ALPRAX 2 alprazolam 2mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alprazolam, Quantity: 2 mg

Available from:

Aspen Pharma Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sodium benzoate; docusate sodium; maize starch; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate; povidone; microcrystalline cellulose; lactose

Administration route:

Oral

Units in package:

30 tablets, 10 tablets, 50 tablets

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Anxiety: the short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression, and Panic Disorder: the treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks.

Product summary:

Visual Identification: A white rectangular tablet, marked with breakline "A" partial breakline "2" breakline on one side and triple scored on the other side; Container Type: Bottle; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2002-07-30

Patient Information leaflet

ALPRAX- Consumer Medicine Information
Page 1 of 4
Alprax
alprazolam
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALPRAX.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking ALPRAX against
the benefits they expect it will have
for you.
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to read
it again.
WHAT ALPRAX IS USED
FOR
ALPRAX is used to treat:
•
anxiety
•
panic attacks.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
this medicine for another reason.
ALPRAX belongs to a group of
medicines called benzodiazepines.
These medicines are thought to
work by their action on brain
chemicals.
In general, benzodiazepines such as
ALPRAX should be taken for short
periods only (for example 2 to 4
weeks). Continuous long term use
is not recommended unless advised
by your doctor. The use of
benzodiazepines may lead to
dependence on the medicine.
ALPRAX is not recommended for
use in children, as there have been
no studies of its effects in children.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE IT
When you must not take it
DO NOT TAKE ALPRAX IF YOU ARE
ALLERGIC TO:
•
medicines containing alprazolam
•
any other benzodiazepine
medicine
•
any of the ingredients listed at
the end of this leaflet.
DO NOT TAKE ALPRAX IF YOU
HAVE:
•
severe and chronic lung disease
•
severe muscle weakness known
as myasthenia gravis.
DO NOT TAKE IT IF THE EXPIRY DATE
(EXP.) PRINTED ON THE PACK OR
BOTTLE HAS PASSED.
DO NOT TAKE IT IF THE PACKAGING
SHOWS SIGNS OF TAMPERING OR
THE TABLETS DO NOT LOOK QUITE
RIGHT.
Before you start to take it
TELL YOUR DOCTOR IF YOU ARE
ALLERGIC TO ANY OTHER MEDICINES,
FOODS, DYES OR PRESERVATIVES.
TELL Y

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ALPRAX (ALPRAZOLAM) TABLETS
1
NAME OF THE MEDICINE
Alprazolam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alprax tablets come in four strengths and contain 0.25 mg, 0.5 mg 1.0
mg or 2.0 mg of alprazolam.
The tablets also contain the following excipients: lactose,
microcrystalline cellulose, maize starch,
sodium benzoate, docusate sodium, povidone, colloidal anhydrous
silica, sodium starch glycollate
and magnesium stearate. Alprax 0.5 tablets also contain pigment blend
PB-20026 purple and Alprax
1 tablets also contain indigo carmine. The tablets are gluten free.
3
PHARMACEUTICAL FORM
Alprax 0.25 (0.25 mg tablet): Oval, white convex tablet marked with
“A

25” on one side and plain on
the other.
Alprax 0.5 (0.5 mg tablet): Oval, pink convex tablet marked with “A

5” on one side and plain on the
other.
Alprax 1 (1 mg tablet):
Oval, light blue convex tablet marked with “A

1” on one side and plain on
the other.
Alprax 2 (2 mg tablet):
Rectangular, white tablet embossed with “

A

2

” on one side and three
scorelines on the other.
Note: Not all strengths or presentations may be marketed.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Alprazolam is indicated for:
Anxiety: the short-term symptomatic treatment of anxiety including
treatment of anxious patients
with some symptoms of depression.
Panic Disorder: the treatment of panic disorder with or without some
phobic avoidance, and for
blocking or attenuation of panic attacks and phobias in patients who
have agoraphobia with panic
attacks.
2
Panic Disorder: The diagnostic criteria for Panic Disorder in
DSM-III-R are:
(i)
The panic attacks (discrete periods of intense fear or discomfort) at
least initially, are
unexpected. Later in the course of this disturbance certain
situations, e.g. driving a car or
being in a crowded place, may become associated with having a panic
attack. These panic
attacks are not triggered by situations in which the person is the
focus of others attention
(as in social phobia