Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
Sertraline hydrochloride
Dr Reddys Laboratories Australia Pty Ltd
Sertraline hydrochloride
SERTRALINE-DRLA CMI 1 of 9 V2 SERTRALINE-DRLA 50 MG AND 100 MG TABLETS _Sertraline hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sertraline-DRLA tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Sertraline-DRLA tablets against the benefits it is expect to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SERTRALINE-DRA TABLETS ARE USED FOR Sertraline-DRLA tablets are used to treat depression and conditions called obsessive compulsive disorder (OCD), panic disorder, social phobia (social anxiety disorder) and premenstrual dysphoric disorder (PMDD). PMDD affects some women in the days before their period. PMDD is different from premenstrual syndrome (PMS). The mood symptoms (anger, sadness, tension, etc) in PMDD are more severe than in PMS and affects the woman’s daily activities and relationships with others. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). They are thought to work by blocking the uptake of a chemical called serotonin into nerve cells in the brain. Serotonin and other chemicals called amines are involved in controlling mood. Your doctor, however, may prescribe Sertraline- DRA for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SERTRALINE-DRLA TABLETS HAVE BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor’s prescription. There is no evidence that sertraline is addictive. BEFORE YOU TAKE SERTRALINE-DRLA TABLETS _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE SERTRALINE-DRLA TABLETS IF 1. you have ever had an allergic reaction to sertraline or any of the ingredients listed at the end of this leaflet. SOME OF THE SYMPTOMS OF AN ALLERGIC REACTION TO SERTRALINE-DR Citiți documentul complet
Page 1 of 20 Sertraline–DRLA tablets Sertraline (as Hydrochloride) Name of the Medicine Chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1- naphthalenamine hydrochloride Molecular formula: C 17 H 17 NCl 2 •HCl CAS number: 79559-97-0 Molecular weight: 342.7 Structural formula: Description Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline-DRLA is an antidepressant for oral administration. It is chemically unrelated to tricyclic, tetracyclic or other available antidepressant agents. Sertraline-DRLA tablets are supplied as film coated tablets containing sertraline hydrochloride equivalent to 50 and 100 mg sertraline. Sertraline - DRLA tablets also contain the following excipients: Microcrystalline cellulose, calcium hydrogen phosphate, colloidal anhydrous silica, sodium starch glycollate, hydroxypropylcelluloase, magnesium stearate, Opadry complete film coating system OY- 58900 White and polysorbate 80. Pharmacology Pharmacodynamics The mechanism of action of sertraline is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin (5HT). Studies at clinically relevant doses in man have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that sertraline is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on noradrenaline and dopamine neuronal reuptake. In vitro studies have shown that sertraline has no significant affinity to adrenergic (α 1 , α 2 , β) cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT 1A , 5HT 1B , 5HT 2 ) or benzodiazepine receptors; antagonism of such receptors has been hypothesised to be associated with various anticholinergic, sedative _Sertraline-DRLA tablets _ _Dr Reddy’s Laboratories Australia Pty Ltd _ _Product Information _ _V3 _ _ _ Page 2 of 20 and cardiovascular effects for other psychotropic drugs. The c Citiți documentul complet