Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
lurasidone hydrochloride, Quantity: 20 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: hypromellose; maize starch; mannitol; croscarmellose sodium; magnesium stearate; titanium dioxide; macrogol 8000
Oral
28 tablets, 30 Tablets
(S4) Prescription Only Medicine
APO- Lurasidone is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).
Visual Identification: White to off white round shaped biconvex film-coated tablets debossed with 515 on one side and L on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-06-24
APO-LURASIDONE 1 APO-LURASIDONE CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING APO-LURASIDONE? APO-LURASIDONE contains the active ingredient lurasidone hydrochloride. APO-LURASIDONE is used to treat adults and adolescents (aged 13 years and over) with schizophrenia. It is only available with a doctor’s prescription. For more information, see Section 1. Why am I using APO-LURASIDONE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE APO-LURASIDONE? Do not use if you have ever had an allergic reaction to APO-LURASIDONE or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. APO-LURASIDONE IS NOT APPROVED FOR TREATMENT OF ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS OR BEHAVIOURAL DISORDERS. For more information, see Section 2. What should I know before I use APO-LURASIDONE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with APO-LURASIDONE and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE APO-LURASIDONE? Your doctor or pharmacist will tell you how many tablets you will need to take each day. This depends on your condition and whether or not you are taking any other medicines. Unless your doctor gives you other directions, you should take APO- LURASIDONE only once a day. Take APO-LURASIDONE during or immediately after food, consider evening meal. More instructions can be found in Section 4. How do I use APO-LURASIDONE? in the full CMI. CONTINUE TAKING THE TABLETS FOR AS LONG AS YOUR DOCTOR TELLS YOU. 5. WHAT SHOULD I KNOW WHILE USING APO-LURASIDONE? THINGS YOU SHOULD DO • Remin Citiți documentul complet
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 www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION – APO-LURASIDONE (LURASIDONE HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Lurasidone hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each APO-LURASIDONE film coated tablet contains 20 mg, 40 mg, or 80 mg of lurasidone hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Film-coated tablet. APO-LURASIDONE 20 MG TABLET: White to off white, round shaped, biconvex, film-coated tablets debossed with ‘515’ on one side and ‘L’ on other side. APO-LURASIDONE 40 MG TABLET: White to off white, round shaped, biconvex, film-coated tablets debossed with ‘516’ on one side and ‘L’ on other side. APO-LURASIDONE 80 MG TABLET: Pale green, oval shaped, biconvex, film-coated tablets debossed with ‘L 517’ on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS APO-Lurasidone is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years). 4.2 D OSE AND METHOD OF ADMINISTRATION Lurasidone hydrochloride film-coated tablets are intended for oral administration only. The efficacy of Lurasidone hydrochloride has been established at doses of 40, 80, 120 and 160 mg/day. The recommended starting dose is 40 mg once daily. Initial dose titration is not required. Patients should be treated with the lowest effective dose that provides optimal clinical response and tolerability, which is expected to be 40 mg or 80 mg once daily for most patients. Dose increase should be based on physician judgement and observed clinical response. In the six week controlled trials, there was no suggestion of added benefit with the 120 mg/day dose compared to 40 and 80 mg/day. In the pooled analyses, added benefit occurred at 160 mg/day compa Citiți documentul complet