Nortriptyline 50mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NORTRIPTYLINE HYDROCHLORIDE

Available from:

Pinewood Laboratories Ltd BALLYMACARBRY, CLONMEL, CO. TIPPERARY, Ireland

ATC code:

N06AA10

INN (International Name):

NORTRIPTYLINE HYDROCHLORIDE 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

NORTRIPTYLINE HYDROCHLORIDE 50 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-11-11

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NORTRIPTYLINE 10MG FILM-COATED TABLETS
NORTRIPTYLINE 25MG FILM-COATED TABLETS
NORTRIPTYLINE 50MG FILM-COATED TABLETS
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 is and what it is used for
2.
What you need to know before you take Nortriptyline
3.
How to take Nortriptyline
4.
Possible side effects
5.
How to store Nortriptyline
6.
Contents of the pack and other information
1.
WHAT NORTRIPTYLINE IS AND WHAT IT IS USED FOR
Nortriptyline contains the active ingredient nortriptyline
hydrochloride, which is a tricyclic
antidepressant. Nortriptyline is used to treat major depression in
adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRIPTYLINE
_ _
DO NOT TAKE NORTRIPTYLINE IF:
•
you are
ALLERGIC
(hypersensitive) to nortriptyline or any of the other ingredients of
Nortriptyline
(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, ISOCARBOXAZID OR TRANYLCYPROMINE
). If you are taking
MOCLOBEMIDE
you
must stop this at least 24 hours before starting nortriptyline
•
you have to stop treatment with Nortriptyline and wait for 14 days
before you start treatment
with a monoamine oxidase inhibitor
•
have ever had pr

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Nortriptyline 50mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains nortriptyline hydrochloride
equivalent to 50 mg nortriptyline.
Excipients with known effect
Each tablet contains 243.5 mg of lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
White to off white, round, biconvex film coated tablet debossed with
‘NT 50’ on one side and
breakline 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.
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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.
ELDERLY
30 to 50 mg/day in divided doses. Dosage should begin at a low level
(10 – 20