Nortriptyline 25mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Nortriptyline hydrochloride

זמין מ:

Ria Generics Ltd

קוד ATC:

N06AA10

INN (שם בינלאומי):

Nortriptyline hydrochloride

כמות:

25mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04030100; GTIN: 5060325270347 5060325270538 5060325270859

עלון מידע

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

מאפייני מוצר

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