Active ingredient
- gefitinib
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 17901/0328.
Iressa 250mg film-coated tablets
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.
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
Warnings and precautions
Talk to your doctor or pharmacist before taking IRESSA.
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:
These medicines may affect the way IRESSA works.
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.
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.
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:
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
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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
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 nonperforated.
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last revised in December 2020.
© AstraZeneca 2020
IRESSA is a registered trademark of the AstraZeneca group of companies.
ONC 20 0080
Other sources of information
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000
Please be ready to give the following information:
Product name Reference number
Iressa 250 mg Tablets 17901/0328
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