GEFITINIB TEVA 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

1. What is Gefitinib Teva and what is it 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 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 Teva

Do not takeGefitinib Teva

• 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 Teva.

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

Children and adolescents

Gefitinib Teva is not intended for use in children and adolescents under 18 years.

Using Gefitinib Teva with other medicines

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, ketoconazole, posaconazole, or voriconazole (for fungal infections).
• Clarithromycin or telithromycin (for bacterial infections).
• Barbiturates (a type of medicine used for sleep problems).
• 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 Teva 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 not sure, consult your doctor or pharmacist before taking Gefitinib Teva.

Pregnancy, breast-feeding, and fertility

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

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

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

Driving and using machines

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

Gefitinib Teva contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them 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 of your doctor for taking this medicine. If you are not sure, 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 acid in your stomach) 2 hours before or 1 hour after taking Gefitinib Teva.

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 make sure you have taken all the medicine, rinse the glass with half a glass of water and drink it.

If you take moreGefitinib Tevathan you should

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

If you have taken more gefitinib than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount used.

If you forget to takeGefitinib Teva

What to do if you miss a tablet depends on how long it is until your next dose.

• If it is 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 it is less than 12 hours until your next dose: do not take the missed tablet. Take the next tablet at the usual time.

Do not take a double dose (two tablets at the same time) to make up for missed 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 (common), particularly if the symptoms include swollen face, lips, tongue, or throat, difficulty swallowing, hives, and difficulty breathing.
• Severe difficulty breathing, or sudden worsening of difficulty breathing, possibly with cough or fever. This may mean you have a lung condition called 'interstitial lung disease'. This can affect up to 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 can also affect the lips, nose, eyes, and genitals.
• Dehydration (common) caused by persistent or severe diarrhea, vomiting, nausea, 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 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 like acne-like rash, which may appear as itching with dryness and/or cracks in 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 by 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 creatinine levels in blood tests (related to kidney function)
• Cystitis (a feeling of burning when urinating and a frequent and urgent need to urinate)

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1000 people)

• Inflammation of the blood vessels in the skin. This may appear as bruising or areas of skin rash that do not fade when pressed.
• Hemorrhagic cystitis (a feeling of burning when urinating and a 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, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly via 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 Teva

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 blister and carton 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Gefitinib Teva contains

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

Tablet core:

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

Tablet coating:

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

Appearance and packaging

Brown, round, convex film-coated tablet, approximately 11 mm in diameter, 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 a perforated unit dose blister.

Not all pack sizes may be marketed.

Marketing authorisation holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

You can ask for more information about this medicine from the representative of the marketing authorisation holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, (Madrid)

Spain

Manufacturer

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 medicine is authorised 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 comprimidos recubiertos con película 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 last revision of this leaflet:January 2022

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