Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PALIPERIDONE
JOHNSON & JOHNSON SDN BHD
PALIPERIDONE
30 Tablets; 28 Tablets; 30 Tablet Tablets
JANSSEN CILAG MANUFACTURING L.L.C
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 INVEGA ® EXTENDED RELEASE TABLETS Paliperidone (3mg, 6mg, 9mg) WHAT IS IN THIS LEAFLET 1. What INVEGA ® is used for 2. How INVEGA ® works 3. Before you use INVEGA ® 4. How to use INVEGA ® 5. While you are using it 6. Side effects 7. Storage and Disposal of INVEGA ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT INVEGA ® IS USED FOR _SCHIZOPHRENIA _ INVEGA ® belongs to the class of antipsychotic medicines and is used to treat schizophrenia in adults (18 years of age and older). In addition, after symptoms have been relieved, INVEGA ® is used to keep the disorder under control, i.e. to prevent its recurrence. Schizophrenia is a disorder with symptoms such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech, and reduced behavioral/emotional responses. People with this disorder may also feel depressed, anxious, guilty, or tense. _SCHIZOAFFECTIVE DISORDER _ INVEGA ® belongs to the class of antipsychotic medicines and is used to treat schizoaffective disorder in adults (18 years of age and older), used either alone or with other medicines that are also used to treat depression and/or other mood disorders. INVEGA ® is not for treating people with schizoaffective disorder who are younger than 18 years old. Schizoaffective disorder is a mental condition in which a person experiences a combination of schizophrenia symptoms (as listed above) in addition to mood disorder symptoms (feeling very high, feeling sad, feeling agitated, distracted, sleeplessness, talkativeness, losing interest in everyday activities, sleeping too much or too little, eating too much or too little, and recurrent thoughts of suicide). HOW INVEGA ® WORKS INVEGA ® can help alleviate the symptoms of your disease and stop your symptoms from coming back. BEFORE YOU USE INVEGA ® - _When you must not use it _ Do not take INVEGA ® if you know that you a Przeczytaj cały dokument
1 PRODUCT NAME INVEGA ® Extended-Release Tablets INTERNATIONAL NON-PROPRIETARY NAME Paliperidone DOSAGE FORMS AND STRENGTHS Each extended-release tablet contains 3, 6, or 9 mg of paliperidone. For excipients, see List of Excipients. • 3 mg: white capsule-shaped tablet imprinted with “PAL 3” • 6 mg: beige capsule-shaped tablet imprinted with “PAL 6” • 9 mg: pink capsule-shaped tablet imprinted with “PAL 9” The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9- tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2 a]pyrimidin-4-one. For excipients, see List of Excipients. INVEGA ® utilizes osmotic drug-release technology, whereby osmotic pressure delivers paliperidone from the dosage form at a controlled rate. The system, which resembles a capsule-shaped tablet in appearance, comprises an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices on the drug-layer dome of the tablet. Each strength is identified by a unique color overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water is then imbibed through the semipermeable, rate-controlling membrane. The membrane controls the rate at which water enters the tablet core, which, in turn, controls drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifices. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components. CLINICAL INFORMATION THERAPEUTIC INDICATIONS INVEGA ® is indicated for the treatment of schizophrenia in adolescents 15 years and older, including acute treatment and recurren Przeczytaj cały dokument