Nortriptyline 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nortriptyline hydrochloride

Available from:

King 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: 5033003002288

Patient Information leaflet

_S1243 LEAFLET Allegron 20211012 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALLEGRON
® 25MG TABLETS
(nortriptyline hydrochloride)
Your medicine is known as Allegron 25mg Tablets but will be
referred to as Allegron tablets throughout the following leaflet.
Information for other strengths of Allegron tablets (Allegron 10mg
Tablets) also may be present in this 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.
WHAT IS IN THIS LEAFLET
1. What Allegron tablets are and what they are used for
2. What you need to know before you take Allegron tablets
3. How to take Allegron tablets
4. Possible side effects
5. How to store Allegron tablets
6. Contents of the pack and other information
1. 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.
2. 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,
monoa

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.
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.
_ _
_Adolescent patients:_ 30 to 50mg/day in divided doses.
_Plasma level