DELTASOLONE TABLET 5MG

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

PREDNISOLONE

Dostupné z:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Medzinárodný Name):

PREDNISOLONE

Počet v balení:

1000Tablet Tablets; 500 Tablet Tablets; 100 Tablet Tablets

Výrobca:

SUNWARD PHARM PTE LTD

Príbalový leták

DELTASOLONE TABLET 5MG
Prednisolone (5mg)
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What Deltasolone Tablet 5mg is used for
2. How Deltasolone Tablet 5mg works
3. Before you use Deltasolone Tablet 5mg
4. How to use Deltasolone Tablet 5mg
5. While you are using it
6. Side effects
7. Storage and Disposal of Deltasolone Tablet
5mg
8. Product Description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT DELTASOLONE TABLET 5MG IS USED FOR
It is used in the treatment of many different
conditions. Some of these conditions include:
severe
allergies,
asthma,
skin
problems,
arthritis, inflammatory diseases of the bowel,
cancer and "auto-immune" diseases.
HOW DELTASOLONE TABLET 5MG WORKS
The
active
ingredient
in
the
medicine
is
Prednisolone.
Prednisolone
is
known
as
corticosteroid or steroid. It helps by reducing
inflammation
effect
in
many
diseases
and
disorders.
BEFORE YOU USE DELTASOLONE TABLET 5MG
_- When you must not use it _
Do not use Deltasolone Tablet 5mg if you:-

have fungal infections.

are hypersensitivity to prednisolone or any
ingredients listed at the end of this leaflet.
_- Before you start to use it _
Talk to your doctor before taking Deltasolone
Tablet 5mg, if you have:

congestive heart failure

diabetes

long term kidney failure

high blood pressure

recent intestinal operation

infectious diseases

muscle weakness

eye infection due to herpes simplex virus

tuberculosis disease (bacterial infection
that mainly affects the lungs)

systemic
sclerosis
(an
autoimmune
disorder). Taking daily doses of 15 mg or
more may increase the risk of a serious
complication
called
scleroderma
renal
crisis which may cause your blood pressure
to increase and reduce urination.
Corticosteroids
may
mask
some
signs
of
infection,
and
new
infections
may
appear
during their use.
Some medicines may increase the effects of
Deltasolone Tablet 5mg and your doctor may
wish to monitor you carefully if you are taking
these
medicines
(inclu

Súhrn charakteristických

INTERACTIONS WITH OTHER MEDICAMENTS:
Phenytoin, phenobarbital, ephedrine and rifampicin may enhance the
metabolism of corticosteroids resulting in
decreased blood levels and lessened physiologic activity, thus
requiring adjustment in corticosteroid dosage.
Drugs such as barbiturates which induce hepatic microsomal drug
metabolizing enzyme activity may enhance
metabolism of Prednisolone and require the dosage of Deltasolone to be
adjusted.
Co-treatment with CYP3A inhibitors, including cobicistat-containing
products, is expected to increase the risk of
systemic side-effects. The combination should be avoided unless the
benefit outweighs the increased risk of
systemic corticosteroid side-effects, in which case patients should be
monitored for systemic corticosteroid
side-effects.
PREGNANCY AND LACTATION:
Since adequate human reproduction studies have not been done with
corticosteroids, use of these drugs in
pregnancy or in women of childbearing potential requires that the
anticipated benefits be weighed against the
possible hazards to the mother and embryo or fetus. Infants born of
mothers who have received substantial
doses
of
corticosteroids
during
pregnancy
should
be
carefully
observed
for
signs
of
hypoadrenalism.
Corticosteroids appear in breast milk and could suppress growth,
interfere with endogenous corticosteroids
production, or cause other unwanted effects. Mothers taking
pharmacologic doses of corticosteroids should be
advised not to nurse.
SIDE EFFECTS:
Adverse reactions include fluid and electrolyte disturbance, muscle
weakness, osteoporosis, acute pancreatitis,
cushingoid state, growth retardation, menstrual irregularities,
increased intraocular pressure, visual disturbances,
manifestation of latent diabetes mellitus, peptic ulcer with possible
perforation and hemorrhage, impaired wound
healing, convulsion and increased intracranial pressure with
papilloedema. Vision, blurred.
Scleroderma renal crisis: Amongst the different subpopulations the
occurrence of scleroderma renal crisis
varies. The highest