Gefitinib Sinthon

Package Leaflet: Information for the Patient

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

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

Gefitinib Synthon 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 Synthon 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 Synthon

When not to take Gefitinib Synthon

• in women during breastfeeding.

Warnings and precautions

Before taking Gefitinib Synthon, talk to your doctor or pharmacist if you have:

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

Children and adolescents

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

Other medicines and Gefitinib Synthon

Tell your doctor about all the medicines you have taken recently and any 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 Synthon.
• 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 if they apply to you, contact your doctor or pharmacist before taking Gefitinib Synthon.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant, may become pregnant, or are breastfeeding.
Women taking Gefitinib Synthon should avoid becoming pregnant during treatment with Gefitinib Synthon, as it may harm the baby.
Gefitinib Synthon should not be used during breastfeeding.

Driving and using machines

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

Gefitinib Synthon contains lactose.

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

Gefitinib Synthon contains croscarmellose sodium and sodium lauryl sulfate

The medicine contains less than 1 mmol (23 mg) of sodium, i.e., the medicine is considered "sodium-free".

3. How to take Gefitinib Synthon

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

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

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 a higher dose of Gefitinib Synthon than recommended

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

Missing a dose of Gefitinib Synthon

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

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

• Allergic reactions (frequent), 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 Synthon 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 ingrowth of eyelashes into the eyelid. This may indicate that you have developed an ulcer on the surface of the eye (on the cornea)

Tell 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 called alanine aminotransferase in blood tests; if this is too high, your doctor may decide to stop treatment with Gefitinib Synthon

Common: may affect up to 1 in 10 people

• dry mouth
• dryness, redness, and itching of the eyes
• redness and pain of the eyelids
• disorders of the nails, hair loss
• fever
• bleeding (e.g., from the nose or presence of blood in the urine)
• increased bilirubin levels or increased activity of the liver enzyme called aspartate aminotransferase in blood tests. If this is too high, your doctor may decide to stop treatment with Gefitinib Synthon
• increased creatinine levels 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 (characterized by burning during urination and frequent, sudden need to urinate)

Uncommon: may affect up to 1 in 100 people

• pancreatitis. Symptoms include very severe abdominal pain located in the upper part of the abdomen and severe nausea and vomiting
• perforation of the digestive tract
• 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.

Rare: may affect up to 1 in 1000 people

• vasculitis. You may notice bruising or areas of non-blanching rash on the skin
• hemorrhagic cystitis (burning during urination and frequent, sudden need to urinate, with blood in the urine)

Reporting side effects

If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the
Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocides
Jerozolimskie Avenue 181C

• 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 e-mail: ndl@urpl.gov.pl

You can also report side effects 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 Synthon

Keep out of the sight and reach of children.
Do not use Gefitinib Synthon 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 precautions for the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Gefitinib Synthon 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 (E172), yellow iron oxide (E172), black iron oxide (E172).

What Gefitinib Synthon looks like and contents of the pack

Gefitinib Synthon is available as brown, round, and biconvex tablets (about 11 mm in diameter) with the inscription G9FB 250 on one side.
The pack contains 30 tablets or 30 x 1 tablets of Gefitinib Synthon, 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:
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
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: