Gefitinib accord

Patient Information Leaflet

Gefitinib Accord, 250 mg, film-coated tablets
Gefitinibum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

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

Gefitinib Accord contains gefitinib as the active substance, which inhibits the activity of a certain protein called epidermal growth factor receptor (EGFR). This protein affects the growth and spread of cancer cells.
Gefitinib Accord is used in the treatment of adult patients with non-small cell lung cancer. This type of malignant tumour (cancer) develops in lung tissue.

2. Important information before using Gefitinib Accord

When not to use Gefitinib Accord:

• if the patient is allergic (hypersensitive) to gefitinib or any of the other ingredients of this medicine (listed in section 6 “What Gefitinib Accord contains”);
• if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Gefitinib Accord, talk to your doctor, pharmacist,
or nurse

• if the patient has ever had lung disease. Some lung conditions may worsen during treatment with Gefitinib Accord.
• if the patient has ever had liver function disorders.

Children and adolescents
Gefitinib Accord is not indicated for use in children and adolescents under 18 years of age.
Gefitinib Accord and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or 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 medicines containing St John’s wort (Hypericum perforatum, used for depression and anxiety),
• proton pump inhibitors, H2-receptor antagonists, and antacids (used for ulcers, indigestion, heartburn, and reducing stomach acid). These medicines may affect the action of Gefitinib Accord.
• warfarin (an oral anticoagulant, 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, contact the doctor or pharmacist before using Gefitinib Accord.
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 receiving Gefitinib Accord avoid becoming pregnant during treatment with Gefitinib Accord, as it may be harmful to the unborn child.
Do not take Gefitinib Accord during breastfeeding due to safety concerns for the infant.
Driving and operating machinery
During treatment with Gefitinib Accord, the patient may feel weak or fatigued. In such cases, do not drive, use tools, or operate machinery.
Gefitinib Accord contains lactose
If the doctor has informed the patient that they have an intolerance to certain sugars, contact the doctor before taking this medicine.
Gefitinib Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free."
3. How to take Gefitinib Accord
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.

• • The recommended dose is 250 mg (one tablet) 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 (which reduce stomach acid) within 2 hours before or 1 hour after taking Gefitinib Accord.

If difficulty swallowing occurs, the tablet may be dispersed in half a glass of non-carbonated water.
Do not dissolve tablets in any other liquid. Tablets must not be crushed. Stir the water until the tablet dissolves completely. This may take up to 20 minutes. The resulting solution should be consumed immediately after preparation. To ensure the full dose is taken, refill the glass with half a glass of water, stir, and drink.
Taking more Gefitinib Accord than recommended
If more than the recommended dose has been taken, contact a doctor or pharmacist immediately.
Missing a dose of Gefitinib Accord
The course of action depends on how much time remains until 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 once) to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the symptoms listed below occur, inform your doctor
as quickly as possible, 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, 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 Accord 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 also be affected.
• Dehydration (common) caused by prolonged or severe diarrhoea, vomiting, nausea or loss of appetite.
• Eye-related symptoms (uncommon), such as eye pain, redness, excessive tearing, light sensitivity, visual disturbances or ingrown eyelashes. This may indicate that the patient has developed a corneal ulceration on the surface of the eye.

If any of the following adverse reactions are noticed, inform your doctor
as soon as possible:
Very common: may affect more than 1 in 10 people

• Diarrhoea
• Vomiting
• Nausea
• Skin reactions such as acneiform rash, sometimes itchy, with dryness and/or skin cracking
• Loss of appetite
• Weakness
• Redness or pain in the mouth
• Increased activity of liver enzyme called alanine aminotransferase in blood tests; if the activity of this enzyme is too high, your doctor may advise you to stop taking Gefitinib Accord.

Common: may affect no more than 1 in 10 people

• Dryness in the mouth
• Dryness, redness or itching of the eyes
• Redness and pain in the eyelids
• Nail problems
• Hair loss
• Fever
• Bleeding (such as nosebleeds or blood in urine)
• Presence of protein in urine (detected in urine test)
• Increased levels of bilirubin and increased activity of the liver enzyme aspartate aminotransferase in blood tests; if the activity of this enzyme is too high, your doctor may advise you to stop taking Gefitinib Accord
• Increased creatinine levels in blood tests (related to kidney function)
• Cystitis (burning sensation when urinating and frequent urgent need to urinate)

Uncommon: may affect no more than 1 in 100 people

• Pancreatitis. Symptoms include severe abdominal pain located in the upper abdomen, accompanied by severe nausea and vomiting
• Hepatitis. Symptoms may include general malaise, with or without jaundice (yellowing of the skin and whites of the eyes). This adverse reaction is uncommon; however, 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 syndrome or hand-foot syndrome).

Rare: may affect no more than 1 in 1000 people

• Skin vasculitis. Bruising or non-blanching skin rashes may appear
• Haemorrhagic cystitis (burning sensation when urinating and frequent, urgent need to urinate with blood-tinged urine)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring 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 authorisation holder.
Reporting adverse reactions helps provide more information on the
safety of this medicine.

5. How to store Gefitinib Accord
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
After dissolving the tablet in water, the suspension should be consumed within 90 minutes.
Do not dispose of medicines via the sewage system 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 Accord contains
The active substance is gefitinib (Gefitinibum).
One tablet contains 250 mg of gefitinib.

• Other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, povidone K-30, sodium lauryl sulfate, magnesium stearate.
  Coating: polyvinyl alcohol, macrogol 4000/PEG 3350, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Gefitinib Accord looks like and contents of the pack
Gefitinib Accord is a brown, round, biconvex film-coated tablet with the inscription "LP 100" imprinted on one side and plain on the other side.
The tablet diameter is approximately 11.13 mm.
The tablets are packed in perforated, single-dose PVC/PVDC/Aluminium blisters in a PET/Aluminium sachet containing 30 x 1 tablet.

Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Poland

Manufacturer/Importer:
Laboratorios Farmacéuticos Dau
C/C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Wessling Hungary Kft.
Anonymus u. 6
1045 Budapest
Hungary
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
PLA 3000, Paola
Malta

This medicinal product is authorised in the European Economic Area and Great Britain (Northern Ireland) under the following names: