Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Lurasidone Hydrochloride
Mansa Healthcare Sdn Bhd
Lurasidone Hydrochloride
1x10 Tablets; 3x10 Tablets; 10x10 Tablets
MSN Laboratories Private Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ LURATA Lurasidone Hydrochloride (40mg, 80mg) _ _ 1 WHAT IS IN THIS LEAFLET NPRA (R1) 23/006 1. What _Lurata _ is used for and how _Lurata_ works 2. Before you use _Lurata_ 3. How to use _Lurata_ 4. While you are using it 5. Side effects 6. Storage and Disposal of _Lurata_ 7. Product Description 8. Manufacturer and Product Registration Holder 9. Date of revision WHAT _LURATA _IS USED FOR AND HOW _LURATA_ WORKS _Lurata_ contains the active ingredient lurasidone, an atypical antipsychotic used in the treatment of schizophrenia in adults and adolescents (aged 13 to 17 over). Schizophrenia is characterized by symptoms such as: • Hearing, seeing, or sensing things that are not there • Suspiciousness and/or mistaken beliefs • Incoherent speech and behavior • Emotional flatness People may also feel depressed, guilty, anxious or tense. _Lurata_ reduce the symptoms of schizophrenia by blocking receptors in the brain to which dopamine and serotonin attach, thereby, normalizing the activity of the brain. Your doctor may have prescribed _Lurata_ for another reason. Ask your doctor if you have any questions about why _Lurata_ has been prescribed for you. BEFORE YOU USE _LURATA _ _ _ _When you must not use it _ Do not take _Lurata_ if you • Are allergic to lurasidone or any of the ingredients in _Lurata_ • Taking drugs that significantly affect the way _Lurata_ is broken down in your body such as o Medications for fungal infections such as itraconazole, ketoconazole (except as a shampoo), fluconazole, posaconazole or voriconazole o Medicines for an infection such as clarithromycin or telithromycin o Medicines for HIV infections such as cobicistat, indinavir, nelfinavir, ritonavir, and saquinavir o Medicines for chronic hepatitis: boceprevir and telaprevir o Medicine for depression: nefazodone o Medicine for tuberculosis: rifampicin o Medicines for seizures: carbamazepine, phenobarbital and phenytoin o Diuretics (water pills) Do not take _Lurata_ after the expiry date Lees het volledige document
LURATA (LURASIDONE HYDROCHLORIDE TABLETS 40 MG AND 80 MG) NAME OF THE MEDICINAL PRODUCT LURATA (Lurasidone hydrochloride Tablets 40 mg / 80 mg) QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains Lurasidone hydrochloride 40 mg / 80 mg PHARMACEUTICAL FORM Film-coated tablet. 40 mg: White colored, round shaped biconvex, film coated tablets, debossed with “40” on one side and “ML” on other side. 80 mg: Pale green colored, oval shaped biconvex, film coated tablets, debossed with “80” on one side and “ML” on other side. INDICATION AND UAGE Lurata (lurasidone HCl) is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 - 17 years) DOSAGE AND ADMINISTRATION Lurasidone film-coated tablets are intended for oral administration only. The efficacy of lurasidone 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 compared to lower doses. Doses above 80 mg may be considered for certain patients based on individual clinical judgment. The maximum recommended dose is 160 mg/day. Lurasidone should be taken with food. CHILDREN AND ADOLESCENTS The recommended starting dose of lurasidone in adolescent patients 13 to 17 years of age with schizophrenia is 40 mg/day. The maximum recommended dose in adolescent patients is 80 mg/day. Lurasidone was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 40 mg and 80 mg. The safety and efficacy of lurasidone in children aged less than 13 yea Lees het volledige document