InfoCons Consumer Protection informs you – Iressa – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.  Keep this leaflet. Y ou may nee dto 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 onto others. I t may harm them, even if their signs of illness are the same as yours.  If you get any side e ffects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in t hisleaflet :

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

ℹ️ 1. What IRESSA is and what it is used for

IRESSA contains the active substance gefitinib which blocks a protein called ‘epidermal growth fa ctor 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.

⚠️ 2. What yo uneed to know before you take IRESSA

Do not take IRESSA

 if you are allergic to ge fitinib or any of the other ingredients of this medicine (listed in section6, ‘What IRESSA contains’).  if you are breast -feeding.

Warnings and precautions

Talk t o your doc tor 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.

32Children and adolescents IRESSA is not indicated i n children and ad olescents under 18 years.

Other medicines and IRESSA

Tell your doctor or ph armacist if you are taking, have recently taken, or might take any oth er medicines.

In particular, tell your doctor or pharmacist if you are taking any of the fol lowing med icines:  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 u lcers, indigestion, heartburn and to reduce acids in the stomach).

These medicines may affect the way IRESSA works.  Warfarin (a so -called oral anticoagulant, to pr event bloo dclots). If you are taking a medicine containing this active substance, your docto r may need to do blood tests more often.

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

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

It is recomme nded 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.

Driving and using machines

You may feel weak while taking treatment w ith Iressa. If this happens, do not drive or use any tools or machines .

IRESSA contains lac tose

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

IRESSA contains sodium

This medicine contains less than 1 mm ol(23 mg) of sodium per dose, that is to say it is essenti ally ‘sodi um-free’.

💊 3. How to take IRESSA

Always take this medicine exa ctly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

33 The recommended dose is one 250 mg tablet per day.  Take the tablet at about the same time e ach day.  You can take the tablet with or without food.  Do not take antac ids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking IRESSA .

If you have trouble swallowing t hetablet, dissolve it in half a glass of still (non -fizzy )water. D onot use any other liquids. Do not crush the tablet. Swirl th e 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 aglass of water and drink it.

If you take more IRESSA than y ou 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 onhow lon git isuntil 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 th enext tab let 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 do ctor or pharmacist.

❗ 4. Possible side effects

Like all m edicines t his med icine can cause side effects, although not everybody ge ts them.

Tell your doctor immediately if you notice any of the following side effects -you may need urgent medical treatmen t:  Allergic reaction (common), particularly if symptoms i nclude swollen fa ce, lips, tongue or throat, difficulty to swallow, hive s, 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 call ed ‘int erstitial lung disease’. This may affect about 1 in 100 patients taking IRESSA and can be life -threatening.  Sever e skin reactions (rare) affecting large areas of your body. The sign s may include redness, pain, ulcers, blisters, and sheddin gof the s kin. Th elips, 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 ey es, light sensiti vity,changes in vision or ingrowing eyelashes. This ma y mean that you have an ulcer on the surface of the eye (cornea).

34Tell your doctor as soon as possible if you notice any of t hefollowing side effects:

Very common : may affect more t han 1 in 1 0peopl e

 Diarrhoea  Vomiting  Nausea  Skin reactio ns such as an acne -like rash, which is sometimes itchy with dry and/or cracked skin  Loss of appetite  Weakness  Red or sore mout h  Increase of a liver enzyme known as alanine aminotransfera se in a blood test; if too hig h, your doctor may tell you to stop taki ng IRESSA

Common : may affect up to 1 in 10 people

 Dry mouth  Dry, red or itchy eyes  Red and sore eyelids  Nail p roblems  Hair loss  Fever  Bleeding (such as nose bleed or bloo d in your urine)  Protein in your urine (shown in a urine test)  Increas e of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may te llyou to stop taking IRESSA  Increase of creatinine levels i n a blood test (relate dto kidne yfunct ion)  Cystitis (b urning sensatio ns during urination and frequent, urgent need to urinate )

Uncommon : may affect up to 1 in 100 people

 Inflammat ion of the pancreas. The signs include very severe pain in t he upper part of the stomach area and severe na usea an dvomiting.  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.  Gastrointest inal pe rforation  Skin r eaction on the palms of the hands and soles of the feet including tingling, numbness, pain, swelling or reddening (known as palm ar-plantar erythrodysaesthesia syndrome or hand and foot s yndrome).

