Package Leaflet: Information for the User

Gefitinib Accord 250 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

-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 you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Gefitinib Accord

3. How to take Gefitinib Accord

4. Possible side effects

5. Storage of Gefitinib Accord

6. Contents of the pack and additional information

Gefitinib Accord contains the active ingredient gefitinib, which blocks a protein called the “epidermal growth factor receptor” (EGFR). This protein is involved in the growth and spread of cancerous cells.

Gefitinib is used to treat adults with non-small cell lung cancer. This cancer is a disease in which malignant cells (cancerous) form from the tissues of the lung.

Do not takeGefitinib

• if you are allergic to gefitinib orany of the other ingredients ofthis medicine (listed in section 6, “Composition of Gefitinib Accord”).
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gefitinib Accord

• if you have or have had any other lung problem. Some lung problems may worsen during gefitinib treatment.
• if you have ever had any liver problems.

Children and adolescents

This medicine is not indicated for children and adolescents under 18 years.

Use of gefitinib with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medicine.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Phenytoin or carbamazepine (for epilepsy).
• Rifampicin (for tuberculosis).
• Itraconazole (for fungal infections).
• Barbiturates (a type of medicine used for sleep problems).
• Herbal medicines containing St. John's Wort (Hypericum perforatum, used for depression and anxiety).
• Proton pump inhibitors, H2 antagonists and antacids (for ulcers, indigestion, heartburn and to reduce stomach acid).

These medicines may affect the mechanism by which gefitinib works.

• Warfarin (an oral anticoagulant to prevent blood clots). If you are taking a medicine containing this active ingredient, your doctor may need to perform more frequent blood tests.

If you are in any of these situations, or if you have doubts, consult your doctor or pharmacist before taking Gefitinib Accord.

Pregnancy, breastfeeding and fertility

Consult your doctor before taking this medicine if you are pregnant, may be pregnant or are breastfeeding.

It is recommended that you avoid becoming pregnant during gefitinib treatment, as this medicine may cause harm to your baby.

Do not take Gefitinib Accord if you are breastfeeding. This is for the safety of your baby.

Driving and operating machines

You may feel weak during gefitinib treatment. If this occurs, do not drive or use tools or machines.

Gefitinib Accord contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Gefitinib Accord contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per dose; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one 250 mg tablet per day.
• Take the tablet approximately at the same time every day.
• You can take the tablet with or without food.
• Do not take antacids (to reduce the level of acid in your stomach) 2 hours before or 1 hour after taking gefitinib.

If you have trouble swallowing the tablet, dissolve it in half a glass of water (without gas). Do not use any other liquid. Do not crush the tablet. Remove the water until the tablet has dissolved. This may take up to 20 minutes. Drink the liquid immediately. To ensure that all the medication has been taken, rinse the glass well with half a glass of water and drink it.

If you take moreGefitinib Accordthan you should

If you have taken more tablets than you should, contact your doctor or pharmacist immediately.

If you forget to takeGefitinib Accord

What to do if you forget to take a tablet depends on how much time is left until your next dose.

• If there are 12 hours or more until your next dose: take the missed tablet as soon as you remember. Then take the next dose as usual.
• If there are less than 12 hours until your next dose: do not take the missed tablet. Then take the next tablet at the usual time.

Do not take a double dose (two tablets at once) to make up for missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:

• Allergic reaction (frequent), particularly if symptoms include swollen face, lips, tongue, or throat, difficulty swallowing, hoarseness, urticaria, and difficulty breathing.
• Severe difficulty breathing, or sudden worsening of breathing difficulty, possibly with cough or fever. This may mean you have a lung inflammation called "interstitial lung disease". This can affect approximately 1 in 100 patients taking gefitinib and can be life-threatening.
• Severe skin reactions (rare) affecting large areas of your body. Symptoms may include redness, pain, ulcers, blisters, and skin peeling. It may also affect your lips, nose, eyes, and genitals.
• Dehydration (frequent) caused by persistent or severe diarrhea, vomiting (urge to vomit), nausea (feeling of discomfort), or loss of appetite.
• Eye problems (infrequent), such as pain, redness, watery eyes, light sensitivity, changes in vision, or eyelid retraction. This may mean you have a corneal ulcer.

Inform your doctor as soon as possible if you notice any of the following side effects:

Very frequent: side effects (can affect more than 1 in 10 people)

• Dysentery
• Vomiting
• Nausea
• Skin reactions like acne-like eruptions, which sometimes present as itching with dryness and/or cracks in the skin
• Loss of appetite
• Weakness
• Redness or pain of the mouth
• Increased liver enzyme alanine aminotransferase in blood tests; if this increase is too high, your doctor may recommend you stop taking Gefitinib.

Frequent: side effects (can affect up to 1 in 10 people)

• Dry mouth
• Dryness, redness, or itching of the eyes
• Redness and pain of the eyelids
• Nail problems
• Hair loss
• Fever
• Bleeding (such as nasal bleeding or blood in your urine)
• Proteins in your urine (detected by urine analysis)
• Increased bilirubin and another liver enzyme known as aspartate aminotransferase in blood tests; if this increase is too high, your doctor may recommend you stop taking gefitinib
• Increased levels of creatinine in blood tests (related to kidney function)
• Cystitis (sensation of burning while urinating and frequent and urgent need to urinate)

Infrequent: side effects (can affect up to 1 in 100 people)

• Pancreatitis. Symptoms include severe pain in the upper abdominal area and intense nausea and vomiting.
• Hepatitis. Symptoms may include a general feeling of discomfort, with or without possible jaundice (yellowing of the skin and eyes). This side effect is infrequent; however, some patients have died from it.
• Gastrointestinal perforation.
• Skin reaction on the palms of the hands and soles of the feet that includes tingling, numbness, pain, swelling, or redness (known as palmo-plantar erythrodysesthesia syndrome or hand-foot syndrome).

Rare: side effects (can affect up to 1 in 1000 people)

• Angiitis of the skin vessels. This may appear as a hematoma or skin eruption that does not disappear after pressing it.
• Haemorrhagic cystitis (sensation of burning while urinating and frequent and urgent need to urinate, with presence of blood in the urine).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Medicines for Human Use Pharmacovigilance System:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

After dispersing in water, the preparation should be taken within 90 minutes.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and the medications that you no longer need. In this way, you will help protect the environment.

Composition of Gefitinib Accord

The active ingredient is gefitinib. Each tablet contains 250 mg of gefitinib.

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460), povidone (E1201), sodium lauryl sulfate, magnesium stearate.

Tablet coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

Appearance of Gefitinib Accord and packaging contents

Brown, round tablets, marked with “LP100” on one side and smooth on the other. The tablet diameter is approximately 11.13 mm.

It is presented in blister packs of 30 tablets in PVC/PVDC-Alu and PET/Alu overwraps.

Marketing authorization holder:

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona s/n. Edifici Est 6th floor

08039 Barcelona

Spain

Responsible for manufacturing:

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Fundació Dau Laboratories

C/ C, 12-14 Pol. Ind Zona Franca,

08040 Barcelona

Spain

Wessling Hungary Kft.

Anonymus u. 6

Budapest 1045

Hungary

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last reviewed date of this leaflet:February 2022