250 mg film-coated tablets
gefitinib
What Gefitinib Accord is and what it is used for
Gefitinib Accord 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 Accord is used to treat adults with non-small cell lung cancer. This cancer is a disease in which malignant (cancerous) cells form in the lung tissue.
Gefitinib contained in Gefitinib Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before taking Gefitinib Accord
Do not take Gefitinib Accord
- 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, pharmacist, or nurse before taking Gefitinib Accord:
- if you have ever had other lung problems before. Some lung problems may be aggravated by treatment with Gefitinib Accord
- if you have ever had liver problems.
Children and young people
Gefitinib Accord is not intended for use in children and adolescents below 18 years.
Other medicines and Gefitinib Accord
Tell your doctor or pharmacist if you 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 mild depression).
- Proton pump inhibitors , H 2 – antagonists and antacids (for stomach ulcers , stomach upset, heartburn and to reduce stomach acid).
These medicines may affect the effect of Gefitinib Accord.
- 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 Gefitinib Accord.
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 Gefitinib Accord as Gefitinib Accord may harm your baby.
For your baby’s safety, do not use Gefitinib Accord if you are breastfeeding.
Driving and using machines
Should you feel weak while using this medicine, you should be careful when driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Gefitinib Accord 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.
How to take Gefitinib Accord
Always take this medicine exactly as your doctor or pharmacist 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 Gefitinib Accord.
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 Gefitinib Accord than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Gefitinib Accord
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 Gefitinib Accord 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 that the eyelashes grow inwards. 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 in 10 people
- 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
- Elevation of the liver enzyme alanine aminotransferase in blood tests – if too high, your doctor may urge you to stop taking Gefitinib Accord.
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)
- Elevation of bilirubin and the liver enzyme aspartate aminotransferase in blood tests – if too high, your doctor may urge you to stop taking Gefitinib Accord
- 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.
Rare: may affect up to 1 in 1,000 people
- 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 Gefitinib Accord
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 and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
After dispersion (mixing) in water, the mixture should be used within 90 minutes.
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.
- Other ingredients are:Tablet core: Lactose monohydrate , microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulphate, magnesium stearate.Tablet cover: poly (vinyl alcohol), macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
What the medicine looks like and contents of the pack
Gefitinib Accord is a brown, film-coated, round, biconvex tablet, debossed with “LP100” on one side and smooth on the other. The tablet has a diameter of about 11.13 mm.
Pack size of 30 x 1 tablets in PVC / PVDC ‑ Al ‑ perforated unit dose blister packed in PET / Al ‑ bag in a carton.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF, UK
LABORATORI FUNDACIÓ DAU
C / C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040, Spain
Wessling Hungary Kft.
Anonymous u. 6
Budapest, 1045
Hungary
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta