Nortrilen 10 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NORTRIPTYLINE HYDROCHLORIDE

Available from:

H. Lundbeck A.S. 9 Ottiliavej, 2500 Valby, Copenhagen, Denmark

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:

Authorised

Authorization date:

2006-09-18

Patient Information leaflet

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 further questions, please ask your doctor or pharmacist.
•
This medicine has been prescribed for you. 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.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NORTRILEN 10 MG FILM-COATED TABLETS
NORTRILEN 25 MG FILM-COATED TABLETS
Nortriptyline (as hydrochloride)
WHAT IS IN THIS LEAFLET:
1.
What Nortrilen is and what it is used for
2.
What you need to know before you take Nortrilen
3.
How to take Nortrilen
4.
Possible side effects
5.
How to store Nortrilen
6.
Contents of the pack and other information
1.
WHAT NORTRILEN IS AND WHAT IT IS USED FOR
Nortrilen belongs to a group of medicines known as tricyclic
antidepressants. These medicines
help to correct certain chemical imbalances in the brain, which are
causing the symptoms of your
illness.
Nortrilen is used for the treatment of depression and when you feel
better, to help prevent these
symptoms recurring.
Your doctor, however, may prescribe Nortrilen for another purpose. Ask
your doctor if you have any
questions about why Nortrilen has been prescribed for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRILEN
DO NOT TAKE NORTRILEN
•
If you are allergic to nortriptyline or any of the other ingredients
of this medicine (listed in section
6).
•
If you recently have had a heart attack (myocardial infarction),
•
If you have disturbances in heart rhythm which are seen on an
electrocardiogram (ECG),
•
At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs).
MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid,
nialamide, tranylcypromine
and moclobemide all of which are also used for the

Summary of Product characteristics

SPC60100101-2
PKH
1/12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Nortrilen 10 mg film-coated tablets
Nortrilen 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nortrilen 10 mg: Each tablet contains 10 mg nortriptyline (as 11.38 mg
nortriptyline
hydrochloride)
Nortrilen 25 mg: Each tablet contains 25 mg nortriptyline (as 28.45 mg
nortriptyline
hydrochloride)
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
10 mg:
Round, slightly biconvex, white, film-coated tablets with a flat top,
on one side
marked “NL”.
25 mg:
Round, slightly biconvex, white, film-coated tablets with a flat top,
on one side
marked “NO”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nortrilen is indicated in adults for treatments of:
-
Major depressions, especially when inhibition, apathy and lack of
initiative are
features of the illness.
-
Depressive states in schizophrenics used in combination with a
neuroleptic to
prevent exacerbation of hallucinations and paranoid delusions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage should be initiated at a low level and increased gradually,
noting carefully the
clinical response and any evidence of intolerability. Dosages
exceeding 150 mg/day
should preferably be restricted to hospitalised patients (up to
200-250 mg).
_Adults _
Initially 50 mg once a day administered in the morning or 25 mg 2-3
times daily
gradually increased, if necessary, by 25 mg every other day up to
100-150 mg once a
day or 50 mg 2-3 times daily (rarely 200 mg daily in hospitalised
patients). The
additional doses are primarily administered in the morning.
The maintenance dose is the same as the optimal therapeutic dose.
SPC60100101-2
PKH
2/12
_Elderly patients _
Patients over 60 years of age: Initially 10 mg 2-3 times daily or 25
mg once a day,
gradually increased, if necessary, every other day up to 150 mg daily.
The additional
doses are primarily administered in the morning.
The maintenance dose is the same as the optimal therapeutic dose.