APO-DIAZEPAM diazepam 2mg tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

diazepam, Quantity: 2 mg

Disponible des:

Sun Pharma ANZ Pty Ltd

Designació comuna internacional (DCI):

Diazepam

formulario farmacéutico:

Tablet, uncoated

Composición:

Excipient Ingredients: magnesium stearate; purified talc; maize starch; lactose monohydrate; colloidal anhydrous silica

Vía de administración:

Oral

Unidades en paquete:

50 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Diazepam is indicated for the management of anxiety disorders or for the short term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is useful adjunct for the relief of reflux muscle spasm due to local trauma (injury, inflammation) to muscles, bones and joints. It can also be used to combat spasticity due to upper motor neuron lesions such as cerebral palsy and paraplegia, as well as in athetosis and stiff-man syndrome.

Resumen del producto:

Visual Identification: White to off-white, round biconvex, uncoated tablets debossed with "2" on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

2007-11-22

Informació per a l'usuari

APO-DIAZEPAM TABLETS
1
APO- DIAZEPAM TABLETS
_Contains the active ingredient diazepam (dye-AZ-e-pam) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking your medicine.
This leaflet answers some common
questions about APO- Diazepam. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using 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.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Diazepam. It contains the active
ingredient diazepam.
This medicine is used to:
•
treat anxiety disorders. Anxiety
or tension associated with the
normal stress of everyday life
usually does not require
treatment with medicines.
•
stop muscle spasms and relax
muscles
•
treat trembling, confusional
states or anxiety associated with
alcohol withdrawal.
•
panic attacks.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
This medicine belongs to a group of
medicines called benzodiazepines.
It is thought to work by acting on
ch

Fitxa tècnica

1
AUSTRALIAN PRODUCT INFORMATION
APO-DIAZEPAM (DIAZEPAM) TABLETS
1
NAME OF THE MEDICINE
Diazepam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg or 5 mg diazepam, as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
2 MG TABLETS
White to off-white round biconvex uncoated tablets debossed with 2 on
one side and plain on
the other side.
5 MG TABLETS
White to off-white round flat bevelled edged uncoated tablets debossed
with 5 and a scoreline
on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
The management of anxiety disorders or for the short term relief of
the symptoms of
anxiety. Anxiety or tension associated with the stress of everyday
life usually does not
require treatment with an anxiolytic.
•
In acute alcohol withdrawal, diazepam may be useful in the symptomatic
relief of acute
agitation, tremor, impending or acute delirium tremens and
hallucinosis.
•
Diazepam is a useful adjunct for the relief of reflex muscle spasm due
to local trauma
(injury, inflammation) to muscles, bones and joints. It can also be
used to combat
spasticity due to upper motor neuron lesions such as cerebral palsy
and paraplegia, as
well as in athetosis and stiff-man syndrome.
4.2
DOSE AND METHOD OF ADMINISTRATION
Diazepam tablets are intended for oral administration.
DOSAGE
For maximal beneficial effect, the dosage should be carefully
individualised. Dosage may need
to be reduced in patients with hepatic or renal disease as the
elimination half-life may be
prolonged in this sub-group.
_Usual Adult Dosage: _
5–40 mg daily.
2
_Average Dosage for Ambulatory Patients:_
2 mg three times daily or 5 mg in the evening and
2 mg once or twice during the day.
_Elderly or Debilitated Patients:_
2 mg twice daily or half the usual adult dose.
_Children – 6 months to 3 years:_
1–6 mg daily.
_ _
_Children – 4 to 14 years: _
4–12 mg daily or calculated from 0.1–0