Nortriptyline 10mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Nortriptyline hydrochloride

Disponibil de la:

Macleods Pharma UK Ltd

Codul ATC:

N06AA10

INN (nume internaţional):

Nortriptyline hydrochloride

Dozare:

10mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04030100; GTIN: 18901463139568

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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

Caracteristicilor produsului

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