Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
escitalopram oxalate, Quantity: 25.47 mg
Arrotex Pharmaceuticals Pty Ltd
escitalopram oxalate
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; macrogol 400; magnesium stearate; purified talc; hypromellose; croscarmellose sodium; titanium dioxide; colloidal anhydrous silica
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 to off-white, oval, biconvex, film-coated tablet with 'C3' debossed on one side and a notch break-line on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2013-11-06
APO-ESCITALOPRAM 1 APO-ESCITALOPRAM _Contains the active ingredient, escitalopram (as escitalopram oxalate) _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 this medicine against the benefits they expect it will 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 THIS MEDICINE IS USED FOR The name of your medicine is APO- Escitalopram. It contains the active ingredient, escitalopram (as escitalopram oxalate). Escitalopram is used to treat • depression • obsessive-compulsive disorder. It belongs to a group of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Escitalopram and other SSRIs are thought to help by increasing the amount of serotonin in your brain. Depression is longer lasting or more severe than the "low moods" everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing. Escitalopram corrects this chemical imbalance and may help relieve the symptoms of depression. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. There is no evidence that escitalopram is addictive. However, if you sudd Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION APO-ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLETS 1 NAME OF THE MEDICINE Escitalopram oxalate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg or 20 mg escitalopram (as oxalate) as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM 10 MG TABLETS: White to off-white, oval, biconvex, film-coated tablets with “C4” debossed on one side and a notch break-line on the other side. 20 MG TABLETS: White to off-white oval, biconvex, film-coated tablets with “C3” debossed on one side and a notch break-line on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of major depression. • Treatment of obsessive-compulsive disorder. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Escitalopram tablets are intended for oral administration. DOSAGE 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, although the onset of therapeutic effect may be seen earlier. 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. 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. 2 Obsessive-Compulsive Disorder The recommended starting dose is 10 mg (one 10 mg tablet) once daily. Depending on individual patient response, the dose may be increased to 20 mg (one 20 mg tablet) daily. Long-term treatment has been studied for a maximum of 40 weeks. Patients responding to a 16-week open-label treatment phase were randomised to a 24-week placebo-controlled relapse-prevention phase, receiving 10 or 20 mg escitalopram daily. A Read the complete document