Iressa - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

IRESSA 250 mg film-coated tablets gefitinib

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

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 (cancer) cells form in the tissues of the lung.

2. What you need to know before you take IRESSA

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. This is for the safety of your baby.

Driving and using machines

You may feel weak while taking treatment with Iressa. If this happens, do not drive or use any 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’.

3. How to take IRESSA

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 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 medicine, ask 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 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
• 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).

Rare: may affect up to 1 in 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 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 via the national reporting system listed in. 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 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.

6. Contents of the pack and other information

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),

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

SE-151 85

Sódertalje

Sweden

Manufacturer

AstraZeneca AB

Gartunavagen

SE-151 85 Sódertalje

Sweden

AstraZeneca UK Limited

Macclesfield

Cheshire SK10 2NA

United Kingdom

For any information about this medicine, please

Authorisation Holder:

Belgie/Belgiqu­e/Belgien

AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11

Efcarapua

Acmpa3eHeKa Etarapua EOOfl

Tea.: +359 (2) 44 55 000

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AstraZeneca Czech Republic s.r.o.

Tel: +420 222 807 111

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Tlf: +45 43 66 64 62

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Tel: +49 41 03 7080

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AstraZeneca A.E.

Tql: +30 2 106871500

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AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00

France

AstraZeneca

Tél: +33 1 41 29 40 00

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Tel: +385 1 4628 000

contact the local representative of the Marketing

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UAB AstraZeneca Lietuva

Tel: +370 5 2660550

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Tel.: +48 22 245 73 00

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Tel: +351 21 434 61 00

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Kvnpog AXeKTop Oap^aKeuTiK^ At5 TqX: +357 22490305	Sverige AstraZeneca AB Tel: +46 8 553 26 000
Latvija SIA AstraZeneca Latvija Tel: +371 67377100	United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

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