Gefitinib Krka

Package Leaflet: Information for the User

Gefitinib Krka, 250 mg, Film-Coated Tablets

Gefitinib

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

• Keep this package 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 package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents:

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

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

Gefitinib Krka 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 Krka 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 Krka

When not to take Gefitinib Krka

• if you are allergic (hypersensitive) to the active substance or any of the other ingredients of Gefitinib Krka (listed in section 6),
• in women who are breastfeeding.

Warnings and precautions

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

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

Children and adolescents

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

Other medicines and Gefitinib Krka

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

• phenytoinor 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, 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 Krka.
• Anticoagulant medicines, including warfarin(a so-called 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 if you are not sure, contact your doctor or pharmacist before taking Gefitinib Krka.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant, may become pregnant, or are breastfeeding.
It is recommended that female patients treated with Gefitinib Krka avoid becoming pregnant during treatment with Gefitinib Krka, as it may harm the baby.
Gefitinib Krka should not be used during breastfeeding.

Driving and using machines

During treatment with Gefitinib Krka, you may feel weak. In this case, do not drive vehicles, use tools, or operate machines.

Gefitinib Krka contains lactose and sodium.

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking Gefitinib Krka.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Gefitinib Krka

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

• The usual dose of Gefitinib Krka 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 (reducing stomach acid) 2 hours before and 1 hour after taking Gefitinib Krka.

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 prepared liquid immediately after preparation. To ensure you take the full dose, refill the glass with water to about half full, stir, and drink the liquid.

Taking more than the prescribed dose of Gefitinib Krka

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

Missing a dose of Gefitinib Krka

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 Krka can cause side effects, although not everybody gets them.

If you experience any of the following side effects, including those not listed in this package leaflet, inform your doctor or pharmacist, as you may need urgent medical treatment:

• Allergic reactions (frequent), especially if there is 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 Krka 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 genitals may be affected.
• Dehydration (frequent) caused by 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 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

• diarrhea
• vomiting
• nausea
• skin reactions, such as acne-like rash, which may be itchy, and may be accompanied by dry skin and (or) skin cracking
• 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, your doctor may decide to stop treatment with Gefitinib Krka

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 bilirubin or liver enzyme aspartate aminotransferase in blood tests. If this is too high, your doctor may decide to stop treatment with Gefitinib Krka
• increased creatinine in the blood, detected in laboratory tests (creatinine levels indicate kidney function)
• urinary tract infection (symptoms include burning 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 part of the abdomen, and severe nausea and vomiting
• liver inflammation. Symptoms may include general malaise, with or without jaundice (yellowing of the skin and eyes), or without jaundice. 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. Bruises or non-blanching spots may appear on the skin
• hemorrhagic cystitis (burning during urination and frequent, urgent need to urinate, with blood in the urine)

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gefitinib Krka

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

• The active substance is gefitinib. Each 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 (E172), yellow iron oxide (E172), black iron oxide (E172). See section 2 "Gefitinib Krka contains lactose and sodium."

What Gefitinib Krka looks like and contents of the pack

Gefitinib Krka is available as brown, round, biconvex film-coated tablets (about 11 mm in diameter). On one side of the tablet, the inscription "G9FB 250" is embossed.
The pack contains 30, 90, 30 x 1, or 90 x 1 tablets of Gefitinib Krka, in blisters. The blister may be perforated or non-perforated.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer

Synthon Hispania, S.L., C/ Castelló no 1, Pol. Las Salinas, Sant Boi de Llobregat, 08830 Barcelona,
Spain
Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Krka Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00
Date of last revision of the package leaflet:23.10.2021