Xanax
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-04-2024
Summary of Product characteristics
(SPC)
24-04-2024
Active ingredient:
Alprazolam
Available from:
Pfizer Australia Pty Ltd
Class:
Medicine Registered
Patient Information leaflet
XANAX
®
TABLETS
_Alprazolam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xanax. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Xanax against
the benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT XANAX IS USED
FOR
Xanax is used to treat anxiety.
Anxiety or tension associated with
the normal stress of everyday life
usually does not require treatment
with medicines.
Xanax is also used to treat panic
attacks.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed
Xanax for another purpose.
Xanax belongs to a group of
medicines called benzodiazepines.
They are thought to work by their
action on brain chemicals.
IF YOU TAKE XANAX FOR TOO LONG, IT
MAY BECOME HABIT-FORMING.
BENZODIAZEPINES MAY LEAD TO
PHYSICAL OR PSYCHOLOGICAL
DEPENDENCE. IF YOU HAVE ANY
CONCERNS, YOU SHOULD DISCUSS THIS
WITH YOUR DOCTOR.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE XANAX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE XANAX IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
alprazolam
•
any of the ingredients listed at the
end of this leaflet
•
any other medicine in the
benzodiazepine group
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE XANAX IF YOU HAVE OR
HAVE HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
myasthenia gravis which causes
severe muscle weakness
•
severe and chronic lung disease.
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT.
It may affec
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Summary of Product characteristics
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Supersedes: pfpxanat10711
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PRODUCT INFORMATION
XANAX
ALPRAZOLAM
NAME OF THE MEDICINE
Xanax
®
alprazolam 250 microgram, 500 microgram, 1 mg and
2 mg tablets
DESCRIPTION
Xanax tablets contain alprazolam, an anti-anxiety, benzodiazepine derivative chemically and
pharmacologically related to other drugs of this class.
The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H-s-triazolo (4,3-a) (1,4)
benzodiazepine. CAS No: 28981-97-7.
Alprazolam is a white crystalline powder, soluble in methanol or ethanol but with no appreciable
solubility in water. It has a molecular weight of 308.76 and the
following structural formula:
Each Xanax tablet, to be given orally, contains 0.25, 0.5, 1,
or 2 mg alprazolam.
PHARMACOLOGY
Pharmacological properties of alprazolam in animals appear similar to those of other
benzodiazepines, that is, it produces significant anxiolytic, muscle relaxant, sleep promoting and
anti-convulsant effects in appropriate animal models.
The exact site and mechanism of action of benzodiazepines is unknown. It is known that they act
within the central nervous system as selective depressants.
Clinical studies in healthy volunteers at doses up to 4 mg/day and in patients with panic disorder at
doses up to 10 mg/day, produce only effects which can be considered to be extensions of its
pharmacological activities. No clinically significant effects on the cardiovascular or respiratory
systems were observed. Alprazolam doses up to 10 mg/day do not clinically affect laboratory
parameters or vital signs.
Sleep laboratory studies in man showed that
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