Iressa
gefitinib
gefitinib
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 IRESSA is and what it is used for
What you need to know before you take IRESSA
How to take IRESSA
Possible side effects
How to store IRESSA
Contents of the pack and other information
IRESSA contains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor’ (EGFR). This protein is involved in the growth and spread of cancer cells.
IRESSA is used to treat adults with non-small cell lung cancer. This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung.
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.
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.
IRESSA is not indicated in children and adolescents under 18 years.
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.
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. This is for the safety of your baby.
You may feel weak while taking treatment with Iressa. If this happens, do not drive or use any tools or
machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially
‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one 250 mg tablet per day.
Take the tablet at about the same time each day.
You can take the tablet with or without food.
Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking IRESSA.
If you have trouble swallowing the tablet, dissolve it in half a glass of still (non-fizzy) water. Do not use any other liquids. Do not crush the tablet. Swirl the water until the tablet has dissolved. This may take up to 20 minutes. Drink the liquid straight away. To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it.
If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines this medicine can cause side effects, although not everybody gets them.
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).
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
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)
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
Skin reaction on the palms of the hands and soles of the feet including tingling, numbness, pain, swelling or reddening (known as palmar-plantar erythrodysaesthesia syndrome or hand
and foot syndrome).
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).
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 via thenationalreporting
system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister and overwrap foil after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
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).
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.
AstraZeneca AB
SE-151 85
Södertälje
Sweden
SE-151 85 Södertälje
Sweden
AstraZeneca UK Limited Macclesfield
Cheshire SK10 2NA
United Kingdom
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB AstraZeneca Lietuva Tel: +370 5 2660550
АстраЗенека България ЕООД Тел.: +359 (2) 44 55 000
AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111
Associated Drug Co. Ltd Tel: +356 2277 8000
AstraZeneca BV
Tel: +31 79 363 2222
AstraZeneca
Tel: +372 6549 600
AstraZeneca AS
Tlf: +47 21 00 64 00
AstraZeneca A.E.
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AstraZeneca
Tél: +33 1 41 29 40 00
AstraZeneca Produtos Farmacêuticos, Lda. Tel: +351 21 434 61 00
AstraZeneca Pharma SRL Tel: +40 21 317 60 41
AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100
AstraZeneca UK Limited Tel: +386 1 51 35 600
Vistor hf.
Sími: +354 535 7000
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