Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
lurasidone hydrochloride, Quantity: 20 mg
Pharmacor Pty Ltd
Tablet, film coated
Excipient Ingredients: povidone; mannitol; pregelatinised maize starch; lactose monohydrate; citric acid; magnesium stearate; croscarmellose sodium; titanium dioxide; hypromellose; macrogol 400
Oral
30 tablets, 90 tablets, 500 tablets
(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
PHAEMACOR LURASIDONE 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. PHARMACOR LURASIDONE (LURASIDONE HYDROCHLORIDE) FILM-COATED TABLETS LURASIDONE HYDROCHLORIDE CONSUMER MEDICINE INFORMATION(CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PHARMACOR LURASIDONE. 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 PHARMACOR LURASIDONE 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 PHARMACOR LURASIDONE IS USED FOR PHARMACOR LURASIDONE 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 PHARMACOR LURASIDONE for another reason. Ask your doctor if you have any questions about why PHARMACOR LURASIDONE has been prescribed for you. PHARMACOR LURASIDONE 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 PHARMACOR LURASIDONE is addictive or habit forming. This medicine is available only with a doctor's prescription. PHARMACOR LURASIDONE 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 PHARMACOR LURASIDONE _WHEN YOU MUST NOT TAKE IT _ Do not take PHARMACOR LURASIDONE if: • YOU HAVE AN ALLERGY TO LURASIDONE HYDROCHLORIDE (THE ACTIVE INGREDIENT IN PHARM Lestu allt skjalið
PHARMACOR LURASIDONE 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 - PHARMACOR LURASIDONE (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. PHARMACOR LURASIDONE 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 PHARMACOR LURASIDONE 20 mg: White to off white, round shaped, film coated tablets debossed with “20” on one side and “L” on other side. PHARMACOR LURASIDONE 40 mg: White to off white, round shaped, film coated tablets debossed with “40” on one side and “L” on other side. PHARMACOR LURASIDONE 80 mg: Light-green to green, oval shaped, film coated tablets debossed with “80” on one side and “L” on other side. PHARMACOR LURASIDONE Ver: 01 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PHARMACOR LURASIDONE is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years). 4.2 DOSE Lestu allt skjalið