IRESSA 250 mg film-coated tablets

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.

Do not take IRESSA

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

Take special care with IRESSA

Check with 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.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal 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, H 2-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 and breast-feeding

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.

Driving and using machines
IRESSA has no or negligible influence on your ability to drive or use any tools or machines. However, if you feel weak whilst taking this medicine, take care driving or using tools or machines.

Important information about some of the ingredients of IRESSA

This medicine 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.

Always take IRESSA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

• The usual 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 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.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, IRESSA can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows:

• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
• not known: frequency cannot be estimated from the available data.

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

• Allergic reaction (uncommon), particularly if symptoms includeswollen face, tongue or throat, difficulty to swallow, hives and difficulties to breathe.
• 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 changes in vision or ingrowing eyelashes. This may mean that you have an ulcer on the surface of the eye (cornea).

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

Very commonside effects

• 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
• Dry, 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 side effects

• 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)

Uncommonside effects

• 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 side effects

• 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use IRESSA 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What IRESSA contains

• The active substance is gefitinib. Each tablet contains 250 mg of gefitinib.
• The other ingredients 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

AstraZeneca AB
S-151 85 Sodertalje
Sweden

Manufacturer
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 (see contacts list):

BelgiëBelgiqueBelgien NV AstraZeneca SA Tel 32 2 370 48 11 LuxembourgLuxemburg NV AstraZeneca SA TélTel 32 2 370 48 11

AstraZeneca UK Limited . 359 2 971 25 33 Magyarország AstraZeneca kft Tel. 36 1 883 6500

eská republika AstraZeneca Czech Republic s.r.o. Tel 420 222 807 111 Malta Associated Drug Co. Ltd Tel 356 2277 8000

Danmark AstraZeneca AS Tlf 45 43 66 64 62 Nederland AstraZeneca BV Tel 31 79 363 2222

Deutschland AstraZeneca GmbH Tel 49 41 03 7080 Norge AstraZeneca AS Tlf 47 21 00 64 00

Eesti AstraZeneca Tel 372 6549 600 Österreich AstraZeneca Österreich GmbH Tel 43 1 711 31 0

AstraZeneca A.E. 30 2 106871500 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel. 48 22 874 35 00

España AstraZeneca Farmacéutica Spain, S.A. Tel 34 91 301 91 00 Portugal AstraZeneca Produtos Farmacêuticos, Lda. Tel 351 21 434 61 00

France AstraZeneca Tél 33 1 41 29 40 00 România AstraZeneca Pharma SRL Tel 40 21 317 60 41

Ireland AstraZeneca Pharmaceuticals Ireland Ltd Tel 353 1609 7100 Slovenija AstraZeneca UK Limited Tel 386 1 51 35 600

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika AstraZeneca AB o.z. Tel 421 2 5737 7777

Italia AstraZeneca S.p.A. Tel 39 02 98011 SuomiFinland AstraZeneca Oy PuhTel 358 10 23 010

Sverige AstraZeneca AB

357 22490305 Tel 46 8 553 26 000

Latvija AstraZeneca AB prstvniecba Latvij Tel 371 67377100 United Kingdom AstraZeneca UK Ltd Tel 44 1582 836 836

Lietuva
UAB AstraZenecaLietuva
Tel: +370 5 2660550

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