Nortriptyline 10mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Nortriptyline hydrochloride

Dostupné z:

Teva UK Ltd

ATC kód:

N06AA10

INN (Medzinárodný Name):

Nortriptyline hydrochloride

Dávkovanie:

10mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 04030100; GTIN: 5017007611028

Príbalový leták

Nortriptyline 10mg & 25mg 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 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 belongs to a class of medicines called tricyclic
antidepressants. Nortriptyline tablets are used to treat major
depression.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRIPTYLINE
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 TABLETS IF YOU:
•
are allergic to nortriptyline or any of the other ingredients of this
medicine (listed in section 6)
•
have recently had a heart attack or if you have other heart
problems such as palpitations or irregular heartbeats
•
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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Nortriptyline Tablets
if you:
•
are having an operation under general anaesthetic, discuss this
with your GP. You may need to stop taking Nortriptyline Tablets
several days before the opera

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nortriptyline 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains nortriptyline hydrochloride equivalent to
nortriptyline 10mg
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
‘10’ 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