Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Fluoxetine Hydrochloride.
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
Fluoxetine Hydrochloride.
1000Tablet Tablets; 10 Tablet Tablets; 10Tablet Tablets
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ 1 ANZACK TABLETS Fluoxetine Hydrochloride (20mg) WHAT IS IN THIS LEAFLET: 1. What Anzack Tablets is used for 2. How Anzack Tablets works 3. Before you use Anzack Tablets 4. How to use Anzack Tablets 5. While you are using it 6. Side Effects 7. Storage and Disposal of Anzack Tablets 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ANZACK TABLETS IS USED FOR Fluoxetine is the active ingredient for Anzack Tablets. It is used for the traetment of the symptoms of depressive illness, with or without associated anxiety (feeling of unease, such as worry or fear that can be mild or severe) symptoms. It is also used for obsessive-compulsive disorder (a disorder that characterized by persistent thoughts that lead to repetitive behaviors) and pre-menstrual dysphoric (a condition in which a woman has severe depression symptoms, irritability and tension before menstruation) disorder. HOW ANZACK TABLETS WORKS Fluoxetine is a selective inhibitor serotonin reuptake and it works by acting on the brain chemicals. BEFORE YOU USE ANZACK TABLETS - _When you must not use it _ If you have hypersensitivity to fluoxetine or any of the ingredients. If you have been or are taking monoamine oxidase inhibitors (MAOIs). Please talk to your Pharmacist or Doctor if you are not sure about this. - _Before you start to use it _ You must tell your doctor if: you have allergies to any medicine which you have taken previously to treat your current condition. You are pregnant, trying to become pregnant or breast- feeding. You have a history of seizures. You have a history of hypomania (a less severe form of mania) / mania (excitement manifested by mental and physical hyperactivity, disorganization of behavior, and elevation of mood). You have significant liver dysfunction. You are diabetic. You have heart problem. You have weight loss. You are taking oral anticoagulant, medications known to affect platelet f Lire le document complet
7158-05 ANZACK TABLETS 20MG NAME AND STRENGTH OF ACTIVE INGREDIENT(S): Each tablet contains: Fluoxetine Hydrochloride equivalent to Fluoxetine ………………20mg PRODUCT DESCRIPTION: A round, light green, scored, flat of diameter 7mm tablets with ‘MPI’ logo. PHARMACODYNAMICS : Fluoxetine is a selective inhibitor of serotonin reuptake and has practically no affinity to other receptors such as 1 - , 2-, and - adrenergic; serotonergic; dopaminergic; histaminergic; muscarinic; and GABA receptors. PHARMACOKINETICS: Fluoxetine is well absorbed from the gastrointestinal tract following oral administration. At least 60 – 80% of an oral dose appears to be absorbed. The bioavailability is not affected by food intake. Fluoxetine is approximately 94.5% bound to plasma protein and it is widely distributed with volume of distribution of 20-45 l/kg. Steady-state plasma concentrations are achieved after dosing for several weeks. The steady-state concentrations after prolonged dosing are similar to concentrations seen at 4 to 5 weeks. Fluoxetine had a non-linear pharmacokinetic profile with first pass liver effect. Maximum plasma concentration is generally achieved 6 to 8 hours after administration. Fluoxetine is extensively metabolized by the polymorphic enzyme CYP2D6. Fluoxetine is primarily metabolized by the liver to the active metabolite norfluoxetine (desmethylfluoxetine) by desmethylation. The elimination half-life of fluoxetine is 4 to 6 days and for norfluoxetine 4 to 16 days. These long half-lives are responsible for persistence of the drug for 5-6 weeks after discontinuation. Excretion of about 60% is mainly via the kidney. Fluoxetine is secreted into breast milk. _ _ _At-risk populations: _ The kinetic parameters are not altered in healthy elderly patients. In case of hepatic insufficiency, fluoxetine and norfluoxetine half-lives are increased to 7 and 12 days, respectively. A lower or less frequent dose should be considered. The kinetic parameters have not been altered in patients with mild, mod Lire le document complet