Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
sertraline hydrochloride, Quantity: 55.95 mg (Equivalent: sertraline, Qty 50 mg)
Arrotex Pharmaceuticals Pty Ltd
Sertraline hydrochloride
Tablet, film coated
Excipient Ingredients: macrogol 400; titanium dioxide; microcrystalline cellulose; polysorbate 80; calcium hydrogen phosphate; magnesium stearate; sodium starch glycollate type A; hyprolose; hypromellose
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 ? Social phobia (social anxiety disorder) and the prevention of its relapse ? Pre-menstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria
Visual Identification: White to off-white, capsule shaped, biconvex film coated tablets with '50' and 'BL' debossed on either side of the breakline; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-09-27
SERTRA TABLETS 1 SERTRA TABLETS 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 SERTRA? Sertra contains the active ingredient sertraline hydrochloride. Sertra is used to treat obsessive compulsive disorder (OCD) in children over the age of 6 and depression, OCD, panic disorder, social anxiety disorder and pre-menstrual dysphoric disorder (PMDD) in adults. For more information, see Section 1. Why am I using Sertra? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SERTRA? Do not use if you have ever had an allergic reaction to sertraline 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 Sertra? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Sertra 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 SERTRA? OBSESSIVE COMPULSIVE DISORDER Starting dose is 25 mg a day (half a 50 mg tablet) for children and 50 mg tablet per day for adults and adolescents. DEPRESSION Starting dose is one 50 mg tablet per day. PANIC DISORDER AND SOCIAL PHOBIA Starting dose is 25 mg per day (half a 50 mg tablet). PMDD Starting dose is one 50 mg tablet each day, either throughout the menstrual cycle (to a maximum of 150 mg daily) or for the last 14 days before the start of your period (to a maximum of 100 mg daily). More instructions can be found in Section 4. How do I use Sertra? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SERTRA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Sertra. • If you become pregnant while taking this medicine, tell your doctor immediately. • Call your doctor s Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – SERTRA (SERTRALINE HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Sertraline hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg or 100 mg sertraline (as sertraline hydrochloride). For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 50 MG TABLETS White to off white, capsule shaped, biconvex, film coated tablets with breakline on one side and ‘50’ and ‘BL’ debossed on either side of the breakline. 100 MG TABLETS White to off-white, capsule shaped, biconvex film coated tablets with '100' and 'BL' debossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC 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 • Social phobia (social anxiety disorder) and the prevention of its relapse • Pre-menstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria 4.2 DOSE AND METHOD OF ADMINISTRATION SERTRA tablets are intended for oral administration. CHILDREN AND ADOLESCENTS (6-18 YEARS) Obsessive Compulsive Disorder The administration of sertraline hydrochloride 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 hydrochloride 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 2 Initial Treatment – Sertraline treatment should be initiated with a dose of 50 mg once Read the complete document