AMITRIPTYLINE LUPIN amitriptyline hydrochloride 10mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
25-02-2022
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
amitriptyline hydrochloride, Quantity: 10 mg
Available from:
Generic Health Pty Ltd
INN (International Name):
amitriptyline hydrochloride
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: maize starch; titanium dioxide; lactose monohydrate; macrogol 6000; hypromellose; purified talc; crospovidone; colloidal anhydrous silica; brilliant blue FCF aluminium lake; magnesium stearate; microcrystalline cellulose
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: Blue colour, circular, biconvex, film coated tablets with 'IA' over '10' 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
CONSUMER MEDICINE INFORMATION
AMITRIPTYLINE LUPIN
(AMITRIPTYLINE HYDROCHLORIDE) FILM-COATED TABLETS
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.generichealth.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 AMITRIPTYLINE LUPIN
IS USED FOR
The name of your medicine is
Amitriptyline Lupin. It contains
the active ingredient
amitriptyline hydrochloride.
It is used to treat:
•
major depression - the 10 mg
and 25 mg tablets can be
used at any stage in
treatment, however, the
50 mg tablets are approved
only for maintenance
treatment (ie. after symptoms
have improved).
•
Bed-wetting, provided there
is no physical cause (eg.
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 the brain. These chemicals,
called amines, are involved in
controlling mood. By correcting
this imbalance, TCAs
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION – AMITRIPTYLINE LUPIN
(AMITRIPTYLINE HYDROCHLORIDE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Amitriptyline hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amitriptyline hydrochloride as the active
ingredient.
List of excipients with known effect: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
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.
Amitriptyline Lupin v2.0
Page 2 of 16
(amitriptyline hydrochloride) film-coated tablets
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 outpatients are: begin
therapy with 50 to 100 mg preferably
in the evening or at bedtime; this may be increased by 25 to 50 mg as
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