Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - iressa

Document Subject

Generated Narrative: MedicinalProductDefinition mpa7a8f3aaed2850db2f524101df25e7ab

identifier: http://ema.europa.eu/identifier/EU/1/09/526/001 perforated blister

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: IRESSA 250 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a7a8f3aaed2850db2f524101df25e7ab

identifier: http://ema.europa.eu/identifier/EU/1/09/526/001 perforated blister

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - iressa

Attesters

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

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 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 .

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.

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 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.

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), 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 SE-151 S dert lje Sweden Manufacturer AstraZeneca AB G rtunav gen SE-152 57 S dert lje 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: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 (2) 44 55 Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 79 363 2Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 2 106871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 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: