AMITRIPTYLINE VIATRIS amitriptyline hydrochloride 50mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amitriptyline hydrochloride, Quantity: 50 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

amitriptyline hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium starch glycollate; pregelatinised maize starch; colloidal anhydrous silica; lactose monohydrate; magnesium stearate; purified talc; disodium edetate; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000; iron oxide black

Administration route:

Oral

Units in package:

1000, 50, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AMITRIPTYLINE ALPHAPHARM 50mg tablets are indicated only for the maintenance treatment of major depression. (see Precautions). Nocturnal enuresis where organic pathology has been excluded.

Product summary:

Visual Identification: 8 mm hexaganol, tan film coated tablet marked AP 50 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

Authorization status:

Licence status A

Authorization date:

2015-11-11

Patient Information leaflet

AMITRIPTYLINE VIATRIS
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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

Summary of Product characteristics

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