Panafcortelone 5 mg Tablets bottle

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

prednisolone, Quantity: 5 mg

Saatavilla:

Aspen Pharmacare Australia Pty Ltd

Lääkemuoto:

Tablet, uncoated

Koostumus:

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

Antoreitti:

Oral

Kpl paketissa:

60, 500, 30, 90, 5000 and bulk, 1000

luokka:

Medicine Registered

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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

Tuoteyhteenveto:

Visual Identification: Round, flat, white, scored tablet debossed with "PL/5" 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

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

1991-10-21

Pakkausseloste

PANAFCORTELONE
1
PANAFCORTELONE
_prednisolone _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Panafcortelone. It
does not contain all the information
that is known about Panafcortelone.
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
Panafcortelone 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 PANAFCORTELONE
IS USED FOR
Panafcortelone 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.
Panafcortelone 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.
Panafcortelone 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
PANAFCORTELONE 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 PANAFCORTELONE 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 reac

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION
PANAFCORTELONE (PREDNISOLONE) TABLETS
1
NAME OF THE MEDICINE
Prednisolone.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PANAFCORTELONE tablets contain either 1 mg, 5 mg or 25 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
1 mg: Round, flat, white scored tablet debossed with ‘PL/1’ on one
side and plain on the
other.
5 mg: Round, flat, white scored tablet debossed with ‘PL/5’ on one
side and plain on the
other.
25 mg: Round, biconvex, white scored tablet debossed with ‘PL/25’
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
2
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 day