Allegron 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nortriptyline hydrochloride

Available from:

Lexon (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

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
Allegron Tablets 25 mg
Nortriptyline 25 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALLEGRON TABLETS 25 MG/ NORTRIPTYLINE 25 MG TABLETS:
Tablets each containing Nortriptyline Hydrochloride EP equivalent to
25mg nortriptyline
base.
Tablets are orange, scored and have a diameter of 8mm.
They are marked ´KING’.
Excipient(s) with known effect
Lactose
Sunset yellow (E110)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Allegron Tablets 25 mg/ Nortriptyline 25 mg Tablets:
Tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nortriptyline is indicated for the relief of symptoms of depression.
It may also be used for the
treatment of some cases of nocturnal enuresis.
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 and be increased as required. Alternatively, the total daily
dose may be given once a
day. When doses above 100mg 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 and
adolescents. 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.
_ _
_The elderly:_ 30 to 50mg/day in divided doses