البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
amitriptyline hydrochloride, Quantity: 50 mg
Arrotex Pharmaceuticals Pty Ltd
amitriptyline hydrochloride
Tablet
Excipient Ingredients: magnesium stearate; purified talc; microcrystalline cellulose; lactose monohydrate; crospovidone; maize starch; hypromellose; titanium dioxide; sunset yellow FCF aluminium lake; colloidal anhydrous silica; macrogol 6000; indigo carmine aluminium lake
Oral
20, 50 and 100
(S4) Prescription Only Medicine
For the treatment of major depression. Amitriptyline 50 mg tablets are indicated only for the maintenance treatment of major depression ,Nocturnal enuresis where organic pathology has been excluded.
Visual Identification: Brown colour, circular, biconvex, film coated tablets with 'IA' over '50' debossed on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-08-22
APO- AMITRIPTYLINE 1 APO- AMITRIPTYLINE _Contains the active ingredient amitriptyline hydrochloride _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about amitriptyline. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Amitriptyline Tablets. It contains the active ingredient amitriptyline hydrochloride. It is used to treat: • depression - the 10 mg and 25 mg tablets can be used at any stage in treatment; however, the highest strength 50 mg tablets are approved only for maintenance treatment (i.e. after symptoms have improved). • Bed wetting, provided there is no physical cause for the problem (e.g. problems with the bladder). 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. _HOW IT WORKS _ Amitriptyline belongs to a group of medicines called tricyclic antidepressants (TCAs). TCAs work by correcting the imbalance of certain chemicals in اقرأ الوثيقة كاملة
1 AUSTRALIAN PRODUCT INFORMATION - APO-AMITRIPTYLINE (AMITRIPTYLINE) 1 NAME OF THE MEDICINE Amitriptyline hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each APO-Amtriptyline 10 tablets contains 10 mg of amitriptyline hydrochloride as the active ingredient. Each APO-Amitriptyline 25 tablets contains 25 mg of amitriptyline hydrochloride as the active ingredient. Each APO-Amitriptyline 50 tablets contains 50 mg of amitriptyline hydrochloride as the active ingredient. Excipients with known effect: Sugars as lactose. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM APO-Amitriptyline tablets are intended for oral administration. 10 mg tablet: Blue colour, circular, biconvex, film coated tablets with “IA” over “10” debossed on one side and plain on the other side. 25 mg tablet: Yellow colour, circular, biconvex, film coated tablets with “IA” over “25” debossed on one side and plain on the other side. 50 mg tablet: Brown colour, circular, biconvex, film coated tablets with “IA” over “50” debossed on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of major depression. Amitriptyline 50 mg tablets are indicated only for the maintenance treatment of major depression (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Nocturnal enuresis where organic pathology has been excluded. 4.2 DOSE AND METHOD OF ADMINISTRATION DEPRESSION Dosage considerations. _ _ Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. 2 Initial dosage for outpatient adults _. _ 75 mg a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg a day. Increases are made preferably in the late afternoon and/or bedtime doses. The sedative effect is usually rapidly apparent. The antidepressant activity may be evident within three or four days or may take up to 30 days to develop adequately. اقرأ الوثيقة كاملة