Patient leaflet - Gefitinib 250 mg film-coated tablets

1. What Gefitinib is and what it is used for

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.

2. 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 (listed in section 6 ‘What Gefitinib contains’).
if you are breast-feeding.

Warnings and precautions

Talk to 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

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 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.
If any of the above applies to you, or if you are not sure, check with your doctor or pharmacist before taking Gefitinib.
Pregnancy, breast-feeding and fertility
Talk to your doctor or pharmacist 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. This is for the safety of your baby.
Driving and using machines
You may feel weak while taking treatment with Gefitinib. If this happens, do not drive or use any 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.
Gefitinib 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 Gefitinib

Always take this medicine exactly as your doctor or pharmacist has told you to. 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.

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.

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:

Allergic reaction (common), particularly if symptoms include swollen face, lips, tongue or throat, difficulty to swallow, hives, nettle rash and difficulty breathing.

Package leaflet: Information for the patient Gefitinib 250 mg film-coated tablets

gefitinib

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: may affect more than 1 in 10 people

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.
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: may affect up to 1 in 10 people

Dry mouth
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 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: may affect up to 1 in 100 people

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.
Skin reaction on the palms of the hands and soles of the feet
including tingling, numbness, pain, swelling or reddening (known as palmar-plantar erythrodysaesthesia syndrome or hand and foot syndrome).

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

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. 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 affects you can help provide more information on the safety of this medicine.

5. 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 after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Gefitinib contains

The active substance is gefitinib. Each film-coated tablet contains
250 mg of gefitinib.
The other ingredients are lactose monohydrate, cellulose microcrystalline (Grade-101), croscarmellose sodium, povidone (K-30), sodium laurylsulfate and magnesium stearate and coating ingredients are polyvinyl alcohol (part hydrolyzed), macrogol 4000, talc, iron oxide red, iron oxide yellow and titanium dioxide.

What Gefitinib looks like and contents of the pack

Film coated tablets (tablet).

Brown coloured, round, approximately 11mm, biconvex, film coated tablets debossed with “G 250” on one side and plain on the other side.

The tablets are available in market as blister pack (i.e. clear PVC-aluminium foil blister). Pack size of 30 film coated tablets.

Marketing Authorisation Holder

Milpharm Limited

1 Roundwood Avenue

Stockley Park, Uxbridge

UB11 1AF

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate

Hal Far, Birzebbugia, BBG 3000, Malta