Nortriptyline 10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NORTRIPTYLINE HYDROCHLORIDE

Available from:

Macleods Pharma España, S.L.U. Avenida Diagonal, 468, 6°, puerta A, 08006, Barcelona, Spain

ATC code:

N06AA10

INN (International Name):

NORTRIPTYLINE HYDROCHLORIDE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

NORTRIPTYLINE HYDROCHLORIDE 10 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2019-02-18

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
NORTRIPTYLINE 10 MG & 25MG FILM-COATED TABLETS
Nortriptyline
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 THEY ARE USED FOR
Nortriptyline film-coated 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 this
medicine
(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;
-
if you have had a recent heart attack or heartbeat disorder , heart
block or coronary
artery disease;
-
if you are taking, or have stopped taking within the last 14 days, a
monoamine oxidase
inhibitor (e.g.
PHENELZINE,
ISOCARBOXAZID
OR
TRANYLCYPROMINE
). If you are taking
MOCLOBEMIDE
you must stop this at least 24 hours before starting nortriptyline;
-if you have to stop treatment with Nortriptyline Tablets and wait for
14 days before you
start treatment with a monoamin

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nortriptyline 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg nortriptyline (as Nortriptyline
hydrochloride).
Excipient with known effect
Each film-coated tablet contains 43.652 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet.
White to off coloured, film coated, round, biconvex tablets with
debossing “U17” on one
side and plain surface 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
i