Nortriptyline 10 mg Film-coated Tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Nortriptyline

Beschikbaar vanaf:

Pharmafile Limited

ATC-code:

N06AA10

INN (Algemene Internationale Benaming):

Nortriptyline

Dosering:

10 milligram(s)

farmaceutische vorm:

Film-coated tablet

Therapeutisch gebied:

nortriptyline

Autorisatie-status:

Not marketed

Autorisatie datum:

2016-03-11

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORTRIPTYLINE 10 MG FILM-COATED TABLETS
NORTRIPTYLINE 25 MG FILM-COATED TABLETS
nortriptyline
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 more
information)
-
you are ag

Productkenmerken

Health Products Regulatory Authority
20 March 2024
CRN00F50Q
Page 1 of 10
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