FERROCYTE TABLET 50MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FERRIC SODIUM CITRATE

Boleh didapati daripada:

EISAI (MALAYSIA) SDN BHD (18039-D)

INN (Nama Antarabangsa):

FERRIC SODIUM CITRATE

Unit dalam pakej:

100Tablet Tablets

Dikeluarkan oleh:

SANNOVA CO LTD

Risalah maklumat

FERROCYTE
® TABLET 50MG
Sodium Ferrous Citrate (50mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_FERROCYTE®_
is used for
2.
How
_FERROCYTE®_
works
3.
Before you use
_FERROCYTE®_
4.
How to use
_FERROCYTE®_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_FERROCYTE®_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _FERROCYTE®_
IS USED FOR
FERROCYTE® is used for patients with
iron-deficiency anemia (low levels of red
blood cells in the body due to a lack of
iron).
HOW _FERROCYTE®_ WORKS
The absorbed iron enters the body and is
used to make hemoglobin, a protein in
red blood cells.
Sodium ferrous citrate improves anemia
(a condition in which there is a
deficiency of red cells in the blood,
resulting in pallor and weariness)
through recovery of hemoglobin level
and iron reserve.
BEFORE YOU USE _FERROCYTE®_
-
_When you must not use it _
_ _
You should not take
_FERROCYTE®_
•
if you are allergic to any of the
ingredients contained in it.
•
if you are not iron deficient.
_ _
_Pregnancy and lactation _
Do not take
_FERROCYTE®_
if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take
_FERROCYTE®_
if you are
breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
-
_Before you start use it _
_ _
Before you take FERROCYTE®
tablet, tell your doctor if you have:
•
gastrointestinal
diseases
such
as stomach ulcer, or chronic
inflammation
of
the
large
intestine and small intestine.
•
paroxysmal
nocturnal
hemoglobinuria
(rare,
acquired,
life-threatening
disease
of
the
blood
characterized by destruction of
red
blood
cells
by
the
complement system, a part of
the
body's
innate
immune
system).
•
Received treatment with iron-
containing
preparation
(iron
preparation, contrast media of
liver for MRI, etc)
For elderly patients, this product
should
be
used
under
careful
medical supervision.
-
_Taking other medicines _
_ _
Tell your doctor or pharma

Ciri produk

CONTRAINDICATIONS (FERROCYTE IS CONTRAINDICATED IN THE FOLLOWING
PATIENTS.)
Patients who are not iron-deficient
[Since iron overload may occur, caution should be taken to avoid
accidental over-
dosing.]
DESCRIPTION
1.
COMPOSITION
Each white, gastric-soluble, film-coated tablet contains 470.9 mg of
sodium ferrous
citrate (50 mg as elemental iron).
It also contains carmellose, microcrystalline cellulose, titanium
oxide, calcium
stearate, low substituted hydroxypropylcellulose,
hydroxypropylcellulose, hypro-
mellose and macrogol 6000 as inactive ingredients.
2.
PRODUCT DESCRIPTION
Brand name
Dosage form
and identifica-
tion code
Appearance
Description
Face
Reverse
Lateral
Ferrocyte
Tablets 50 mg
Film-coated
tablets
White
S
301
Diameter
(mm)
10.3
Weight
(mg)
550
Thic
kness
(mm)
5.0
INDICATIONS
Iron-deficiency anemia
DOSAGE AND ADMINISTRATION
The usual adult dosage for oral use is 100-200 mg as elemental iron
(2-4 tablets) daily
in one or two divided doses after meals.
The dosage may be adjusted depending on the patient’s age and
symptoms.
PRECAUTIONS
1.
CAREFUL ADMINISTRATION (FERROCYTE SHOULD BE ADMINISTERED WITH CARE IN
THE FOLLOWING PATIENTS.)
(1) Patients with gastrointestinal diseases such as peptic ulcer,
chronic ulcerative
colitis or focal enteritis
[FERROCYTE may aggravate such conditions.]
(2) Patients with paroxysmal nocturnal hemoglobinuria
[FERROCYTE may induce hemolysis and aggravate the condition.]
(3) Patients on therapy with iron-containing preparations (iron
preparations, liv-
er-specific contrast media for MRI, etc.)
[Iron overload may occur.]
2.
IMPORTANT PRECAUTIONS
Hematological tests should be conducted during treatment with
FERROCYTE as
necessary to avoid accidental overdosing.
3.
DRUG INTERACTIONS
Precautions for coadministration (FERROCYTE should be administered
with care
when coadministered with the following drugs.)
DRUGS
SIGNS, SYMPTOMS AND
TREATMENT
MECHANISM AND RISK
FACTORS
Cefdinir
FERROCYTE reduce the
absorption of cefdinir to
about one tenth, so FER-
ROCYTE should be admin-
istered