Gefitinib Teva 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gefitinib Teva 250 mg film-coated tablets EFG

Read the entire 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 must not be given to other people, 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.

Leaflet contents

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

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

Gefitinib Teva 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 (cancerous) cells form in the tissues of the lung.

2. What you need to know before starting Gefitinib Teva

Do not take Gefitinib Teva

• 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 Teva.

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

Children and adolescents

Gefitinib Teva is not indicated in children and adolescents under 18 years of age.

Taking Gefitinib Teva with other medicines

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, ketoconazole, posaconazole, or voriconazole (for fungal infections).
• Clarithromycin or telithromycin (for bacterial 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 way Gefitinib Teva works.

• Warfarin (an oral anticoagulant used to prevent blood clots). If you are taking a medicine containing this active substance, your doctor may need to carry out 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 Teva.

Pregnancy, breastfeeding, and fertility

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

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

Do not take Gefitinib Teva if you are breastfeeding, for the safety of your baby.

Driving and using machines

You may feel weak while being treated with this medicine. If this occurs, do not drive or operate tools or machinery.

Gefitinib Teva contains lactose

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

Gefitinib Teva contains sodium

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

3. How to take Gefitinib Teva

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 the level of acid in your stomach) within 2 hours before or 1 hour after taking Gefitinib Teva.

If you have difficulty 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 all the medicine is taken, rinse the glass thoroughly with half a glass of water and drink that as well.

If you take more Gefitinib Teva than you should

In case of accidental overdose, consult your doctor or go to the nearest emergency room.

If you have taken more gefitinib than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Gefitinib Teva

What you should do if you forget to take a tablet depends on how long it is 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 the same time) to make up for a missed dose.

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.

Tell your doctor immediately if you notice any of the following adverse effects – you may need urgent medical treatment:

• Allergic reaction (common), particularly if symptoms include swelling of the face, lips, tongue or throat, difficulty swallowing, hives, urticaria, or difficulty breathing.
• Severe difficulty breathing, or sudden worsening of breathing problems, possibly with cough or fever. This may indicate lung inflammation known as "interstitial lung disease." This may affect approximately 1 in 100 patients taking gefitinib and can be life-threatening.
• Severe skin reactions (rare) affecting large areas of your body. Symptoms may include redness, pain, ulcers, blisters, and peeling of the skin. It may also affect the lips, nose, eyes, and genitals.
• Dehydration (common) 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).

Tell 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 cracks
• Loss of appetite
• Weakness
• Redness or pain 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
• 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 by a urine test)
• Increased levels of 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 levels of creatinine in blood tests (related to kidney function)
• Cystitis (burning sensation when urinating, and frequent and urgent need to urinate)

Uncommon (may affect up to 1 in 100 people)

• Inflammation of the pancreas. Symptoms include severe pain in the upper abdominal area, and severe nausea and vomiting.
• Liver inflammation. Symptoms may include a general feeling of being unwell, 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 palmoplantar erythrodysesthesia or hand-foot syndrome).

Rare (may affect up to 1 in 1000 people)

• Inflammation of blood vessels in the skin. This may appear as bruise-like areas or skin rashes that do not fade when pressed.
• Haemorrhagic 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 effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 Teva

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

Do not use this medicine after the expiry date stated on the blister and the outer packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

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

6. Contents of the pack and other information

Composition of Gefitinib Teva

• The active substance is gefitinib. Each film-coated tablet contains 250 mg of gefitinib.
• The other components are:

Tablet core:

Lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, povidone, and magnesium stearate.

Tablet coating:

Polyvinyl alcohol, macrogol 3350, talc, yellow iron oxide, red iron oxide, and titanium dioxide.

Appearance of the product and contents of the pack

Brown, round, convex film-coated tablet with a diameter of approximately 11 mm, marked with “250” on one side and plain on the other.

Pack sizes:

Blister pack of 30 film-coated tablets or 30 film-coated tablets in perforated unit dose blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, (Madrid)

Spain

Manufacturer responsible for manufacturing

Teva Pharma, S.L.U.

C/C, n. 4, Polígono Industrial Malpica

50016 Zaragoza

Spain

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren

Germany

or

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

or

Balkanpharma - Dupnitsa AD

3 Samokovsko Shoose Str.

2600 Dupnitsa

Bulgaria

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:

Belgium Gefitinib Teva 250 mg filmomhulde tabletten, comprimés pelliculés, Filmtabletten

Bulgaria ????????? ???? 250 mg ????????? ????????, Gefitinib Teva 250 mg film-coated tablets

Germany Gefitinib-ratiopharm 250 mg Filmtabletten

Denmark Gefitinib Teva

Estonia Gefitinib Teva

Spain Gefitinib Teva 250 mg film-coated tablets EFG

Finland Gefitinib ratiopharm 250 mg tabletti, kalvopäällysteinen

France Géfitinib Teva 250 mg comprimé pelliculé

Croatia Gefitinib Pliva 250 mg filmom obložene tablete

Hungary Gefitinib Teva 250 mg filmtabletta

Italy Gefitinib Teva

Lithuania Gefitinib Teva 250 mg plevele dengtos tabletes

Luxembourg Gefitinib Teva 250 mg comprimés pelliculés

Netherlands Gefitinib Teva 250 mg, filmomhulde tabletten

Portugal Gefitinib Teva

Slovakia Gefitinib Teva 250 mg filmom obalené tablety

United Kingdom Gefitinib 250 mg Film-coated Tablets

(Northern Ireland)

Date of the most recent revision of this package leaflet: January 2022

Detailed 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/)