Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
escitalopram oxalate, Quantity: 25.548 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; maize starch; magnesium stearate; mannitol; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 6000
Oral
28
(S4) Prescription Only Medicine
Treatment of major depression. ,Treatment of social anxiety disorder (social phobia). ,Treatment of generalised anxiety disorder. ,Treatment of obsessive-compulsive disorder.
Visual Identification: White, round, biconvex film coated,tablets with E20 debossed on one side,and break line on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-08-21
BTC ESCITALOPRAM 1 BTC ESCITALOPRAM 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 BTC ESCITALOPRAM? BTC ESCITALOPRAM contains the active ingredient escitalopram. BTC ESCITALOPRAM is used to treat depression. For more information, see Section 1. Why am I using BTC ESCITALOPRAM? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BTC ESCITALOPRAM? Do not use if you have ever had an allergic reaction to escitalopram, citalopram 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 BTC ESCITALOPRAM? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with BTC ESCITALOPRAM 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 BTC ESCITALOPRAM? • The standard dose for this medicine is 10 mg per day More instructions can be found in Section 4. How do I use BTC ESCITALOPRAM? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING BTC ESCITALOPRAM? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using BTC ESCITALOPRAM. • If you become pregnant while taking BTC ESCITALOPRAM, tell your doctor immediately. • Tell your doctor immediately if you have thoughts about killing yourself, or you experience symptoms such as restlessness or difficulty in sitting or standing still, if you suddenly experience an episode of mania. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Do not give the tablets to anyone else, even if they have the same condition as you. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how BTC ESCITALOPRAM affects you. • If you Read the complete document
AUSTRALIAN PRODUCT INFORMATION - BTC ESCITALOPRAM (ESCITALOPRAM OXALATE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE ESCITALOPRAM OXALATE 2 QUALITATIVE AND QUANTITATIVE COMPOSITION BTC ESCITALOPRAM 10 mg tablets. Film-coated tablets containing 10mg escitalopram (as oxalate) BTC ESCITALOPRAM 20 mg tablets. Film-coated tablets containing 20 mg escitalopram (as oxalate). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM BTC ESCITALOPRAM 10 mg tablets are white, round, biconvex film coated tablets plain on both sides. BTC ESCITALOPRAM 20 mg tablets are white, round, biconvex film coated tablets plain on both sides. Escitalopram is the active enantiomer (S-enantiomer) of citalopram. Escitalopram oxalate is a fine white to yellow, crystalline material. Escitalopram oxalate is sparingly soluble in water, slightly soluble in acetone, soluble in ethanol and freely soluble in methanol. No polymorphic forms have been detected. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depression. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder. 4.2 DOSE AND METHOD OF ADMINISTRATION _ADULTS _ Escitalopram is administered as a single oral dose and may be taken with or without food. _Major depression _ Usually 2 - 4 weeks are necessary for antidepressant response, The recommended dose is 10 mg (one 10 mg tablet) once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg (one 20 mg tablet) daily, although the onset of therapeutic effect may be seen earlier. The treatment of a single episode of depression requires treatment over the acute and the medium term. After the symptoms resolve during acute treatment, a period of consolidation of the response is required. Therefore, treatment of a depressive episode should be continued for a minimum of 6 months. _Social anxiety disorder _ The recommended dose is 10 mg (one 10 mg tablet) once daily. Depend Read the complete document