Rare : may affect up to 1in 1000 people

 Inflammation of the blood vessels in the skin. This may give the appearance of bruising or patches of non -blanching rash on the ski n.  Haemo rrhagic cystitis ( burning sensations during urinat ion and frequent, urgent need to urinate with bloo din the u rine).

35Reporting 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 via the national reporting system listed in Appendix V . By reporti ng side effects you can help provide more information on t he safety of this medicine.

🌡️ 5. How to store IRESSA

Keep this me dicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, bliste r and overwrap foil after EXP. The expiry date refers to t he last day of that month.

Store in the original package i norder to protect from moisture.

Do not throw away any medicines via wastewater or h ousehold waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

📦 6. Contents of the pac k and othe rinfor mation

What IRESSA contains

 The active substance is gefitinib. Each tablet con tains 250 mg of gefitinib.  The other ingredients (exc ipients) are lactose monohydrate, microcrystalline cellulo se (E460), croscarmellose sodium, povidone (K29 -32)(E1201) ,sodiu mlaurilsulfate, magnesium stearate, hypromellose (E464), macrogol 300, titaniu m dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

What IRESSA looks like and contents of t he pack IRESSA is a round brown tablet marked wi th‘IRESSA 250’ o none side and plain on the other.

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

Marketing Authorisation Holder

AstraZeneca AB SE-15185 Södertälje Sweden

Manufacturer

AstraZeneca A B Gärtunav ägen SE-152 57 Södertälje Sweden 36AstraZeneca UK Limited Macclesfield Cheshire SK10 2NA United Kingdom For any information about this med icine, please contact the local representative of the Mark eting Authorisation Holder:

België/Belgique/Belg ien AstraZ eneca S.A./N.V.

Tel: +32 2 370 48 11Lietuva UAB AstraZeneca Lietuva Tel: +370 5 26605 50 България АстраЗенека България ЕООД Тел.: +359 ( 2) 44 55 000Luxembourg/Luxemburg AstraZeneca S.A./N.V.

Tél/Tel: +32 2 370 48 11 Česká republika AstraZe necaCzech Republic s.r.o.

Tel: +420 222 807 111Magyarország AstraZeneca Kft.

Tel.: +36 1 883 6500 Danmark AstraZeneca A/S Tlf: +45 43 66 64 62Malta Associated Drug Co. Ltd Tel: +356 2277 8000 Deutschland AstraZeneca GmbH Tel: +49 40 809034100Neder land Astra Zene caBV Tel: +31 79 363 2222 Eesti AstraZeneca Tel: +372 6549 600Norge AstraZeneca AS Tlf: +47 21 00 64 00 Ελλάδα AstraZeneca A.E.

Τηλ: +30 2 106871500Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0 España AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00Polska AstraZeneca Pharma Poland Sp. z o.o.

Tel.: +48 22 245 73 00 France AstraZ eneca Tél: +33 1 41 29 4 0 00Portugal AstraZeneca Produtos Farmacêuticos, Lda.

Tel: +351 21 434 61 00 Hrvatska AstraZeneca d.o.o.

Tel: +385 1 4628 000România AstraZeneca Pharma SRL Tel: +40 21 317 60 41 37Ireland AstraZeneca Pharmaceuticals (Ireland )DAC Tel: +353 1609 710 0Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600 Ísland Vistor hf.

Sími: +354 535 7000Slovenská republika AstraZeneca AB, o.z.

Tel: +421 2 5737 7777 Italia AstraZeneca S.p.A.

Tel: +39 02 00704500Suomi/Finland Astra Zeneca Oy Puh/Tel: +358 10 23 010 Κύπρος Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305Sverige AstraZeneca AB Tel: +46 8 553 26 000 Latvija SIA AstraZeneca Latvija Tel: +371 67377100United Kingdom (Northe rn Ireland) AstraZeneca UK Lt d Tel: +44 1582 83 6836

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema. europa.eu

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Iressa (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/09/526).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.