Iressa – Gefitinib uses, dose and side effects

}

250 mg film-coated tablets
gefitinib

1. What IRESSA is and what it is used for

IRESSA 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.

IRESSA is used to treat 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 taking IRESSA

Do not take IRESSA

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

Warnings and cautions

Talk to your doctor or pharmacist before taking IRESSA:

  • if you have ever had other lung problems before. Some lung problems may be aggravated by treatment with IRESSA.
  • if you have ever had liver problems

Children and young people

IRESSA is not intended for 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 – TBC).
  • Itraconazole (for fungal infections).
  • Barbiturates (a type of medicine used to treat sleep problems).
  • Herbal medicines containing St. John’s wort ( Hypericum perforatum , which is used for depression and anxiety).
  • Proton pump inhibitors , H2 antagonists and antacids (for stomach ulcers , stomach upset, heartburn and to reduce stomach acid).

These medicines may affect the effect of IRESSA.

  • Warfarin (a so-called oral anticoagulant to prevent blood clots). If you are taking a medicine containing this active substance, your doctor may need to take blood samples more often.

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before taking IRESSA.

Pregnancy, breastfeeding and fertility

If you are pregnant, pregnant, or breastfeeding, ask your doctor for advice before taking this medicine.

It is recommended that you avoid becoming pregnant while being treated with IRESSA as IRESSA may harm your baby.

Do not use IRESSA if you are breastfeeding. This is for your child’s safety.

Driving and using machines

You may feel weak while taking IRESSA. If this happens, do not drive or use any tools or machines.

IRESSA contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

IRESSA contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.

3. How to take IRESSA

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

  • The recommended dose is 1 tablet (250 mg) daily.
  • 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 amount of acid in your stomach) 2 hours before or 1 hour after taking IRESSA.

If you have problems swallowing the tablet, you can dissolve it in half a glass of water that does not contain carbon dioxide. Do not use any other liquid. Do not crush the tablet. Swirl the glass until the tablet has dissolved. This can take up to 20 minutes. Then drink the liquid immediately. To be sure that you have ingested all the medicine, rinse the glass very thoroughly with half a glass of water and drink from it.

If you take more IRESSA than you should

If you have taken too many tablets, contact your doctor or pharmacist immediately.

If you forget to take IRESSA

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

  • If it is 12 hours or more until the next dose: take the forgotten tablet as soon as you remember that you forgot it. Then take the next dose at the usual time.
  • If it is less than 12 hours until you take the next dose: skip the missed dose . Then take the next dose at the usual time.

Do not take a double dose (two doses at the same time) to compensate for a missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor immediately if you get any of the following side effects – you may need immediate medical attention:

  • Allergic reaction (common) especially if the symptoms include swelling of the face, lips, tongue or throat, difficulty swallowing, hives, hives and difficulty breathing.
  • Severe shortness of breath, or sudden worsening of shortness of breath and possibly also cough and fever. This may mean that you have an inflammation of the lungs called “interstitial lung disease”. It affects approximately 1 in 100 patients taking IRESSA and can be life-threatening.
  • Severe skin reactions (rare) that affect large areas of the body. Signs of this can be redness , pain, sores, blisters and flaking of the skin. Lips, nose, eyes and genitals can also be affected.
  • Dehydration (common) caused by prolonged or severe diarrhea, vomiting, nausea or loss of appetite.
  • Eye problems (rare) such as pain, red eyes, watery eyes, photosensitivity, changes in vision or inward growth of the eyelashes . This may mean that you have a wound on the surface of the eye (cornea).

