País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
amitriptyline hydrochloride, Quantity: 10 mg
Arrotex Pharmaceuticals Pty Ltd
amitriptyline hydrochloride
Tablet
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; croscarmellose sodium; colloidal anhydrous silica; purified talc; magnesium stearate; macrogol 6000; hypromellose; titanium dioxide; brilliant blue FCF aluminium lake; polyvinyl alcohol; macrogol 3350
Oral
100's, 50's
(S4) Prescription Only Medicine
For the treatment of major depression. Nocturnal enuresis where organic pathology has been excluded.
Visual Identification: Round blue coloured biconvex tablets debossed AM on one side and 10 on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/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
2015-11-27
ENTRIP _contains the active ingredient amitriptyline hydrochloride _ _ _ ENTRIP CMI v2.0 1 CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ENTRIP. 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 ENTRIP against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. PLEASE READ THIS LEAFLET CAREFULLY AND KEEP IT WITH YOUR MEDICINE. You may need to read it again. WHAT ENTRIP IS USED FOR ENTRIP is used to treat depression. ENTRIP 10 mg and 25 mg tablets can be used at any stage in the treatment of depression. However, the highest strength ENTRIP 50 mg, is approved only for the maintenance treatment of depression (after your symptoms have improved). ENTRIP belongs to a group of medicines called tricyclic antidepressants (TCAs). TCA medicines work by correcting the imbalance of certain chemicals in the brain. These chemicals, called amines, are involved in controlling mood. By correcting this imbalance, TCAs can help relieve the symptoms of depression. ENTRIP can also be used to treat bed-wetting, provided that there is no physical cause for the problem (e.g. problems with the bladder). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ENTRIP HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed ENTRIP for another reason. ENTRIP IS NOT APPROVED FOR USE IN CHILDREN AND ADOLESCENTS BELOW 18 YEARS OF AGE FOR THE TREATMENT OF DEPRESSION. The safe use and effectiveness of ENTRIP in treating the above condition, for this age group, has not been established. ENTRIP is available only with a doctor's prescription. BEFORE YOU TAKE ENTRIP _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ENTRIP IF YOU ARE ALLERGIC TO MEDICINES CONTAINING AMITRIPTYLINE (E.G. TRYPTANOL) OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the sy Leia o documento completo
1 AUSTRALIAN PRODUCT INFORMATION – ENTRIP (AMITRIPTYLINE HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Amitriptyline hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ENTRIP tablets contain 10 mg, 25 mg or 50mg of amitriptyline hydrochloride. Excipients with known effect: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ENTRIP 10 mg tablet: Round blue coloured biconvex tablets debossed AM on one side and 10 on the other side. ENTRIP 25 mg tablet: Round yellow coloured biconvex tablets debossed AM on one side and 25 on the other side. ENTRIP 50 mg tablet: Round brown coloured biconvex tablets debossed AM on one side and 50 on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS For the treatment of major depression. ENTRIP 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 D OSE AND METHOD OF ADMINISTRATION DEPRESSION _Dosage considerations _ 2 Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. _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. Alternative methods for initiating therapy in outpatients are: begin therapy with 50 to 100 mg preferably in the evening or at bedtime; this may be increased by 25 to 50 mg as necessary to a total of 150 mg per day. _Dosage for hospitalised patients _ 100 mg a day may be required initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalised patients may need as mu Leia o documento completo