देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ARIPIPRAZOLE
HEALOL PHARMACEUTICALS SDN. BHD.
ARIPIPRAZOLE
3 x 10 Tablets
Macleods Pharmaceuticals Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ABILIMAC 10 (ARIPIPRAZOLE TABLETS 10MG) ABILIMAC 15 (ARIPIPRAZOLE TABLETS 15MG) Aripiprazole (10mg & 15mg) 1 WHAT IS IN THIS LEAFLET 1. What Abilimac is used for 2. How Abilimac works 3. Before you use Abilimac 4. How to use Abilimac 5. While you are using it 6. Side effects 7. Storage and Disposal of Abilimac 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT IS ABILIMAC USED FOR Abilimac is indicated for the treatment of: • Acute episodes of schizophrenia (a brain disorder where people interpret reality abnormally) and for maintenance of clinical improvement during continuation therapy. • Acute manic episodes (uncontrollable unusual behaviour) associated with Bipolar I Disorder (extreme mood swings ranging from episodes of depression to mania) HOW ABILIMAC WORKS Its exact mode of action is not fully understood. Aripiprazole is thought to work by affecting the activity of some brain chemicals by adjusting the activities of both dopamine and serotonin. BEFORE YOU USE ABILIMAC _-When you must not use it _ Do not use Abilimac if you are allergic to the active ingredient Aripiprazole or any inactive ingredients listed in this leaflet _ _ _ _ _-Before you start to use it _ Before treatment with Abilimac, tell your doctor if you suffer from: • Neuroleptic malignant syndrome (a reaction to some medicines) • Tardive dyskinesia (a reaction to some medicines causing jerking movements of the face and body) • Problems with your heart or blood vessels • Low blood pressure • Problems with blood clots • Seizures (fits) • Alzheimer’s disease or dementia • History of suicidal episodes • History of alcohol and/or drug abuse or dependence Talk to your doctor or pharmacist if you have: • A history of excessive gambling or other unusual urges (e.g. increased sexual urges, binge or compulsive eating, and compulsive shopping). Talk to your doctor or pharmacist if you: • Have or are at a risk of पूरा दस्तावेज़ पढ़ें
ABILIMAC 15 ( ARIPIPRAZOLE TABLETS 15 MG) No dosage adjustment is required for patients with hepatic impairment (Child-Pugh Class A, B, or C) Pediatric The safety and efficacy of Aripiprazole in patients under 18 years of age have not been established. Elderly No dosage adjustment is required for patients ≥ 65 years of age. However, experience with this patient population is limited. Gender No dosage adjustment is required for female patients relative to male patients. Patients taking medications metabolized by CYP2D6 or 3A4 Dosage adjustment for patients taking aripiprazole concomitantly with potent CYP3A4 or CYP2D6 inhibitors: When concomitant administration of a potent CYP3A4 or CYP2D6 inhibitor with aripiprazole occurs, the aripiprazole dose should be reduced to one-half of the usual dose. When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, the aripiprazole dose should then be increased. Dosage adjustment for patients taking potent CYP3A4 inducers: When a potent CYP3A4 inducer is added to aripiprazole therapy, the aripiprazole dose should be doubled. Additional dose increases of aripiprazole should be based on clinical evaluation. When the CYP3A4 inducer is withdrawn from the combination therapy, the aripiprazole dose should be reduced. Consideration should be given to reducing the daily dose in individual patients who are on multiple concomitant medications that inhibit CYP3A4 and CYP2D6 enzymes. Smoking Status No dosage adjustment is required for smoking patients relative to non-smoking patients. ROUTE OF ADMINISTRATION Oral CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. WARNINGS AND PRECAUTIONS During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks. Patients should be closely monitored throughout this period. The occurrence of suicidal behaviour is inherent in psychotic illnesses and mood disorders and in some cases has been reported early after initiation or switch of antipsyc पूरा दस्तावेज़ पढ़ें