Talk to your doctor as soon as possible if you get any of the following side effects:

Very common: may affect more than 1 user in 10

  • Diarrhea
  • Vomiting
  • Nausea
  • Skin reactions, such as acne-like rashes that sometimes itch and include dry and / or cracked skin
  • Loss of appetite
  • Weakness
  • Red or sore mouth
  • Increase in liver enzyme alanine aminotransferase in blood tests – if too high, your doctor may urge you to stop taking IRESSA

Common: may affect up to 1 in 10 users

  • Dry mouth
  • Dry, red or itchy eyes
  • Red and sore eyelids
  • Nail problems
  • Hair loss
  • Fever
  • Bleeding (eg nosebleeds or blood in the urine)
  • Protein in the urine (as seen in urine samples)
  • Increase in bilirubin and the liver enzyme aspartate aminotransferase in blood tests – if too high, your doctor may urge you to stop taking IRESSA
  • Increased levels of creatinine in blood tests (shows how your kidneys are working)
  • Cystitis (burning sensation when urinating and frequent, acute urges)

Uncommon: may affect up to 1 in 100 people

  • Inflammation of the pancreas. It is characterized by very severe pain in the upper abdomen and severe nausea and vomiting.
  • Inflammation of the liver. The symptoms may be a general feeling of illness with or without any jaundice (the skin and whites of the eyes turn yellow). This side effect is less common, but some patients have died from it.
  • Holes ( perforation are) in the gastrointestinal tract
  • Skin reaction on the palms and soles of the feet including tingling, numbness, pain, swelling or redness (known as palmar-plantar erythrodysesthesia or hand-foot syndrome).

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

  • Inflammation of the blood vessels in the skin. It may look like bruises or blemishes on the skin that do not fade away.
  • Hemorrhagic cystitis (burning sensation when urinating and frequent, acute urination with blood in the urine)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

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, blister, and foil laminate after EXP. The expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and contents of the pack

IRESSA is a round brown tablet marked “IRESSA 250” on one side and smooth on the other side.

IRESSA is supplied in blister packs of 30 tablets. The blister foil may be perforated or unperforated.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-151 85 Södertälje

Sweden

AstraZeneca UK Limited,

Macclesfield

Cheshire

SK10 2NA

UK

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11LithuaniaUABAstraZeneca LietuvaTel: +370 5 2660550
BulgariaAstrology Bulgaria BODYTel: +359 (2) 44 55 000Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11
Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111HungaryAstraZeneca Kft.Tel .: + 36 1 883 6500
DenmarkAstraZeneca A / STel: +45 43 66 64 62MaltaAssociated Drug Co. Ltd.Tel: + 356 2277 8000
GermanyAstraZeneca GmbHTel: + 49 41 03 7080The NetherlandsAstraZeneca BVTel: +31 79 363 2222
EestiAstraZenecaTel: +372 6549 600NorwayAstraZeneca ASTel: + 47 21 00 64 00
GreeceAstraZeneca AE:Ηλ: + 30 2 106871500AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0
SpainAstraZeneca Pharmacéutica Spain, SATel: + 34 91 301 91 00PolandAstraZeneca Pharma Poland Sp. z ooTel .: + 48 22 245 73 00
FranceAstraZenecaTel: + 33 1 41 29 40 00PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: + 351 21 434 61 00
CroatiaAstraZeneca dooTel: +385 1 4628 000RomaniaAstraZeneca Pharma SRLTel: + 40 21 317 60 41
IrelandAstraZeneca Pharmaceuticals (Ireland) LtdTel: + 353 1609 7100SloveniaAstraZeneca UK LimitedTel: + 386 1 51 35 600
IcelandVistor hf.Phone: + 354 535 7000Slovak RepublicAstraZeneca AB ozTel: + 421 2 5737 7777
ItalyAstraZeneca SpATel: +39 02 9801 1Finland / FinlandAstraZeneca OyPuh / Tel: +358 10 23 010
ΚύπροςAlexander the Great:Ηλ: +357 22490305SwedenAstraZeneca ABTel: +46 8 553 26 000
LatviaPROPHESYAstraZeneca LatvijaTel: + 371 67377100United KingdomAstraZeneca UK LtdTel: + 44 1582 836 836

Leave a Reply