Norpress

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Nortriptyline hydrochloride 28.463mg equivalent to 25 mg Nortriptyline; Nortriptyline hydrochloride 28.463mg equivalent to 25 mg Nortriptyline

Disponibbli minn:

Viatris Limited

INN (Isem Internazzjonali):

Nortriptyline hydrochloride 28.463 mg (= 25 mg Nortriptyline)

Dożaġġ:

25 mg

Għamla farmaċewtika:

Tablet

Kompożizzjoni:

Active: Nortriptyline hydrochloride 28.463mg equivalent to 25 mg Nortriptyline Excipient: Chloroform as 61.1%w/w of Colour Film Coat 5520 Diethyl phthalate as 0.433%w/w of Colour Film Coat 5520 Alcohol absolute HGF3 as 32.8%w/w of Colour Film Coat 5520   Opaspray orange K-1-2433 as 2.0%w/w of Colour Film Coat 5520 Lactose monohydrate Magnesium stearate Maize starch Active: Nortriptyline hydrochloride 28.463mg equivalent to 25 mg Nortriptyline Excipient: Allura red AC Brilliant blue FCF Lactose monohydrate Lecithin Macrogol 3350 Magnesium stearate Maize starch Polyvinyl alcohol Purified talc Sunset yellow FCF Titanium dioxide

Unitajiet fil-pakkett:

Blister pack, Clear PVC/PVDC 50 tablets, 50 tablets

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Olon SpA

Sommarju tal-prodott:

Package - Contents - Shelf Life: Blister pack, Clear PVC/PVDC - 50 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC/PVDC - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC/PVDC - 180 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC/PVDC - 250 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC/PVDC - 500 tablets - 36 months from date of manufacture stored at or below 25°C

Data ta 'l-awtorizzazzjoni:

1985-12-05

Fuljett ta 'informazzjoni

NEW ZEALAND CONSUMER MEDICINE INFORMATION
NORPRESS
_NORTRIPTYLINE (AS HYDROCHLORIDE) 10 MG & 25 MG TABLETS_
WHAT IS IN THIS LEAFLET
Please
read
this
leaflet
carefully
before you start taking Norpress.
This leaflet answers some common
questions about Norpress. It does
not
contain
all
the
information
available on this medicine.
It does not take the place of talking
to your doctor or pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
taking
Norpress
against the benefits they expect it
will have for you.
If
you
have
any
concerns
about
taking
this
medicine,
ask
your
doctor or pharmacist.
Keep this leaflet. You may want to
read it again.
WHAT NORPRESS IS
TAKEN FOR AND HOW IT
WORKS
Your Norpress tablets contain the
active
ingredient
nortriptyline
hydrochloride. It belongs to a group
of
medicines
known
as
tricyclic
antidepressants (TCAs).
Norpress
is
used
to
treat
depression. Depression may affect
your whole body and may cause
emotional and physical symptoms
such as feeling low in spirit, loss of
interest in activities, being unable to
enjoy
life,
poor
appetite
or
overeating,
disturbed
sleep,
often
waking up early, loss of sex drive,
lack
of
energy
and
feeling
guilty
over nothing.
Norpress is also used as an aid to
smoking
cessation
and
may
help
you stop smoking.
Your
doctor
may,
however,
prescribe
Norpress
for
another
reason. Ask your doctor if you have
any questions about why Norpress
has been prescribed for you.
NORPRESS IS NOT RECOMMENDED FOR
USE IN CHILDREN 12 YEARS OF AGE
AND UNDER.
NORPRESS IS NOT RECOMMENDED FOR
USE IN ADOLESCENTS (13-18 YEARS
OF
AGE)
FOR
THE
TREATMENT
OF
DEPRESSION,
UNLESS
UNDER
THE
SUPERVISION OF A SPECIALIST.
NORPRESS IS NOT RECOMMENDED FOR
USE
IN
ADOLESCENTS
(UNDER
18
YEARS
OF
AGE)
AS
AN
AID
IN
SMOKING CESSATION.
Norpress
is
only
available
on
prescription from your doctor.
BEFORE YOU TAKE
NORPRESS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NORPRESS IF YOU:
•
ARE ALLERGIC TO
NORTRIPTYLINE, OTHER
TRICYCLIC ANTIDEPRESSANTS
OR ANY OTHER INGREDIENTS
LISTED A

Karatteristiċi tal-prodott

Page 1 of 11
NEW ZEALAND DATA SHEET
NORPRESS
1. PRODUCT NAME
Norpress, 10 mg & 25 mg, film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 10 mg or 25 mg of nortriptyline (as
hydrochloride).
Excipient with known effect: Contains sulfites and sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
NORPRESS 10 mg tablets are yellow, film coated convex tablets, 5.6 mm
diameter_ _
NORPRESS 25 mg tablets are orange, film coated convex tablets, 8.7 mm
diameter, with a scoreline
on one side and blank on the other. The tablet can be divided into
equal doses.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Nortriptyline hydrochloride is indicated for the relief of symptoms of
depression. Endogenous
depressions are more likely to be alleviated than are other depressive
states.
Nortriptyline hydrochloride is indicated for the treatment of nicotine
dependence as an aid to smoking
cessation.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
FOR THE RELIEF OF SYMPTOMS OF DEPRESSION
Nortriptyline hydrochloride is administered orally in the form of
tablets. Lower than usual dosages
are recommended for elderly patients. The use of lower dosages for
outpatients is more important
than for hospitalised patients who will be treated under close
supervision. The physician should
initiate dosage at a low level and increase it gradually, checking the
clinical response carefully and
noting any evidence of intolerance. Given the propensity of
nortriptyline to induce SVT or ECG
conduction defects, it is recommended physicians perform pre-treatment
ECG’s to establish a
patient’s cardiovascular health status._ _ Following remission,
maintenance medication may be
required for a longer period of time at the lowest dose that will
maintain remission.
If a patient develops minor side effects, the dosage should be
reduced. The medicine should be
discontinued promptly if adverse effects of a serious nature or
allergic manifestations occur.
Page 2 of 11
_DOSE_
_ADULT