Gefitinib Accord

Package Leaflet: Information for the Patient

Gefitinib Accord, 250 mg, Film-Coated Tablets

Gefitinib

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 or Pharmacist.
• 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 or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack and Other Information

• 1. What Gefitinib Accord Is and What It Is Used For
• 2. Before You Take Gefitinib Accord
• 3. How to Take Gefitinib Accord
• 4. Possible Side Effects
• 5. How to Store Gefitinib Accord
• 6. Contents of the Pack and Other Information

1. What Gefitinib Accord Is and What It Is Used For

Gefitinib Accord Contains the Active Substance Gefitinib, Which Inhibits the Activity of a Certain Protein Called Epidermal Growth Factor Receptor (EGFR). This Protein Affects the Growth and Spread of Cancer Cells.

Gefitinib Accord Is Used to Treat Adults with Non-Small Cell Lung Cancer. This Type of Cancer Develops in the Lung Tissue.

2. Before You Take Gefitinib Accord

Do Not Take Gefitinib Accord:

• If You Are Allergic (Hypersensitive) to Gefitinib or Any of the Other Ingredients of This Medicine (Listed in Section 6);
• If You Are Breast-Feeding.

Warnings and Precautions

Before Taking Gefitinib Accord, Tell Your Doctor, Pharmacist, or Nurse:

• If You Have Ever Had Lung Disease. Some Lung Diseases May Get Worse During Treatment with Gefitinib Accord.
• If You Have Ever Had Liver Problems.

Children and Adolescents

Gefitinib Accord Is Not Recommended for Children and Adolescents Under 18 Years of Age.

Gefitinib Accord and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking or Have Recently Taken, and About Any Medicines You Plan to Take.

In Particular, Tell Your Doctor or Pharmacist If You Are Taking:

• Phenytoin or Carbamazepine (Used to Treat Epilepsy),
• Rifampicin (Used to Treat Tuberculosis),
• Itraconazole (Used to Treat Fungal Infections),
• Barbiturates (Used to Treat Sleep Disorders),
• St. John's Wort (Hypericum Perforatum, Used to Treat Depression and Anxiety),
• Proton Pump Inhibitors, H2 Receptor Antagonists, or Antacids (Used to Treat Ulcers, Indigestion, Heartburn, and Reduce Stomach Acid). These Medicines May Affect the Action of Gefitinib Accord.
• Warfarin (a Blood-Thinning Medicine). In This Case, Your Doctor May Recommend More Frequent Blood Tests.

If Any of These Conditions Apply to You, or If You Are Not Sure, Talk to Your Doctor or Pharmacist Before Taking Gefitinib Accord.

Pregnancy, Breast-Feeding, and Fertility

Tell Your Doctor If You Are Pregnant, Might Become Pregnant, or Are Breast-Feeding.

Women Taking Gefitinib Accord Should Avoid Becoming Pregnant During Treatment with Gefitinib Accord, as It May Harm the Baby.

Do Not Take Gefitinib Accord If You Are Breast-Feeding, as It May Harm the Baby.

Driving and Using Machines

During Treatment with Gefitinib Accord, You May Feel Weak. In This Case, Do Not Drive or Operate Machinery.

Gefitinib Accord Contains Lactose

If Your Doctor Has Told You That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicine.

Gefitinib Accord Contains Sodium

This Medicine Contains Less Than 1 Mmol (23 Mg) of Sodium per Dose, Which Is Essentially Sodium-Free.

3. How to Take Gefitinib Accord

Always Take This Medicine Exactly as Your Doctor Has Told You. If You Are Not Sure, Check with Your Doctor or Pharmacist.

• The Recommended Dose Is 250 Mg (One Tablet) per Day.
• Take the Medicine Once a Day, at About the Same Time.
• You Can Take the Tablets with or Without Food.
• Do Not Take Antacids (Medicines to Reduce Stomach Acid) 2 Hours Before or 1 Hour After Taking Gefitinib Accord.

If You Have Difficulty Swallowing the Tablet, You Can Dissolve It in Half a Glass of Water. Do Not Dissolve the Tablet in Any Other Liquid. Do Not Crush the Tablet. Stir the Water Until the Tablet Dissolves. This May Take Up to 20 Minutes. Drink the Liquid Immediately After Preparation. To Make Sure You Take the Full Dose, Refill the Glass with Water, Stir, and Drink.

If You Take More Gefitinib Accord Than You Should

If You Have Taken More Than the Recommended Dose, Contact Your Doctor or Pharmacist Immediately.

If You Forget to Take Gefitinib Accord

The Action to Be Taken Depends on the Time Left Until the Next Dose.

• If There Are 12 Hours or More Until the Next Dose, Take the Missed Dose as Soon as Possible. Take the Next Dose at the Usual Time.
• If There Are Less Than 12 Hours Until the Next Dose, Do Not Take the Missed Dose. Take the Next Dose at the Usual Time.

