| Information for
patients
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| Drug Information |
Gefitinib 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. Gefitinib 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. |
| Drug Alert |
| Alert |
|
| Before Consuming
the Medicine
|
| Avoid Drug |
•If you are allergic (hypersensitive) to gefitinib or any of the other ingredients of Gefitinib.
•If you are breast-feeding. |
| Drug Special Care |
•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. |
| Drug Drug Interactions |
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal 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 Gefitinib 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. |
| Drug Pregnancy Interaction |
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. |
| Drug Breast feeding Interaction |
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. |
| Drug Machinery Interaction |
Gefitinib has no or negligible influence on your ability to drive or use any tools or machines. However, if you feel weak whilst taking this medicine, take care driving or using tools or machines. |
| Drug More Information |
|
| How to take the
Medicine
|
| Consumption Info |
|
| Drug quanitty |
•The usual 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. |
| Drug Dose |
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. |
| Excess Drug Consumption |
If you have taken more tablets than you should, talk to a doctor or pharmacist straight away. |
| Forgot Drug Consumption |
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 product, ask your doctor or pharmacist. |
| Stop Drug Consumption |
|
| Possible Side
Effects
|
| General Information |
•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 Drug Side Effects |
•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). |
| Rare Drug Side Effects |
•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). |
| Very Rare Drug Side Effects |
•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. |
| Drug Side Effects Symptoms |
•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 changes in vision or ingrowing eyelashes. This may mean that you have an ulcer on the surface of the eye (cornea). |
| How to Store the
Medicine
|
| How to Store the Medicine |
Keep out of the reach and sight of children. Do not use Gefitinib 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. 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 to protect the environment. |
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