Patient Information Leaflet

Gefitinib Genoptim, 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 personally. 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

What Gefitinib Genoptim is and what it is used for
Important information before taking Gefitinib Genoptim
How to take Gefitinib Genoptim
Possible side effects
How to store Gefitinib Genoptim
Contents of the pack and other information

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

Gefitinib Genoptim contains the active substance gefitinib, which inhibits the activity of a protein called epidermal growth factor receptor (EGFR). This protein influences 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 tumour originates from lung cells.

2. Important information before taking Gefitinib Genoptim

When not to take Gefitinib Genoptim

if the patient has hypersensitivity (allergy) to gefitinib or to any of the other components of this medicine (listed in section 6),
in women who are breastfeeding.

Warnings and precautions
Before taking Gefitinib Genoptim, talk to your doctor or pharmacist if the patient:

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

Children and adolescents
Gefitinib Genoptim must not be used in children and adolescents under 18 years of age.
Other medicines and Gefitinib Genoptim
Tell your doctor about all medicines you are currently taking or plan to take.
In particular, inform your 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 medicines containing St John’s wort Hypericum perforatum (used for depression and anxiety)
proton pump inhibitors, H2-receptor antagonists (used for ulcers, indigestion, heartburn and reducing gastric acid secretion), and antacids. These medicines may affect the action of Gefitinib Genoptim.
Anticoagulants, including warfarin (oral anticoagulant medicines 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 their doctor or pharmacist before taking Gefitinib Genoptim.
Pregnancy, breastfeeding and fertility
Inform your treating doctor if the patient is pregnant, could become pregnant, or is breastfeeding.
It is recommended that female patients receiving Gefitinib Genoptim avoid becoming pregnant during treatment, as the medicine may be harmful to the unborn child.
Gefitinib Genoptim 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 Genoptim contains lactose.
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Gefitinib Genoptim contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium, which means the medicine is considered "sodium-free".

3. How to take Gefitinib Genoptim

Gefitinib Genoptim should always be taken as prescribed by your doctor. If you have any
doubts, please contact your doctor or pharmacist again.

The usual dose of Gefitinib Genoptim 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 Genoptim.

If you have difficulty swallowing, the tablet can be dissolved in half a glass of non-carbonated water.
Do not dissolve the tablet in any other liquid. Do not crush the tablet. The solution should be stirred 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 Genoptim than recommended
If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.

If you miss a dose of Gefitinib Genoptim
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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Gefitinib Genoptim can cause adverse reactions, although not everyone experiences them.
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet,
consult a doctor or pharmacist immediately, 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 breathing difficulties.
Severe shortness of breath 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 out of every 100 patients treated with Gefitinib Genoptim 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 be involved.
Dehydration (common) caused by prolonged or severe diarrhoea, vomiting, nausea or loss of appetite.
Eye-related symptoms (uncommon), such as eye pain, redness, tearing, light sensitivity, visual disturbances or ingrown eyelashes. This may indicate that the patient has developed an ulcer on the surface of the eye (on the cornea).

Contact a doctor immediately if any of the following adverse reactions occur:
Very common (may affect more than 1 in 10 people)

loss of appetite
diarrhoea
vomiting, nausea, redness or irritation of the mouth
skin reactions, such as: acneiform rash, sometimes itchy, possibly accompanied by dry skin and/or skin cracking
fatigue
in blood tests, increased activity of a liver enzyme called alanine aminotransferase; if this increase is too high, the doctor may decide to discontinue 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 presence of blood in urine)
increased blood levels of bilirubin or increased activity of the liver enzyme aspartate aminotransferase in blood tests. If this increase is too high, the doctor may decide to discontinue treatment with Gefitinib Genoptim
increased blood creatinine levels found in laboratory tests (indicating kidney function), presence of protein in urine (detected in laboratory tests), cystitis (characterized 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
gastrointestinal perforation
hepatitis. Symptoms may include general malaise, possibly with jaundice (yellowing of the skin and eyes) or without jaundice. This adverse reaction is uncommon, but some patients have died from it.
Skin reaction on the palms and soles, including tingling, numbness, pain, swelling or redness (known as hand-foot skin reaction or palmar-plantar erythrodysesthesia syndrome).

Rare (may affect up to 1 in 1000 people)

skin vasculitis. Bruising or areas of non-blanching rash may appear on the skin.
haemorrhagic cystitis (burning sensation during urination and frequent, urgent need to pass blood-tinged urine).

Reporting of adverse reactions
If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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 authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Gefitinib Genoptim

Keep the medicine out of the sight and reach of children.
Do not use Gefitinib Genoptim after the expiry date (EXP) stated on the cardboard box and blister pack. The expiry date refers to the last day of the specified month.
No special storage instructions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with 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.
Other ingredients: sodium lauryl sulfate, monohydrate lactose, microcrystalline cellulose, povidone K-29/32, sodium croscarmellose, 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 a brown, round, biconvex tablet with the imprint "G9FB 250" on one side.
The pack contains 30 tablets or 30 x 1 tablet of Gefitinib Genoptim in blisters. The blister may be perforated or non-perforated.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Poland

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