Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
Quetiapine fumarate
Synthon Au Pty Ltd
Medicine Registered
QUETIAPINE-SYNTHON CMI MAY 2012 Page 1 of 9 QUETIAPINE-SYNTHON _Quetiapine fumarate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about QUETIAPINE- SYNTHON. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking it against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT QUETIAPINE-SYNTHON IS USED FOR QUETIAPINE-SYNTHON is an antipsychotic medicine that is only available with a doctor’s prescription. It helps to correct chemical imbalances in the brain. It is used to treat conditions such as: • Schizophrenia, an illness with disturbances in thinking, feelings and behaviour • Bipolar disorder, an illness in which there are sustained mood swings either up (mania) or down (depression). During mania, patients experience episodes of overactivity, elation or irritability. During depression, patients may feel depressed or guilty, lack energy, lose their appetite and have trouble sleeping. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Your doctor may prescribe this medicine for another reason. Lire le document complet
QUETIAPINE-SYNTHON PRODUCT INFORMATION MAY 2012 Page 1 of 40 QUETIAPINE-SYNTHON _Quetiapine fumarate _ PRODUCT INFORMATION _ _ NAME OF THE MEDICINE QUETIAPINE-SYNTHON (quetiapine fumerate) Active: Quetiapine as quetiapine fumarate Chemical name: bis[2-(2- [4-(dibenzo[b,f][1,4] -thiazepin-11-yl) piperazin-1-yl] ethoxy) ethanol] fumarate. Quetiapine fumarate has no chiral centres and only one morphological entity has been detected throughout development. Structural Formula: Molecular Formula: 2(C 21 H 25 N 3 O 2 S) . C 4 H 4 O 4 Molecular Weight 883.09 CAS number: 111974-72-2. DESCRIPTION Quetiapine fumarate is a weak acid (pKa 3.3, 6.8) which exhibits moderate pH dependent solubility (94.3 to 2.37 mg/mL at pH values from 1 to 9) and lipophilicity characteristics (log P) which vary with pH (0.45 in water, 1.37 at pH 5, 2.65 at pH 7 and 2.59 at pH 9). Quetiapine fumarate displays good solid state stability, has an aqueous solubility of 3.29 mg/mL at 25°C and exhibits suitable tableting properties when combined with appropriate excipients. Excipients are: Povidone, calcium hydrogen phosphate, cellulose-microcrystalline, lactose, sodium starch glycollate type A, magnesium stearate, hypromellose, QUETIAPINE-SYNTHON PRODUCT INFORMATION MAY 2012 Page 2 of 40 macrogol 400, titanium dioxide, iron oxide yellow C177492 (25 mg and 100 mg) and iron oxide red C177491 (25 mg). PHARMACOLOGY MEC Lire le document complet