Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
oxazepam, Quantity: 30 mg
Alphapharm Pty Ltd
Tablet, uncoated
Excipient Ingredients: magnesium stearate; lactose monohydrate; quinoline yellow aluminium lake; maize starch; erythrosine aluminium lake
Oral
50 tablets, 90 tablets, 1000 tablets, 25 tablets
Medicine Registered
(S4) Prescription Only Medicine
INDICATIONS AS AT 25 JANUARY 2005 : Alepam is indicated for: Management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety associated with depression is also responsive to oxazepam therapy. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The physician should periodically reassess the usefulness of the drug for the individual patient. Alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal are responsive to therapy.
Visual Identification: 8 mm pale orange flat bevelled edged tablet marked OM/30 on one side, G on reverse; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
1991-09-20
ALEPAM _contains the active ingredient oxazepam_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ALEPAM It does not contain all of 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 ALEPAM against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT ALEPAM IS USED FOR ALEPAM is used for: • anxiety, such as the anxiety associated with depression • tremor, anxiety and confusion associated with alcohol withdrawal. ALEPAM contains the active ingredient oxazepam, which belongs to a group of medicines called benzodiazepines. These medicines are thought to work by their action on brain chemicals. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ALEPAM HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed ALEPAM for another reason. In general, benzodiazepines such as ALEPAM should be taken for short periods only (for example 2 to 4 weeks). Continuous long term use is not recommended unless advised by your doctor. The use of benzodiazepines may lead to dependence on the medicine. ALEPAM is not recommended for use in children under 16 years of age, as its safety and effectiveness have not been established in this age group. ALEPAM is available only with a doctor's prescription. BEFORE YOU TAKE ALEPAM _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ALEPAM IF YOU ARE ALLERGIC TO: • oxazepam or any other benzodiazepine medicine • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath. DO NOT TAKE ALEPAM IF YOU HAVE: • severe and chronic respiratory (lung or airways) disease • sleep a Przeczytaj cały dokument
AUSTRALIAN PRODUCT INFORMATION ALEPAM _Oxazepam tablet _ 1 NAME OF THE MEDICINE Oxazepam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ALEPAM 15 and ALEPAM 30 tablet contains 15 mg and 30 mg of oxazepam, respectively. Excipients with known effect: sugars as lactose and trace quantities of sulfites. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ALEPAM 15 (oxazepam) 15 mg: 8 mm pale yellow flat bevelled edged tablet marked OM/15 on one side, G on reverse. ALEPAM 30 (oxazepam) 30 mg: 8 mm pale orange flat bevelled edged tablet marked OM/30 on one side, G on reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALEPAM is indicated for: • Management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety associated with depression is also responsive to oxazepam therapy. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The physician should periodically reassess the usefulness of the drug for the individual patient. • Alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal are responsive to therapy. 4.2 DOSE AND METHOD OF ADMINISTRATION ALEPAM is administered orally. For optimal results, dose, frequency of administration and duration of therapy should be individualised according to patient response. For mild to moderate anxiety, with associated tension, irritability, agitation or related symptoms of functional origin or secondary to organic disease, the usual dose is 7.5 to 15 mg, 3 or 4 times daily. For severe anxiety syndromes, agitation or anxiety associated with depression, the usual dose is 15 to 30 mg, 3 or 4 times daily. For older patients with anxiety, tension, irritability and agitation, the initial dose is 7.5 mg, 2 to 3 times daily. If necessary, increase cautiously to 15 mg, 3 or 4 times daily. For alcoholics with tremulousness or anxiety on withdrawal, the usual dose is 15 to 30 mg, 3 or 4 times daily. ALEPAM Przeczytaj cały dokument