Nortriptyline 25mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Nortriptyline hydrochloride

متاح من:

DE Pharmaceuticals

ATC رمز:

N06AA10

INN (الاسم الدولي):

Nortriptyline hydrochloride

جرعة:

25mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 04030100

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NORTRIPTYLINE10MG AND 25MG TABLETS
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 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 tablets contain the active ingredient Nortriptyline
hydrochloride, which is a
tricyclic antidepressant. Nortriptyline tablets are indicated for the
treatment of major
depressive disorders in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRIPTYLINE TABLETS
DO NOT TAKE NORTRIPTYLINE TABLETS:
–
If you are
ALLERGIC
to Nortriptyline hydrochloride or any of the other ingredients of
this medicine (listed in section 6). An allergic reaction may include
rash, itching,
difficulty breathing or swelling of the face, lips, throat or tongue
If 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 inhibit

خصائص المنتج

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
Each tablet contains 107.65mg of 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 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 (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