Iressa

Package leaflet: Information for the patient

IRESSA 250 mg film-coated tablets

gefitinib
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What IRESSA is and what it is used for

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 cells (cancer) form in the lung tissue.

2. What you need to know before taking IRESSA

Do not take IRESSA

• if you are allergic to gefitinib or to any of the other ingredients of this medicine (listed in section 6, “What IRESSA contains”).
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking IRESSA

• if you have ever had any other lung problems. Some lung conditions may worsen during treatment with IRESSA.
• if you have ever had liver problems.

Children and adolescents
IRESSA is not indicated in children and adolescents under 18 years of age.
Other medicines and IRESSA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform 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 sleep 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 stomach acidity). These medicines may affect how IRESSA works.
• Warfarin (an oral anticoagulant used to prevent blood clots). If you are taking a medicine containing this active substance, your doctor may need to perform blood tests more frequently.

If any of the above conditions apply to you, or if you have any doubts, consult your doctor or pharmacist before taking IRESSA.

Pregnancy, breastfeeding, and fertility
Consult your doctor before taking this medicine if you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding.
It is recommended to avoid becoming pregnant during treatment with IRESSA, as IRESSA may harm the unborn baby.
Do not take IRESSA if you are breastfeeding. This is for the safety of the baby.

Driving and using machines
You may feel weak during treatment with IRESSA. If this occurs, you must not drive or operate tools or machinery.

IRESSA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

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

3. How to take IRESSA

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

• The recommended dose is one 250 mg tablet daily.
• Take the tablet at approximately the same time each day.
• You may take the tablet with or without food.
• Do not take antacids (to reduce the acidity level in your stomach) within two hours before or one hour after taking IRESSA.

If you have difficulty swallowing the tablet, dissolve it in half a glass of plain water (not sparkling). Do not use any other liquid. Do not crush the tablet. Gently swirl the glass until the tablet dissolves, which may take up to 20 minutes. Drink the liquid immediately. To ensure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink it as well.

If you take more IRESSA than you should
If you have taken more tablets than prescribed, contact your doctor or pharmacist immediately.

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

• If there are 12 hours or more until your next dose: take the missed tablet as soon as you remember. Then take your next dose at the usual time.
• If there are less than 12 hours until your next dose: skip the missed tablet and take the next tablet at the usual time. Do not take a double dose (two tablets at the same time) to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of the following side effects –
you may need urgent medical treatment:

• Allergic reactions (common), especially if symptoms include swelling of the face, lips, tongue or throat, difficulty swallowing, hives, or breathing difficulties.
• Severe shortness of breath or sudden worsening of shortness of breath, possibly with cough or fever. This could mean you have inflammation of the lungs called "interstitial lung disease". This occurs in about 1 in 100 patients taking IRESSA and can be life-threatening.
• Severe skin reactions (rare) affecting large areas of the body. Symptoms may include redness, pain, ulcers, blisters, and peeling of the skin. Lips, nose, eyes, and genitals may also be affected.
• Dehydration (common) caused by persistent or severe diarrhoea, vomiting (feeling unwell), nausea (feeling sick), or loss of appetite.
• Eye problems (uncommon), such as pain, redness, watering, sensitivity to light, changes in vision, or inward growth of eyelashes. This could indicate 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 acne-like rash, sometimes with itching and dry and/or cracked skin
• Loss of appetite
• Weakness
• Red or sore mouth
• Increase in a liver enzyme known as alanine aminotransferase in blood tests; if too high, your doctor may tell you to stop treatment with IRESSA

Common: may affect up to 1 in 10 people

• Dry mouth
• Dry, red or itchy eyes
• Red and painful eyelids
• Nail problems
• Hair loss
• Fever
• Bleeding (such as nosebleeds or blood in the urine)
• Presence of protein in the urine (detected by urine test)
• Increase in bilirubin and another liver enzyme known as aspartate aminotransferase in blood tests; if too high, your doctor may tell you to stop treatment with IRESSA
• Increase in creatinine levels in blood tests (related to kidney function)
• Cystitis (burning sensation when passing urine, and frequent and urgent need to urinate)

Uncommon: may affect up to 1 in 100 people

• Inflammation of the pancreas. Signs include severe pain in the upper stomach area and severe nausea and vomiting.
• Inflammation of the liver. Symptoms may include a general feeling of being unwell, with or without jaundice (yellowing of the skin and eyes). This is an uncommon side effect; however, some patients have died from this event.
• Gastrointestinal perforation.
• Skin reaction on the palms of the hands and soles of the feet including tingling, numbness, pain, swelling or redness (known as palmar-plantar erythrodysesthesia or hand-and-foot syndrome).

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

• Inflammation of blood vessels in the skin. This may cause bruising or red patches that do not fade when pressure is applied to the skin.
• Haemorrhagic cystitis (burning sensation when passing urine, frequent and urgent need to urinate, with blood in the urine).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IRESSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and foil sheet following EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What IRESSA contains

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

Description of the appearance of IRESSA and contents of the pack
IRESSA is a round, brown tablet, marked with "IRESSA 250" on one side and smooth on the other.
IRESSA is supplied in packs of 30 tablets in blisters. The blister may be perforated or non-perforated.

Marketing Authorization Holder
AstraZeneca AB,
SE-151 85, Södertälje,
Sweden

Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden
AstraZeneca UK Limited,
Macclesfield,
Cheshire, SK10 2NA,
United Kingdom

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
AstraZeneca SA/NV UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

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

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft
Tel: +420 222 807 111 Tel.: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 79 363 2222

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 2 106871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

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

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija United Kingdom (Northern Ireland)
SIA AstraZeneca Latvija AstraZeneca UK Ltd
Tel: +371 67377100 Tel: +44 1582 836 836

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu