Gefitinib Zentiva

Package Leaflet: Information for the Patient

Gefitinib Zentiva, 250 mg, Coated Tablets

Gefitinib

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, so you can Read it Again if Necessary.
• If you have any Further Questions, Ask your Doctor, Pharmacist, or Nurse.
• This Medication has been Prescribed for a Specific Person. Do not Pass it on to Others. The Medication may Harm them, even if their Symptoms are the Same.
• If the Patient Experiences any Side Effects, including those not Listed in the Package Leaflet, they should Inform their Doctor, Pharmacist, or Nurse. See Section 4.

Package Leaflet Contents

• 1. What is Gefitinib Zentiva and what is it Used for
• 2. Important Information Before Taking Gefitinib Zentiva
• 3. How to Take Gefitinib Zentiva
• 4. Possible Side Effects
• 5. How to Store Gefitinib Zentiva
• 6. Package Contents and other Information

1. What is Gefitinib Zentiva and what is it 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 Adults with Non-Small Cell Lung Cancer. This Type of Malignant Tumor 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 Medication (Listed in Section 6).
• In Women who are Breastfeeding.

Warnings and Precautions

Before Starting Gefitinib Zentiva, the Patient should Discuss with their Doctor or Pharmacist whether they:

• Have ever had Lung Disease. Some Lung Diseases may Worsen during Treatment with Gefitinib Zentiva.
• Have any Liver Diseases.

Children and Adolescents

Gefitinib Zentiva should not be Used in Children and Adolescents Below 18 Years of Age.

Gefitinib Zentiva and other Medications

The Patient should Tell their Doctor or Pharmacist about all Medications they are Currently Taking or have Recently Taken, as well as any Medications they Plan to Take.

In Particular, the Patient should Inform their Doctor or Pharmacist if they are Taking:

• Phenytoin or Carbamazepine (Medications Used to Treat Epilepsy),
• Rifampicin (a Medication Used to Treat Tuberculosis),
• Itraconazole (a Medication Used to Treat Fungal Infections),
• Barbiturates (Medications Used to Treat Sleep Disorders),
• Herbal Medications Containing St. John's Wort (Hypericum Perforatum) (Used to Treat Depression and Anxiety),
• Proton Pump Inhibitors, Medications that are H2 Receptor Antagonists (Used to Treat Ulcers, Indigestion, Heartburn, and Reduce Stomach Acid).

These Medications may Affect the Action of Gefitinib Zentiva.

• Warfarin (an Oral Anticoagulant Used to Prevent Blood Clots). In this Case, the Doctor may Recommend more Frequent Blood Tests.

If any of these Situations Apply to the Patient or if the Patient is Unsure, they should Contact their Doctor or Pharmacist before Taking Gefitinib Zentiva.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant, Breastfeeding, Thinks they may be Pregnant, or Plans to have a Child, they should Consult their Doctor before Taking this Medication.

It is Recommended that Female Patients Treated with Gefitinib Zentiva Avoid Becoming Pregnant during Treatment with Gefitinib Zentiva, as it may be Harmful to the Unborn Child.

For the Safety of the Baby, Gefitinib Zentiva should not be Taken during Breastfeeding.

Driving and Using Machines

If the Patient Experiences Weakness while Taking this Medication, they should be Cautious when Driving, Operating Machinery, or Using Tools.

Gefitinib Zentiva Contains Lactose and Sodium

If the Patient has been Diagnosed with an Intolerance to some Sugars, they should Consult their Doctor before Taking this Medication.

The Medication Contains less than 1 mmol (23 mg) of Sodium per Dose, which means it is Considered "Sodium-Free".

3. How to Take Gefitinib Zentiva

This Medication should Always be Taken as Directed by the Doctor. If the Patient has any Questions, they should Ask their Doctor or Pharmacist.

• The Usual Dose of Gefitinib Zentiva is one Tablet (250 mg) per Day.
• The Medication should be Taken once a Day, at about the Same Time.
• The Tablets can be Taken with or without Food.
• Antacids (Medications that Reduce Stomach Acid) should not be Taken 2 Hours before or 1 Hour after Taking Gefitinib Zentiva.

If the Patient has Difficulty Swallowing the Tablet, it can be Dissolved in Half a Glass of Still Water.

The Tablet should not be Dissolved in any other Liquid. The Tablet should not be Crushed. The Liquid should be Stirred until the Tablet Dissolves, which may take up to 20 Minutes. The Prepared Liquid should be Taken Immediately after Preparation. To Ensure the Entire Dose is Taken, the Glass should be Refilled with Water, Stirred, and the Liquid Taken.

Taking more than the Recommended Dose of Gefitinib Zentiva

If a Higher Dose than Recommended is Taken, the Patient should Immediately Contact their Doctor or Pharmacist.

Missing a Dose of Gefitinib Zentiva

The Action to be Taken Depends on the Time Remaining until the Next Dose.

• If there are 12 Hours or more until the Next Dose, the Patient should Take the Missed Dose as Soon as Possible. The Next Dose should be Taken at the Usual Time.
• If there are less than 12 Hours until the Next Dose, the Missed Dose should not be Taken. The Next Dose should be Taken at the Usual Time. A Double Dose (Two Tablets at the Same Time) should not be Taken to Make up for the Missed Dose.

If the Patient has any Further Questions about Taking this Medication, they should Ask their Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Gefitinib Zentiva can Cause Side Effects, although not Everybody gets them.

