Gefitinib Sandoz 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gefitinib Sandoz 250 mg film-coated tablets EFG

gefitinib

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

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

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

Gefitinib Sandoz 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 cancer cells.

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

2. What you need to know before taking Gefitinib Sandoz

Do not take Gefitinib Sandoz

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

Warnings and precautions

Talk to your doctor or pharmacist before starting gefitinib:

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

Children and adolescents

Gefitinib Sandoz is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Gefitinib Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, 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 disorders).
• 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 stomach acid).

These medicines may affect the way gefitinib works.

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

If you are in any of these situations, or if you have any doubts, consult 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.

You are advised to avoid becoming pregnant during treatment with gefitinib, as this medicine may harm your unborn baby.

Do not take gefitinib if you are breastfeeding, for your baby's safety.

Driving and using machines

If you feel weak while taking this medicine, be cautious when driving or operating tools or machinery.

Gefitinib Sandoz contains sodium and lactose

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

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

3. How to take Gefitinib Sandoz

Follow exactly the instructions given by your doctor for taking this medicine. If in 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 may take the tablet with or without food.
• Do not take antacids (to reduce stomach acid levels) 2 hours before or 1 hour after taking gefitinib.

If you have difficulty swallowing the tablet, dissolve it in half a glass of water (non-carbonated). 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 you have taken the entire dose, rinse the glass thoroughly with half a glass of water and drink it as well.

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 at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Gefitinib Sandoz

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

• If 12 hours or more remain until your next dose: take the missed tablet as soon as you remember. Then take your next dose as usual.
• If less than 12 hours remain until your next dose: do not take the missed tablet. Then take your next tablet at the regular time.

Do not take a double dose (two tablets at the same time) to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Immediately inform your doctor if you notice any of the following adverse effects – you may require urgent medical treatment:

• Allergic reaction (frequent), particularly if symptoms include swelling of the face, lips, tongue or throat, difficulty swallowing, hives, rash, or difficulty breathing.
• Severe difficulty breathing, or sudden worsening of breathing problems, possibly with cough or fever. This may indicate a lung inflammation known as "interstitial lung disease". This may occur in approximately 1 in 100 patients taking gefitinib and can be life-threatening.
• Severe skin reactions (rare) affecting large areas of the body. Symptoms may include redness, pain, ulcers, blisters, and skin peeling. It may also affect the lips, nose, eyes, and genitals.
• Dehydration (frequent) caused by persistent or severe diarrhea, vomiting (feeling sick), nausea (feeling unwell), or loss of appetite.
• Eye problems (uncommon), such as eye pain, redness, watery eyes, light sensitivity, changes in vision, or eyelash retraction. This may indicate a corneal ulcer (ulcer on the surface of the eye).

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

Very common: (may affect more than 1 in 10 people)

• diarrhea,
• vomiting,
• nausea,
• skin reactions such as acne-like rash, sometimes accompanied by itching, dryness and/or skin cracking,
• loss of appetite,
• weakness,
• redness or soreness in the mouth,
• increased blood levels of the liver enzyme alanine aminotransferase; if this increase is too high, your doctor may recommend stopping gefitinib.

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

• dry mouth,
• dry, red or itchy eyes,
• redness and pain in the eyelids,
• nail problems,
• hair loss,
• fever,
• bleeding (such as nosebleeds or blood in urine),
• protein in the urine (detected in a urine test),
• increased bilirubin and another liver enzyme known as aspartate aminotransferase 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 when urinating, and frequent, urgent need to urinate).

Uncommon: (may affect up to 1 in 100 people)

• inflammation of the pancreas. Symptoms include severe pain in the upper abdomen, with intense nausea and vomiting,
• liver inflammation. Symptoms may include general feeling of illness, with or without possible jaundice (yellowing of the skin and eyes). This adverse effect is uncommon; 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 palmar-plantar erythrodysesthesia or hand-foot syndrome).

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

• inflammation of blood vessels in the skin. This may appear as bruise-like areas or skin rashes that do not fade when pressed,
• hemorrhagic cystitis (burning sensation when urinating, frequent and urgent need to urinate, with blood in the urine).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gefitinib Sandoz

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after CAD/EXP. The expiry date refers to the last day of the month indicated.
• This medicine does not require any special storage temperature. Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gefitinib Sandoz

• The active substance is gefitinib.

Each film-coated tablet contains 250 mg of gefitinib.

• The other components are: monohydrate lactose, 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).

Nature of the product and contents of the container

Gefitinib Sandoz are brown, round, film-coated tablets marked with "250" on one side and smooth on the other. The diameter of the film-coated tablet is 11.1 mm. Gefitinib Sandoz film-coated tablets are packaged in single-dose perforated blisters of Aluminum OPA/AL/PVC or non-perforated blisters of Aluminum OPA/AL/PVC.

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

Multiple packs containing 60 x1 (2 packs of 30x1) film-coated tablets.

Multiple packs containing 90 x1 (3 packs of 30x1) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

or

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

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

Germany: Gefitinib HEXAL 250 mg Film Tablets
Belgium: Gefitinib Sandoz 250 mg film-coated tablets
Bulgaria: ????????? ?????? 250 mg ????????? ????????
Cyprus: Gefitinib Sandoz film-coated tablets 250 mg
Croatia: Gefitinib Sandoz 250 mg film-coated tablets
France: GEFITINIB SANDOZ 250 mg, comprimé pelliculé
Netherlands: Gefitinib Sandoz 250 mg, film-coated tablets
Hungary: Gefitinib Sandoz 250 mg filmtabletta
Italy: Gefitinib Sandoz
Lithuania: Gefitinib Sandoz 250 mg plėvelę dengtos tabletės
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

Date of the most recent revision of this leaflet: November 2021.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/