Nortriptyline Chanelle Medical 25 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nortriptyline hydrochloride

Available from:

Chanelle Medical Unlimited Company

ATC code:

N06AA; N06AA10

INN (International Name):

Nortriptyline hydrochloride

Dosage:

25 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Non-selective monoamine reuptake inhibitors; nortriptyline

Authorization status:

Not marketed

Authorization date:

2019-10-24

Patient Information leaflet

ID:
PL
208M / 209M
(IE/H/0587/001-002/DC) VERSION:
06
REVISION DATE:
15/02/2022
Page 7 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORTRIPTYLINE
CHANELLE MEDICAL
10 MG
FILM-COATED TABLETS
NORTRIPTYLINE
CHANELLE MEDICAL
25 MG
FILM-COATED TABLETS
nortriptyline (as hydrochloride)
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.
THE NAME OF THIS MEDICINE IS NORTRIPTYLINE
CHANELLE MEDICAL
10 MG/25 MG
FILM-COATED
TABLETS.
_In the rest of the leaflet Nortriptyline Chanelle Medical 10 mg/25 mg
Film-Coated Tablet is _
_called Nortriptyline film-coated tablets. _
WHAT IS IN THIS LEAFLET
1.
What Nortriptyline film-coated tablets are and what they are used for
2.
What you need to know before you take Nortriptyline film-coated
tablets
3.
How to take Nortriptyline film-coated tablets
4.
Possible side effects
5.
How to store Nortriptyline film-coated tablets
6.
Contents of the pack and other information
1.
WHAT NORTRIPTYLINE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Nortriptyline film-coated tablets contain the active ingredient
nortriptyline hydrochloride,
which is a tricyclic antidepressant. Nortriptyline film-coated tablets
is indicated for the
treatment of major depressive episodes in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRIPTYLINE FILM-COATED
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 FILM-COATED TABLETS:
-
If you are allergic to nortriptyline hydrochloride or any of the other
ingredients

Summary of Product characteristics

Health Products Regulatory Authority
11 January 2023
CRN00D8ZX
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nortriptyline Chanelle Medical 25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg nortriptyline (as
hydrochloride).
Excipient(s) with known effect:
Lactose, 146.05 mg per tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
The 25 mg tablets are white, film-coated, circular, with “C2” on
one side and plain on the other side. They are approximately 8
mm in diameter.
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 25 mg three or four times daily.
Dosage should begin at a low level and be increased as
required. Alternatively, the total daily dose may be given once a day
usually at night. When doses above 100 mg daily are
administered, plasma levels of nortriptyline should be monitored and
maintained in the optimum range of 50 to 150 ng/ml.
Doses above 150 mg 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 50 mg/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 co