Gefitinib Genoptim

Package Leaflet: Information for the Patient

Gefitinib Genoptim, 250 mg, Coated Tablets

Gefitinib

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Gefitinib Genoptim and what is it used for
• 2. Important information before taking Gefitinib Genoptim
• 3. How to take Gefitinib Genoptim
• 4. Possible side effects
• 5. How to store Gefitinib Genoptim
• 6. Contents of the pack and other information

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

Gefitinib Genoptim 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 Genoptim is used to treat adult patients with non-small cell lung cancer. This type of malignant tumor originates from lung cells.

2. Important information before taking Gefitinib Genoptim

When not to take Gefitinib Genoptim

• if you are allergic (hypersensitive) to gefitinib or any of the other ingredients of this medicine (listed in section 6),
• in women during breast-feeding.

Warnings and precautions

Before taking Gefitinib Genoptim, you should discuss with your doctor or pharmacist whether you have:

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

Children and adolescents

Gefitinib Genoptim should not be used in children and adolescents under 18 years of age.

Other medicines and Gefitinib Genoptim

Tell your doctor about all the medicines you have taken recently and the medicines you plan to take.
In particular, inform your doctor or pharmacist if you are taking:

• phenytoin or carbamazepine (medicines used in epilepsy)
• rifampicin (a medicine used in tuberculosis)
• itraconazole (a medicine used in fungal infections)
• barbiturates (medicines used in sleep disorders)
• a herbal medicine containing St. John's Wort (Hypericum perforatum) (used in the treatment of depression and anxiety)
• proton pump inhibitors, medicines that are H2 receptor antagonists (used in the treatment of ulcers, indigestion, heartburn, and reducing stomach acid) and antacids. These medicines may affect the action of Gefitinib Genoptim.
• Anticoagulant medicines, including warfarin (an oral anticoagulant used to prevent blood clots). In this case, your doctor may recommend more frequent blood tests.

If any of these situations apply to you or you are not sure if they apply to you, you should contact your doctor or pharmacist before taking Gefitinib Genoptim.

Pregnancy, breast-feeding, and fertility

Inform your doctor if you are pregnant, may become pregnant, or are breast-feeding.
It is recommended that women treated with Gefitinib Genoptim avoid becoming pregnant during treatment with Gefitinib Genoptim, as it may harm the baby.
Gefitinib Genoptim should not be used during breast-feeding.

Driving and using machines

If you experience weakness while taking this medicine, you should be careful when driving vehicles and operating machines or using tools.

Gefitinib Genoptim contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.

Gefitinib Genoptim contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium, which means it is essentially 'sodium-free'.

3. How to take Gefitinib Genoptim

Always take Gefitinib Genoptim exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• The usual dose of Gefitinib Genoptim is one tablet (250 mg) per day.
• Take the medicine every day, at about the same time.
• The tablets can be taken with or without food.
• Do not take antacids (medicines that reduce stomach acid) 2 hours before and 1 hour after taking Gefitinib Genoptim.

If you have difficulty swallowing the tablet, you can dissolve it in half a glass of non-carbonated water.
Do not dissolve the tablets in any other liquid. Do not crush the tablet. Stir the liquid 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 of the medicine, refill the glass with water to about half full, stir, and drink the liquid.

Taking more than the prescribed dose of Gefitinib Genoptim

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

Missing a dose of Gefitinib Genoptim

The action to be taken depends on the time remaining until the next dose of the medicine.

• If there are 12 hours or more until the next dose, take the tablet 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 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 the missed dose.

If you have any further questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gefitinib Genoptim can cause side effects, although not everybody gets them.

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, as you may need urgent medical attention:

• Allergic reactions (frequently), especially if you experience swelling of the face, lips, tongue, or throat, difficulty swallowing, hives, rash, 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 you have developed interstitial lung disease. This side effect may occur in about 1 in 100 patients treated with Gefitinib Genoptim and may be life-threatening.
• Severe skin reactions (rarely), 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 genitals may be affected.
• Dehydration (frequently) caused by prolonged or severe diarrhea, vomiting, nausea, or loss of appetite.
• Eyelid disorders (not very frequently), such as pain, redness of the eye, tearing, 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)

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

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

• loss of appetite
• diarrhea
• vomiting, nausea, redness, or irritation of the mouth
• skin reactions, such as acne-like rash, which may be itchy, and may be accompanied by dry skin and (or) cracking of the skin
• weakness
• increased activity of the liver enzyme alanine aminotransferase in blood tests; if this is too high, your doctor may decide to stop treatment with Gefitinib Genoptim

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)
• increased bilirubin or liver enzyme aspartate aminotransferase in blood tests. If this is too high, your doctor may decide to stop treatment with Gefitinib Genoptim
• increased creatinine in the blood, detected in laboratory tests (creatinine levels indicate kidney function), presence of protein in the urine (detected in laboratory tests), urinary tract infection (manifested 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 in the upper abdomen and severe nausea and vomiting
• gastrointestinal perforation
• hepatitis. Symptoms may include general malaise, with or without jaundice (yellowing of the skin and eyes). This side effect occurs uncommonly, but some patients have died from it.
• Skin reaction on the palms and soles, 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. Bruises or non-blanching rashes may appear on the skin,
• hemorrhagic cystitis (burning during urination and frequent, sudden need to urinate, with blood in the urine).

Reporting side effects

If any side effect gets worse or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 the medicine.

5. How to store Gefitinib Genoptim

Keep out of the sight and reach of children.
Do not use Gefitinib Genoptim after the expiry date EXP stated on the carton and blister. The expiry date refers to the last day of that month.
There are no special precautions for storage.
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 Genoptim contains

• The active substance is gefitinib. One tablet contains 250 mg of gefitinib.
• The other ingredients are: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, povidone K-29/32, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, macrogol 4000, talc, red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172).

What Gefitinib Genoptim looks like and contents of the pack

Gefitinib Genoptim is available as brown, round, and biconvex tablets with the inscription G9FB 250 on one side.
The pack contains 30 tablets or 30 x 1 tablets of Gefitinib Genoptim, in blisters. The blister may be perforated or non-perforated.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Synoptis Pharma Sp. z o.o.
Krakowiaków 65
02-255 Warsaw

Manufacturer:

Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania S.L.
C/ Castelló no 1, Pol. Las Salinas
Sant Boi de Llobregat, Barcelona, 08830
Spain

Date of last revision of the leaflet: 07.2021