国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PAROXETINE HYDROCHLORIDE
UNIMED SDN BHD
PAROXETINE HYDROCHLORIDE
3 x 10's tablet Tablets
Aurobindo Pharma Limited (Unit III),
XALEZA TABLETS Paroxetine hydrochloride hemihydrate 20mg 1 _Consumer Medication Information Leaflet (RiMUP)_ WHAT IS IN THIS LEAFLET 1. What Paroxetine is used for 2. How Paroxetine works 3. Before you use Paroxetine 4. How to use Paroxetine 5. While you are using Paroxetine 6. Side effects 7. Storage and Disposal of Paroxetine 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PAROXETINE IS USED FOR Paroxetine is used to treat: Depression Obsessive-compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour) Panic disorder with and without agoraphobia (fear of public and open spaces) Social anxiety or social phobia (fear or avoidance of social situations) Generalised anxiety disorder (generally feeling very anxious or nervous) Post-traumatic stress disorder (anxiety: caused by a traumatic event) HOW PAROXETINE WORKS This medicine belongs to a group known as selective serotonin reuptake inhibitor (SSRI) antidepressants, which act by inhibiting the neuronal uptake of serotonin in the central nervous system, thereby relieving the symptoms of depression. Serotonin is one of several brain chemicals called amines which are involved in controlling mood. BEFORE YOU USE PAROXETINE_ _ _When you must not use it _ _Pregnancy and Breast-feeding: _ Ask your doctor or pharmacist for advice before taking any medicine. As there might be a small increased risk of birth defects (cardiovascular malformation) when taking Paroxetine during the first three months of pregnancy. It is important, that you informed your doctor if you are planning to get pregnant or if you are already pregnancy. In the general population, about 1 in 100 babies are born with a heart defect. This increased to about 2 in 100 babies in mothers who took Paroxetine. Your doctor will have to decide whether treatment with Paroxetine is clearly necessary or whether an alternative treatment is possible for you. You should not discontinue treatment with Paroxetine abruptly. Ma 阅读完整的文件
1. PRODUCT NAME XALEXA 20 (Paroxetine Tablets 20 mg) 2. NAME AND STRENGTH OF ACTIVE INGREDIENT (S) Paroxetine Tablets 20 mg 3. PRODUCT DESCRIPTION White to off-white coloured film –coated modified capsule shaped, biconvex tablets debossed with ‘56’ on one side and ‘C’ with a deep break line on the other side. Each film-coated tablet contains: Paroxetine Hydrochloride Hemihydrate Ph. Eur. equivalent to Paroxetine 20 mg. 4. PHARMACODYNAMICS / PHARMACOKINETICS PHARMACODYNAMICS Paroxetine is a potent and selective inhibitor of 5-hydroxytryptamine (5-HT, serotonin) reuptake and its antidepressant action and efficacy in the treatment of OCD, Social Anxiety disorder / Social Phobia, General Anxiety Disorder, Post-traumatic Stress Disorder and panic disorder is thought to be related to its specific inhibition of 5-HT uptake in brain neurons. Paroxetine is chemically unrelated to the tricyclic, tetracyclic and other available antidepressants. Paroxetine has low affinity for muscarinic cholinergic receptors and animal studies have indicated only weak anti-cholinergic properties. Paroxetine does not impair psychomotor function and does not potentiate the depressant effects of ethanol. In the treatment of depressive disorders, Paroxetine exhibits comparable efficacy to standard antidepressants. Morning dosing with Paroxetine does not have any detrimental effect on either the quality or duration of sleep. Moreover, patients are likely to experience improved sleep as they respond to Paroxetine therapy. Dose response: In the fixed doses there is a flat dose response curve, providing no suggestion of advantage in terms of efficacy for using higher than the recommended doses. Long-term efficacy: The long-term efficacy of Paroxetine in treating social anxiety disorder and generalised anxiety disorder and Post-traumatic Stress Disorder has not been sufficiently demonstrated. PHARMACOKINETICS Absorption: Paroxetine is well absorbed after oral dosing and undergoes first-pass metabolism. Due to first-pass metabolism, the amo 阅读完整的文件