Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
temazepam, Quantity: 10 mg
Alphapharm Pty Ltd
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; maize starch; magnesium stearate
Oral
25 tablets, 50 tablets, 30 tablets
(S4) Prescription Only Medicine
Adjunctive therapy for the short term management of insomnia in adults.
Visual Identification: 5.5 mm flat bevel edged white to off-white tablet, debossed TE over 10 on one side, alpha symbol on the reverse.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
1998-05-13
TEMAZE _contains the active ingredient temazepam_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Temaze. 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 Temaze 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 TEMAZE IS USED FOR Temaze is used to treat sleeping problems, also called insomnia. Temaze belongs to a group of medicines called benzodiazepines. These medicines are thought to work by acting on brain chemicals. In general, benzodiazepines such as Temaze 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. Temaze is not recommended for use in children under the age of 16, as its safety and effectiveness have not been established in this age group. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TEMAZE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Temaze for another reason. Temaze is available only with a doctor's prescription. BEFORE YOU TAKE TEMAZE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE TEMAZE IF YOU ARE ALLERGIC TO: • temazepam 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 TEMAZE IF YOU HAVE: • severe lung disease or breathing difficulties • sleep apnoea, a condition where you have breathing problems when you sleep. DO NOT TAKE TEMAZE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING I Perskaitykite visą dokumentą
AUSTRALIAN PRODUCT INFORMATION TEMAZE _temazepam tablets _ 1 NAME OF THE MEDICINE Temazepam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Temaze tablet contains 10 mg of temazepam. Excipients with known effect: Sugars (as lactose). Also contains traces of galactose and sulfites. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Temazepam 10 mg tablet: 5.5 mm flat bevel edged white to off-white tablet, debossed “TE” on one side and "α" on the other. 10 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Temaze is indicated for: • Adjunctive therapy in the short term management of insomnia in adults. 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage should be individualised for maximum beneficial effect. For use as a hypnotic, the usual adult dose is 10 to 30 mg, taken one-half hour before retiring. In elderly or debilitated patients, 10 mg Temaze is the initial recommended dosage (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE - Elderly or debilitated patients). The need for continued therapy with Temaze in patients who have been taking medication for several weeks should be evaluated periodically. Temaze is not recommended for children. 4.3 CONTRAINDICATIONS Temaze is contraindicated in: • Patients with a known hypersensitivity to benzodiazepines or to any of the components of the formulation. • Patients with chronic obstructive airways disease with incipient respiratory failure. • Patients with sleep apnoea. Temazepam should not be used as monotherapy to treat depression, or symptoms of anxiety associated with depression, due to a risk of suicide (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE HYPOTENSION Although hypotension has occurred rarely, Temaze should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac or cerebral complications. This is particularly important in elderly patients. TEMAZE – PRODUCT INFORMATION 2 AMNESIA Transient amnesia or memo Perskaitykite visą dokumentą