Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
lurasidone hydrochloride, Quantity: 20 mg
Pharmacor Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium stearate; citric acid; povidone; croscarmellose sodium; lactose monohydrate; pregelatinised maize starch; mannitol; titanium dioxide; hypromellose; macrogol 400
Oral
90's, 30's, 500's
(S4) Prescription Only Medicine
Lurasidone hydrochloride film-coated tablets are indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).
Visual Identification: White to off white, round shaped, film coated tablets debossed with '20' on one side and 'L' on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2020-10-16
LURACOR Ver: 01 1 ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effect to your doctor, or directly at https://www.tga.gov.au/reporting-problems. LURACOR (LURASIDONE HYDROCHLORIDE) FILM-COATED TABLETS LURASIDONE HYDROCHLORIDE CONSUMER MEDICINE INFORMATION(CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LURACOR. 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 LURACOR 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 LURACOR IS USED FOR LURACOR is used to treat adults and adolescents (aged 13 years or over) with schizophrenia. Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour. Your doctor may have prescribed LURACOR for another reason. Ask your doctor if you have any questions about why LURACOR has been prescribed for you. LURACOR belongs to a group of medicines called atypical antipsychotics. It helps to correct chemical imbalances in the brain, which may cause mental illness. There is no evidence that LURACOR is addictive or habit forming. This medicine is available only with a doctor's prescription. LURACOR is not recommended for use in children or adolescents under 13 years of age, as safety and effectiveness have not been established in this age group. BEFORE YOU TAKE LURACOR _WHEN YOU MUST NOT TAKE IT _ Do not take LURACOR if: • YOU HAVE AN ALLERGY TO LURASIDONE HYDROCHLORIDE (THE ACTIVE INGREDIENT IN LURACOR ) OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. • YOU ARE TAKING MEDICINES THAT CAN AFFECT HOW YOUR BODY PROCESSES LURACOR SUCH AS: - KETOCONAZOLE OR Przeczytaj cały dokument
LURACOR Ver: 01 1 ▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION - LURACOR (LURASIDONE HYDROCHLORIDE) FILM-COATED TABLETS 1. NAME OF THE MEDICINE Lurasidone Hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lurasidone hydrochloride (HCl) is chemically identified as (3a_R_,4_S_,7_R_,7a_S_)-2-{(1_R_,2_R_)-2-[4- (1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano- 2H-isoindole-1,3-dione hydrochloride. Lurasidone is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. It has antagonist activity on the dopamine 2 (D2) and serotonin (5-HT)-2A receptors. Lurasidone HCl (active entity) is a white to off- white powder. It is insoluble in water, slightly soluble in methanol, and has a pKa of 7.6. LURACOR 20 mg, 40 mg and 80 mg tablets contain 20 mg lurasidone hydrochloride (equivalent to 18.62 mg lurasidone), 40 mg lurasidone hydrochloride (equivalent to 37.24 mg lurasidone) or 80 mg lurasidone hydrochloride (equivalent to 74.49 mg lurasidone).” For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM LURACOR 20 mg: White to off white, round shaped, film coated tablets debossed with “20” on one side and “L” on other side. LURACOR 40 mg: White to off white, round shaped, film coated tablets debossed with “40” on one side and “L” on other side. LURACOR 80 mg: Light-green to green, oval shaped, film coated tablets debossed with “80” on one side and “L” on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LURACOR is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years). LURACOR Ver: 01 2 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The efficacy of lurasidone has been established at doses of 40, 80, Przeczytaj cały dokument