Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Gefitinib
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
Gefitinib
30 Tablets; 100 Tablets; 60 Tablets
Remedica Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ GEFITINIB SANDOZ FILM COATED TABLET 250MG _ _ Gefitinib (250mg) 1 WHAT IS IN THIS LEAFLET 1. What Gefitinib Sandoz is used for 2. How Gefitinib Sandoz works 3. Before you use Gefitinib Sandoz 4. How to use Gefitinib Sandoz 5. While you are using it 6. Side effects 7. Storage & Disposal of Gefitinib Sandoz 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT GEFITINIB SANDOZ IS USED FOR Gefitinib Sandoz is used to treat advanced non-small cell lung cancer, which is one type of lung cancer. HOW GEFITINIB SANDOZ WORKS Gefitinib Sandoz 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. BEFORE YOU USE GEFITINIB SANDOZ _- When you must not use it _ Do not take Gefitinib Sandoz if you are allergic to gefitinib or any of the other ingredients of Gefitinib Sandoz, listed at the end of this leaflet. If you think you may be allergic, ask your doctor for advice. Gefitinib Sandoz is not recommended for use in children or adolescents. _ _ _- Before you start to use it_ Before taking Gefitinib Sandoz: • Tell your doctor if you have or have had any other lung diseases, other than your lung cancer. Some of them may worsen during treatment with Gefitinib Sandoz. • Tell your doctor if you are pregnant or trying to become pregnant. You should avoid becoming pregnant during treatment with Gefitinib Sandoz. • Tell your doctor if you are breast- feeding. For the safety of your baby, you should discontinue breast-feeding during treatment with Gefitinib Sandoz. _- Taking other medicines _ Please inform your doctor if you are taking or have taken any medicines (including medicines taken some time ago), even those not prescribed. Your doctor especially needs to know: • if you take any of the following medicines: phenytoin, carbamazepine, rifampicin, barbiturates, St John’s Wort or itra Preberite celoten dokument
1. NAME OF THE MEDICINAL PRODUCT Gefitinib Sandoz Film Coated Tablet 250mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg of gefitinib. Excipient with known effect: Each tablet contains 163.5 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Brown, round, biconvex, film-coated tablets impressed with "250" on one side and plain on the other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gefitinib Sandoz is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of Gefitinib Sandoz is one 250 mg tablet once a day, taken with or without food. If a dose of Gefitinib Sandoz is missed, it should be taken as soon as the patient remembers. If it is less than 12 hours to the next dose, the patient should not take the missed dose. Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose. Where dosing of whole tablets is not possible, such as patients who are only able to swallow liquids, tablets may be administered as a dispersion in water. The tablet should be dropped into half a glass of drinking water (non-carbonated), without crushing, and the glass stirred until the tablet has dispersed (approximately 15 minutes) and the contents subsequently drunk immediately. The glass should be rinsed with a further half glass of water and the contents drunk. The liquid can also be administered via a nasogastric tube. Gefitinib Sandoz is not recommended for use in children or adolescents as safety and effectiveness in these patient populations has not been studied. No dosage adjustment is required on the basis of patient age, body weight, gender, ethnicity or renal function or in patients with moderate to severe hepatic impairment due to liver metastases. Dosage adjustment: Patients with poorly tolerated diarrhoea or skin Preberite celoten dokument