Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
sertraline hydrochloride, Quantity: 55.96 mg (Equivalent: sertraline, Qty 50 mg)
Sun Pharma ANZ Pty Ltd
Sertraline hydrochloride
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; calcium hydrogen phosphate dihydrate; sodium starch glycollate; hyprolose; magnesium stearate; titanium dioxide; hypromellose; purified talc; macrogol 400
Oral
30 tablets
(S4) Prescription Only Medicine
Adults: Setrona is indicated for the treatment of major depression. Setrona is indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD) as defined by DSM-IV criteria.
Visual Identification: White film coated caplet shaped tablets debossed with '50' on one side and a break-line on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2006-06-22
SETRONA 1 SETRONA CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING SETRONA? SETRONA contains the active ingredient sertraline hydrochloride. SETRONA is used to treat depression and conditions called obsessive compulsive disorder (OCD), panic disorder, social phobia (social anxiety disorder) and premenstrual dysphoric disorder (PMDD). For more information, see Section 1. Why am I using SETRONA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SETRONA? Do not use if you have ever had an allergic reaction to SETRONA or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use SETRONA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with SETRONA and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE SETRONA? • SETRONA is to be taken by mouth, every morning or evening with or without food. Swallow the tablet whole with a full glass of water. • Take SETRONA exactly as your doctor has prescribed. More instructions can be found in Section 4. How do I use SETRONA? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SETRONA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using SETRONA. • Take SETRONA exactly as your doctor tells you to. • Visit your doctor regularly for check ups. THINGS YOU SHOULD NOT DO • Do not give this medicine to anyone else, even if they have the same condition as you. • Do not use SETRONA tablets to treat any other complaints unless your doctor tells you to. • Do not stop taking SETRONA tablets, or lower the dose, without first checking with your doctor. DRIVING OR USIN Read the complete document
SETRONA PI V13_Aug 2022 Page 1 of 39 AUSTRALIAN PRODUCT INFORMATION -SETRONA ( SERTRALINE HYDROCHLORIDE ) TABLETS 1. NAME OF THE MEDICINE Sertraline Hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each white, film coated caplet shaped tablet contains 50 mg or 100 mg of sertraline as sertraline hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM SERTONA 50 mg tablet is debossed with “50” on one side and a break line on the other. SERTONA 100 mg tablet is imprinted with “100” on one side and a break line on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CHILDREN AND ADOLESCENTS Setrona is indicated for the treatment of children (aged 6 years of age and older) and adolescents with Obsessive Compulsive Disorder (OCD). ADULTS Setrona is indicated for the treatment of major depression, OCD and panic disorder. Setrona is indicated for the treatment of social phobia (social anxiety disorder) and the prevention of its relapse. Setrona is indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD) as defined by DSM-IV criteria. 4.2 DOSE AND METHOD OF ADMINISTRATION _CHILDREN AND ADOLESCENTS_ (6-18 YEARS) _Obsessive Compulsive Disorder: _ The administration of sertraline in children with OCD (ages 6-12 years) is recommended to commence at 25 mg/day (half a 50 mg SETRONA PI V13_Aug 2022 Page 2 of 39 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 half-life of approximately 26 hours; a once daily dose in the morning is recommended. _ADULTS (18 YEARS AND OLDER) _ _Major Depression/Obsessive Compulsive Disorder _ Sertraline treatment should be initiated with a dose of 50 mg once daily. The usual therapeutic dose for depression and OCD i Read the complete document