מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
escitalopram oxalate, Quantity: 25.548 mg (Equivalent: escitalopram, Qty 20 mg)
Arrotex Pharmaceuticals Pty Ltd
escitalopram oxalate
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; purified talc; titanium dioxide; polyvinyl alcohol; macrogol 3000
Oral
28 tablets
(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, oval convex shaped, coated tablet with 'E' bisect '2' on one side and plain on the other.; Container Type: Blister Pack; Container Material: PCTFE (Aclar)/AI; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-07-05
LEXAM- Consumer Medicine Information Page 1 of 6 LEXAM escitalopram oxalate CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LEXAM. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking LEXAM against the benefits they expect it will have for you. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. Keep this leaflet with your medicine. You may need to read it again. WHAT LEXAM IS USED FOR LEXAM is used to treat depression. It belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work by their action on brain chemicals called amines which are involved in controlling mood. Depression is longer lasting and/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 like 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. LEXAM corrects this chemical imbalance and may help relieve the symptoms of depression. LEXAM may also be used to treat patients who may avoid and/or are fearful of social situations. LEXAM may also be used to treat patients who have excessive anxiety and worry. LEXAM may also be used to treat irrational fears or obsessional behaviour (obsessive-compulsive disorder). Obsessive-compulsive disorder involves having both obsessions and compulsions. Obsessions are unwanted thoughts that occur over and over again. Compulsions are the ongoing need to repeat certain actions as a result of these thoughts. Your doctor may have prescribed this medicine for a קרא את המסמך השלם
1 AUSTRALIAN PRODUCT INFORMATION – LEXAM (ESCITALOPRAM (AS OXALATE)) TABLETS 1 NAME OF THE MEDICINE Escitalopram (as oxalate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LEXAM tablets come in two strengths and contain either 10 mg or 20 mg of escitalopram (as oxalate). For full list of excipients, see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM LEXAM 10_ _ White, oval convex shaped, coated tablet with ‘E’ bisect ‘1’ on one side and plain on the other side. LEXAM 20_ _ White, oval convex shaped, coated tablet with ‘E’ bisect ‘2’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment of major depression. 4.2 D OSE 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 an antidepressant response. The recommended dose is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg 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 six months. ELDERLY PATIENTS (≥ 65 YEARS OF AGE). A longer half-life and a decreased clearance have been demonstrated in the elderly. 10 mg is the recommended maximum maintenance dose in the elderly 2 (see section 5.2 PHARMACOKINETIC PROPERTIES and section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). CHILDREN AND ADOLESCENTS (< 18 YEARS OF AGE). Safety and efficacy have not been established in this population. Escitalopram should not be used in children and adolescents under 18 years of age (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). RENAL INSUFFICIENCY. Dosage adjustment is not necessary in patients with mild or moderate renal impairment. No information is available on the treatme קרא את המסמך השלם