NortriTABS nortriptyline (as hydrochloride) 25 mg uncoated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nortriptyline hydrochloride, Quantity: 28.5 mg (Equivalent: nortriptyline, Qty 25 mg)

Available from:

Amdipharm Mercury Australia Pty Ltd

INN (International Name):

Nortriptyline hydrochloride

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: maize starch; lactose monohydrate; magnesium stearate

Administration route:

Oral

Units in package:

50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression

Product summary:

Visual Identification: White to off white, round, biconvex, uncoated tablets, debossed 'NM' on one side and '25' on other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2015-04-02

Patient Information leaflet

NORTRITABS
_Nortriptyline hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NortriTABS. It does
not contain all the available
information. 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 NortriTABS
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 WITH THE MEDICINE.
You may need to read it again.
WHAT NORTRITABS IS
USED FOR
NortriTABS is used to treat
depression.
There are many different types of
medicines used to treat depression.
NortriTABS belongs to a group of
medicines called tricyclic
antidepressants (TCAs). TCAs are
thought to work by their action on
brain chemicals called amines, which
are involved in controlling mood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend the use of this medicine
for children or adolescents under the
age of 18 years.
BEFORE YOU TAKE
NORTRITABS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NORTRITABS IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
nortriptyline
•
any of the ingredients listed at the
end of this leaflet.
•
any other similar medicines such
as other tricyclic antidepressants.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF:
•
you are taking another medicine
for depression called a
monoamine oxidase inhibitor
(MAOI), or have been taking a
MAOI within the last 14 days.
Check with your doctor or
pharmacist if you are unsure as to
whether or not you are taking a
MAOI.
•
you ar

Summary of Product characteristics

NORTITABS
1
AUSTRALIAN PRODUCT INFORMATION
NORTRITABS
NORTRIPTYLINE HYDROCHLORIDE
TABLET
1
NAME OF THE MEDICINE
Nortriptyline hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NortriTABS 10 mg and 25 mg tablets contain 10 mg and 25 mg
nortriptyline (present as the
hydrochloride) as the active ingredient, respectively.
Excipients with known effect: Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
NortriTABS 10 mg
White to off white, round, biconvex, uncoated tablets, debossed
‘NM’ on one side and ‘10’
on other side.
NortriTABS 25 mg
White to off white, round, biconvex, uncoated tablets, debossed
‘NM’ on one side and ‘25’
on other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NortriTABS is indicated for the treatment of major depression.
4.2 DOSE AND METHOD OF ADMINISTRATION
NortriTABS is not recommended for children.
NortriTABS is administered orally in the form of tablets. Lower than
usual dosages are
recommended for elderly patients and adolescents. The dosage for
outpatients should also
be lower than that for hospitalised patients who will be under close
supervision. The
physician should initiate dosage at a low level and increase it
gradually, noting carefully the
NORTITABS
2
clinical response and any evidence of intolerance. 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 adverse reactions, the dosage should be
reduced. The drug should
be discontinued promptly if adverse effects of a serious nature or
allergic manifestations
occur.
Usual adult dose
25 mg 3 or 4 times daily; dosage should begin at a low level and be
increased as required.
Doses above 100 mg per day are not recommended.
Use in children and adolescents (<18 years)
The safety and efficacy of nortriptyline for the treatment of
depression or other psychiatric
disorders in children and adolescents aged less than 18 years has not
been satis