Gefitinib Medac

Patient Information Leaflet

GEFITINIB MEDAC 250 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What GEFITINIB MEDAC is and what it is used for
2. What you need to know before taking GEFITINIB MEDAC
3. How to take GEFITINIB MEDAC
4. Possible side effects
5. How to store GEFITINIB MEDAC
6. Contents of the pack and other information

1. What GEFITINIB MEDAC is and what it is used for

GEFITINIB MEDAC contains the active substance gefitinib, which blocks a protein called “epidermal growth factor receptor” (EGFR). This protein is involved in the growth and spread of cancer cells.
GEFITINIB MEDAC is used to treat adults with non-small cell lung cancer.
This cancer is a disease in which malignant cells (cancer) form in the lung tissue.

2. What you should know before taking GEFITINIB MEDAC

Do not take GEFITINIB MEDAC:

• if you are allergic to gefitinib or to any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking GEFITINIB MEDAC:

• if you have ever had any other lung problems. Some lung conditions may worsen during treatment with GEFITINIB MEDAC.
• if you have ever had liver problems.

Children and adolescents
GEFITINIB MEDAC is not indicated in children and adolescents under 18 years of age.
Other medicines and GEFITINIB MEDAC
Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 disorders).
• Herbal remedies containing St. John’s wort (Hypericum perforatum, used for depression and anxiety).
• Proton pump inhibitors, H\2-receptor antagonists, and antacids (for ulcers, indigestion, heartburn, and to reduce stomach acidity). These medicines may affect how GEFITINIB MEDAC works.
• Warfarin (an oral anticoagulant used to prevent blood clots). If you are taking a medicine containing this active substance, your doctor may need to perform blood tests more frequently. If any of the above conditions apply to you, or if you have any doubts, consult your doctor or pharmacist before taking GEFITINIB MEDAC.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
It is recommended to avoid becoming pregnant during treatment with GEFITINIB MEDAC, as GEFITINIB MEDAC may harm the unborn child.
Do not take GEFITINIB MEDAC if you are breastfeeding, for the safety of the infant.
Driving and using machines
If you feel weak while taking this medicine, exercise caution when driving or operating tools or machinery.
GEFITINIB MEDAC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
GEFITINIB MEDAC contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to take GEFITINIB MEDAC

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

• The recommended dose is one 250 mg tablet daily.
• Take the tablet at approximately the same time each day.
• You may take the tablet with or without food.
• Do not take antacids (to reduce stomach acidity) within two hours before or one hour after taking GEFITINIB MEDAC.

If you have difficulty swallowing the tablet, dissolve it in half a glass of still (non-carbonated) water.
Do not use any other liquid. Do not crush the tablet. Swirl the glass gently until the tablet dissolves, which may take up to 20 minutes. Drink the solution immediately. To ensure you receive the full dose, rinse the glass thoroughly with half a glass of water and drink it as well.

If you take more GEFITINIB MEDAC than you should
If you have taken more tablets than prescribed, contact a doctor or pharmacist immediately.

If you forget to take GEFITINIB MEDAC
What you should do if you miss a dose depends on how close it is to the next dose.

• If there are 12 hours or more before your next dose: take the missed tablet as soon as you remember. Then take the next dose at the usual time.
• If less than 12 hours remain before your next dose: skip 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 forgotten tablet.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Tell your doctor immediately if you notice any of the following side effects –
you may need urgent medical treatment:

• Allergic reactions (common), especially if symptoms include swelling of the face, lips, tongue or throat, difficulty swallowing, hives, and difficulty breathing.
• Severe shortness of breath or sudden worsening of shortness of breath, possibly with cough or fever. This could mean you have inflammation of the lungs called "interstitial lung disease". This occurs in about 1 in 100 patients taking GEFITINIB MEDAC and can be life-threatening.
• Severe skin reactions (rare) affecting large areas of the body. Symptoms may include redness, pain, ulcers, blisters, and peeling of the skin. Lips, nose, eyes, and genitals may also be affected.
• Dehydration (common) caused by persistent or severe diarrhoea, vomiting (feeling unwell), nausea (feeling sick), or loss of appetite.
• Eye problems (uncommon), such as eye pain, redness, tearing, sensitivity to light, changes in vision, or inward-growing eyelashes. This could indicate a corneal ulcer (ulcer on the surface of the eye).

Tell your doctor as soon as possible if you notice any of the following side effects:
Very common: may affect more than 1 in 10 people

• Diarrhoea
• Vomiting
• Nausea
• Skin reactions such as acne-like rash, sometimes with itching and dry and/or cracked skin
• Loss of appetite
• Weakness
• Red or sore mouth
• Increase in a liver enzyme known as alanine aminotransferase in blood tests; if too high, your doctor may instruct you to stop treatment with GEFITINIB MEDAC.

Common (may affect up to 1 in 10 people)

• Dry mouth
• Dry, red or itchy eyes
• Red and painful eyelids
• Nail problems
• Hair loss
• Fever
• Bleeding (such as nosebleeds or blood in the urine)
• Presence of protein in the urine (detected by urine test)
• Increase in bilirubin and another liver enzyme known as aspartate aminotransferase in blood tests; if too high, your doctor may instruct you to stop treatment with GEFITINIB MEDAC
• Increased levels of creatinine in blood tests (related to kidney function)
• Cystitis (burning sensation when passing urine and frequent, urgent need to urinate).

Uncommon (may affect up to 1 in 100 people)

• Inflammation of the pancreas. Signs include severe pain in the upper stomach area and severe nausea and vomiting.
• Liver inflammation. Symptoms may include general feeling of being unwell, with or without jaundice (yellowing of the skin and eyes). This is an uncommon side effect; however, some patients have died from this event.
• 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 or hand and foot syndrome).

Rare (may affect up to 1 in 1,000 people)

• Inflammation of blood vessels in the skin. This may cause bruising or red patches that do not fade when pressure is applied to the skin.
• Haemorrhagic cystitis (burning sensation when passing urine and frequent, urgent need to urinate with blood in the urine).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GEFITINIB MEDAC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What GEFITINIB MEDAC contains

• The active substance is gefitinib. Each film-coated tablet contains 250 mg of gefitinib.
• The other components are: Tablet core: monohydrate lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, povidone, and magnesium stearate. Coating: polyvinyl alcohol, macrogol 3350, talc, yellow iron oxide, red iron oxide, titanium dioxide.

Description of the appearance of GEFITINIB MEDAC and contents of the pack
Film-coated tablet, brown, round, biconvex, with a diameter of approximately 11 mm, marked with "250" on one side and blank on the other.
Pack sizes:
30 film-coated tablets in blisters.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
medac pharma s.r.l
Via Viggiano 90
00178 Roma
Italy
Manufacturer:
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25
Zagreb
10000, Croatia
Balkanpharma – Dupnitsa AD
3 Samokovsko Shoose Str.
2600 Dupnitsa
Bulgaria