Prospect: information for the patient

Gefitinib Teva 250 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist or nurse.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Gefitinib Teva

3. How to take Gefitinib Teva

4. Possible adverse effects

5. Storage of Gefitinib Teva

6. Contents of the pack and additional information

Gefitinib Teva contains the active ingredient gefitinib, which blocks a protein called the “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 cells (cancerous) form from the tissues of the lung.

Do not takeGefitinib Teva

• if you are allergic to gefitinib orany of the other ingredients ofthis medicine (listed in section 6).
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gefitinib Teva.

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

Children and adolescents

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

Use of Gefitinib Teva with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medicine.

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 mechanism by which Gefitinib Teva acts.

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

If you are in any of these situations, or if you have 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, may be pregnant or are breastfeeding.

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

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

Driving and operating machines

You may feel weak while on treatment with 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 a certain sugar intolerance, consult with 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”.

Follow exactly the administration instructions for this medication as 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 approximately at the same time every 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 Teva.

If you have trouble swallowing the tablet, dissolve it in half a glass of water (without gas). Do not use any other liquid. Do not crush the tablet. Remove the water until the tablet has dissolved. This may take up to 20 minutes. Drink the liquid immediately. To ensure that all the medication has been taken, rinse the glass well with half a glass of water and drink it.

If you take more Gefitinib Teva than you should

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

If you have taken more gefitinib than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Gefitinib Teva

What to 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 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 once) to make up for missed doses.

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

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

Inform your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:

• Allergic reaction (frequent), particularly if symptoms include swollen face, lips, tongue, or throat, difficulty swallowing, hoarseness, urticaria, and difficulty breathing.
• Severe difficulty breathing, or sudden worsening of breathing difficulty, possibly with cough or fever. This may mean 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. Symptoms may include redness, pain, ulcers, blisters, and skin peeling. It can also affect your lips, nose, eyes, and genitals.
• Dehydration (frequent) caused by persistent or severe diarrhea, vomiting (urge to vomit), nausea (feeling of discomfort), or loss of appetite.
• Eye problems (infrequent), such as pain, redness, watery eyes, light sensitivity, changes in vision, or eyelid retraction. This may mean you have a corneal ulcer.

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

Very frequent (can affect more than 1 in 10 people)

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

Frequent (can 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 nosebleed or blood in your urine)
• Proteins in your urine (detected by urine analysis)
• Increased bilirubin and another liver enzyme known as aspartate aminotransferase in blood tests; if this increase is too high, your doctor may recommend you stop taking gefitinib
• Increased levels of creatinine in blood tests (related to kidney function)
• Cystitis (burning sensation while urinating and frequent and urgent need to urinate)

Infrequent (can affect up to 1 in 100 people)

• Pancreatitis. Symptoms include severe pain in the upper stomach area and intense nausea and vomiting.
• Hepatitis. Symptoms may include general feeling of discomfort, with or without possible jaundice (yellowing of the skin and eyes). This side effect is infrequent; however, some patients have died from 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 erythromelalgia palmoplantar syndrome or hand and foot syndrome).

Rare (can affect up to 1 in 1000 people)

• Angiitis of the skin vessels. This may appear as a hematoma or skin rash that does not disappear after pressing it.
• Haemorrhagic cystitis (burning sensation while urinating and frequent and urgent need to urinate, with presence of blood in the urine).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's a possible side effect not listed in this prospectus. You can also report them directly through the Spanish Medication for Human Use Pharmacovigilance System:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the blister andthe boxafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be thrown into the drains or trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt,please ask your pharmacisthow to dispose ofthepackaging and themedications you no longerneed. This way, you will help protect the environment.

Composition of Gefitinib Teva

• The active ingredient 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.

Film coating:

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

Appearance of the product and contents of the package

Film-coated tablet, brown, round, convex, approximately 11 mm in diameter, marked with “250” on one side and smooth on the other.

Package sizes:

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

Only some package sizes may be marketed.

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

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

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 barunaFilipovica 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:

BélgicaGefitinib Teva 250 mg filmomhulde tabletten, comprimés pelliculés, Filmtabletten

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

GermanyGefitinib-ratiopharm 250 mg Filmtabletten

DinamarcaGefitinib Teva

EstoniaGefitinib Teva

SpainGefitinib Teva 250 mg comprimidos recubiertos con película EFG

FinlandGefitinib ratiopharm 250 mg tabletti, kalvopäällysteinen

FranceGéfitinib Teva 250 mg comprimé pelliculé

CroatiaGefitinib Pliva 250 mg filmom obložene tablete

HungaryGefitinib Teva 250 mg filmtabletta

ItalyGefitinib Teva

LithuaniaGefitinib Teva 250 mg plevele dengtos tabletes

LuxembourgGefitinib Teva 250 mg comprimés pelliculés

NetherlandsGefitinib Teva 250 mg, filmomhulde tabletten

PortugalGefitinib Teva

SlovakiaGefitinib Teva 250 mg filmom obalené tablety

United KingdomGefitinib 250 mg Film-coated Tablets

(Northern Ireland)

Last revision date of thissummary of product characteristics:January 2022

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)