Nortriptyline 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nortriptyline hydrochloride

Available from:

Sigma Pharmaceuticals Plc

ATC code:

N06AA10

INN (International Name):

Nortriptyline hydrochloride

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100

Patient Information leaflet

It may still be all right for you to be given Nortriptyline
Tablets. Your doctor will be able to decide what is
suitable for you.
PREGNANCY AND BREAST-FEEDING
Do not take Nortriptyline Tablets if you are breast-
feeding. The safety of nortriptyline for use during
pregnancy has not been established. If you are
pregnant, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
DRIVING AND USING MACHINES
Nortriptyline hydrochloride may affect alertness. Use
caution when driving or operating heavy machinery until
you’re aware of how this drug affects you. If you feel
Nortriptyline Tablets affect your ability to drive or use
machines, tell your doctor immediately.
NORTRIPTYLINE TABLETS CONTAIN LACTOSE
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.
NORTRIPTYLINE 25MG TABLETS CONTAIN SUNSET YELLOW
(E110) Sunset yellow (E110) may cause allergic
reactions.
3.
HOW TO TAKE NORTRIPTYLINE TABLETS
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
DOSAGE
ADULTS:
The usual adult dose is 25mg three or four times daily
or the dose may be given once a day, usually at night.
The dose should begin at a low level, 10mg, 3-4 times
daily, for example and be increased gradually as
required. The maximum dose is 150mg per day.
THE ELDERLY:
The usual dose is 30 to 50mg/day in divided doses.
Treatment may start with 10mg three times a day.
ADOLESCENT PATIENTS:
The usual dose is 30 to 50mg/day in divided doses.
Treatment may start with 10mg three times a day.
Lower dosages are recommended for outpatients than
for patients in hospital who will be under close
supervision.
NORTRIPTYLINE 25MG TABLETS
Package leaflet: information for the user
(nortriptyline 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 nee

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nortriptyline 25mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains nortriptyline hydrochloride equivalent to
nortriptyline 25mg
Excipient with known effect
The tablet also contains lactose monohydrate.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White to off-white round biconvex tablets, debossed ‘NO’ on one
side and
‘25’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nortriptyline is indicated for the treatment of Major Depressive
Episodes.
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 (50mg once daily or 25mg 2-3 times daily). If
necessary, dose could be
gradually increased in 25mg increments no more rapidly than every
other day to be
added to the morning dose. When doses above 100mg daily are
administered,
monitoring of plasma levels of nortriptyline should be considered 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. The maintenance dose should be the same as the optimal
therapeutic dose.
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 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 higher dosing in an elderly pat