Gefitinib Glenmark 250 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Gefitinib Glenmark is and what it is used for
2. What you need to know before you take Gefitinib Glenmark
3. How to take Gefitinib Glenmark
4. Possible side effects
5. How to store Gefitinib Glenmark
6. Contents of the pack and other information

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

Talk to your doctor or pharmacist before taking Gefitinib Glenmark

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

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

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 Glenmark 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 Glenmark.

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 Glenmark because Gefitinib Glenmark could harm your baby.

Do not take Gefitinib Glenmark if you are breast-feeding. This is for the safety of your baby.

You may feel weak while taking treatment with Gefitinib Glenmark. If this happens, do not drive or use any tools or machines.

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

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

If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.

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.

• 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 Glenmark 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).

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 Glenmark

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 Glenmark
• 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 1000 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).

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

Gefitinib Glenmark is a round, brown, biconvex film-coated tablet, marked with “250” on one side and plain on the other. The film-coated tablets have a diameter of approx. 11.1 mm and a thickness of approx. 5.6 mm.

Gefitinib Glenmark comes in blister packs of 30 tablets. The blister foil may be perforated or non-perforated.

Marketing Authorisation Holder:

Manufacturer: