Package Insert: Information for the Patient

Gefitinib Tablets 250 mg Film-Coated EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Gefitinib Tablet contains the active ingredient gefitinib, which blocks a protein called the "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 cells (cancerous) form from the tissues of the lung.

Do not takeGefitinib

• if you are allergic to gefitinib or any of the other ingredients in this medicine (listed in section 6 “Composition of Gefitinib”).
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take gefitinib

• if you have or have had any other lung problems. Some lung problems may worsen during gefitinib treatment.
• if you have ever had liver problems.

Children and adolescents

Gefitinib is not indicated for children and adolescents under 18 years.

Use of gefitinib with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Particularly, inform 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 sleep problems).
• Herbal medicines 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 stomach acid).

These medicines may affect the mechanism by which gefitinib acts.

• Warfarin (an oral anticoagulant to prevent blood clots). If you are taking a medicine containing this active ingredient, your doctor may need to perform more frequent blood tests.

If you find yourself in any of these situations, or if you have doubts, consult with your doctor or pharmacist before taking gefitinib.

Pregnancy, breastfeeding and fertility

Consult your doctor before taking this medicine if you are pregnant, may be pregnant or are breastfeeding.

It is recommended that you avoid becoming pregnant during gefitinib treatment, as this medicine may cause harm to your baby.

Do not take gefitinib if you are breastfeeding. This is for the safety of your baby.

Driving and operating machines

You may feel weak while on gefitinib treatment. If this happens, do not drive or use tools or machines.

Gefitinib contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Gefitinib contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one 250 mg tablet per day.
• Take the tablet approximately at the same time every day.
• You can take the tablet with or without food.
• Do not take antacids (to reduce the level of acid in 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 water (without gas). Do not use any other liquid. Do not crush the tablet. Remove the water until the tablet has dissolved. This may take up to 20 minutes. Drink the liquid immediately. To ensure that you have drunk all the medication, rinse the glass well with half a glass of water and drink it.

If you take moreGefitinibthan you should

If you have taken more tablets than you should, contact your doctor or pharmacist immediately.

If you forget to takeGefitinib

What to do if you forget to take a tablet depends on how much time is left until your next dose.

• If there are 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 there are less than 12 hours until your next dose: do not take the missed tablet. Then take the next tablet at the usual time.

Do not take a double dose (two tablets at once) to make up for missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:

• Allergic reaction (frequent), particularly if symptoms include swollen face, lips, tongue, or throat, difficulty swallowing, hoarseness, urticaria, and difficulty breathing.
• Severe difficulty breathing, or sudden worsening of breathing difficulty, possibly with cough or fever. This may indicate interstitial lung disease, a lung inflammation. This may affect approximately 1 in 100 patients taking gefitinib and may pose a life-threatening risk.
• Severe skin reactions (rare) affecting extensive areas of your body. Symptoms may include redness, pain, ulcers, blisters, and skin peeling. It may also affect your lips, nose, eyes, and genitals.
• Dehydration (frequent) caused by persistent or severe diarrhea, vomiting (urge to vomit), nausea (feeling of discomfort), or loss of appetite.
• Eye problems (infrequent), such as pain, redness, watery eyes, light sensitivity, changes in vision, or eyelid retraction. This may indicate a corneal ulcer.

Inform your doctor as soon as possible if you notice any of the following side effects:

Very frequent: may affect more than 1 in 10 people

• Diarrea
• Vomiting
• Nausea
• Skin reactions like acne-like rash, which sometimes presents as itching with dryness and/or cracks in the skin
• Loss of appetite
• Weakness
• Redness or pain in the mouth
• Increased alanine aminotransferase liver enzyme in blood tests; if this increase is too high, your doctor may recommend you stop taking gefitinib.

Frequent: may affect up to 1 in 10 people

• Dry mouth
• Dryness, redness, or itching of the eyes
• Redness and pain of the eyelids
• Nail problems
• Hair loss
• Fever
• Bleeding (such as nasal bleeding or blood in your urine)
• Proteins in your urine (detected by urine analysis)
• Increased bilirubin and another liver enzyme known as aspartate aminotransferase in blood tests; if this increase is too high, your doctor may recommend you stop taking gefitinib
• Increased levels of creatinine in blood tests (related to kidney function)
• Cystitis (burning sensation while urinating and frequent and urgent need to urinate)

Infrequent: may affect up to 1 in 100 people

• Pancreatitis. Symptoms include severe pain in the upper abdominal area and intense nausea and vomiting.
• Hepatitis. Symptoms may include general feeling of discomfort, with or without possible jaundice (yellowing of the skin and eyes). This side effect is infrequent; however, some patients have died from it.
• Gastrointestinal perforation.
• Skin reaction on the palms of the hands and soles of the feet, including tingling, numbness, pain, swelling, or redness (known as erythromelalgia or hand-foot syndrome).

Rare: may affect up to 1 in 1000 people

• Angiitis of the skin vessels. This may appear as a hematoma or skin rash that does not disappear after pressing it.
• Haemorrhagic cystitis (burning sensation while urinating and frequent and urgent need to urinate, with presence of blood in the urine).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish Medicinal Product Vigilance System:Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

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Composition ofGefitinib

• The active ingredient is gefitinib. Each tablet contains 250 mg of gefitinib.
• The other components (excipients) are sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, magnesium stearate, polyvinyl alcohol, macrogol, talc, iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172).

Appearance of the product and contents of the package

Gefitinib Sala are brown, round, coated tablets (with an approximate diameter of 11 mm), marked with “G9FB 250” on one side.

Gefitinib Sala is presented in blister packs containing 30 or 30 x 1 tablets. The blister pack may be pre-cut or not pre-cut.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Responsible manufacturer:

Synthon Hispania, S.L.

C/Castelló nº1, Pol. Las Salinas

Sant Boi de Llobregat, 08830 (Barcelona)

Spain

or

Synthon BV

Microweg 22

Nijmen

6545 CM

Netherlands

This medicine is authorized in the Member States of the EEA under the following names:

The NetherlandsGefitinib Synthon 250 mg, filmomhulde tabletten

Czech RepublicGefitinib Synthon

SlovakiaGefitinib Synthon 250 mg

PolandGefitinib Synthon

FinlandGefitinib Avansor 250 mg tabletti, kalvopäällysteinen/ Gefitinib Avansor

SwedenGefitinib Avansor

IcelandGefitinib WH

EstoniaGefitinib Auxilia

CroatiaGefitinib Alpha-Medical 250 mg filmom obložene tablete

GreeceGefitinib/Faran 250 mg/tab, επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Last review date of this prospectus:November 2021

The detailed information of this medicine is available on the web of the Spanish Agency of Medicines (AEMPS):http://www.aemps.gob.es/