Nortriptyline 10 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NORTRIPTYLINE HYDROCHLORIDE

Available from:

Alissa Healthcare Research Limited

ATC code:

N06AA; N06AA10

INN (International Name):

NORTRIPTYLINE HYDROCHLORIDE

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Non-selective monoamine reuptake inhibitors; nortriptyline

Authorization status:

Not marketed

Authorization date:

2016-03-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NORTRIPTYLINE 10 MG FILM-COATED TABLETS
NORTRIPTYLINE 25 MG FILM-COATED TABLETS
NORTRIPTYLINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
− Keep this leaflet. You may need to read it
again.
− If you have any further questions, ask your
doctor or pharmacist.
− This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
− If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Nortriptyline Tablets are and what
they are used for
2. What you need to know before you take
Nortriptyline Tablets
3. How to take Nortriptyline Tablets
4. Possible side effects
5. How to store Nortriptyline Tablets
6. Contents of the pack and other information
1. WHAT NORTRIPTYLINE TABLETS
ARE AND WHAT THEY ARE USED FOR
Nortriptyline tablets contain the active
ingredient nortriptyline hydrochloride, which
is known as a tricyclic antidepressant.
Nortriptyline tablets relieve the symptoms of
depression.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE NORTRIPTYLINE TABLETS
You should not take Nortriptyline Tablets
until you are sure it is safe for you to do so.
Nortriptyline Tablets are for adults only.
DO NOT TAKE NORTRIPTYLINE TABLETS IF:
• you are allergic to nortriptyline or any
of the other ingredients of this medicine
(listed in section 6). An allergic reaction
may include rash, itching, difficulty
breathing or swelling of the face, lips,
throat or tongue
• you have had a recent heart attack or
heartbeat disorder
• you are taking, or have taken in the last
two weeks, monoamine oxidase inhibitors
(another type of antidepressant)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Nortriptyline Tablets, if:
• you feel suicidal or aggressive (see the
section below for m

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nortriptyline 10 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains nortriptyline hydrochloride equivalent to 10 mg
nortriptyline
Excipient(s) with known effect: Lactose monohydrate
Each tablet contains 26.80 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
The 10 mg tablets are white, round shaped, film-coated tablets
debossed “10” on one side with diameter of 5.55 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nortriptyline is indicated for the relief of symptoms of depression.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual adult dose is 25mg three or four times daily. Dosage should
begin at a low level (50mg once daily or 25mg
2-3 times daily). If necessary, dose could be gradually increased in
25mg increments no more than rapidly than every
other day to be added to the morning dose.
When doses above 100mg daily are administered,
monitoring of plasma
levels of nortriptyline should be considered and maintained in the
optimum range of 50 to 150ng/ml.
Doses above
150mg per day are not recommended.
Lower than usual dosages are recommended for elderly patients. Lower
dosages are also recommended for outpatients
than 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 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 side-effects,
the dosage should be reduced.
The drug should be discontinued promptly if
adverse effects of a serious nature or allergic manifestations occur.
_Plasma levels_
The dosage should be started at a low level
and gradually increased,
with the clinical
response and any evidence of
intolerance is closely monitored.
The optima