Nortriptyline 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nortriptyline hydrochloride

Available from:

A A H Pharmaceuticals Ltd

ATC code:

N06AA10

INN (International Name):

Nortriptyline hydrochloride

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 5025903009474

Patient Information leaflet

PATIENT INFORMATION LEAFLET
NORTRIPTYLINE 25 MG TABLETS
(nortriptyline hydrochloride)
This product is available in other strengths.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

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. Do not pass it on
to others. It may harm them, even if their symptoms 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.
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 relieve the symptoms of depression.
Nortriptyline tablets may also be used for the treatment of bed-
wetting in children 6 years and older.
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;

If you have severe liver disease;

If you suffer from mania (abnormally raised mood);

If you are breast-feeding;

If the child is under 6 years of age;

If you are taking, or have taken in the last two weeks,
monoamine oxidase inhibitors (another type of
antidepressant);

If you are taking adrenaline-like drugs including ephedrine,
isoprenaline, noradrenaline, phenylep

Summary of Product characteristics

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
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
‘25’ 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