ENTRIP amitriptyline hydrochloride 25 mg tablets blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

amitriptyline hydrochloride, Quantity: 25 mg

Saadav alates:

Arrotex Pharmaceuticals Pty Ltd

INN (Rahvusvaheline Nimetus):

amitriptyline hydrochloride

Ravimvorm:

Tablet

Koostis:

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

Manustamisviis:

Oral

Ühikuid pakis:

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

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

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

Toote kokkuvõte:

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

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2015-11-27

Infovoldik

ENTRIP
_contains the active ingredient amitriptyline hydrochloride _
_ _
ENTRIP CMI v2.0
1
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ENTRIP.
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 ENTRIP 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 ENTRIP IS USED FOR
ENTRIP is used to treat depression.
ENTRIP 10 mg and 25 mg tablets
can be used at any stage in the
treatment of depression. However,
the highest strength ENTRIP 50 mg,
is approved only for the maintenance
treatment of depression (after your
symptoms have improved).
ENTRIP 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.
ENTRIP 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 ENTRIP HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
ENTRIP for another reason.
ENTRIP 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
ENTRIP in treating the above
condition, for this age group, has not
been established.
ENTRIP is available only with a
doctor's prescription.
BEFORE YOU TAKE ENTRIP
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ENTRIP IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
AMITRIPTYLINE (E.G. TRYPTANOL) OR
ANY OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Some of the sy

Toote omadused

1
AUSTRALIAN PRODUCT INFORMATION – ENTRIP (AMITRIPTYLINE
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Amitriptyline hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ENTRIP 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
ENTRIP 10 mg tablet: Round blue coloured biconvex tablets debossed AM
on one side and 10 on the
other side.
ENTRIP 25 mg tablet: Round yellow coloured biconvex tablets debossed
AM on one side and 25 on
the other side.
ENTRIP 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. ENTRIP 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 necessary.
A small number of hospitalised patients may need as mu