Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
sertraline hydrochloride
Upjohn Australia Pty Ltd
Registered
ZOLOFT ® _Sertraline (sir-tra-leen) hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Zoloft. 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 Zoloft against the benefits it is expected 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 ZOLOFT IS USED FOR Zoloft 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. Zoloft 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 Zoloft for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ZOLOFT HAS BEEN PRESCRIBED FOR YOU. Zoloft 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 of Zoloft for the treatment of medical conditions (other than OCD) in this age group has not been satisfactorily established. For the treatment of OCD, Zoloft 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 available with a doctor's presc Læs hele dokumentet
Version: ujpzolot11020 Supersedes: pfpzolot10919 Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION – ZOLOFT (SERTRALINE HYDROCHLORIDE) 1. NAME OF THE MEDICINE Sertraline hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ZOLOFT 50 mg tablets contain 50 mg sertraline (as hydrochloride). ZOLOFT 100 mg tablets contain 100 mg sertraline (as hydrochloride). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM ZOLOFT 50 mg capsule-shaped tablets: white film coated tablets embossed with the Pfizer logo on one side, and “ZLT” scoreline “50” on the other side. ZOLOFT capsule-shaped 100 mg tablets: white film coated tablets embossed with the Pfizer logo on one side, and “ZLT 100” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CHILDREN AND ADOLESCENTS ZOLOFT (sertraline hydrochloride) is indicated for the treatment of children (aged 6 years of age and older) and adolescents with OCD. ADULTS ZOLOFT (sertraline hydrochloride) is indicated for the treatment of major depression, obsessive compulsive disorder (OCD) and panic disorder. ZOLOFT (sertraline hydrochloride) is indicated for the treatment of social phobia (social anxiety disorder) and the prevention of its relapse. ZOLOFT (sertraline hydrochloride) is indicated for the treatment of premenstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria. Version: ujpzolot11020 Supersedes: pfpzolot10919 Page 2 of 28 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE CHILDREN AND ADOLESCENTS (6-18 YEARS) _OBSESSIVE COMPULSIVE DISORDER _ The administration of ZOLOFT in children with OCD (ages 6-12 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 13-18 years) may commence at 50 mg/day. Clinical effects may be noted after 2 weeks of treatment but clinical responses should be monitored for 6 weeks before any increase in dose. In children, a dose of 200 mg/day should not be exceeded. Sertraline has an elimination ha Læs hele dokumentet