Product Information for the Patient

Gefitinib Sandoz 250 mg Film-Coated Tablets EFG

gefitinib

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

1. What isGefitinib Sandozand for what it is used

2. What you need to know before starting to takeGefitinib Sandoz

3. How to takeGefitinib Sandoz

4. Possible side effects

5. Storage ofGefitinib Sandoz

6. Contents of the pack and additional information

Gefitinib Sandoz 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 take Gefitinib Sandoz

• if you are allergic to gefitinib or any of the other ingredients in this medication (listed in section 6),
• 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 Sandoz is not indicated for children and adolescents under 18 years.

Other medications and Gefitinib Sandoz

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

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• Phenytoin or carbamazepine (for epilepsy).
• Rifampicin (for tuberculosis).
• Itraconazole (for fungal infections).
• Barbiturates (a type of medication 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, stomach acid, and to reduce stomach acid).

These medications may affect the mechanism by which gefitinib acts.

• Warfarin (an oral anticoagulant for preventing blood clots). If you are taking a medication 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 medication if you are pregnant, may be pregnant, or are breastfeeding.

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

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

Driving and operating machinery

If you feel weak while taking this medication, be careful when driving or using tools or machines.

Gefitinib Sandoz contains sodium and lactose

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; this is essentially “sodium-free”.

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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 more Gefitinib Sandoz than you should

If you have taken more tablets than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Gefitinib Sandoz

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 can 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, which can affect approximately 1 in 100 patients taking gefitinib and may be life-threatening.
• 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 retraction of eyelids. 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)

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

Frequent: (may affect up to 1 in 10 people)

• Dry mouth,
• Dryness, redness, or itching of the eyes,
• Redness and pain of eyelids,
• Nail problems,
• Hair loss,
• Fever,
• Bleeding (such as nosebleeds or blood in urine),
• Protein in urine (detected in a urine test),
• Increased bilirubin and aspartate aminotransferase enzyme levels in blood tests; if this increase is too high, your doctor may recommend stopping gefitinib,
• Increased creatinine levels 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 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,

Hand and foot syndrome, which includes tingling, numbness, pain, swelling, or redness (also known as erythema multiforme or palmar-plantar erythrodysesthesia syndrome).

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

• Angiitis of the skin. 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 blood in urine).

Reporting 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 theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keepthis medicationout of the sight and reach of children.
• Do not usethis medicationafter the expiration date that appears onthe box and blisterpack after CAD/EXP. The expiration date is the last day of the month indicated.
• This medication does not require any special storage temperature.Store in the original packaging to protect it from moisture.

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

Composition ofGefitinib Sandoz

• The active ingredient is gefitinib.

Each film-coated tablet contains 250 mg of gefitinib.

• The other components are:lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone K30 (E1201), magnesium stearate (E470b), sodium lauryl sulfate, polyvinyl alcohol (E1203), macrogol 3350 (E1521), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

Appearance of the product and contents of the package

Gefitinib Sandoz arebrown film-coated, round, tablets marked with a “250” on one side and smooth on the other side. The diameter of the film-coated tablet is 11.1 mm. Gefitinib Sandoz film-coated tabletsare packaged in perforated aluminum blisters OPA/AL/PVC or non-perforated aluminum blisters OPA/AL/PVC.

Package sizes: 30 and 30x1, 60x1, 90x1, 100x1, and 120x1 film-coated tablets.

Multi-pack containers containing 60 x1 (2 packs of 30x1) film-coated tablets.

Multi-pack containers containing 90 x1 (3 packs of 30x1) film-coated tablets

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

or

Lek Pharmaceuticalsd.d.

Verovškova, 57

SLO-1526Ljubljana

Slovenia

This medicinal product is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Germany:Gefitinib HEXAL 250 mg Filmtabletten

Belgium:Gefitinib Sandoz 250 mg filmomhulde tabletten

Bulgaria:????????? ?????? 250 mg ????????? ????????

Cyprus:Gefitinib Sandoz film-coated tablets 250mg

Croatia:Gefitinib Sandoz 250 mg filmom obložene tablete

France:GEFITINIB SANDOZ 250 mg, comprimé pelliculé

Netherlands:Gefitinib Sandoz 250 mg, filmomhuldetabletten

Hungary:Gefitinib Sandoz 250 mg filmtabletta

Italy:Gefitinib Sandoz

Lithuania:Gefitinib Sandoz 250 mg plevele dengtos tabletes

Latvia:Gefitinib Sandoz 250 mg apvalkotas tabletes

Poland:Gefitinib Sandoz, 250 mg, tabletki powlekane

United Kingdom

(Northern Ireland)

:Gefitinib Sandoz 250 mg Film-coated Tablets

Czech Republic:Gefitinib Sandoz

Romania:Gefitinib Sandoz 250 mg comprimate filmate

Last date of revision of thissummary of product characteristics:November 2021.

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/