IRESSA 250 mg FILM-COATED TABLETS

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).
• if you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking IRESSA

• if you have or have had any other lung problems. Some lung problems may get worse during treatment with IRESSA.
• if you have ever had liver problems.

Children and adolescents

IRESSA is not intended for use 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 sleep problems).
• Herbal medicines 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 stomach acid).

These medicines may affect how IRESSA works.

• Warfarin (an oral anticoagulant to prevent blood clots). If you are taking a medicine that contains this active substance, your doctor may need to perform blood tests more often.

If you are in any of these situations, or if you have any doubts, talk to your doctor or pharmacist before taking IRESSA.

Pregnancy, breast-feeding, and fertility

Talk to your doctor before taking this medicine if you are pregnant, might be pregnant, or are breast-feeding.

You are advised to avoid becoming pregnant while taking IRESSA, as this medicine may harm your baby.

Do not take IRESSA if you are breast-feeding. This is because of the potential risk to your baby.

Driving and using machines

You may feel weak while taking IRESSA. If this happens, do not drive or use tools or machines.

IRESSA contains lactose

If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

IRESSA contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially "sodium-free".

3. How to take IRESSA

Take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

• 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 in your stomach) 2 hours before or 1 hour after taking IRESSA.

If you have problems swallowing the tablet, you can dissolve it in half a glass of water (still water, not sparkling). Do not use any other liquid. Do not crush the tablet. Stir the water until the tablet has dissolved. This may take up to 20 minutes. Drink the liquid immediately. To make sure you take all the medicine, rinse the glass 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 your doctor or pharmacist immediately.

If you forget to take IRESSA

What you should do if you forget a dose depends on how much time is left until your next dose.

• If there are 12 hours or more until your next dose: take the missed dose as soon as you remember. Then take the next dose as usual.
• If there are less than 12 hours until your next dose: do not take the missed dose. Take the next dose 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 other questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, IRESSA 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 the symptoms include swollen face, lips, tongue, or throat, difficulty swallowing, hives, and difficulty breathing.
• Severe difficulty breathing, or sudden worsening of breathing difficulties, possibly with cough or fever. This may mean you have a condition called "interstitial lung disease". This can affect up to 1 in 100 patients taking IRESSA and can be life-threatening.
• Severe skin reactions (rare) affecting large areas of your body. The symptoms may include redness, pain, ulcers, blisters, and skin peeling. It can also affect your lips, nose, eyes, and genitals.
• Dehydration (common) caused by persistent or severe diarrhea, vomiting, nausea, or loss of appetite.
• Eye problems (uncommon), such as pain, redness, watery eyes, sensitivity to light, changes in vision, or eyelid retraction. This may mean you have an ulcer on the surface of your 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

• Diarrhea
• Vomiting
• Nausea
• Skin reactions such as acne-like rash, which may be itchy with dryness and/or cracking of the skin
• Loss of appetite
• Weakness
• Mouth redness or pain
• Increased liver enzyme alanine aminotransferase in blood tests; if this increase is too high, your doctor may recommend that you stop taking IRESSA.

Common: may affect up to 1 in 10 people

• Dry mouth
• Dry, red, or itchy eyes
• Redness and pain of the eyelids
• Nail problems
• Hair loss
• Fever
• Bleeding (such as nosebleeds or blood in your urine)
• Protein in your urine (detected in a urine test)
• Increased bilirubin and another liver enzyme called aspartate aminotransferase in blood tests; if this increase is too high, your doctor may recommend that you stop taking IRESSA.
• Increased creatinine levels in blood tests (related to kidney function)
• Cystitis (pain when urinating and needing to urinate frequently and urgently)

Uncommon: may affect up to 1 in 100 people

• Pancreatitis (inflammation of the pancreas). The symptoms include severe pain in the upper part of the stomach area and severe nausea and vomiting.
• Hepatitis (inflammation of the liver). The symptoms may include a general feeling of being unwell, with or without possible yellowing of the skin and eyes (jaundice). This side effect is uncommon; however, some patients have died from it.
• Gastrointestinal perforation.
• Skin reaction on the palms of your hands and soles of your feet that includes tingling, numbness, pain, swelling, or redness (known as palmar-plantar erythrodysesthesia syndrome or hand-and-foot syndrome).

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

• Vasculitis (inflammation of blood vessels in the skin). This may look like bruising or areas of skin rash that do not fade when pressed.
• Hemorrhagic cystitis (pain when urinating and needing to urinate frequently and urgently, with blood in your 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.

5. Storage of 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 tubular container after EXP. The expiry date refers to the last day of the month stated.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help 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 are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, povidone (K29-32) (E1201), sodium lauryl sulfate, magnesium stearate, hypromellose (E464), macrogol 300, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Appearance and packaging

IRESSA is a brown, round tablet marked with "IRESSA 250" on one side and plain on the other.

IRESSA is available in blister packs containing 30 tablets. The blister may be precut or not precut.

Marketing authorisation 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

You can get more information about this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.