Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ARIPIPRAZOLE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
ARIPIPRAZOLE
10tablet Tablets; 30tablet Tablets; 100tablet Tablets
TORRENT PHARMACEUTICALS LTD.
ARIPTOR TABLET _ _ Aripiprazole (10 mg, 15 mg) _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is ARIPTOR used for 2. How ARIPTOR works 3. Before you use ARIPTOR 4. How to use ARIPTOR 5. While you are using it 6. Side effects 7. Storage and Disposal of ARIPTOR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT ARIPTOR IS USED FOR ARIPTOR contains the active substance Aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat schizophrenia- a mental disorder characterized by abnormal social behavior and failure to understand what is real and in brain disorder that causes mania, unusual shifts in mood, energy and activity levels. HOW ARIPTOR WORKS It acts on brain cells and corrects chemical imbalance. BEFORE YOU USE ARIPTOR - _When you must not use it _ Do not take ARIPTOR Talk to your doctor before taking Aripiprazole if you suffer from: • Seizure. • Involuntary, irregular muscle movements, especially in the face. • Cardiovascular diseases, family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure • Blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots • Past experience of excessive gambling. • Suicidal thoughts and behaviors have been reported during Aripiprazole treatment. Do not take ARIPTOR if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking ARIPTOR. _ _ _ _ _ _ _Pregnancy and lactation _ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole in the last trimester (last three months of their pregnancy): • Shaking. • Muscle stiffness and/or weakness. • Sleepiness. • Agitation. • Breathing problems. • Difficulty in feeding. Read the complete document
Proposed Prescribing Information For the use of a Registered Medical Practitioner or a Hospital or a Laboratory ARIPTOR TABLET 5 MG ARIPTOR TABLET 10 MG ARIPTOR TABLET 15 MG ARIPTOR TABLET 20 MG ARIPIPRAZOLE TABLETS USP 5 MG, 10MG, 15 MG AND 20 MG BRAND OR PRODUCT NAME ARIPTOR TABLET 5 MG ARIPTOR TABLET 10 MG ARIPTOR TABLET 15 MG ARIPTOR TABLET 20 MG NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) ARIPTOR TABLET 5 MG Each uncoated tablet contains: Aripiprazole USP....................... 5 mg Excipients .................... q.s. ARIPTOR TABLET 10 MG Each uncoated tablet contains: Aripiprazole USP....................... 10mg Excipients .................... q.s. ARIPTOR TABLET 15 MG Each uncoated tablet contains: Aripiprazole USP....................... 15 mg Excipients .................... q.s. ARIPTOR TABLET 20 MG Each uncoated tablet contains: Aripiprazole USP....................... 20 mg Excipients .................... q.s. PRODUCT DESCRIPTION ARIPTOR TABLET 5 MG White to off-white, round uncoated tablets debossed with “5” on one side and “17” on other side. ARIPTOR TABLET 10 MG White to off-white, round uncoated tablets debossed with “10” on one side and “18” on other side. ARIPTOR TABLET 15 MG White to off-white, round uncoated tablets debossed with “15” on one side and “19” on other side. ARIPTOR TABLET 20 MG White to off-white, round uncoated tablets debossed with “20” on both sides. DOSAGE FORM Uncoated tablets PHARMACODYNAMIC PROPERTIES _Mechanism of action_ It has been proposed that aripiprazole's efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5HT1a receptors and antagonism of serotonin 5HT2a receptors. Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties in animal models of dopaminergic hypoactivity. Aripiprazole exhibited high binding affinity _in vitro _ for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for Read the complete document