GEFITINIB GENTHON 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Gefitinib Genthon 250 mg film-coated tablets EFG

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.
• 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. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Gefitinib Genthon and what is it used for

Gefitinib Genthon contains the active substance gefitinib, which blocks a protein called "epidermal growth factor receptor" (EGFR). This protein is involved in the growth and spread of tumor cells.

Gefitinib is used to treat adults with non-small cell lung cancer. This cancer is a disease in which malignant (cancerous) cells form in the tissues of the lung.

2. What you need to know before you take Gefitinib Genthon

Do not take Gefitinib Genthon

• if you are allergic to gefitinibor to any of the other ingredientsof this medicine (listed in section 6).
• if you are breast-feeding

Warnings and precautions

Consult your doctor or pharmacist before taking Gefitinib Genthon

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

Children and adolescents

This medicine is not indicated in children and adolescents under 18 years.

Other medicines and Gefitinib Genthon

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:

• Phenytoinor 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, H2antagonistsand antacids(for ulcers, indigestion, heartburn and to reduce stomach acid).

These medicines may affect how gefitinib works

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

If you are in any of these situations, or if you have any doubts, consult your doctor or pharmacist before taking this medicine.

Pregnancy, breast-feeding and fertility

Consult your doctor before taking this medicine if you are pregnant, might be pregnant or are breast-feeding.

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

Do not take gefitinib if you are breast-feeding, for the safety of your baby

Driving and using machines

You may feel weak while taking Gefitinib Genthon. If this happens, do not drive or use tools or machines

Gefitinib Genthoncontains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Gefitinib Genthoncontains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Gefitinib Genthon

Follow exactly the instructions of administration of this medicine 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 at approximately the same time each day.
• You can take the tablet with or without food.
• Do not take antacids (to reduce the acid level in your stomach) 2 hours before or 1 hour after taking gefitinib.

If you have problems swallowing the tablet, dissolve it in half a glass of water (still water). Do not use any other liquid. Do not crush the tablet. Stir the water until the tablet has dissolved. This may take up to 20 minutes. Drink the liquid immediately. To ensure that you have taken all the medicine, rinse the glass well with half a glass of water and drink it.

If you take moreGefitinib Genthonthan you should

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

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to takeGefitinib Genthon

What you should 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 left until your next dose: take the forgotten tablet as soon as you remember. Then take the next dose as usual.
• If there are less than 12 hours left until your next dose: do not take the forgotten 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 forgotten doses.

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

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 (frequent), particularly if the symptoms include face, lips, tongue or throat swelling, difficulty swallowing, hives and difficulty breathing.
• Severe difficulty breathing, or sudden worsening of difficulty breathing, possibly with cough or fever. This may mean that you have a lung inflammation called "interstitial lung disease". This can affect approximately 1 in 100 patients taking gefitinib and can be life-threatening.
• Severe skin reactions (rare) affecting large areas of your body. The symptoms can include redness, pain, ulcers, blisters and peeling of the skin. It can also affect the lips, nose, eyes and genitals.
• Dehydration (frequent) caused by persistent or severe diarrhea, vomiting (nausea), nausea (feeling unwell) or loss of appetite.
• Eye problems (uncommon), such as pain, redness, watery eyes, sensitivity to light, changes in vision or retraction of the eyelids. 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

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

Common: 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 nosebleeds or blood in your urine)
• Increased bilirubin and another liver enzyme called aspartate aminotransferase in blood tests; if this increase is too high, your doctor may recommend that you stop taking gefitinib
• Increased creatinine levels in blood tests (related to kidney function), protein in your urine (detected in a urine test), cystitis (burning sensation when urinating and frequent and urgent need to urinate)

Uncommon: may affect up to 1 in 100 people

• Pancreatitis. The symptoms include severe pain in the upper part of the stomach area and intense nausea and vomiting.
• Gastrointestinal perforation
• Liver inflammation. The symptoms can include a feeling of general discomfort, with or without possible jaundice (yellowing of the skin and eyes). This side effect is uncommon; however, some patients have died from it.
• Skin reaction on the palms of the hands and soles of the feet that includes tingling, numbness, pain, swelling or redness (known as palmar-plantar erythrodysesthesia syndrome or hand and foot syndrome).

Rare: may affect up to 1 in 1000 people

• Inflammation of the blood vessels in the skin. This can appear as bruising or skin rashes that do not disappear when pressed
• Hemorrhagic cystitis (burning sensation when urinating and frequent and urgent need to urinate, with blood in the urine).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gefitinib Genthon

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 is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the carton and any remaining tablets in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the carton and any remaining tablets. This will help protect the environment.

6. Contents of the pack and other information

Composition ofGefitinib Genthon 250 mg film-coated tablets EFG

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

Appearance of the product and pack size

Gefitinib Genthon are brown, round, biconvex film-coated tablets (with a diameter of approximately 11 mm) marked with G9FB 250 on one side.

They are available in packs of 30 tablets or 30 tablets in unit-dose blisters. The blister may be pre-cut or not pre-cut.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Genthon BV

Microweg, 22

6545 CM (Nijmegen)

Netherlands

Manufacturer:

Synthon Hispania, S.L.

C/ Castelló no1, Pol. Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22,

6545 CM Nijmegen

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Gefitinib Genthon 250 mg, filmomhulde tabletten

France: Gefitinib Genthon 250 mg, comprimé pellicullés

Germany: Gefitinib Genthon 250 mg Filmtabletten

Malta: Gefitinib Genthon 250 mg, film-coated tablets

Poland: Gefitinib Genthon

Spain: Gefitinib Genthon 250 mg comprimidos recubiertos con película EFG

Estonia: Gefitinib Norameda

Latvia: Gefitinib Norameda

Lithuania: Gefitinib Norameda

Date of last revision of this leaflet: July 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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