REXICALE Calcium Carbonate 500mg Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Calcium Carbonate

Boleh didapati daripada:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

Calcium Carbonate

Unit dalam pakej:

500 Tablets; 1000 Tablets

Dikeluarkan oleh:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
REXICALE CALCIUM CARBONATE 500 MG TABLETS
Calcium Carbonate (500mg)
1
WHAT IS IN THIS LEAFLET
1.
What REXICALE is used for
2.
How REXICALE works
3.
Before you use REXICALE
4.
How to use REXICALE
5.
While you are using REXICALE
6.
Side effects
7.
Storage and disposal
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT REXICALE IS USED FOR
REXICALE
is
used
for
symptomatic
relief
of
acid
indigestion,
heartburn,
flatulence, nausea, as a supplementary
source, osteoporosis therapy, and as a
phosphate binder to treat patients with
chronic kidney disease, renal failure and
renal
osteodystrophy
(renal
bone
disease).
HOW REXICALE WORKS
ANTACID:
It
contains
calcium
carbonate
which
helps to neutralize existing amounts of
stomach
acid
to
provide
relief
of
hyperacidity symptoms.
SUPPLEMENTARY:
It
contains
calcium
carbonate
which
helps to increase the calcium absorption
and reduces phosphate absorption.
BEFORE YOU USE REXICALE
_-When you must not use it _
Tell
your
doctor
before
using
REXICALE if you

are individual on low phosphate diets,
or receiving cardiac glycosides or with
impaired liver or kidney function.

have
hypersensitivity
to
any
of
the
ingredients.

have hypercalcaemia (increase calcium
level in blood), hypercalciuria (excess
calcium in urine) and calcium renal
calculi (kidney stone).
_-Pregnancy and breastfeeding _
Tell your doctor or pharmacist if you are
pregnant, planning to get pregnant or are
breastfeeding. Data on a large number of
exposed pregnancies indicate no adverse
effects
of
500
mg
calcium
carbonate
tablets on pregnancy or on the health of
the fetus/newborn child.
Calcium carbonate can be used during
lactation if taken as instructed.
_ _
_-Before you start to use it_
- Use with caution in diseases associated
with hypercalcaemia (high calcium level
in the blood) and some malignancies and
in patients with a history of kidney stone.
- In renal insufficiency the tablets should
be
given
only
under

Ciri produk

REXICALE CALCIUM CARBONATE 500 MG TABLETS
NAME AND STRENGTH OF ACTIVE SUBSTANCE:
Calcium Carbonate…………………………. 500mg
PRODUCT DESCRIPTION
Pink, circular, flat, bevelled edged and uncoated tablet with break
line on one side.
_ _
THERAPEUTIC INDICATIONS
Recommended for the symptomatic relief of acid indigestion, heartburn,
flatulence and nausea
also as a supplementary source of calcium
when normal requirements are high and in the
correction of calcium deficiency in the diet. They can be used in
osteoporosis therapy as an
adjunct to more specific conventional treatments. It is also used as
phosphate binder to treat
patients with chronic kidney disease, renal failure and renal
osteodystrophy
_ _
PHARMACOLOGICAL
Mechanism of actions:
ANTACID:
Calcium Carbonate reacts chemically to neutralise or buffer existing
amounts of stomach acid
but has no direct effect on its output. This action results in
increased pH value of stomach
contents, hence providing relief of hyperacidity symptoms. It also
reduces acid concentration
within the lumen of the oesophagus, thus causing an increase in
intra-oesophageal pH and a
decrease in pepsin activity, which helps in the control of
gastro-oesophageal reflux
.
SUPPLEMENTARY:
Intake of recommended dosage of calcium carbonate results in increased
intestinal calcium
absorption. This action results in decrease of calcium deficiency.
Calcium carbonate, also
binds phosphate in the gastrointestinal tract to form insoluble
complexes and reduces
phosphate absorption
.
_ _
_ _
PHARMACOKINETICS
Absorption:
Calcium carbonate is converted to calcium chloride by gastric acid
(hydrochloric acid) in the
stomach, which results in the formation of carbon dioxide and water.
Calcium is then absorbed
to the extent of about 15-25% from the intestines but the majority is
reconverted into insoluble
calcium salts such as carbonate and stearate which is excreted in the
faeces.
Distribution, Metabolism and Excretion:
Once
absorbed
from
the
stomach,
physiological
concentrations
of
calcium
are
tig