Nortriptyline 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nortriptyline hydrochloride

Available from:

Ria Generics Ltd

ATC code:

N06AA10

INN (International Name):

Nortriptyline hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 5060325270330 5060325270514 5060325270842

Patient Information leaflet

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GTIN 13:
[e-mail]
Version 3
05.11.2019
T. Hull
11.11.2019
12.11.2019
T. Hull
160x270
7pt
Centaur
11.11.2019
12.11.2019
n/a
NORTRIPTYLINE ALL STRENGTHS TABLETS PIL - UK
Black
BBBA6898
2
Profile
•
Antidepressants may not make you feel better for the first two
weeks or more of treatment, so keep taking Nortriptyline Tablets
until your doctor tells you to stop. Do not stop these tablets
without discussing it with your doctor first.
•
Do not suddenly stop taking the tablets. Your doctor will tell you
how to cut them down gradually.
IF YOU TAKE MORE NORTRIPTYLINE TABLETS THAN YOU SHOULD
Do not take more tablets than your doctor tells you to. If you ever
take too many, or if a child has taken any nortriptyline, go to the
nearest hospital casualty department or tell your doctor at once. An
overdose can be very dangerous.
IF YOU FORGET TO TAKE NORTRIPTYLINE TABLETS
If you forget to take a dose, take it as soon as you remember. If it
is
almost time for your next dose do not take a double dose to make
up for a forgotten dose, just carry on as before. If you have missed
several doses, discuss this with your doctor.
IF YOU STOP TAKING NORTRIPTYLINE TABLETS
If you stop taking Nortriptyline Tablets abruptly after prolonged
therapy, you may have withdrawal symptoms, including not being
able to sleep, headache, nausea, irritability and sweating.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them. IF ANY OF THE SIDE EFFECTS GETS
SERIOUS, OR IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS
LEAFLET, PL

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nortriptyline 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nortriptyline 10 mg Tablets:
Each Tablets contains Nortriptyline Hydrochloride equivalent to 10mg
nortriptyline
Excipient(s) with known effect
Each tablet contains 43.06 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Nortriptyline 10 mg Tablets:
Tablet.
Biconvex white round tablets, marked 10 on one side (Diameter:
5.5±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 patient