Nortriptyline 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nortriptyline hydrochloride

Available from:

Viatris UK Healthcare Ltd

ATC code:

N06AA10

INN (International Name):

Nortriptyline hydrochloride

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 5016695009148

Patient Information leaflet

SAME SIZE ARTWORK
LEAFLET SIZE: 120 mm x 670 mm
670 mm
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NORTRIPTYLINE 10 MG FILM-COATED TABLETS
NORTRIPTYLINE 25 MG FILM-COATED TABLETS
NORTRIPTYLINE 50 MG FILM-COATED TABLETS
Nortriptyline hydrochloride
120 mm
FONT TYPE: TIMES NEW ROMAN
FONT SIZE: 9 PT
DATE: 08-03-2019
VERSION: 01 (NL)
Variation No. NL/H/4630/001-003/IA/001
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE
YOU
START
USING
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 ARE THEY USED FOR
Nortriptyline
Tablets
contain
the
active
ingredient
nortriptyline
hydrochloride, which is a tricyclic
antidepressant. Nortriptyline Tablets
are used to treat major depression in
adults.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE NORTRIPTYLINE TABLETS
DO NOT TAKE NORTRIPTYLINE TABLETS
IF:
●
you are
ALLERGIC
(hypersensitive)
to nortriptyline or any of the other
ingredients
of
Nortriptyline
Tablets (see list of ingredients 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, heart
block or coronary artery disease;
●
you are taking, or have stopped
taking within the last 14 days, a
monoamine oxidase inhibitor (e.g.
PHENELZINE,
ISOC

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nortriptyline 50 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50mg tablet contains nortriptyline hydrochloride equivalent to 50
mg
nortriptyline base.
Excipients with known effect:
Each 50 mg tablet contains 60 mg Lactose Monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablet
50mg
White to off white, round shaped, film coated, biconvex tablets,
debossed with
‘Y374’ on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nortriptyline is indicated for the treatment of Major Depressive
Episodes in adults.
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 e.g. 10mg three or four times daily, and be increased
as required.
Alternatively, the total daily dose may be given once a day, usually
given at night.
When doses above 100mg daily are administered, plasma levels of
nortriptyline
should be monitored 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.
THE ELDERLY: 30 to 50mg/day in divided doses. Dosage should begin at a
low level
(10 – 20 mg daily) and be increased as required to the maximum dose
of 50mg. If it is
considered necessary to use hig