Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RISPERIDONE
JOHNSON & JOHNSON SDN BHD
RISPERIDONE
1
CILAG AG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ RISPERDAL ® CONSTA ® INJECTION Risperidone (25mg, 37.5mg, 50mg) 1 WHAT IS IN THIS LEAFLET 1. What RISPERDAL ® CONSTA ® is used for 2. How RISPERDAL ® CONSTA ® works 3. Before you use RISPERDAL ® CONSTA ® 4. How to use RISPERDAL ® CONSTA ® 5. While you are using it 6. Side effects 7. Storage and disposal of RISPERDAL ® CONSTA ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT RISPERDAL ® CONSTA ® IS USED FOR RISPERDAL ® CONSTA ® is used to treat a group of disorders called psychoses (e.g. schizophrenia). It is also used to treat bipolar disorder, formerly called manic depressive illness. Both sets of conditions are brain function disorders. Psychosis includes symptoms like unusual or bizarre thoughts, including suspiciousness, impaired perception (like hearing a voice of someone who is not there), confusion, and being excessively introverted or becoming alienated from society. The symptoms of bipolar disorder include changing moods (depression and/or euphoria), being excessively friendly and without inhibitions, extreme changes in motivation or energy, irritability, aggressiveness, or actions including poor judgment. These symptoms result in disturbed mental state, anxiety, and tension. HOW RISPERDAL ® CONSTA ® WORKS RISPERDAL ® CONSTA ® helps to correct a chemical imbalance associated with these conditions. BEFORE YOU USE RISPERDAL ® CONSTA ® - _When you must not use it _ Do not take RISPERDAL ® CONSTA ® if you know that you are allergic (hypersensitive) to Risperidone or other ingredients listed at the end of this leaflet. - _Before you start to use it _ If you have never taken any form of RISPERDAL ® , you should begin with oral RISPERDAL ® before beginning treatment with RISPERDAL ® CONSTA ® . Tell your doctor if: • you or someone else in your family has a history of blood clots. Blood clots in the lungs can be fatal. • you know that you have had low levels of white blood cells in Aqra d-dokument sħiħ
1 PRODUCT NAME RISPERDAL ® CONSTA ® 25 mg RISPERDAL ® CONSTA ® 37.5 mg RISPERDAL ® CONSTA ® 50 mg DOSAGE FORMS AND STRENGTHS RISPERDAL ® CONSTA ® contains 25 mg, 37.5 mg or 50 mg risperidone. RISPERDAL ® CONSTA ® is an extended release microspheres formulation of risperdone, composed of risperidone drug substance micro-encapsulated in polylactide- co-glycolide, at a concentration of 381 mg risperidone per gram of microspheres. Prolonged-release powder and diluent for suspension for injection. _ _ _Vial with powder. _ White to off-white free flowing powder. _Pre-filled syringe of diluent for reconstitution. _ Clear, colorless aqueous solution. For excipients, see _List of Excipients._ CLINICAL INFORMATION INDICATIONS RISPERDAL ® CONSTA ® is indicated for the treatment of schizophrenia and schizoaffective disorders. RISPERDAL ® CONSTA ® is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. DOSAGE AND ADMINISTRATION For risperidone naive patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with RISPERDAL ® CONSTA ® . Schizophrenia and Schizoaffective Disorders _DOSAGE - ADULTS (OLDER THAN 18 YEARS OF AGE) _ The recommended dose is 25 mg intramuscular every two weeks. Some patients may benefit from a higher doses of 37.5 mg or 50 mg. No additional benefit was observed with 75 mg in clinical trials in patients with schizophrenia. Doses higher than 50 mg every 2 weeks are not recommended. Sufficient antipsychotic coverage should be ensured during the three-week lag period following the first RISPERDAL ® CONSTA ® injection (see _Pharmacokinetic _ _Properties_ ). Upward dosage adjustment should not be made more frequently than every 4 weeks. The effect of this dose adjustment should not be anticipated earlier than 3 weeks after the first injection with the higher dose. Bipolar Disorder 2 The recommended dose for monotherapy or adjunctive therapy to lithium or valproate for the Aqra d-dokument sħiħ