Gefitinib synthon

Package leaflet: Information for the patient

Gefitinib Synthon, 250 mg, film-coated tablets
Gefitinib
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Gefitinib Synthon is and what it is used for
2. What you need to know 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 Gefitinib Synthon is and what it is used for

Gefitinib Synthon contains the active substance gefitinib, which inhibits the activity of a protein known as the epidermal growth factor receptor (EGFR). This protein influences the growth and spread of cancer cells.
Gefitinib Synthon is used in the treatment of adult patients with non-small cell lung cancer. This type of malignant tumour originates from lung cells.

2. Important information before taking Gefitinib Synthon

When not to take Gefitinib Synthon

• if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of Gefitinib Synthon (listed in section 6. What Gefitinib Synthon contains),
• in women who are breastfeeding.

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

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

Children and adolescents
Gefitinib Synthon must not be used in children and adolescents under 18 years of age.
Other medicines and Gefitinib Synthon
Tell your doctor about all medicines the patient has recently taken, as well as any medicines the patient plans 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 remedy containing St John's wort Hypericum perforatum (used for depression and anxiety)
• proton pump inhibitors, H_-receptor antagonist medicines (used to treat ulcers, indigestion, heartburn and to reduce stomach acid), and antacids. These medicines may affect the action of Gefitinib Synthon.
• Anticoagulant medicines including warfarin (so-called oral anticoagulants 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 Synthon.
Pregnancy, breastfeeding and fertility
Inform your treating doctor if the patient is pregnant, may become pregnant, or is breastfeeding.
It is recommended that female patients being treated with Gefitinib Synthon avoid becoming pregnant during treatment with Gefitinib Synthon, as it may be harmful to the unborn child.
Gefitinib Synthon 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 Synthon contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
Gefitinib Synthon contains sodium croscarmellose and sodium lauryl sulphate
This medicine contains less than 1 mmol (23 mg) of sodium, which means it is considered "sodium-free".

3. How to take Gefitinib Synthon

Gefitinib Synthon should always be taken exactly as your doctor has instructed. If you are unsure, contact your doctor or pharmacist again.

• The usual dose of Gefitinib Synthon is one tablet (250 mg) taken daily.
• The medicine should be taken every day, approximately at the same time.
• Tablets may be taken with food or on an empty stomach.
• Do not take antacids (medicines that reduce stomach acid) within 2 hours before or 1 hour after taking Gefitinib Synthon.

If you have difficulty swallowing the tablet, it may be dispersed in half a glass of non-carbonated water.
Do not use any other liquid to dissolve the tablet. Do not crush the tablet. Stir the liquid until the tablet dissolves completely, which may take up to 20 minutes. The resulting 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.

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

If you forget to take Gefitinib Synthon
Your course of action depends on how much time remains until your next dose.

• If 12 hours or more remain before your next dose, take the missed tablet as soon as possible. Take the next dose at your usual time.
• If less than 12 hours remain before your next dose, do not take the missed tablet. Take the next tablet at your 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Gefitinib Synthon may cause adverse reactions, although not everyone will experience 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 breathlessness or rapidly worsening breathlessness, possibly accompanied by cough or fever. This may indicate that the patient has developed a type of lung inflammation called interstitial lung disease. This adverse reaction may occur in approximately 1 out of every 100 patients treated with Gefitinib Synthon 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. These may indicate corneal ulceration (an ulcer on the surface of the eye).

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 Synthon

Common: may affect up to 1 in 10 people

• dry mouth
• dry, red, itchy eyes
• redness and pain in the eyelids
• nail disorders, hair loss
• fever
• bleeding (e.g. nosebleeds or blood in the urine)
• increased bilirubin levels 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 Synthon
• increased blood creatinine levels detected in laboratory tests (elevated creatinine indicates 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 upper abdominal pain, 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.

Rare: may affect up to 1 in 1000 people

• skin vasculitis. Bruising or non-blanching skin rash may appear
• haemorrhagic cystitis (burning sensation during urination and frequent, urgent need to urinate with blood-tinged urine)

Reporting of adverse reactions
If any adverse symptom worsens or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Faks: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 cardboard box and blister pack. The expiry date refers to the last day of the specified month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.
• Other ingredients: sodium lauryl sulfate, monohydrate lactose, microcrystalline cellulose, povidone K-29/32, sodium croscarmellose, magnesium stearate, polyvinyl alcohol, polyethylene glycol 4000, talc, iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172).

What Gefitinib Synthon looks like and contents of the pack
Gefitinib Synthon is a brown, round, biconvex tablet (approximately 11 mm in diameter) with the imprint 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

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