Iressa Consumer Medicine Information
gefitinib 250 mg tablets
What is in this leaflet
This leaflet answers some of the common questions people ask about Iressa. It does not contain all the information that is known about Iressa.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Iressa against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Iressa is used for
Iressa is used to treat non-small cell lung cancer, which is one type of lung cancer.
How Iressa works
Iressa is a selective inhibitor of a growth factor that is found in non-small cell lung cancer. By blocking the action of the growth factor Iressa may slow or stop the growth of non-small cell lung cancer.
Before you use Iressa
When you must not use it
Do not use Iressa if:
- You are allergic to gefitinib or any of the other ingredients of Iressa;
Do not use Iressa if the packaging is torn or shows signs of tampering.
Do not use it to treat any other complaints unless your doctor tells you to.
Do not give this medicine to anyone else even if their symptoms seem similar to yours.
Do not give Iressa to children. There is no information on its use in children.
Before you start to use it:
Before taking Iressa, tell your doctor if you have or have had any other lung diseases, other than your lung cancer. Some of them may worsen during treatment with Iressa.
Before taking Iressa tell your doctor if you are pregnant or trying to become pregnant. You should avoid becoming pregnant during treatment with Iressa.
Before taking Iressa tell your doctor if you are breast-feeding. For the safety of your baby, you should discontinue breast-feeding during treatment with Iressa.
Taking other medicines
Tell your doctor if you are taking any other medicines, including:
- phenytoin
- carbamazepine
- rifampicin
- barbiturates
- St John's Wort
- itraconazole.
These medicines may affect the way Iressa works.
Tell your doctor if you take warfarin (to prevent blood clots), as Iressa may affect it. Your doctor may need to check your blood more often.
Tell your doctor if you are taking other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
Using Iressa
Taking your medicine
It is important to keep taking Iressa every day and as your doctor has told you to. The instructions on the label should remind you of what the doctor has said.
The usual dose is one 250 mg tablet each day.
It is best to take your tablet at the same time each day, e.g. in the morning, but it does not matter whether you take it with or without food.
Swallow the tablet whole with a glass of water. Do not chew or crush the tablet.
The tablet can also be dispersed in half a glass of drinking water (non-carbonated). No other liquids should be used. Drop the tablet in the water without crushing it, stir until the tablet is dispersed (approximately 10 minutes) and drink the liquid immediately. Rinse the glass with half a glass of water and drink.
If you forget to take it:
Take the last missed dose as soon as you remember, as long as it is at least 12 hours before the next dose is due.
If it is less than 12 hours to the next dose, do not take the dose you have missed.
Do not take a double dose to make up for the dose that you missed.
Overdose
Telephone your doctor or the National Poison Centre (Ph: 0800 POISON or 0800 764 766) or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much Iressa - even if there are no signs of discomfort or poisoning.
While you are using Iressa
Things you must do:
Be sure to keep all your appointments with your doctor so your progress can be checked. You doctor may want to do some tests from time to time to check your progress and investigate any unwanted side effects.
Tell any other doctors, dentists and pharmacists who are treating you that you are taking Iressa.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking Iressa.
If you go into hospital, please let the medical staff know you are taking Iressa.
Things you must not do:
Do not stop taking Iressa without checking with you doctor.
Side effects
Like all medicines, Iressa can have side effects. These are usually mild to moderate in intensity. Do not be alarmed by the list of side effects. You may not have any of them.
Contact your doctor without delay if any of the following happens to you, as you may need further examinations or treatment:
- Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever. Some patients taking Iressa get an inflammation of the lungs called interstitial lung disease. This side effect is uncommon and some of the patients have died from this.
- Persistent or severe diarrhoea, vomiting, nausea (feeling sick) or loss of appetite. Some patients have suffered from dehydration following these side effects.
- New eye problem, such as pain, redness or change in vision. Some patients have suffered from ulcer on the surface of the eye (cornea), sometimes with ingrowing eyelashes.
- Severe skin reactions affecting large portions of your body including redness, pain, ulcers, blisters, skin sloughing or involvement of lips and mucous membranes. This type of skin reaction is very rare.
Tell your doctor if any of the following side effects bother you.
Very common side effects:
- Diarrhoea
- Nausea (feeling sick)
- Skin reactions such as acne-like rash, sometimes itchy with dry skin.
Common side effects:
- Vomiting
- Loss of appetite
- Dehydration
- Red and sore mouth
- Nail problems
- Loss of hair
- Weakness
- Red and itchy eye
- Red and sore eyelid
- Nose bleed and blood in your urine.
Rare side effects:
- Inflammation of the pancreas, with symptoms such as very severe pain in the upper part of the stomach area and severe nausea (feeling sick) and vomiting.
Very rare side effects:
- Allergic reactions, including swelling of lips and hives.
The following side effects can also occur with Iressa, and are seen when a blood test is taken:
- Changes of the levels of liver enzymes. If these levels become very high, your doctor may need to stop the treatment.
- Changes to the way your blood clots, if you are taking warfarin (medicine to prevent your blood clotting).
Important: This leaflet alerts you to some of the situations when you should call your doctor. Other situations, which cannot be predicted, may arise. Nothing in this leaflet should stop you from calling your doctor or pharmacist with any questions or concerns you have about using Iressa.
After using it
Storage
Keep your tablets in the blister pack until it is time to take them. If you take Iressa out of the blister pack it will not keep well.
Keep the tablets in a cool dry place where the temperature stays below 30°C.
Do not store it or any other medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Do not leave it in the car on hot days.
Disposal
Return any unused medicine to your pharmacist(chemist).
Product description
Iressa tablets are round, brown, film-coated tablets. One side of the tablet is marked with "IRESSA 250".
Each tablet contains 250 mg of gefitinib as the active ingredient.
Each tablet also contains
- Lactose monohydrate
- Microcrystalline cellulose
- Croscaramellose sodium
- Povidone
- Sodium lauryl sulphate
- Magnesium stearate
- Hypromellose
- Macrogol 300
- Titanium dioxide
- Yellow iron oxide
- Red iron oxide.
Iressa comes in a blister pack containing 30 tablets.
Trademarks herein are the property of the AstraZeneca group.
10 May 2004
