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 25 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nortriptyline 25 mg Tablets:
Each
Tablets
contains
Nortriptyline
Hydrochloride
equivalent
to
25
mg
nortriptyline.
Excipient(s) with known effect
Each tablet contains 107.65 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Nortriptyline 25 mg Tablets:
Tablet.
Biconvex
white
round
tablets,
marked
25
on
one
side
(Diameter:
8.0±0.20mm).
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 (10 mg three or four times daily) and be increased as
required.
Alternatively, the total daily dose may be given once a day, usually
given 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 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 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.
_Elderly patients: _
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