APX-AMITRIPTYLINE amitriptyline hydrochloride 25 mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

amitriptyline hydrochloride, Quantity: 25 mg

Disponível em:

Arrotex Pharmaceuticals Pty Ltd

Forma farmacêutica:

Tablet

Composição:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; croscarmellose sodium; colloidal anhydrous silica; purified talc; magnesium stearate; macrogol 6000; hypromellose; titanium dioxide; iron oxide yellow; polyvinyl alcohol; macrogol 3350

Via de administração:

Oral

Unidades em pacote:

10's, 1000's, 50's, 100's, 90's

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

For the treatment of major depression. Nocturnal enuresis where organic pathology has been excluded.

Resumo do produto:

Visual Identification: Round yellow coloured biconvex tablets debossed AM on one side and 25 on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Registered

Data de autorização:

2020-05-18

Folheto informativo - Bula

APX-AMITRIPTYLINE
_contains the active ingredient amitriptyline hydrochloride _
_ _
APX-AMITRIPTYLINE CMI
1
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APX-
AMITRIPTYLINE.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking APX-
AMITRIPTYLINE against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY
AND KEEP IT WITH YOUR MEDICINE.
You may need to read it again.
WHAT APX-AMITRIPTYLINE
IS USED FOR
APX-AMITRIPTYLINE is used to
treat depression.
APX-AMITRIPTYLINE 10 mg and
25 mg tablets can be used at any
stage in the treatment of depression.
However, the highest strength APX-
AMITRIPTYLINE 50 mg, is
approved only for the maintenance
treatment of depression (after your
symptoms have improved).
APX-AMITRIPTYLINE belongs to
a group of medicines called tricyclic
antidepressants (TCAs). TCA
medicines 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 can help relieve the symptoms
of depression.
APX-AMITRIPTYLINE can also be
used to treat bed-wetting, provided
that there is no physical cause for the
problem (e.g. problems with the
bladder).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY APX-
AMITRIPTYLINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed
APX-AMITRIPTYLINE for another
reason.
APX-AMITRIPTYLINE IS NOT
APPROVED FOR USE IN CHILDREN AND
ADOLESCENTS BELOW 18 YEARS OF AGE
FOR THE TREATMENT OF DEPRESSION.
The safe use and effectiveness of
APX-AMITRIPTYLINE in treating
the above condition, for this age
group, has not been established.
APX-AMITRIPTYLINE is available
only with a doctor's prescription.
BEFORE YOU TAKE APX-
AMITRIPTYLINE
_WHEN YOU MUST NOT TAK

Características técnicas

1
AUSTRALIAN PRODUCT INFORMATION – APX-AMITRIPTYLINE
(AMITRIPTYLINE HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Amitriptyline hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-AMITRIPTYLINE tablets contain 10 mg, 25 mg or 50mg of
amitriptyline hydrochloride.
Excipients with known effect: lactose monohydrate. For the full list
of excipients, see SECTION 6.1
LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APX-AMITRIPTYLINE 10 mg tablet: Round blue coloured biconvex tablets
debossed AM on one side
and 10 on the other side.
APX-AMITRIPTYLINE 25 mg tablet: Round yellow coloured biconvex tablets
debossed AM on one side
and 25 on the other side.
APX-AMITRIPTYLINE 50 mg tablet: Round brown coloured biconvex tablets
debossed AM on one side
and 50 on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the treatment of major depression. APX-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
D
OSE AND METHOD OF ADMINISTRATION
DEPRESSION
_Dosage considerations _
2
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 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 necessary to a total
of 150 mg per day.
_Dosage for hospitalised patients _
100 mg a day may be required initially. This can be increased
gradually to 200 mg a day if