Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ARIPIPRAZOLE
UNIMED SDN BHD
ARIPIPRAZOLE
100tablet Tablets; 30tablets Tablets
Indoco Remedies Limited
ARIAN TABLETS Aripiprazole USP (10mg, 15mg, 20mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What ARIAN is used for 2. How ARIAN works 3. Before you use ARIAN 4. How to use ARIAN 5. While you are using it 6. Side effects 7. Storage and Disposal of ARIAN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ARIAN IS USED FOR ARIAN is one of a group of medicines called antipsychotics. It is used to treat schizophrenia and related manic disorders in patients who suffer from a disease characterized by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behavior and emotional flatness. People with this conditions may also feel depressed, guilty, anxious or tense. HOW ARIAN WORKS ARIAN works by acting on various receptors in the brain, particularly dopamine receptors and serotonin (5HT) receptors. Dopamine and serotonin are natural compounds called neurotransmitters, and are involved in transmitting messages between brain cells. Psychotic illness is considered to be caused by disturbances in the activity of neurotransmitters (mainly dopamine) in the brain. Aripiprazole is thought to work mainly by stabilising the dopamine activity in the brain. BEFORE YOU USE ARIAN BEFORE YOU START TO USE IT 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). - _When you must not use it _ _ _ _ _ _ _ _ _ DO NOT TAKE ARIAN: If you are allergic (hypersensitive) to ARIAN or any of the other ingredients of ARIAN. _ _ _Pregnancy and lactation _ Pregnancy Ask your doctor or pharmacist for advice before taking any medicine. Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant. Breastfeeding Ask your doctor or pharmacist for advice before taking any medicine. If you are taking ARIAN Aqra d-dokument sħiħ
Y:\A\Arian\Arian 10\malaysia\Current 23\Arian 10 mg\Arian mg Leaflet 2008567.cdr Item: LEAFLET Item Code: 2008567 Open Size: 110 x 260 mm Folding Size: H:Unfolded: mm Folded: 130 mm 260 W:Unfolded: 110 mm Folded: 27. 5 mm GSM/ Paper: 40 gsm ITC Superfine paper Colour: Black Pharmacode: 257 std 9919934-002 Layout No.: INDOCO REMEDIES LTD. PACKAGING DEVELOPMENT DEPARTMENT REASON FOR PREPARATION / REVISION : 1) Text Change Path DATE: 16.01.23/ 18.01.23 Prepared by Checked by Approved by R1 2008567 110 mm 260 mm 260 mm 110 mm 16 mm 130 mm SMOKING STATUS No dosage adjustment is required for smoking patients relative to non-smoking patients. ROUTE OF ADMINISTRATION Oral CONTRAINDICATION Known hypersensitivity reaction to Aripiprazole tablets. Reactions have ranged from pruritus/ urticarial to anaphylaxis. WARNING AND PRECAUTIONS NEUROLEPTIC MALIGNANT SYNDROME (NMS) A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including Aripiprazole. The management of NMS should include: 1. Immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy. 2. Intensive symptomatic treatment and medical monitoring; and 3. Treatment of any concomitant serious medical problems for which specific treatments are available. TARDIVE DYSKINESIA If signs and symptoms of tardive dyskinesia appear in a patient on Aripiprazole, drug discontinuation should be considered. However, some patients may require treatment with Aripiprazole despite the presence of the syndrome. HYPERGLYCEMIA AND DIABETES MELLITUS: Hyperglycemia in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death in patients treated with atypical antipsychotics. Assessment of the relationship between atypical antipsychotics use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing inciden Aqra d-dokument sħiħ