Nortriptyline 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nortriptyline hydrochloride

Available from:

Macleods Pharma UK 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: 18901463139575

Patient Information leaflet

ALLEGRON 25MG TABLETS
(nortriptyline hydrochloride)
PATIENT INFORMATION LEAFLET
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.
IN THIS LEAFLET:
What Allegron tablets are and what they are used for
What you need to know before you take Allegron tablets
How to take Allegron tablets
Possible side effects
How to store Allegron tablets
Contents of the pack and other information
WHAT ALLEGRON TABLETS ARE AND WHAT THEY ARE USED FOR
Allegron tablets contain the active ingredient nortriptyline
hydrochloride,
which is a tricyclic antidepressant. Allegron tablets relieve the
symptoms of
depression.
Allegron tablets may also be used for the treatment of bed-wetting in
children 6 years and older.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLEGRON
TABLETS
DO NOT TAKE ALLEGRON 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, phenylephrine and phenylpropanolamine. These drugs are
often contained in cough and cold remedie

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