ALLEGRON nortriptyline (as hydrochloride) 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nortriptyline, Quantity: 25 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; hypromellose; glycerol; maize starch; calcium phosphate; sunset yellow FCF aluminium lake

Administration route:

Oral

Units in package:

50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ALLEGRON is indicated for the treatment of major depression.

Product summary:

Visual Identification: an orange coated tablet upper surface regular convex lower surface regular convex scored; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1995-10-17

Patient Information leaflet

ALLEGRON
®
1
ALLEGRON
®
_nortriptyline hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about this medicine. It
does not contain all the available
information and does not take the
place of talking with your doctor.
All medicines have risks and
benefits.
Your doctor has more information
about this medicine than is contained
in this leaflet. Also, your doctor has
had the benefit of taking a full and
detailed history from you and is in
the best position to make an expert
judgement to meet your individual
needs.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE. YOU MAY NEED TO READ IT
AGAIN.
WHAT ALLEGRON IS
USED FOR
ALLEGRON is used to treat
depression.
There are many different types of
medicines used to treat depression.
ALLEGRON belongs to a group of
medicines called tricyclic
antidepressants (TCAs). TCAs are
thought to work by their action on
brain chemicals called amines which
are involved in controlling mood.
Your doctor may have prescribed
ALLEGRON for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ALLEGRON
HAS BEEN PRESCRIBED FOR YOU.
BEFORE TAKING
ALLEGRON
TELL YOUR DOCTOR IF YOU HAVE ANY OF
THE FOLLOWING CONDITIONS OR IF YOU
HAVE EVER EXPERIENCED ANY OF THESE
CONDITIONS.
_WHEN YOU MUST NOT TAKE _
_ALLEGRON _
DO NOT TAKE ALLEGRON
•
IF YOU HAVE HAD AN ALLERGIC
REACTION TO ANY MEDICINES
CONTAINING NORTRIPTYLINE OR TO
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET (SEE
'PRODUCT DESCRIPTION').
Signs of an allergic reaction may
include rash, itching of the skin,
shortness of breath and swelling
of the tongue or face.
•
IF YOU ARE TAKING ANOTHER
MEDICINE FOR DEPRESSION CALLED A
MONOAMINE OXIDASE INHIBITOR
(MAOI), OR HAVE BEEN TAKING A
MAOI WITHIN THE LAST 14 DAYS.
CHECK WITH YOUR DOCTOR OR
PHARMACIST IF YOU ARE UNSURE AS
TO WHETHER OR NOT YOU ARE
TAKING A MAOI.
•
IF YOU ARE TAKING ANOTHER
MEDICINE FOR S

Summary of Product characteristics

1
AUSTRALIAN PI – ALLEGRON (NORTRIPTYLINE HYDROCHLORIDE)
TABLETS
1
NAME OF THE MEDICINE
Nortriptyline hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALLEGRON 10 mg and 25 mg tablets contain 10 mg and 25 mg nortriptyline
(present as the
hydrochloride) as the active ingredient, respectively.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ALLEGRON 10 mg tablets are plain, round, white tablets.
ALLEGRON 25 mg tablets are orange round tablets with a scoreline on
one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ALLEGRON is indicated for the treatment of major depression.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ALLEGRON is not recommended for children.
ALLEGRON is administered orally in the form of tablets. Lower than
usual dosages are recommended
for elderly patients and adolescents. The dosage for outpatients
should also be lower than that 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 adverse reactions, the dosage should be
reduced. The drug should be
discontinued promptly if adverse effects of a serious nature or
allergic manifestations occur.
2
Usual Adult Dose - 25 mg 3 or 4 times daily; dosage should begin at a
low level and be increased as
required. Doses above 100 mg per day are not recommended.
Use in children and adolescents (<18 years) – The safety and
efficacy of ALLEGRON for the treatment
of depression or other psychiatric disorders in children and
adolescents aged less than 18 years has
not been satisfactorily established. ALLEGRON should not be used in
this age group for the
treatment of depression or other psychiatric disorders (see SECTION
4.4 SPECIAL WARNIN