ALEPAM 15 oxazepam 15mg tablet bottle

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

oxazepam, Quantity: 15 mg

Disponível em:

Alphapharm Pty Ltd

Forma farmacêutica:

Tablet, uncoated

Composição:

Excipient Ingredients: magnesium stearate; erythrosine aluminium lake; maize starch; quinoline yellow aluminium lake; lactose monohydrate

Via de administração:

Oral

Unidades em pacote:

1000 tablets, 25 tablets, 50 tablets, 90 tablets

Classe:

Medicine Registered

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

INDICATIONS AS AT 25 JANUARY 2005 : Alepam 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 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.

Resumo do produto:

Visual Identification: 8 mm pale yellow flat bevelled edged tablet marked OM/15 on one side, G on reverse; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status de autorização:

Registered

Data de autorização:

1991-09-20

Folheto informativo - Bula

ALEPAM
_contains the active ingredient oxazepam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALEPAM
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 ALEPAM against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ALEPAM IS USED
FOR
ALEPAM is used for:
•
anxiety, such as the anxiety
associated with depression
•
tremor, anxiety and confusion
associated with alcohol
withdrawal.
ALEPAM contains the active
ingredient oxazepam, which belongs
to a group of medicines called
benzodiazepines. These medicines
are thought to work by their action
on brain chemicals.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ALEPAM HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
ALEPAM for another reason.
In general, benzodiazepines such as
ALEPAM 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.
ALEPAM is not recommended for
use in children under 16 years of age,
as its safety and effectiveness have
not been established in this age
group.
ALEPAM is available only with a
doctor's prescription.
BEFORE YOU TAKE
ALEPAM
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ALEPAM IF YOU ARE
ALLERGIC TO:
•
oxazepam or any other
benzodiazepine medicine
•
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 ALEPAM IF YOU HAVE:
•
severe and chronic respiratory
(lung or airways) disease
•
sleep a

Características técnicas

AUSTRALIAN PRODUCT INFORMATION
ALEPAM
_Oxazepam tablet _
1
NAME OF THE MEDICINE
Oxazepam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ALEPAM 15 and ALEPAM 30 tablet contains 15 mg and 30 mg of
oxazepam, respectively.
Excipients with known effect: sugars as lactose and trace quantities
of sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ALEPAM 15 (oxazepam) 15 mg: 8 mm pale yellow flat bevelled edged
tablet marked OM/15 on one side, G
on reverse.
ALEPAM 30 (oxazepam) 30 mg: 8 mm pale orange flat bevelled edged
tablet marked OM/30 on one side, G
on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALEPAM 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 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
DOSE AND METHOD OF ADMINISTRATION
ALEPAM 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 to 15
mg, 3 or 4 times daily.
For severe anxiety syndromes, agitation or anxiety associated with
depression, the usual dose is 15 to 30 mg,
3 or 4 times daily.
For older patients with anxiety, tension, irritability and agitation,
the initial dose is 7.5 mg, 2 to 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 to 30 mg, 3 or 4 times daily.
ALEPAM