Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
amitriptyline hydrochloride, Quantity: 10 mg
Alphapharm Pty Ltd
Tablet, film coated
Excipient Ingredients: pregelatinised maize starch; colloidal anhydrous silica; lactose monohydrate; disodium edetate; sodium starch glycollate; microcrystalline cellulose; magnesium stearate; purified talc; titanium dioxide; brilliant blue FCF; xanthan gum; lecithin
Oral
50
(S4) Prescription Only Medicine
For the treatment of major depression. Nocturnal enuresis where organic pathology has been excluded.
Visual Identification: 7mm normal convex blue film coated tablet debossedwith 'AP10' on one side and Greek alpha symbol on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1999-09-20
ENDEP ® E n d e p ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING ENDEP? ENDEP contains the active ingredient amitriptyline hydrochloride. ENDEP is used to treat depression. It can also be used to treat bedwetting, provided that there is no physical cause for the problem (eg. problems with the bladder). For more information, see Section 1. Why am I using ENDEP? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ENDEP? Do not use if you have ever had an allergic reaction to ENDEP or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use ENDEP? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with ENDEP and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ENDEP? • For depression, the usual starting dose is 75 mg to 150 mg per day in divided doses. • The doses recommended for bedwetting are lower than the doses used to treat depression and usually depend on the person's age and weight. • More instructions can be found in Section 4. How do I use ENDEP? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ENDEP? THINGS YOU SHOULD DO • Tell your doctor immediately if you have any suicidal thoughts or other mental/mood changes. • Keep all of your appointments with your doctor so that your progress can be checked. • Remind any doctor, dentist or pharmacist you visit that you are using ENDEP. THINGS YOU SHOULD NOT DO • Do not stop taking ENDEP, or lower the dose, without checking with your doctor. • Do not use ENDEP to treat any other conditions unless your doctor tells you to. DRIVING OR USING MACHINES • ENDEP may reduce yo Pročitajte cijeli dokument
AUSTRALIAN PRODUCT INFORMATION ENDEP ® _Amitriptyline hydrochloride tablet _ 1 NAME OF THE MEDICINE Amitriptyline hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ENDEP 10 tablets contains 10 mg of amitriptyline hydrochloride as the active ingredient. Each ENDEP 25 tablets contains 25 mg of amitriptyline hydrochloride as the active ingredient. Each ENDEP 50 tablets contains 50 mg of amitriptyline hydrochloride as the active ingredient. Excipients with known effect in 10 mg tablet: Sugars as lactose, soya bean products and traces of sulfites.. Excipients with known effect in 25 mg and 50 mg: tablets: Sugars as lactose and traces of sulfites. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM _ENDEP 10,_ 10 mg tablet: 7mm, normal convex, blue film coated tablet debossed with ‘AP 10’ on one side and α on the other. _ENDEP 25,_ 25 mg tablet: 7 mm yellow, film coated, normal convex tablet marked AP/25 on one side, α on reverse. _ENDEP 50,_ 50 mg tablet: 8 mm hexagonal, tan film coated tablet marked AP 50 on one side, α on reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of major depression. ENDEP 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. _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 initiati Pročitajte cijeli dokument