GEFITINIB ACCORD 250 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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Gefitinib 250mg Film-coated Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• The full name of this medicine is Gefitinib 250mg Film-coated Tablets but within this leaflet it will be referred to as Gefitinib Tablets.

What is in this leaflet:

j What Gefitinib Tablets are and what they are used for

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What you need to know before you take Gefitinib Tablets

How to take Gefitinib Tablets

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Possible side effects

How to store Gefitinib Tablets

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Contents of the pack and other information

j What Gefitinib Tablets are and what they are used for

Gefitinib Tablets contain 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 Tablets are 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.

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What you need to know before you take Gefitinib Tablets

Do not take Gefitinib Tablets

• if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section 6, ‘’What Gefitinib Tablets contain’’).
• if you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Gefitinib Tablets

• if you have ever had any other lung problems. Some lung problems may get worse during treatment with Gefitinib Tablets
• if you have ever had problems with your liver.

Children and adolescents

Gefitinib Tablets are not indicated in children and adolescents under 18 years.

Other medicines and Gefitinib Tablets

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 Tablets work.

• 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 Tablets.

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 Tablets because Gefitinib Tablets could harm your baby. Do not take Gefitinib Tablets 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 Tablets. If this happens, do not drive or use any tools or machines.

Gefitinib Tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Gefitinib Tablets contain sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3 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 250mg 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 Tablets.

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 Tablets 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 Tablets

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.

Possible side effects

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How to store Gefitinib Tablets

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 swallowing, hives, nettle rash and difficulty breathing.
• 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 Tablets 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 Tablets
• 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 a blood test; if too high, your doctor may tell you to stop taking Gefitinib Tablets
• Increase of creatinine levels in a blood test (related to kidney function)
• Cystitis (burning sensations during urination and frequent, urgent need to urinate)
• 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).
• 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).

Contents of the pack and other information

What Gefitinib Tablets contain

The active substance is gefitinib. Each tablet contains 250mg of gefitinib.

The other ingredients are:

Tablet core: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium laurilsulfate, magnesium stearate in the core of the tablet.

Film-coating: Poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

What Gefitinib Tablets look like and contents of the pack

Gefitinib Tablets are Brown, film-coated, round, biconvex tablets, debossed with “LP100” on one side and plain on the other side. The diameter of tablet is approximately 11.13mm.

Pack size of 30 × 1 tablets in PVC/PVDC-Al perforated unit dose blisters packed in PET/Al pouch in a carton pack.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex

HA1 4HF

United Kingdom

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola

PLA 3000

Malta

This leaflet was last revised in October 2021.

If you would like a leaflet with larger text, please contact 01271 385257.

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