Do Not Take a Double Dose (Two Tablets at the Same Time) to Make Up for a Forgotten Dose.

If You Have Any Further Questions on 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.

If You Notice Any of the Following, Tell Your Doctor Immediately, as You May Need Urgent Medical Attention:

• Allergic Reactions (Frequent), Particularly If You Experience Swelling of the Face, Lips, Tongue, or Throat, Difficulty Swallowing, Hives, Itchy Rash, and Difficulty Breathing.
• Severe Shortness of Breath or Suddenly Worsening Shortness of Breath, Which May Be Accompanied by Cough or Fever. This May Indicate That You Have Developed Pneumonia, Called Interstitial Lung Disease. This Side Effect May Occur in About 1 in Every 100 Patients Treated with Gefitinib Accord and May Be Life-Threatening.
• Severe Skin Reactions (Rare), Affecting a Large Area of the Body. Symptoms Include Redness, Pain, Ulcers, Blisters, and Skin Peeling. The Area Around the Mouth, Nose, Eyes, and Genital Area May Also Be Affected.
• Dehydration (Frequent) Caused by Prolonged or Severe Diarrhea, Vomiting, Nausea, or Loss of Appetite.
• Eye Symptoms (Uncommon), Such as Pain, Redness, Excessive Tear Production, Sensitivity to Light, Vision Disturbances, or Ingrown Eyelashes. This May Indicate That You Have Developed an Ulcer on the Surface of the Eye (on the Cornea).

If You Notice Any of the Following, Tell Your Doctor as Soon as Possible:

Very Common: May Affect More Than 1 in 10 People

• Diarrhea
• Vomiting
• Nausea
• Skin Reactions, Such as Acne-Like Rash, Sometimes Itchy, with Dryness and (or) Cracking of the Skin
• Loss of Appetite
• Weakness
• Redness or Pain in the Mouth
• Increased Activity of the Liver Enzyme Alanine Aminotransferase in Blood Tests; If the Activity of This Enzyme Is Too High, Your Doctor May Recommend Stopping Gefitinib Accord.

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 the Urine)
• Presence of Protein in the Urine (Shown in Urine Tests)
• Increased Levels of Bilirubin and the Liver Enzyme Aspartate Aminotransferase in Blood Tests; If the Activity of This Enzyme Is Too High, Your Doctor May Recommend Stopping Gefitinib Accord
• Increased Creatinine Levels in Blood Tests (Related to Kidney Function)
• Urinary Tract Infection (Burning Sensation While Urinating 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 Part of the Abdomen, and Severe Nausea and Vomiting
• Hepatitis. Symptoms May Include General Feeling of Illness, with or Without Jaundice (Yellowing of the Skin and Whites of the Eyes). This Side 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 Palmar-Plantar Erythrodysesthesia or Hand-Foot Syndrome).

Rare: May Affect Up to 1 in 1000 People

• Vasculitis. You May Notice Bruises or Areas of Non-Blanching Rash on the Skin
• Hemorrhagic Cystitis (Pain While Urinating and Frequent, Urgent Need to Urinate, with Blood in the Urine)

Reporting of Side Effects

If You Get Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet.

You Can Also Report Side Effects Directly to the Regulatory Agency.

5. How to Store Gefitinib Accord

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 Refers to the Last Day of That Month.

There Are No Special Storage Conditions for This Medicine.

After Dissolving the Tablet in Water, the Suspension Should Be Taken Within 90 Minutes.

Medicines Should Not Be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. This Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Gefitinib Accord Contains

The Active Substance Is Gefitinib (Gefitinibum).

One Tablet Contains 250 Mg of Gefitinib.

• The Other Ingredients Are: Tablet Core: Lactose Monohydrate, Microcrystalline Cellulose, Sodium Croscarmellose, Povidone K-30, Sodium Lauryl Sulfate, Magnesium Stearate. Coating: Polyvinyl Alcohol, Macrogol 4000/PEG 3350, Talc, Titanium Dioxide (E 171), Yellow Iron Oxide (E 172), Red Iron Oxide (E 172).

What Gefitinib Accord Looks Like and Contents of the Pack

Gefitinib Accord Is a Brown, Round, Biconvex, Film-Coated Tablet with "LP 100" Engraved on One Side and Plain on the Other.

The Diameter of the Tablet Is Approximately 11.13 Mm.

The Tablets Are Packaged in Perforated, Single-Dose PVC/PVDC/Aluminum Blisters in a PET/Aluminum Sachet Containing 30 x 1 Tablet.

Marketing Authorization Holder:

Accord Healthcare Polska Sp. z o.o.

Ul. Taśmowa 7

02-677 Warszawa

Manufacturer/Importer:

Laboratori Fundaci ó Dau

C/C, 12-14 Pol. Ind. Zona Franca

08040 Barcelona

Spain

Wessling Hungary Kft.

Anonymus u. 6

1045 Budapest

Hungary

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

PLA 3000, Paola

Malta

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:

Date of Last Revision of the Leaflet:February 2022