Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
lurasidone hydrochloride, Quantity: 20 mg
Lupin Australia Pty Limited
Tablet, film coated
Excipient Ingredients: hypromellose; mannitol; magnesium stearate; croscarmellose sodium; titanium dioxide; macrogol 6000
Oral
30 tablets
(S4) Prescription Only Medicine
Lurasidone Lupin is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).
Visual Identification: White to off-white colored, round shaped, biconvex, film-coated tablets debossed with 'F' on one side and '1' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-05-07
This medicine 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 effects to your doctor, or directly at www.tga.gov.au/ reporting-problems. CONSUMER MEDICINE INFORMATION LURASIDONE LUPIN (LURASIDONE HYDROCHLORIDE) TABLETS WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Lurasidone LUPIN. 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 Lurasidone LUPIN 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 LURASIDONE LUPIN IS USED FOR Lurasidone LUPIN 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 Lurasidone LUPIN for another reason. Ask your doctor if you have any questions about why Lurasidone LUPIN has been prescribed for you. Lurasidone LUPIN 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 Lurasidone LUPIN is addictive or habit forming. This medicine is available only with a doctor's prescription. Lurasidone LUPIN 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 LURASIDONE LUPIN _WHEN YOU MUST NOT TAKE IT _ Do not take Lurasidone LUPIN if: YOU HAVE AN ALLERGY TO LURASIDONE HYDROCHLORIDE (THE ACTIVE INGREDIENT IN LURASIDONE LUPIN) OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. • YOU ARE TAKING MEDICINES THAT CAN AFFECT HOW YOUR BODY PROCESSES L Lire le document complet
Lurasidone LUPIN v1.0 Page 1 of 24 (lurasidone hydrochloride) tablets ▼ 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 – LURASIDONE LUPIN (LURASIDONE HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Lurasidone hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Lurasidone LUPIN tablet contains 20 mg, 40 mg, or 80 mg of lurasidone hydrochloride. Lurasidone hydrochloride (HCl) is chemically identified as (3aR,4S,7R,7aS)-2-{(1R,2R)-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 very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene very slightly soluble in acetone and has a pKa of 7.6. Lurasidone LUPIN tablets contain 20 mg lurasidone hydrochloride (equivalent to 18.62 mg of lurasidone), 40 mg (equivalent to 37.24 mg lurasidone), or 80 mg (equivalent to 74.49 mg lurasidone). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Lurasidone LUPIN 20 mg: White to off-white colored, round shaped, biconvex, film-coated tablets debossed with “F” on one side and “1” on the other side. Lurasidone LUPIN 40 mg: White to off-white colored, round shaped, biconvex, film-coated tablets debossed with “F” on one side and “2” on the other side. Lurasidone LUPIN 80 mg: Green colored, oval shaped, biconvex, film-coated tablets debossed with “F” on one side and “4” Lire le document complet