SEREPAX oxazepam 30 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxazepam, Quantity: 30 mg

Available from:

Aspen Pharma Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; methylcellulose; polacrilin potassium; lactose monohydrate; sunset yellow FCF

Administration route:

Oral

Units in package:

50 tablets, 25 tablets, 5 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 22 FEB 1995 : Management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety associated with depression is also responsive to SEREPAX 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 reponsive to therapy.

Product summary:

Visual Identification: 30mg - Orange, 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: 4 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1991-07-04

Patient Information leaflet

SEREPAX- Consumer Medicine Information
Page 1 of 4
Serepax

oxazepam
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Serepax. 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 this medicine
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 SEREPAX IS USED
FOR
Serepax is used to treat
•
Anxiety
•
Tremor, confusion or anxiety
associated with alcohol
withdrawal.
Your doctor may have prescribed
this medicine for another reason.
Ask your doctor if you have any
questions about why it has been
prescribed for you.
Serepax contains the active
ingredient oxazepam, a
benzodiazepine. It is thought to
work by acting on the brain
chemicals.
In general, benzodiazepines 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 SEREPAX 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 THIS MEDICINE IF YOU
HAVE:
•
severe and chronic lung disease
or breathing difficulties
•
sleep apnoea
DO NOT TAKE IT IF THE PACKAGING
SHOWS SIGNS OF TAMPERING OR THE
TABLETS DO NOT LOOK QUITE RIGHT.
DO NOT TAKE IT IF THE EXPIRY DATE
(EXP) PRINTED ON THE PACK HAS
PASSED.
SEREPAX IS NOT RECOMMEN

Summary of Product characteristics

SEREPAX- Product Information
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
SEREPAX (OXAZEPAM) TABLET
1.
NAME OF THE MEDICINE
Oxazepam.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SEREPAX tablets are available in two (2) strengths, 15mg and 30mg
tablet. The excipients include
lactose monohydrate.
For the full list of excipients, see section 6.1: List of excipients.
3. PHARMACEUTICAL FORM
SEREPAX oxazeapm 15 mg tablets: White, round tablet, one face convex
embossed “15”, opposite
face flat with Ezi-split breakline.
SEREPAX oxazepam 30 mg tablets: Orange, round tablet, one face convex
embossed “30”, opposite
face flat with Ezi-split breakline.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SEREPAX is indicated for:
1.
Management of anxiety disorders or for the short-term relief of the
symptoms of anxiety.
Anxiety associated with depression is also responsive to SEREPAX
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.
2.
Alcoholics with acute tremulousness, confusional state or anxiety
associated with alcohol
withdrawal are responsive to therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
SEREPAX 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
SEREPAX- Product Information
Page 2 of 10
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.
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 o