Gefitinib Tablets

WHAT YOU NEED TO KNOW BEFORE YOU TAKE GEFITINIB

Do not take Gefitinib

• If you are allergic to gefitinib or any of the other ingredients of this medicine.
• If you are breast-feeding.

Warnings and Precautions

• Check with your doctor or pharmacist before taking Gefitinib.
• If you have ever had any other lung problems.
• Some lung problems may get worse during treatment with Gefitinib.
• If you have ever had problems with your liver.

Children and Adolescents

• Gefitinib is not indicated in children and adolescents under 18 years.

Other Medicines and Gefitinib

• Please tell your doctor or pharmacist if you are taking or have recently taken 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).

If you take more Gefitinib 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 Gefitinib

• 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.

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 Gefitinib because Gefitinib could harm your baby.
• Do not take Gefitinib if you are breast-feeding for the safety of your baby.

Driving and using machines

• If you feel weak whilst taking this medicine, take care driving or using tools or machines.
• Gefitinib 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.

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 (uncommon), particularly if symptoms include swollen face, tongue or throat, difficulty to swallow, hives and difficulties to breathe.
  — 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 Gefitinib 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 Side Effects (affects more than 1 user in 10)
• 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.
•  Dry, 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 Gefitinib.

Common Side Effects (affects 1 to 10 users in 100)

•  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 Gefitinib.
•  Increase of creatinine levels in a blood test (related to kidney function).
•  Cystitis (burning sensations during urination and frequent, urgent need to urinate).

Uncommon Side Effects (affects 1 to 10 users in 1,000)

•  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.

Rare Side Effects (affects 1 to 10 users in 10,000)

•  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.

HOW TO TAKE GEFITINIB TABLETS

• 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 Gefitinib.
• 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.

HOW TO STORE GEFITINIB

• 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.