देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
amitriptyline hydrochloride, Quantity: 25 mg
Alphapharm Pty Ltd
amitriptyline hydrochloride
Tablet, film coated
Excipient Ingredients: pregelatinised maize starch; sodium starch glycollate; colloidal anhydrous silica; microcrystalline cellulose; disodium edetate; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; indigo carmine; sunset yellow FCF; quinoline yellow; macrogol 4000
Oral
50, 90, 1000, 10 (sample)
(S4) Prescription Only Medicine
For the treatment of major depression. Nocturnal enuresis where organic pathology has been excluded.
Visual Identification: 7mm yellow film coated normal convex tablet marked AP/25 on one side, alpha symbol on reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2015-11-11
AMITRIPTYLINE VIATRIS A M I T R I P T Y L I N E V I A T R I S 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 AMITRIPTYLINE VIATRIS? AMITRIPTYLINE VIATRIS contains the active ingredient amitriptyline hydrochloride. AMITRIPTYLINE VIATRIS 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 AMITRIPTYLINE VIATRIS? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE AMITRIPTYLINE VIATRIS? Do not use if you have ever had an allergic reaction to AMITRIPTYLINE VIATRIS 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 AMITRIPTYLINE VIATRIS? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with AMITRIPTYLINE VIATRIS 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 AMITRIPTYLINE VIATRIS? • 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 AMITRIPTYLINE VIATRIS? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING AMITRIPTYLINE VIATRIS? 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 AMITRIPTYLINE VIATRIS. THINGS YOU पूरा दस्तावेज़ पढ़ें
AUSTRALIAN PRODUCT INFORMATION AMITRIPTYLINE VIATRIS _Amitriptyline hydrochloride tablet _ 1 NAME OF THE MEDICINE Amitriptyline hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg tablet contains 10 mg of amitriptyline hydrochloride as the active ingredient. Each 25 mg tablet contains 25 mg of amitriptyline hydrochloride as the active ingredient. Each 50 mg tablet contains 50 mg of amitriptyline hydrochloride as the active ingredient. Excipients with known effect in 10 mg tablet: Sugars as lactose, traces of sulfites and soya bean products. 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 10 mg tablet: 7 mm, normal convex, blue film coated tablet debossed with ‘AP 10’ on one side and α on the other. 25 mg tablet: 7 mm yellow, film coated, normal convex tablet marked AP/25 on one side, α on reverse. 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. AMITRIPTYLINE VIATRIS 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 initiating therapy in outpat पूरा दस्तावेज़ पढ़ें