Gefitinib zentiva

Package leaflet: Information for the user

Gefitinib Zentiva, 250 mg, film-coated tablets
Gefitinib
Please read all of this leaflet carefully before 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 other people even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Gefitinib Zentiva contains the active substance gefitinib, which inhibits the activity of a protein
called epidermal growth factor receptor (EGFR). This protein affects the growth and spread of
cancer cells.
Gefitinib Zentiva is used to treat adult patients with non-small cell lung cancer. This type of
malignant tumour originates from lung cells.

2. Important information before taking Gefitinib Zentiva

When not to take Gefitinib Zentiva

• if the patient is allergic to gefitinib or any of the other ingredients of this medicine (listed in section 6).
• in women who are breastfeeding.

Warnings and precautions
Before starting treatment with Gefitinib Zentiva, discuss with the doctor or pharmacist whether the patient:

• has ever had a lung disease. Some lung diseases may worsen during treatment with Gefitinib Zentiva.
• has any liver diseases.

Children and adolescents
Gefitinib Zentiva must not be used in children and adolescents under 18 years of age.

Gefitinib Zentiva and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor or pharmacist if the patient is taking:

• phenytoin or carbamazepine (medicines used for epilepsy),
• rifampicin (a medicine used for tuberculosis),
• itraconazole (a medicine used for fungal infections),
• barbiturates (medicines used for sleep disorders),
• herbal products containing St. John's wort (Hypericum perforatum) (used in the treatment of depression and anxiety),
• proton pump inhibitors, H-receptor antagonist medicines (used in the treatment of ulcers, indigestion, heartburn and reducing gastric acid secretion).

These medicines may affect the action of Gefitinib Zentiva.

• warfarin (an oral anticoagulant medicine used to prevent blood clots). In this case, the doctor may recommend more frequent blood tests.

If any of the situations listed above apply to the patient, or if the patient is unsure whether they apply, the patient should contact the doctor or pharmacist before taking Gefitinib Zentiva.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
It is recommended that female patients receiving Gefitinib Zentiva avoid becoming pregnant during treatment with Gefitinib Zentiva, as it may be harmful to the unborn child.
For the safety of the infant, Gefitinib Zentiva must not be used during breastfeeding.

Driving and operating machinery
If the patient experiences weakness while taking this medicine, caution should be exercised when driving, operating machinery or using tools.

Gefitinib Zentiva contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to take Gefitinib Zentiva

This medicine should always be taken as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

• The usual dose of Gefitinib Zentiva is one tablet (250 mg) taken daily.
• The medicine should be taken every day, approximately at the same time.
• Tablets may be taken with or without food.
• Do not take antacids (medicines that reduce stomach acid) within 2 hours before or 1 hour after taking Gefitinib Zentiva.

If you have difficulty swallowing, the tablet can be dispersed in half a glass of non-carbonated water.
Do not dissolve the tablet in any other liquid. Do not crush the tablet. Stir the liquid until the tablet dissolves completely, which may take up to 20 minutes. The prepared solution should be drunk immediately after preparation. To ensure the full dose is taken, refill the glass with half a glass of water, stir, and drink the liquid.

Taking more Gefitinib Zentiva than prescribed
If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately.

Missing a dose of Gefitinib Zentiva
The action to take depends on how much time is left before the next dose.

• If 12 hours or more remain before the next dose, take the missed tablet as soon as possible. Take the next dose at the usual time.
• If less than 12 hours remain before the 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 a missed dose.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the following adverse reactions occur, seek immediate medical advice, as prompt treatment may be necessary:

• Allergic reactions (common), especially if there is swelling of the face, lips, tongue or throat, difficulty swallowing, urticaria, hives or difficulty breathing.
• Severe breathlessness or rapidly worsening breathlessness, which may be accompanied by cough or fever. This may indicate that the patient has developed lung inflammation known as interstitial lung disease. This adverse reaction may occur in approximately 1 patient in every 100 treated with Gefitinib Zentiva and may be life-threatening.
• Severe skin reactions (rare), affecting a large area of the body. Symptoms include: skin redness, pain, ulceration, blisters and skin peeling. The area around the mouth, nose, eyes and genital organs may also be affected.
• Dehydration (common) caused by prolonged or severe diarrhoea, vomiting, nausea or loss of appetite.
• Eye-related symptoms (uncommon), such as eye pain, redness, excessive tearing, light sensitivity, visual disturbances or ingrown eyelashes. These may indicate that the patient has developed a corneal ulceration (ulcer on the surface of the eye).

