SONE prednisone 5 mg tablet bottle

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

prednisone, Quantity: 5 mg

Pieejams no:

iNova Pharmaceuticals (Australia) Pty Ltd

Zāļu forma:

Tablet, uncoated

Kompozīcija:

Excipient Ingredients: lactose monohydrate; propyl hydroxybenzoate; wheat starch; maize starch; magnesium stearate; Gelatin

Ievadīšanas:

Oral

Vienības iepakojumā:

1000 tablets, 60 tablets, 90 tablets

Klase:

Medicine Registered

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

INDICATIONS AS AT 26 MARCH 1997 : Wherever corticosteroid therapy is indicated.

Produktu pārskats:

Visual Identification: White round biconvex tablet, uncoated one face plain, other with a break bar radius of curvature 21/64" diameter 1/4"; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorizācija statuss:

Licence status A

Autorizācija datums:

1996-07-04

Lietošanas instrukcija

SONE
_Prednisone (PRED-ni-sone)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SONE (prednisone
tablets). It does not contain all the
available information about SONE
tablets. It does not replace talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
SONE against the benefits he or she
expects it will have.
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 IS SONE
The name of your medicine is SONE
and is available in 5 mg and 25 mg
tablet strengths.
The active ingredient is called
prednisone.
Prednisone belongs to a group of
medicines called corticosteroids.
Corticosteroids are used to help
reduce inflammation in your body or
suppress your immune system, when
a disease may be due to an auto-
immune reaction (where your body
fights against itself).
WHAT SONE IS USED
FOR
SONE is used to treat a number of
medical conditions.
Your doctor will be able to help
decide if SONE is suitable for your
condition.
Ask your doctor if you have any
questions about why SONE has been
prescribed for you.
If you have any concerns, you should
discuss this with your doctor.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE SONE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SONE IF YOU ARE
ALLERGIC TO:
•
Prednisone or other cortisone
type medications, or any of the
ingredients listed at the end of
this leaflet including lactose
monohydrate.
Some of the symptoms of an allergic
reaction to SONE may include
urticaria and other skin rashes,
difficulty breathing, swelling of the
face or throat or faintness.
DO NOT TAKE SONE IF YOU:
•
have a peptic ulcer
•
suffer from osteoporosis (brittle
bones)
•
have severe disturbances in
thoughts, feelings and behaviours
(psychoneuroses)
•
have tuberculosis.
DO NOT TAKE SONE IF YOU ARE
BREASTFEEDING OR PLAN TO BREAST-
FEED.
DO NO

Produkta apraksts

1
AUSTRALIAN PRODUCT INFORMATION – SONE (PREDNISONE) TABLET
1
NAME OF THE MEDICINE
Prednisone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sone tablets contain 5 mg or 25 mg prednisone as the active
ingredient.
List of excipients with known effect:
Contains sugars as lactose monohydrate and hydroxybenzoates.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablet, uncoated.
5 mg tablet: – White round biconvex tablet, uncoated, one face
plain, and other face scored.
25 mg tablet: – White flat round, bevelled edges tablet, uncoated,
one face plain and other face
scored.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Wherever corticosteroid therapy is indicated.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults:
10 to 100 mg daily in divided doses.
Children:
1 to 5 years: 2.5 to 10 mg twice daily.
6 to 12 years: 5 to 20 mg twice daily.
4.3
C
ONTRAINDICATIONS
Systemic fungal infections and known hypersensitivity to prednisone or
any of the excipients.
Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses.
Patients with active or doubtfully
quiescent tuberculosis should not be given these hormones except as
adjuncts to treatment with
tuberculostatic drugs.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
Corticosteroids should be used with caution in the presence of
diminished cardiac reserve or
congestive heart failure, in patients with diabetes mellitus,
infectious diseases, chronic renal failure,
uraemia and in elderly persons.
2
In patients on corticosteroid therapy subjected to unusual stress,
increased dosage of rapidly acting
corticosteroids before, during, and after the stressful situation is
indicated.
Corticosteroids may mask some signs of infection, and new infections
may appear during their use.
Infections with any pathogen including viral, bacterial, fungal,
protozoan or helminthic infections,
in any location of the body, may be associated with the use of
corticosteroids alone or in
combination
with
other
immunosuppressive
agents
that
affect
cellular
im