IRESSA 250 мг Фильм-coated таблетки

Содержание инструкции

1. IRESSA 250 mg film-coated tablets
   1. What is IRESSA and what is it used for
   2. What you need to know before you take IRESSA
   3. How to take IRESSA
   4. Possible side effects
   5. How to store IRESSA
   6. Package contents and other information

IRESSA 250 mg film-coated tablets

gefitinib

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is IRESSA and what is it used for

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

2. What you need to know before you take IRESSA

Do not take IRESSA

• if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section 6, “What IRESSA contains”).
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking IRESSA

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

Children and adolescents
IRESSA is not indicated in children and adolescents under 18 years of age.

Other medicines and IRESSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell 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 remedies 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 acidity in the stomach). These medicines may have an effect on how IRESSA works.
• Warfarin (an oral anticoagulant so called for the prevention of blood clots). If you are using a medicine containing this active substance, your doctor may need to have your blood tested more often. If any of the above conditions apply to you, or if you have any doubts, consult your doctor or pharmacist before taking IRESSA.

Pregnancy, breastfeeding and fertility
Consult your doctor before taking this medicine if you are pregnant, suspect or are
planning a pregnancy or if you are breastfeeding.
It is recommended to avoid becoming pregnant during treatment with IRESSA because
IRESSA may harm the baby.
Do not take IRESSA if you are breastfeeding. This is for the safety of the baby.

Driving and using machines
You may feel weak during treatment with Iressa. If this happens, do not drive vehicles or
use tools or machinery.

IRESSA contains lactose
If your doctor has diagnosed you as having intolerance to some sugars, contact him before taking
this medicine.

IRESSA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially ‘sodium-free’.

3. How to take IRESSA

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

• The recommended dose is one 250 mg tablet per day.
• Take the tablet at about the same time each day.
• You can take the tablet with or without food.
• Do not take antacids (to reduce the levels of acidity in your stomach) two hours before or one hour after taking IRESSA.

If you have difficulty swallowing the tablet, dissolve it in half a glass of still (non
carbonated) water. Do not use other liquids. Do not crush the tablet. Rotate the glass with the water until
the tablet has dissolved. This may take up to 20 minutes. Drink the liquid immediately. To
ensure you have drunk all the medicine, rinse the glass very well with half a glass
of water and drink it all.

If you take more IRESSA than you should
If you have taken more tablets than you should, seek immediate medical advice or contact a pharmacist.

If you forget to take IRESSA
What to do if you forget to take a tablet depends on how much time is left before the next dose.

• If 12 hours or more remain before the next dose: take the forgotten tablet as soon as you remember. Then take the next dose as usual.
• If less than 12 hours remain before the next dose: skip the forgotten tablet. Then 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you notice any of the following side effects –
you may need urgent medical attention:

• Allergic reactions (common), especially if the 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, with possible cough or fever. This could mean you have inflammation of the lungs called “interstitial lung disease”. This can occur in about 1 in 100 patients taking IRESSA and can be life-threatening.
• Severe skin reactions (rare) affecting large areas of the body. Symptoms may include redness, pain, ulcers, blisters and peeling 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 pain, redness, watering, sensitivity to light, changes in vision or eyelashes growing inwards. This could mean there is an ulcer on the surface of the eye (cornea).

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 acneiform rash, sometimes with itching and dry and/or cracked skin
• Loss of appetite
• Weakness
• Sore or red mouth
• Increase in a liver enzyme known as alanine aminotransferase in blood tests; if too high, your doctor may tell you to stop treatment with IRESSA

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 urine)
• Presence of protein in 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 tell you to stop treatment with IRESSA
• Increase in creatinine levels in blood tests (related to kidney function)
• Cystitis (burning sensation when passing urine and frequent and urgent need to urinate)

Uncommon: may affect up to 1 in 100 people

• Inflammation of the pancreas. Signs include very intense pain in the upper area of the stomach and severe nausea and vomiting.
• Inflammation of the liver. Symptoms may include a 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 as a result of 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 palmo-plantar erythrodysesthesia or hand-foot syndrome).

Rare: may affect up to 1 in 1,000 people

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store IRESSA

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 carton, on the blister, and on the leaflet
after EXP. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
Do not dispose of any medicine in waste water 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 IRESSA contains

• The active ingredient is gefitinib. Each tablet contains 250 mg of gefitinib.
• The other ingredients (excipients) are lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose, povidone (K29-32) (E1201), sodium lauryl sulfate, magnesium stearate, hypromellose (E464), macrogol 300, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of IRESSA and package contents
IRESSA is a round, brown tablet with the inscription “IRESSA 250” on one side and smooth
on the other side.
IRESSA is available in packs of 30 tablets in blisters. The blister may be perforated or not
perforated.

Marketing Authorisation Holder
AstraZeneca AB,
SE-151 85, Södertälje,
Sweden

Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden
AstraZeneca UK Limited,
Macclesfield,
Cheshire, SK10 2NA,
United Kingdom
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
AstraZeneca SA/NV
Tel: +32 2 370 48 11

Lietuva
UAB AstraZeneca Lietuva
Tel: +370 5 2660550

България
АстраЗенека България EOOД
Тел.: +359 (2) 44 55 000

Luxembourg/Luxemburg
AstraZeneca S.A./N.V.
Tél/Tel: + 32 2 370 48 11

Česká republika
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111

Magyarország
AstraZeneca Kft
Tel.: + 36 1 883 6500

Danmark
AstraZeneca A/S
Tlf: +45 43 66 64 62

Malta
Associated Drug Co. Ltd
Tel: + 356 2277 8000

Deutschland
AstraZeneca GmbH
Tel: +49 40 809034100

Nederland
AstraZeneca BV
Tel: +31 79 363 2222

Eesti
AstraZeneca
Tel: +372 6549 600

Norge
AstraZeneca AS
Tlf: + 47 21 00 64 00

Ελλάδα
AstraZeneca A.E.
Τηλ: + 30 2 106871500

Österreich
AstraZeneca Österreich GmbH
Tel: +43 1 711 31 0

España
AstraZeneca Farmacéutica Spain, S.A.

Polska
AstraZeneca Pharma Poland Sp. z o.o.
Tel: + 34 91 301 91 00 Tel.: + 48 22 245 73 00

France
AstraZeneca
Tél: + 33 1 41 29 40 00

Portugal
AstraZeneca Produtos Farmacêuticos, Lda.
Tel: + 351 21 434 61 00

Hrvatska
AstraZeneca d.o.o.
Tel: +385 1 4628 000

România
AstraZeneca Pharma SRL
Tel: + 40 21 317 60 41

Ireland
AstraZeneca Pharmaceuticals (Ireland) DAC
Tel: + 353 1609 7100

Slovenija
AstraZeneca UK Limited
Tel: + 386 1 51 35 600

Slovenská republika
AstraZeneca AB o.z.
Tel: + 421 2 5737 7777

Ísland
Vistor hf.
Sími: + 354 535 7000

Suomi/Finland
AstraZeneca Oy
Puh/Tel: + + 358 10 23 010

Italia
AstraZeneca S.p.A.
Tel: +39 02 00704500

Κύπρος
Αλέκτωρ Φαρµακευτική Λτδ
Τηλ: +357 22490305

Sverige
AstraZeneca AB
Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: + 371 67377100

United Kingdom (Northern Ireland)
AstraZeneca UK Ltd
Tel: + 44 1582 836 836

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu