PREDSOLONE prednisolone 1mg tablet bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

prednisolone, Quantity: 1 mg

Disponible desde:

Aspen Pharmacare Australia Pty Ltd

formulario farmacéutico:

Tablet, uncoated

Composición:

Excipient Ingredients: magnesium stearate; maize starch; povidone; lactose monohydrate; crospovidone

Vía de administración:

Oral

Unidades en paquete:

1000 tablets, bulk tablets, 90 tablets, 100 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Wherever corticosteroid therapy is indicated such as: pemphigus vulgaris, allergic dermatitis, eczema, exfoliative dermatitis, dermatitis herpetiformis, dermatitis medicamentosa, erythema multiforme; disseminated lupus erythematosus, dermatomyositis, polyarteritis nodosa; severe bronchial asthma and status asthmaticus, emphysema, pulmonary fibrosis; andrenal hyperplasia (adrenogenital syndrome); idiopathic thrombocytopenic purpura, acquired haemolytic anaemia, acute leukaemia; nephrotic syndrome; iridochoroiditis; ulcerative colitis; rheumatoid arthritis; ankylosing spondylitis, rheumatic fever, gout, periarthritis of the shoulder.

Resumen del producto:

Visual Identification: Round, flat, white, scored tablet debossed with "PL/1" on one side and plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Licence status A

Fecha de autorización:

2004-02-23

Información para el usuario

PREDSOLONE - CMI
1
PREDSOLONE
_prednisolone _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Predsolone. It does
not contain all the information that is
known about Predsolone.
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 Predsolone
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 PREDSOLONE IS
USED FOR
Predsolone contains prednisolone as
the active ingredient. Prednisolone
belongs to a group of medicines
called corticosteroids which are a
synthetic version of a naturally
occurring body hormone called
cortisol.
Predsolone works by entering
inflammatory cells and blocking the
inflammatory reaction. This
medicine is only able to prevent or
reduce symptoms of your condition,
it does not cure it.
Predsolone is used in the treatment of
many different conditions. Some of
these conditions include: severe
allergies, severe or chronic asthma,
skin problems, arthritis,
inflammatory diseases of the bowel,
cancer and "auto-immune" diseases.
It is also used to prevent or reduce
the symptoms of inflammation (such
as swelling, redness, pain, tenderness
or itching) in any part of the body.
These symptoms can occur in
response to injury or can be caused
by many different conditions.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PREDSOLONE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is only available with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PREDSOLONE IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO:

prednisolone or prednisone

any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,

Ficha técnica

1
AUSTRALIAN PRODUCT INFORMATION
PREDSOLONE (PREDNISOLONE) TABLETS
1
NAME OF THE MEDICINE
Prednisolone.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PREDSOLONE tablets contain 1 mg of the active prednisolone.
List of excipients with known effects: lactose monohydrate. For the
full list of excipients, see
Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Round, flat, white scored tablet debossed with ‘PL/1’ on one side
and plain on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Wherever corticosteroid therapy is indicated such as: pemphigus
vulgaris, allergic dermatitis,
eczema, exfoliative dermatitis, dermatitis herpetiformis, dermatitis
medicamentosa, erythema
multiforme; disseminated lupus erythematosus, dermatomyositis,
polyarteritis nodosa; severe
bronchial
asthma
and
status
asthmaticus,
emphysema,
pulmonary
fibrosis;
adrenal
hyperplasia
(adrenogenital
syndrome);
idiopathic
thrombocytopenic
purpura,
acquired
haemolytic anaemia, acute leukaemia; nephrotic syndrome;
iridochoroiditis; ulcerative colitis;
rheumatoid arthritis; ankylosing spondylitis, rheumatic fever, gout,
periarthritis of the shoulder.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The severity, prognosis, expected duration of the disease, and the
patient's reaction to
medication are primary factors in determining dosage.
Despite the 1 mg tablet being scored, it should not be broken.
Adults: The initial adult dosage may range from 20 to 40 mg daily, but
can be 60 to 80 mg
daily if necessary, depending on the disease being treated.
Maintenance dosage: Usually 5
to 20 mg daily. In long term therapy the ideal dosage should not be
greater than 40 mg per
day so as to minimise side-effects. It is usually administered in 2-4
divided doses or as a
single daily dose after breakfast or on alternate days.
Alternate-Day Therapy
Alternate-day therapy is the dosage regimen of choice for long-term
oral glucocorticoid
treatment of most conditions. In alternate-day therapy, a single dose
is administered every
other
morning.
This
regimen
provides
re