticoagulant, to prevent blood clots). If you are taking a medicine containing this active substance, your doctor may need to do blood tests more often.

If any of the above applies to you, or if you are not sure, check with your doctor or pharmacist before taking IRESSA.

Pregnancy, breast-feeding and fertility

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

It is recommended that you avoid becoming pregnant during treatment with IRESSA because IRESSA could harm your baby.

Do not take IRESSA if you are breast-feeding for the safety of your baby.

Driving and using machines

If you feel weak whilst taking this medicine, take care driving or using tools or machines.

IRESSA contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

IRESSA contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially ‘sodium-free’.

If you take more IRESSA than you should

If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.

If you forget to take IRESSA

What to do if you forget to take a tablet depends on how long it is until your next dose.

• If it is 12 hours or more until your next dose: take the missed tablet as soon as you remember. Then take the next dose as usual.
• If it is less than 12 hours until your next dose: skip the missed tablet. Then take the next tablet at the usual time.

Do not take a double dose (two tablets at the same time) to make up for a forgotten dose.

Tell your doctor immediately if you notice any of the following side effects-you may need urgent medical treatment:

• Allergic reaction (common), particularly if symptoms include swollen face, lips, tongue or throat, difficulty to swallow, hives, nettle rash and difficulty breathing.
• Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever. This may mean that you have an inflammation of the lungs called ‘interstitial lung disease’. This may affect about 1 in 100 patients taking IRESSA and can be life-threatening.
• Severe skin reactions (rare) affecting large areas of your body. The signs may include redness, pain, ulcers, blisters, and shedding of the skin. The lips, nose, eyes and genitals may also be affected.
• Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
• Eye problems (uncommon), such as pain, redness, watery eyes, light sensitivity, changes in vision or ingrowing eyelashes. This may mean that you have an ulcer on the surface of the eye (cornea).

Tell your doctor as soon as possible if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

• Diarrhoea.
• Vomiting.
• Nausea.
• Skin reactions such as an acne-like rash, which is sometimes itchy with dry and/or cracked skin.
• Loss of appetite.
• Weakness.
• Red or sore mouth.
• Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA.

Common: may affect up to 1 in 10 people

• Dry mouth
• Dry, red or itchy eyes.
• Red and sore eyelids.
• Nail problems.
• Hair loss.
• Fever.
• Bleeding (such as nose bleed or blood in your urine).
• Protein in your urine (shown in a urine test).
• Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA.
• Increase of creatinine levels in a blood test (related to kidney function).
• Cystitis (burning sensations during urination and frequent, urgent need to urinate).

Uncommon: may affect up to 1 in 100 people

• Inflammation of the pancreas. The signs include very severe pain in the upper part of the stomach area and severe nausea and vomiting.
• Inflammation of the liver. Symptoms may include a general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes). This side effect is uncommon; however, some patients have died from this.
• Gastrointestinal perforation.

Rare: may affect up to 1 in 1,000 people

• Inflammation of the blood vessels in the skin. This may give the appearance of bruising or patches of non-blanching rash on the skin.
• Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

UK

Ireland

Malta

What IRESSA contains

• The active substance is gefitinib. Each tablet contains 250 mg of gefitinib.
• The other ingredients (excipients) are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, povidone (K29-32) (E1201), sodium laurilsulfate, magnesium stearate, hypromellose (E464), macrogol 300, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

What IRESSA looks like and contents of the pack

IRESSA is a round brown tablet marked with ‘IRESSA 250’ on one side and plain on the other.

IRESSA comes in blister packs of 30 tablets. The blister foil may be perforated or non-perforated.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Manufacturer: