TERRY WHITE CHEMISTS AMITRIPTYLINE amitriptyline hydrochloride 50mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
amitriptyline hydrochloride
Available from:
Apotex Pty Ltd
INN (International Name):
amitriptyline hydrochloride
Authorization status:
Registered
Patient Information leaflet
TERRY WHITE CHEMISTS
AMITRIPTYLINE
_Contains the active ingredient amitriptyline (as 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 Terry
White Chemists Amitriptyline
Tablets. 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 (i.e.
after symptoms have improved).
•
Bed wetting, provided there is no
physical cause (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 the brain. The
Read the complete document
Summary of Product characteristics
Product Information – Australia
Terry White Chemists Amitriptyline Tablets
Page 1
TERRY WHITE CHEMISTS AMITRIPTYLINE TABLETS
NAME OF THE MEDICINE
Amitriptyline hydrochloride
ACTIVE INGREDIENT
Chemical Name:
3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-
dimethylpropylamine hydrochloride
Structural Formula:
Molecular Formula:
C
20
H
23
N.HCl
Molecular Weight:
313.9
CAS Registry Number:
549-18-8
DESCRIPTION
Amitriptyline hydrochloride occurs as colourless crystals or a white
or almost white powder; odourless
or almost odourless; taste, bitter and burning, followed by a
sensation of numbness. It is soluble in 1
part of water, in 1.5 parts of ethanol (96%), in 1.2 parts of
chloroform and in 1 part of methanol. It is
practically insoluble in ether. pKa of amitriptyline hydrochloride is
9.4.
Each tablet contains amitriptyline hydrochloride as the active
ingredient. In addition, each tablet
contains the following inactive ingredients: lactose, microcrystalline
cellulose, crospovidone, maize
starch, colloidalanhydrous silica, purified talc, magnesium stearate,
hypromellose, titanium dioxide,
macrogol 6000, brilliant blue FCF aluminium lake (10mg only),
quinoline yellow aluminium lake (25mg
only), sunset yellow FCF aluminium lake and indigo carmine aluminium
lake (50mg only).
PHARMACOLOGY
Amitriptyline is a tricyclic antidepressant with sedative properties.
MECHANISM OF ACTION
The mechanism of action of amitriptyline in man is not known. It is
not a monoamine oxidase inhibitor
and it does not act primarily by stimulation of the central nervous
system. In broad clinical use,
amitriptyline has been found to be well tolerated.
Amitriptyline inhibits the membrane pump mechanism responsible for
uptake of noradrenaline and
serotonin in adrenergic and serotonergic neurons. Pharmacologically,
this action may potentiate or
prolong neuronal activity since reuptake of these biogenic amines is
important physiologically in
terminating its transmitting activity. This interference with the
uptake of noradrenaline and/or s
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