AXCEL PREDNISOLONE-5MG EC TABLET

Valsts: Malaizija

Valoda: angļu

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

Aktīvā sastāvdaļa:

PREDNISOLONE

Pieejams no:

KOTRA PHARMA (M) SDN. BHD.

SNN (starptautisko nepatentēto nosaukumu):

PREDNISOLONE

Vienības iepakojumā:

100Tablet Tablets; 300 Tablet Tablets; 100 Tablet Tablets

Ražojis:

KOTRA PHARMA (M) SDN. BHD.

Lietošanas instrukcija

AXCEL PREDNISOLONE-5MG EC TABLET
Prednisolone (5mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What
Axcel
Prednisolone-5mg
EC Tablet is used for.
2.
How
Axcel
Prednisolone-5mg
EC Tablet works.
3.
Before
you
use
Axcel
Prednisolone-5mg EC Tablet.
4.
How to use Axcel Prednisolone-
5mg EC Tablet.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Prednisolone-5mg EC Tablet.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT AXCEL PREDNISOLONE-5MG EC
TABLET IS USED FOR
Axcel Prednisolone-5mg EC Tablet is
used
for
the
treatment
of
inflammatory condition such as
•
Rheumatic fever.
•
Rheumatoid arthritis (joint pain
and inflammation).
•
Allergic diseases.
•
Nephritic syndrome.
•
Asthma.
•
Other
corticosteroid-indicated
conditions.
HOW AXCEL PREDNISOLONE-5MG EC
TABLET WORK
Axcel Prednisolone-5mg EC Tablet is
an anti-inflammatory agent. It is
a
steroid that decrease or prevent tissue
responses to inflammatory processes,
thereby
reducing
symptoms
of
inflammation
without
affecting
the
underlying cause. It is also prevent
production and /or release of several
chemical that initiate inflammation.
BEFORE YOU USE AXCEL PREDNISOLONE-
5MG EC TABLET
_-When you must not use it _
Do not take Axcel Prednisolone-5mg
EC Tablet if:
•
You are having allergy to any
component of this medication.
•
You
are
having
active
osteoporosis
(fragile
bone),
active
ulcer
on
your
stomach,
esophagus or small intestine or
mental disorder.
•
It is not prescribed by a qualified
doctor or pharmacist for you.
•
You are having acute infections.
•
You are taking medicines to treat
tuberculosis
(bacterial
infection
that mainly affects the lungs).
•
You are pregnant, trying to get
pregnant or think you may be
pregnant.
•
You are having systemic fungal
infections.
•
You are having vaccination.
•
You are breast-feeding. Ask your
doctor or pharmacist for advice
before taking any medicine.
_-Before you start to use it _
Tell y

Produkta apraksts

relatively
low
doses.
Prolonged
therapy
may
produce
posterior sub-capsular cataracts. Glaucoma with possible
damage to optic nerve. Steroid myopathy and Cushing’s
habitus may develop with long term therapy. Hepatic
cirrhosis and hypothyroidism may enhance corticosteroid
effects. Withdrawal syndrome (abdominal or back pain,
dizziness, fainting, low grade fever, prolonged loss of
appetite, muscle or joint pain, nausea, vomiting, shortness
of breath, frequent or continuing unexplained headaches,
unusual
tiredness
or
weakness,
rapid
weight
loss,
reappearance of disease symptoms). Caution is required in
patients with systemic sclerosis because of an increased
incidence of (possibly fatal) scleroderma renal crisis with
hypertension and decreased urinary output observed with
a daily dose of 15mg or more prednisolone.
_Use in Pregnancy and Lactation:_
_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
adversely 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
received
substantial
doses
or
corticosteroid
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).
SIDE EFFECTS:
The risk of adverse effects with pharmacologic doses of
corticosteroid generally increases with the duration of
therapy and frequency of administration and to a lesser
extent, with dosage. The following side effects may occur:
C