Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
sertraline hydrochloride, Quantity: 111.92 mg (Equivalent: sertraline, Qty 100 mg)
Arrotex Pharmaceuticals Pty Ltd
Sertraline hydrochloride
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; hyprolose; sodium starch glycollate type A; magnesium stearate; calcium hydrogen phosphate dihydrate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; PEG-150 distearate; lauromacrogol 400
Oral
30 tablets
(S4) Prescription Only Medicine
Children and Adolescents Sertraline hydrochloride is indicated for the treatment of children (aged 6 years of age and older) and adolescents with OCD.,Adults Sertraline hydrochloride is indicated for: the treatment of major depression, obsessive compulsive disorder (OCD) and panic disorder. Sertraline hydrochloride is indicated for the treatment of social phobia (social anxiety disorder) and the prevention of its relapse. Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria.
Visual Identification: Oblong, biconvex, white, film-coated tablet debossed with SR100 on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2005-08-04
SERTRA- Consumer Medicine Information Page 1 of 5 Sertra sertraline CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SERTRA. 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 SERTRA against the benefits it is expected to have for you. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SERTRA IS USED FOR SERTRA is 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 affect the woman’s daily activities and relationships with others. SERTRA 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 SERTRA for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. SERTRA should not be used in children and adolescents under the age of 18 years for the treatment of any medical condition other than obsessive compulsive disorder (OCD). The safety and efficacy for the treatment of medical conditions (other than OCD) in this age group has not been satisfactorily established. For the treatment of OCD, this medicine is not recommended for use in children under the age of 6, as the safety and efficacy in children of this age group has not been established. This medicine is only avail Կարդացեք ամբողջական փաստաթուղթը
1 AUSTRALIAN PI – SERTRA (SERTRALINE HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Sertraline hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SERTRA 50 tablets contain 50 mg of sertraline (as hydrochloride). SERTRA 100 tablets contain 100 mg of sertraline (as hydrochloride). EXCIPIENTS: For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM SERTRA 50 tablets are oval, white film-coated tablet, scored on one side. SERTRA 100 tablets are oval, white film-coated tablet. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS CHILDREN AND ADOLESCENTS Sertraline hydrochloride is indicated for the treatment of children (aged 6 years of age and older) and adolescents with OCD. ADULTS Sertraline hydrochloride is indicated for the treatment of major depression, obsessive compulsive disorder (OCD) and panic disorder. Sertraline hydrochloride is indicated for the treatment of social phobia (social anxiety disorder) and the prevention of its relapse. Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria. 2 4.2 D OSE AND METHOD OF ADMINISTRATION CHILDREN AND ADOLESCENTS (6 TO 18 YEARS) Obsessive compulsive disorder The administration of sertraline in children with OCD (ages 6 to 12 years) is recommended to commence at 25 mg/day (half a 50 mg tablet) for the first week and then increasing to 50 mg/day. Adolescents (ages 13 to 18 years) may commence at 50 mg/day. Clinical effects may be noted after two weeks of treatment but clinical responses should be monitored for six weeks before any increase in dose. In children, a dose of 200 mg/day should not be exceeded. Sertraline has an elimination half-life of approximately 26 hours; a once daily dose in the morning is recommended. ADULTS Major depression/ obsessive compulsive disorder Initial treatment. Sertraline (sertraline hydrochloride) treatment should be initiated with a dose of 50 mg once daily. The usual therapeutic dose for depression and OCD is 50 mg/day. Wh Կարդացեք ամբողջական փաստաթուղթը