Prednisyn Tablet 5mg

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

PREDNISOLONE

Beschikbaar vanaf:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

INN (Algemene Internationale Benaming):

PREDNISOLONE

Eenheden in pakket:

1000 Tablet Tablets

Geproduceerd door:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Bijsluiter

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PREDNISYN TABLET
®
Prednisolone (5mg)
WHAT IS IN THIS LEAFLET
1.
What Prednisyn is used for
2.
How Prednisyn works
3.
Before you use Prednisyn
4.
How to use Prednisyn
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Prednisyn
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PREDNISYN IS USED FOR
Prednisyn is used in the treatment of many
different
conditions.
Some
of
these
conditions
include:
rheumatic
fever,
rheumatoid
arthritis,
kidney
disease,
asthma,
and
other
corticosteroid-
indicated conditions.
Ask your doctor if you have any questions
about why Prednisyn has been prescribed
for you. Your doctor may have prescribed
it for another purpose.
HOW PREDNISYN WORKS
Prednisolone
belongs
to
a
group
of
medicines
called
corticosteroids
which
are
a
synthetic
version
of
a
naturally
occurring body hormone called cortisol.
Prednisyn
works
by
decreasing
or
preventing
tissue
responses
to
inflammatory processes, thereby reducing
development
of
symptoms
of
inflammation
without
affecting
the
underlying cause.
This medicine is only able to prevent or
reduce symptoms of your condition, it
does not cure it.
BEFORE YOU USE PREDNISYN
-
_When you must not use it _
Do not take Prednisyn if you have ever
had an allergic reaction to:
•
prednisolone or Prednisyn
•
any of the ingredients listed at the end
of this leaflet.
Symptoms of an allergic reaction may
include shortness of breath, wheezing or
difficulty in breathing; swelling of the
face, lips, tongue or any other parts of the
body; rash, itching or hives on the skin.
Do not take Prednisyn if you have:
•
a current serious or uncontrolled
infection, including fungal infections
•
osteoporosis (softening of the bone)
•
mental disorder
•
active stomach or intestinal ulcer
Do not take this medicine after the expiry
date
printed
on
the
pack
or
if
the
packaging
is
torn
or
shows
signs
of
tampering. If it has expired or is damaged,
return it to your pharmacist

Productkenmerken

Prednisolone is excreted in the urine as free and conjugated
metabolites,
together
with
an
appreciable
proportion
of
unchanged
prednisolone
crosses
the
placenta
and
small
amounts are excreted in breast milk.
PREGNANCY/REPRODUCTION
_FERTILITY:_ Corticosteroids have been reported to increase or
decrease the number or motility of spermatozoa. However, it is
not known whether reproductive capacity in humans is adverse-
ly affected.
_PREGNANCY:_
Corticosteroids
cross
the
placenta.
Although
adequate studies have not been done in humans, there is some
evidence
that
pharmacologic
doses
of
corticosteroids
may
increase
the
risk
of
placental
insufficiency,
decreased
birthweight,
or
stillbirth.
However,
teratogenic
effects
in
humans have not been confirmed. Infants born to mothers who
have
received
substantial
doses
of
corticosteroids
during
pregnancy
should
be
carefully
observed
for
signs
of
hypoadrenalism
and
replacement
therapy
administered
as
required. Studies in animals have shown that corticosteroids
increase the incidence of cleft palate, placental insufficiency,
spontaneous absorption and intrauterine growth retardation.
(FDA Pregnancy Category C).
Osteoporosis, active peptic ulcer, psychoses or severe psycho-
neurosis. Systemic fungal infections. Acute infections unless
effective, specific concurrent chemotherapy can be adminis-
tered. Patients should not undergo immunisations. Tuberculosis
as adjunctive treatment with tuberculostatic drug. Pregnancy
and lactation. Should be used with great caution in the presence
of congestive heart failure or hypertension, in patients with
diabetes mellitus, epilepsy, glaucoma, infections diseases, ocular
herpes simplex, chronic renal failure, and uraemia, and in
elderly persons.
The risk of adverse effects with pharmacologic doses of corticos-
teroids generally increases with the duration of therapy and
frequency of administration and, to a lesser extent, with dosage.
The following side effects may occur:
Cushing’s
syndrome,
acne,
hirsutism,
osteoporosis,
aseptic
osteonecrosis,