Patient leaflet - Gefitinib Sandoz 250 mg film-coated tablets
what it is used for
with Gefitinib because Gefitinib could harm your baby.
Do not take Gefitinib if you are breast-feeding for the safety of your baby.
Gefitinib contains the active substance gefitinib which blocks a protein called
‘epidermal growth factor receptor’
Driving and using machines
(EGFR). This protein is involved in the
If you feel weak whilst taking this medicine, take care driving or using tools or machines.
growth and spread of cancer cells.
Gefitinib is used to treat adults with
non-small cell lung cancer.
Gefitinib contains sodium and lactose
This cancer is a disease in which
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
malignant (cancer) cells form in the
tissues of the lung.
Continued on the next page >> 2 What you need to know
before you take Gefitinib
Do not take Gefitinib
3 How to take Gefitinib
if you are allergic to gefitinib or any
of the other ingredients of this
medicine (listed in section 6).
if you are breast-feeding.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Gefitinib
if you have ever had any other lung
- The recommended dose is one 250 mg tablet per day.
problems. Some lung problems may get worse during treatment with
- Take the tablet at about the same time each day.
Gefitinib.
if you have ever had problems with
You can take the tablet with or without food.
your liver.
- 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.
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).
If you take more Gefitinib than you should
- Rifampicin (for tuberculosis).
Itraconazole (for fungal infections).
If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.
Barbiturates (a type of medicine
used for sleeping problems).
Herbal remedies containing St
John’s wort (Hypericum perforatum, used for depression and anxiety).
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.
Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion,
heartburn and to reduce acids in the stomach).
- 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.
These medicines may affect the way
Gefitinib works.
Warfarin (a so-called oral
- 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.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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
non-blanching rash on the skin.
- Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).
4 Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them.
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 (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in Google play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
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.
- 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.
5 How to store Gefitinib
and other information Signature Panel:
- 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 and blister after EXP. The expiry date refers to the last day of that month.
- 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.
- This medicine does not require any special temperature storage conditions. Store in the original container in order to protect from moisture.
- Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
- 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.
- 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:
6 Contents of the pack
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
What Gefitinib contains
- The active substance is gefitinib. Each film-coated tablet contains 250 mg of gefitinib.
- The other ingredients are lactose monohydrate, microcrystalline cellulose (E 460), croscarmellose sodium (E 468), povidone K30 (E 1201), magnesium stearate (E 470b), sodium laurilsulfate, polyvinyl alcohol (E 1203), macrogol 3350 (E 1521), talc (E 553b), titanium dioxide (E 171), red iron oxide (E 172) and yellow iron oxide (E 172).
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 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)
What Gefitinib looks like and contents of the pack
Gefitinib is a round brown film-coated tablet marked with ‘250’ on one side and plain on the other side, with a diameter of 11.1 mm. Gefitinib film-coated tablets are packed in perforated unidose blisters or non-perforated blisters.
Pack sizes of 30 and 30x1, 60x1, 90x1, 100x1 and 120x1 film-coated tablets.
Multipack containing 60x1 (2 packs of 30x1) film-coated tablets
Multipack containing 90x1 (3 packs of 30x1) film-coated tablets
Not all pack sizes may be marketed.
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 1000 people
Inflammation of the blood vessels in the skin. This may give the appearance of bruising or patches of
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Sandoz Limited
Park View, Riverside Way
Watchmoor Park
Camberley, Surrey
GU15 3YL
United Kingdom
Manufacturer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate, 3056 Limassol
Cyprus
or
Lek Pharmaceuticals d.d.
Verovškova ulica 57, Ljubljana, 1526 Slovenia
This leaflet was last revised in 08/2021.
AQWA#:
Production site:
Technical num:
Old Comp num:
V005: Adaption of SPC and PIL to reference product. 005.0
Legend:
01/09/2021
Cutting:
157 x 500 mm
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