País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate, Quantity: 115.142 mg (Equivalent: quetiapine, Qty 100 mg)
Sun Pharma ANZ Pty Ltd
Quetiapine fumarate
Tablet, film coated
Excipient Ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate type A; lactose monohydrate; calcium hydrogen phosphate dihydrate; povidone; titanium dioxide; hypromellose; purified talc; macrogol 400
Oral
20, 90
(S4) Prescription Only Medicine
Quetiapine RBX tablets are indicated for: Bipolar disorder = Maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes = Treatment of depressive episodes associated with bipolar disorder (see DOSAGE AND ADMINISTRATION) = Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate Schizophrenia = Treatment of schizophrenia
Visual Identification: White, film-coated, round tablets debossed with 'Q3' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2011-03-11
QUETIAPINE RBX CMI V5 Page 1 of 12 QUETIAPINE RBX TABLETS QUETIAPINE FUMARATE CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about QUETIAPINE RBX quetiapine tablets. 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 has weighed the risks of you taking QUETIAPINE RBX against the benefits it is expected to 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 RBX IS USED FOR The name of your medicine is QUETIAPINE RBX. QUETIAPINE RBX contains the active ingredient quetiapine. Quetiapine belongs to a group of medicines called antipsychotics. It interacts with a large number of molecules in the brain, helping to correct chemical imbalances which may cause mental illness. QUETIAPINE RBX IS USED TO TREAT MENTAL ILLNESSES SUCH AS: • Schizophrenia, an illness causing hallucinations (like hearing unexplained voices), strange and frightening thoughts, changes in how you act, and feelings of being lonely and confused. • Bipolar disorder, an illness resulting in sustained mood swings, either feeling very high (mania) or low (depressions). During mania, patients experience episodes of overactivity, elation or irritability. During depression, patients may feel depressed, guilty, lack of energy, appetite loss, and have trouble sleeping. Your doctor may have prescribed QUETIAPINE RBX for another reason. QUETIAPINE RBX CMI V5 Page 2 of 12 Ask your doctor if you have any questions about why QUETIAPINE RBX has been prescribed for you. QUETIAPINE RBX is not addictive. QUETIAPINE RBX is available only with a doctor’s prescription. BEFORE YOU TAKE QUETIAPINE RBX _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE QUETIAPINE RBX • IF YOU HAVE AN ALLERGY TO QUETIAPINE OR ANY OF THE INACTIVE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Sympto Llegiu el document complet
QUETIAPINE RBX PI _V7 Page 1 of 32 PRODUCT INFORMATION QUETIAPINE RBX QUETIAPINE 25/100/150/200/300 MG TABLETS NAME OF MEDICINE Quetiapine fumarate Structural formula: 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. 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 mg/mL to 2.37 mg/mL at pH values from 1 to 9) and lypophilicity 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 tabletting properties when combined with appropriate excipients. Each film-coated tablet of QUETIAPINE RBX contains quetiapine fumarate equivalent to quetiapine 25 mg, 100 mg, 150 mg, 200 mg or 300 mg, and the inactive ingredients: calcium hydrogen phosphate, lactose, microcrystalline cellulose, povidone, sodium starch glycollate type A, magnesium stearate, hypromellose, titanium dioxide and macrogol 400. In addition, the 25 mg tablet contains iron oxide yellow, and the 100, 150, 200 and 300 mg tablets contain purified talc. PHARMACOLOGY MECHANISM OF ACTION Quetiapine is an atypical antipsychotic agent. Quetiapine and the human plasma metabolite, norquetiapine, interact with a broad range of neurotransmitter receptors. Quetiapine and QUETIAPINE RBX PI _V7 Page 2 of 32 norquetiapine exhibit affinity for brain serotonin (5HT 2 ) and dopamine D 1 and D 2 receptors; this combination of receptor antagonism with a higher selectivity for 5HT 2 relative to D 2 receptors is believed to contribute to the clinical antipsychotic properties and low extrapyramidal side effects (EPS) liability of quetiapine. Additionally, norquetiapine has high affinity (higher than quetiapine) for the noradrenaline transporter, 5HT 1 Llegiu el document complet