Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Celecoxib
Pfizer Limited
L01XX33
celecoxib
Antineoplastic agents
Adenomatous Polyposis Coli
Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4).The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)
Revision: 13
Withdrawn
2003-10-17
43 B. PACKAGE LEAFLET Medicinal product no longer authorised 44 PACKAGE LEAFLET: INFORMATION FOR THE USER ONSENAL 200 MG HARD CAPSULES CELECOXIB READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Onsenal is and what it is used for 2. Before you take Onsenal 3. How to take Onsenal 4. Possible side effects 5. How to store Onsenal 6. Further information 1. WHAT ONSENAL IS AND WHAT IT IS USED FOR Onsenal belongs to a group of medicines called cyclo-oxygenase-2 (COX-2) inhibitors. Cyclo-oxygenase-2 is an enzyme that increases at inflammatory sites and in abnormally growing cells. Onsenal works by inhibiting COX-2, to which such dividing cells are sensitive. As a consequence the cells die. Onsenal is used to reduce the number of gastrointestinal polyps in patients with Familial Adenomatous Polyposis (FAP). FAP is an inherited disorder in which the rectum and colon are covered with many polyps that might develop colorectal cancer. Onsenal should be used along with the usual care for FAP patients such as surgery and endoscopic surveillance. 2. BEFORE YOU TAKE ONSENAL DO NOT TAKE ONSENAL - if you have had an allergic reaction to any of the ingredients of Onsenal - if you have had an allergic reaction to a group of medicines called “sulphfonamides”. These include some antibiotics (Bactrim and Septra used in combination of sulfamethoxazole and trimethoprim), which can be used to treat infections - if you have a stomach or duodenal ulcer, or bleeding in the stomach or intestines - if after taking aspirin or another anti-inflammatory medicine you have had nasal polyps or severe n Lesen Sie das vollständige Dokument
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Onsenal 200 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200 mg of celecoxib. Excipients: Lactose Monohydrate 49.8 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. White, opaque capsules with two gold bands marked 7767 and 200. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4). The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended oral dose is two 200 mg capsules twice per day, taken with food (see section 5.2). Usual medical care for FAP patients should be continued while on celecoxib. The maximum recommended daily dose is 800 mg. _Hepatic impairment_ : In patients with moderate hepatic impairment (serum albumin of 25-35 g/l), the daily recommended dose of celecoxib should be reduced by 50% (see sections 4.3 and 5.2). Caution should be used as there is no experience in such patients at doses higher than 200 mg. _ _ _Renal impairment:_ Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution (see sections 4.3, 4.4 and 5.2). _ _ _Paediatric patients:_ Experience with celecoxib in FAP patients below the age of 18 years is limited to a single pilot study in a very small population, in which patients were treated with celecoxib at doses up to 16 mg/kg daily, which corresponds to the recommended adult FAP dose of 800 mg daily (see section 5.1). _CYP2C9 Poor Metabolizers:_ Patients who are known or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience w Lesen Sie das vollständige Dokument