APO-OXAZEPAM oxazepam 30mg tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxazepam, Quantity: 30 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Oxazepam

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; methylcellulose; polacrilin potassium; lactose monohydrate

Administration route:

Oral

Units in package:

25 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety associated with depression is also responsive to APO-OXAZEPAM therapy. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The physician should periodically reassess the usefulness of the drug for the individual patient. Alcoholics with acute termulousness, confusional state or anxiety associated with alcohol withdrawal are responsive to therapy.

Product summary:

Visual Identification: White, round tablet, one face convex embossed "30", opposite face flat with Ezi-split breakline.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-05-12

Patient Information leaflet

APO-OXAZEPAM- Consumer Medicine Information
Page 1 of 4
Apo-Oxazepam
oxazepam
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Apo-Oxazepam. 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 risks and
benefits. Your doctor has weighed
the risks of you taking Apo-
Oxazepam against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT APO-OXAZEPAM
IS USED FOR
Apo-Oxazepam is used to treat
•
Anxiety
•
Tremor, confusion or anxiety
associated with alcohol
withdrawal.
Your doctor may have prescribed
Apo-Oxazepam for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY APO-
OXAZEPAM HAS BEEN PRESCRIBED
FOR YOU.
Apo-Oxazepam contains the active
ingredient oxazepam, as
benzodiazepine. It is thought to
work by acting on the brain
chemicals.
In general, benzodiazepines such
as Apo-Oxazepam 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.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE IT
When you must not take it
DO NOT TAKE APO-OXAZEPAM IF
YOU ARE ALLERGIC TO:
•
Oxazepam or any other
benzodiazepine medicines
•
Any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include skin
rash, itching or hives; swelling of
the face, lips or tongue which may
cause difficulty in swallowing or
breathing; wheezing or shortness
of breath.
DO NOT TAKE APO-OXAZEPAM IF
YOU HAVE:
•
severe and chronic lung
disease or breathing difficulties
•
sleep apnoea
DO NOT TAKE APO-OXAZEPAM IF
THE PACKAGING SHOWS SIGNS OF
TAMPERING OR THE TABLETS DO NOT
LOOK QUITE RIGHT.
DO NOT TAKE IT IF THE E

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-OXAZEPAM (OXAZEPAM) TABLET
1
NAME OF THE MEDICINE
Oxazepam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-OXAZEPAM tablets contain oxazepam 30 mg.
Excipients with known effect:
lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
APO-OXAZEPAM 30 mg tablets- white, round tablet, one face convex
embossed “30”, opposite face
flat with Ezi-split breakline;
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
APO-OXAZEPAM is indicated for:
•
Management of anxiety disorders or for the short-term relief of the
symptoms of anxiety.
Anxiety associated with depression is also responsive to APO-OXAZEPAM
therapy. Anxiety
or tension associated with the stress of everyday life usually does
not require treatment
with an anxiolytic. The physician should periodically reassess the
usefulness of the drug for
the individual patient.
•
Alcoholics with acute tremulousness, confusional state or anxiety
associated with alcohol
withdrawal are responsive to therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
APO-OXAZEPAM is administered orally. For optimal results, dose,
frequency of administration, and
duration of therapy should be individualised according to patient
response.
For mild to moderate anxiety, with associated tension, irritability,
agitation or related symptoms of
functional origin or secondary to organic disease, the usual dose is
7.5-15 mg, 3 or 4 times daily.
For severe anxiety syndromes, agitation or anxiety associated with
depression, the usual dose is 15-
30 mg, 3 or 4 times daily.
2
For older patients with anxiety, tension, irritability and agitation,
the initial dose is 7.5 mg, 2-3 times
daily. If necessary, increase cautiously to 15 mg, 3 or 4 times daily.
For alcoholics with tremulousness or anxiety on withdrawal, the usual
dose is 15-30 mg, 3 or 4 times
daily. APO-OXAZEPAM should not be administered to alcoholics with
acute inebriation.
Paediatric Use - APO-OXAZEPAM is not indicated in children under 16
years of age.