GEFITINIB SANDOZ 250 mg FILM-COATED TABLETS

Introduction

Patient Information 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, 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.

Contents of the pack

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

1. What is Gefitinib Sandoz and what is it 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 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 Sandoz

Do not take Gefitinib Sandoz

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

Warnings and precautions

Tell your doctor or pharmacist before you start taking gefitinib:

• 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

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

Other medicines and Gefitinib Sandoz

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 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 how gefitinib works.

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

If you are in any of these situations, or if you are unsure, consult your doctor or pharmacist before taking gefitinib.

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

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

Gefitinib Sandoz contains sodium and lactose

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

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

3. How to take Gefitinib Sandoz

Follow exactly the instructions of administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

• The recommended dose is one 250 mg tablet per day.
• Take the tablet at about the same time each 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 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 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, telephone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Gefitinib Sandoz

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 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 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 questions 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 condition called "interstitial lung disease". This can affect about 1 in 100 patients taking gefitinib and can be life-threatening.
• Severe skin reactions (rare) affecting large areas of your body. The symptoms may 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 (feeling sick), nausea (feeling unwell), or loss of appetite.
• Eye problems (uncommon), such as pain, redness, watery eyes, sensitivity to light, changes in vision, or eyelid retraction. This may mean that you have an ulcer on the surface of your 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)

• diarrhea,
• vomiting,
• nausea,
• skin reactions such as acne-like rash, which may be itchy with dryness and/or cracking of the skin,
• loss of appetite,
• weakness,
• redness or pain in the mouth,
• 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),
• protein in your urine (detected in a urine test),
• 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 levels of creatinine in blood tests (related to kidney function),
• cystitis (pain when urinating and frequent or urgent need to urinate).

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

• inflammation of the pancreas. The symptoms include severe pain in the upper part of the stomach area and severe nausea and vomiting,
• inflammation of the liver. The symptoms may 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 due to it,
• gastrointestinal perforation,

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 1,000 people)

• inflammation of the blood vessels in the skin. This may appear as bruising or areas of skin rash that do not disappear when pressed,
• hemorrhagic cystitis (pain when urinating and frequent or urgent need to urinate, with blood in the urine).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is 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 Sandoz

• 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. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Gefitinib Sandoz

• The active substance is gefitinib.

Each film-coated tablet contains 250 mg of gefitinib.

• The other ingredients 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), red iron oxide (E172), yellow iron oxide (E172).

Appearance and packaging

Gefitinib Sandoz are brown, round, film-coated 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 tablets are packaged in perforated unit dose 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.

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

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

Not all 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 medicine 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-coated tablets

Belgium:Gefitinib Sandoz 250 mg film-coated tablets

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

Cyprus:Gefitinib Sandoz film-coated tablets 250mg

Croatia:Gefitinib Sandoz 250 mg film-coated tablets

France:GEFITINIB SANDOZ 250 mg, film-coated tablet

Netherlands:Gefitinib Sandoz 250 mg, film-coated tablets

Hungary:Gefitinib Sandoz 250 mg film tabletta

Italy:Gefitinib Sandoz

Lithuania:Gefitinib Sandoz 250 mg plevele 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 last revision of this leaflet:November 2021.

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