Inform your doctor as soon as possible if any of the following adverse reactions occur:

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

• diarrhoea
• vomiting
• nausea
• skin reactions such as acneiform rash, which may sometimes be itchy, possibly accompanied by dry skin and/or skin cracking
• loss of appetite
• weakness
• redness or irritation of the mouth
• in blood tests, increased activity of a liver enzyme called alanine aminotransferase; if this increase is too great, your doctor may decide to discontinue treatment with Gefitinib Zentiva.

Common (may affect up to 1 in 10 people)

• dry mouth
• dry, red and itchy eyes
• redness and pain of the eyelids
• nail disorders
• hair loss
• fever
• bleeding (e.g. nosebleeds or presence of blood in urine)
• presence of protein in the urine (detected in laboratory tests)
• increased blood levels of bilirubin and increased activity of the liver enzyme aspartate aminotransferase in blood tests. If these increases are too great, your doctor may decide to discontinue treatment with Gefitinib Zentiva.
• increased blood creatinine levels detected in laboratory tests (creatinine levels indicate kidney function)
• cystitis (characterised by burning sensation during urination and frequent, urgent need to urinate).

Uncommon (may affect up to 1 in 100 people)

• pancreatitis. Symptoms include severe abdominal pain located in the upper abdomen, accompanied by severe nausea and vomiting.
• hepatitis. Symptoms may include general malaise, with or without jaundice (yellowing of the skin and eyes). This adverse reaction is uncommon, but some patients have died from it.
• gastrointestinal perforations
• skin reactions on the palms of the hands and soles of the feet, including tingling, numbness, pain, swelling or redness (known as hand-foot syndrome or palmar-plantar erythrodysesthesia syndrome).

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

• skin vasculitis. May present as bruises or non-blanching skin rashes.
• haemorrhagic cystitis (burning sensation during urination and frequent, urgent need to pass urine with blood-tinged urine).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Gefitinib Zentiva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and foil covering following EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
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 packaging and other information

What Gefitinib Zentiva contains

• The active substance is gefitinib. Each tablet contains 250 mg of gefitinib.
• The other ingredients (excipients) are: monohydrate lactose, microcrystalline cellulose (E 460), sodium croscarmellose (E 468), povidone K-30 (E 1201), sodium lauryl sulfate, magnesium stearate, polyvinyl alcohol (E 1203), macrogol 3350 (E 1521), talc (E 553b), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Gefitinib Zentiva looks like and contents of the pack
Gefitinib Zentiva is a brown, round tablet with a diameter of 11.13 ± 0.5 mm. One side of the tablet is embossed with the code "LP 100", the other side is smooth.
The tablets are packed in unit dose blisters containing 10 tablets each, then placed in a foil pouch and put into a cardboard box.
Each pack contains 30 tablets of Gefitinib Zentiva.

Marketing Authorisation Holder
Zentiva k.s.
U Kabelovny 130
Dolni Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer / Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
PLA 3000, Paola
Malta
S.C. Labormed - Pharma S.A.
44B Theodor Pallady Blvd, 3rd District
032266 Bucharest
Romania

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Iceland Gefitinib Alvogen 250 mg film-coated tablets
Bulgaria Gefitinib Zentiva 250 mg film-coated tablets
Croatia Gefitinib Zentiva 250 mg film-coated tablets
Hungary Gefitinib Zentiva 250 mg film-coated tablet
Lithuania Gefitinib Zentiva 250 mg film-coated tablets
Poland Gefitinib Zentiva
Czech Republic Gefitinib Zentiva
Romania Gefitinib Labormed 250 mg film-coated tablets

For further information, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00