SP-CORTIL 10 SYRUP

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PREDNISOLONE

Boleh didapati daripada:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

PREDNISOLONE

Unit dalam pakej:

100 ml; 120 ml; 60 ml; 3800 ml; 3600 ml; 120 ml; 100 ml; 60 ml

Dikeluarkan oleh:

SUNWARD PHARMACEUTICAL SDN. BHD.

Risalah maklumat

SP-CORTIL 10 SYRUP
Prednisolone (10mg/5ml)
1
_ Consumer Medication Information Leaflet (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What SP-Cortil 10 Syrup is used for
2. How SP-Cortil 10 Syrup works
3. Before you use SP-Cortil 10 Syrup
4. How to SP-Cortil 10 Syrup
5. While you are using it
6. Side effects
7. Storage and disposal of SP-Cortil 10 Syrup
8. Product description
9. Manufacturer and Product Registration
Holder
10.Date of revision
WHAT SP-CORTIL 10 SYRUP IS USED FOR
It
is
used
rheumatic
disorders
(affecting
muscles,
tendons,
joints,
bones),
collagen
diseases (systemic lupus erythematosus), skin
diseases (pemphigus, severe psoriasis, severe
seborrheic dermatitis), bronchial asthma, eye
diseases
(eye
inflammation,
herpes
zoster
ophthalmicus, allergic conjunctivitis), blood
disorders, swelling states and gastrointestinal
diseases.
HOW SP-CORTIL 10 SYRUP 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. Prednisolone is extensively bound
to
plasma
protein,
although
less
so
than
hydrocortisone
(cortisol).
Prednisolone
is
excreted in the urine as free and conjugated
metabolites,
together
with
an
appreciable
proportion of unchanged prednisolone.
BEFORE YOU USE SP-CORTIL 10 SYRUP
_- When you must not use it _
Do not use SP-Cortil 10 Syrup if:-

you have systemic fungal infections.

You
have
injected
with
live
virus
vaccinations.

you have hypersensitivity to prednisolone
or any ingredients listed at the end of this
leaflet.
_- Before you start to use it _
You should check with your doctor if you
have the following :-

congestive heart failure

diabetes mellitus

chronic renal failure

high blood pressure

recent intestinal operation

infectious diseases

muscle weakness

eye inflammation due to herpes simplex
virus

tuberculosis disease (bacterial infection that
mainly affects the lungs)

hypothyroidism (underactive thyroid
disease)

exposure to

Ciri produk

PACKAGE INSERT
Corticosteroid may cause psychic derangements including euphoria,
insomnia, mood swings, personality
changes, severe depression or frank psychosis. Pre-existing emotional
instability or psychotic tendencies may
be aggravated by corticosteroids.
Scleroderma renal crisis:
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 15 mg or more prednisolone.
USE IN 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.
CONTRAINDICATIONS:
It is contraindicated in peptic ulcer, osteoporosis, psychoses, or
psychoneuroses, live vaccines and systemic
fungal infections.
DRUG INTERACTIONS:
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. These interactions may interfere with dexamethasone
suppression tests which should be interpreted
with caution during administration of these drugs.
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 outweights the increased risk
of systemic corticosteroid side-effects, in which case patients should
be m