APO-AMITRIPTYLINE 50 amitriptyline hydrochloride 50mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
17-11-2021
Summary of Product characteristics
(SPC)
28-06-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
amitriptyline hydrochloride, Quantity: 50 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
amitriptyline hydrochloride
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: magnesium stearate; purified talc; microcrystalline cellulose; lactose monohydrate; crospovidone; maize starch; hypromellose; titanium dioxide; sunset yellow FCF aluminium lake; colloidal anhydrous silica; macrogol 6000; indigo carmine aluminium lake
Administration route:
Oral
Units in package:
20, 50 and 100
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
For the treatment of major depression. Amitriptyline 50 mg tablets are indicated only for the maintenance treatment of major depression ,Nocturnal enuresis where organic pathology has been excluded.
Product summary:
Visual Identification: Brown colour, circular, biconvex, film coated tablets with 'IA' over '50' debossed on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-08-22
Patient Information leaflet
APO- AMITRIPTYLINE
1
APO- AMITRIPTYLINE
_Contains the active ingredient amitriptyline hydrochloride _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about amitriptyline. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Amitriptyline Tablets. It contains the
active ingredient amitriptyline
hydrochloride.
It is used to treat:
•
depression - the 10 mg and 25 mg
tablets can be used at any stage in
treatment; however, the highest
strength 50 mg tablets are
approved only for maintenance
treatment (i.e. after symptoms
have improved).
•
Bed wetting, provided there is no
physical cause for the problem
(e.g. problems with the bladder).
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
Amitriptyline belongs to a group of
medicines called tricyclic
antidepressants (TCAs). TCAs work
by correcting the imbalance of
certain chemicals in
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION - APO-AMITRIPTYLINE
(AMITRIPTYLINE)
1
NAME OF THE MEDICINE
Amitriptyline hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each APO-Amtriptyline 10 tablets contains 10 mg of amitriptyline
hydrochloride as the active
ingredient.
Each APO-Amitriptyline 25 tablets contains 25 mg of amitriptyline
hydrochloride as the active
ingredient.
Each APO-Amitriptyline 50 tablets contains 50 mg of amitriptyline
hydrochloride as the active
ingredient.
Excipients with known effect:
Sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-Amitriptyline tablets are intended for oral administration.
10 mg tablet:
Blue colour, circular, biconvex, film coated tablets with “IA”
over “10” debossed on one side and plain
on the other side.
25 mg tablet:
Yellow colour, circular, biconvex, film coated tablets with “IA”
over “25” debossed on one side and
plain on the other side.
50 mg tablet:
Brown colour, circular, biconvex, film coated tablets with “IA”
over “50” debossed on one side and
plain on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of major depression. Amitriptyline 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.
2
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.
Read the complete document
