Nortriptyline NRIM

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

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Active ingredient:

Nortriptyline hydrochloride 28.5mg equivalent to nortriptyline base 25 mg

Available from:

Boucher & Muir (New Zealand) Limited t/a BNM Group

INN (International Name):

Nortriptyline hydrochloride 28.5 mg (= nortriptyline base 25 mg)

Dosage:

25 mg

Pharmaceutical form:

Tablet

Composition:

Active: Nortriptyline hydrochloride 28.5mg equivalent to nortriptyline base 25 mg Excipient: Lactose monohydrate Magnesium stearate Maize starch

Units in package:

Blister pack, Alu-Alu/PVC, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Centaur Pharmaceuticals Private Limited

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.

Product summary:

Package - Contents - Shelf Life: Blister pack, Alu-Alu/PVC - 100 tablets - 24 months from date of manufacture stored at or below 25°C. Store in original container.

Authorization date:

2012-02-14

Patient Information leaflet

                                1 
 
NORTRIPTYLINE NRIM
 
 
 
09052013
 
Consumer Medicine Information 
NORTRIPTYLINE NRIM 
 
_NORTRIPTYLINE (AS HYDROCHLORIDE) _ 
10 mg & 25 mg Tablets 
 
 
WHAT IS IN THIS LEAFLET 
 
Please read this leaflet carefully before you
start taking Nortriptyline NRIM. 
 
This leaflet answers some common questions about Nortriptyline
NRIM. It does not 
contain all the available information. The
most up-to-date Consumer Medicine 
Information can be downloaded from www.medsafe.govt.nz. 
 
Reading this leaflet 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 
Nortriptyline NRIM against the benefits this medicine
is expected to 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 want to read it again. 
 
 
WHAT NORTRIPTYLINE NRIM IS USED FOR 
 
Nortriptyline NRIM  contains  nortriptyline
hydrochloride. It belongs to a group of 
medicines known as tricyclic antidepressants (TCAs).  
 
Nortriptyline NRIM is used to treat depression. Depression
is thought to be caused by a 
chemical imbalance in parts of the
brain. This affects your whole body and can 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.  
 
Nortriptyline works by correcting this chemical imbalance and may help relieve the 
symptoms of depression.  
 
Nortriptyline is also used as an aid to smoking cessation and
may help you stop 
smoking.  
 
Your doctor may have
prescribed this medicine for another re
                                
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Summary of Product characteristics

                                1 
  NORTRIPTYLINE NRIM 
 
 
09052013 
NEW ZEALAND DATA SHEET  
 
NORTRIPTYLINE NRIM 
 
_NORTRIPTYLINE (AS HYDROCHLORIDE) 10 MG AND 25 MG TABLETS  _
_ _
This product may not be interchangeable with similar products on
the New Zealand market
 
PRESENTATIONS 
Nortriptyline NRIM  10  mg tablets are white to off-white
round biconvex tablets, debossed 
‘NM’ on one side and ‘10’ on the other side.  
 
Nortriptyline NRIM  25  mg tablets are white to off-white
round biconvex tablets, debossed 
‘NM’ on one side and ‘25’ on the other side.  
 
Do not halve tablet.  Dose equivalence when the tablet is divided
has not been established. 
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.  
DOSAGE AND 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
                                
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