If any of the Following Side Effects Occur, the Patient should Immediately Contact their Doctor, as they may Require Urgent Treatment:

• Allergic Reactions (Frequent), especially if there is Swelling of the Face, Lips, Tongue, or Throat, Difficulty Swallowing, Hives, Urticaria, and Difficulty Breathing.
• Severe Shortness of Breath or Rapidly Worsening Shortness of Breath, which may be Accompanied by Cough or Fever. This may Indicate that the Patient has Developed Interstitial Lung Disease. This Side Effect may Occur in about 1 in every 100 Patients Treated with Gefitinib Zentiva and may be Life-Threatening.
• Severe Skin Reactions (Rare), Affecting a Large Area of the Body. Symptoms include Redness of the Skin, Pain, Ulcers, Blisters, and Peeling of the Skin. The Area around the Mouth, Nose, Eyes, and Genital Organs may be Affected.
• Dehydration (Frequent) due to Prolonged or Severe Diarrhea, Vomiting, Nausea, or Loss of Appetite.
• Eye Symptoms (Uncommon), such as Pain, Redness of the Eye, Tearing, Sensitivity to Light, Vision Disturbances, or Ingrown Eyelashes. This may Indicate that the Patient has Developed an Ulcer on the Surface of the Eye (on the Cornea).

The Patient should Immediately Inform their Doctor if they Experience 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, and may be Accompanied by Dry Skin and/or Cracking of the Skin
• Loss of Appetite
• Weakness
• Redness or Irritation of the Mouth
• Increased Activity of the Liver Enzyme Alanine Aminotransferase in Blood Tests; if this is too High, the Doctor may Decide to Stop Treatment with Gefitinib Zentiva.

Common (may Affect up to 1 in 10 People)

• Dry Mouth
• Dryness, Redness, and Itching of the Eyes
• Redness and Pain of the Eyelids
• Nail Disorders
• Hair Loss
• Fever
• Bleeding (e.g., Nosebleeds or Blood in the Urine)
• Presence of Protein in the Urine (Detected in Laboratory Tests)
• Increased Levels of Bilirubin and the Liver Enzyme Aspartate Aminotransferase in Blood Tests. If this is too High, the Doctor may Decide to Stop Treatment with Gefitinib Zentiva
• Increased Creatinine Levels in the Blood, Detected in Laboratory Tests (Creatinine Levels Indicate Kidney Function)
• Urinary Tract Infection (Characterized by Burning during Urination and Frequent, Sudden Need to Urinate)

Uncommon (may Affect up to 1 in 100 People)

• Pancreatitis. Symptoms include Severe Abdominal Pain, Nausea, and Vomiting
• Hepatitis. Symptoms may include General Malaise, with or without Jaundice (Yellowing of the Skin and Eyes). This Side Effect is Uncommon, but 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 Palmar-Plantar Erythrodysesthesia or Hand-Foot Syndrome).

Rare (may Affect up to 1 in 1000 People)

• Vasculitis. This may Appear as Bruises or Non-Blanching Rashes on the Skin
• Hemorrhagic Cystitis (Burning during Urination and Frequent, Sudden Need to Urinate, with Blood in the Urine).

Reporting Side Effects

If the Patient Experiences any Side Effects, including those not Listed in the Package Leaflet, they should Inform their Doctor, Pharmacist, or Nurse.

Side Effects can be Reported Directly to the Department of Adverse Reaction Monitoring 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

Side Effects can also be Reported to the Marketing Authorization Holder.

Reporting Side Effects will Help to Gather more Information on the Safety of this Medication.

5. How to Store Gefitinib Zentiva

The Medication should be Stored out of Sight and Reach of Children.

Do not Use this Medication after the Expiry Date Stated on the Carton, Blister, and Foil Wrap after EXP. The Expiry Date Refers to the Last Day of the Month Stated.

There are no Special Precautions for Storage.

Medications should not be Disposed of via Wastewater or Household Waste. The Patient should Ask their Pharmacist how to Dispose of Medications they no Longer Use. This will Help Protect the Environment.

6. Package Contents and other Information

What Gefitinib Zentiva Contains

• The Active Substance is Gefitinib. Each Tablet Contains 250 mg of Gefitinib.
• The other Ingredients are: Lactose Monohydrate, 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 what the Package Contains

Gefitinib Zentiva is Available in the Form of Brown, Round Tablets, 11.13 ± 0.5 mm in Size. One Side of the Tablet has the Imprint "LP 100", and the other Side is Smooth.

The Tablets are Packaged in Single-Dose Blisters of 10 Tablets each, then in a Foil Bag and a Cardboard Box.

The Package Contains 30 Tablets of Gefitinib Zentiva.

Marketing Authorization 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 Authorized in the Member States of the European Economic Area under the Following Names:

Iceland

Gefitinib Alvogen 250 mg Film-Coated Tablets

Bulgaria

Гефитиниб Зентива 250 mg филмирани таблетки

Croatia

Gefitinib Zentiva 250 mg Film-Coated Tablets

Hungary

Gefitinib Zentiva 250mg Filmtabletta

Lithuania

Gefitinib Zentiva 250 mg Plėvele Dengtos Tabletės

Poland

Gefitinib Zentiva

Czech Republic

Gefitinib Zentiva

Romania

Gefitinib Labormed 250 mg Comprimate Filmate

For Further Information, Please Contact the Marketing Authorization Holder's Representative in Poland:

Zentiva Polska Sp. z o.o.

ul. Bonifraterska 17

00-203 Warsaw

Tel. +48 22 375 92 00

Date of Last Revision of the Package Leaflet:January 2023