Phosex

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Calcium acetate

Tilgjengelig fra:

Pharmacosmos A/S

ATC-kode:

V03AE; V03AE07

INN (International Name):

Calcium acetate

Dosering :

1000 milligram(s)

Legemiddelform:

Tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Drugs for treatment of hyperkalemia and hyperphosphatemia; calcium acetate

Autorisasjon status:

Marketed

Autorisasjon dato:

2011-10-07

Informasjon til brukeren

PHOSEX®
1000
MG
TABLETS
CALCIUM
ACETATE
PACKAGE
LEAFLET:
INFORMATION
FOR
THE
USER
File
Name:
Forme Ref:
Size:
"P63
Phosex t
000
mg
Tablets
(Calcium
Acetate)
Please read this leaflet carefully before
you start taking your medicine.
It
contains
important information
about
Phosex
1000
mg
Tablets.
Keep
this
leaflet. You
may
need
to
read
it
again
.
If you
have
any
questions ask your
doc
tor or pharmacist.
This
medicine has
been
prescribed
for you personally.
Do
not
pass
it
on
to
others. It
may
horm them.
even
if
their symptoms are the same
as
yours.
If
an
y
of
the s
id
e effects b
eco
me
serious.
or if you
notice
any
si
de eff
ec
ts
not
listed in
this
leaflet. please te
ll
your
d
octor
or pharmacist.
IN
THIS
LEAFLET
I.
What Phosex Tablets are
and
what
they
are
used for
2.
Read
this
before
_you _
take
Phosex
Tablets
3.
How to
take
Phosex Tabiets
4.
Possible side effects
5.
How to store Phosex Tablets
6.
Further information
WHAT
PHOSEX
TABLETS
ARE
AND
WHAT
THEY
ARE
USED
FOR
Phosex
Tablets
belong to a group
of
med
icines
called
phosphate
binders
and
are
only
avai
lable on prescription from your
doctor
.
The
tabl
ets
ore
most
commonly
used
to remove
phosphate
from
your body
when
it
has
too much.
PhoseILLeafl
eLf
lO
23
Pharmacode:
as shown
Item
Code:
F1023
292
x
159mm
Colours:
..
.
(
)
(
)
(
)
(
They
must
be
used
together
with a dvice
on your
diet
and
in
addition
to your other
kidney tr
eatment.
2
READ
THIS BEFORE
YOU
TAKE
PHOSEX
TABLETS
Do
not
take
Phosex
If:
you
have
been
given
Phosex (calcium
a
ce
tat
e)
before
and
had
an
a
ll
ergic
reaction
.
(See
Section 4 for symptoms.)
you
have
had
an
allergic
reaction
to
any
of
the
other
ingredients.
(See
Secti
on
6 for a
list
of
these.)
you suffer from high levels
of
calcium
in your bl
ood
(hyper
calcaemia)
.
T~ke
Speclll' Cllre
with
Phosex
Before you start taking these
tab
lets. tell
your
doctor
if:
you are
pregnant.
or
may
become
pregnant.
or you are breast feeding;
you are taking:
-
any
antibiot
i
cs
.
-
cal
cium antagonists such
as
verapamil
(for your
heart
or
blood
pressure)

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phosex 1000 mg tablet.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains.
Calcium acetate 1000 mg (calcium acetate anhydrous 986.36 mg)
equivalent to 250 mg calcium.
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Oval yellow tablet embossed “PHOS-EX” on one side with a
score-line on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Correction of hyperphosphataemia associated with chronic renal failure
in patients undergoing dialysis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Initially one tablet 3 times a day.
The tablet should be swallowed whole with a meal to achieve the
maximal phosphate
binding effect.
Where the patient cannot swallow the tablets whole they may be broken
and taken with food.
Tablets,
whether whole or broken,
should not be chewed due to their bitter taste.
The dose can be increased until the desired
serum phosphate level is achieved, as long as hypercalcaemia does not
occur.
Most patients need 4 to 6 tablets per day
(1 to 2 tablets with each meal).
The maximum recommended daily dose is 12 tablets.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Hypercalcaemia.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use of phosphate binders in renal failure should be in conjunction
with dietary advice regarding phosphate intake
and methods of dialysis appropriate to the patient.
The dose will need to be adjusted depending on phosphate intake or
removal by dialysis and on the ensuing effect on
serum calcium.
This requires regular monitoring, for example weekly, of both the
serum phosphate and calcium levels
to determine efficacy and prevent hypercalcaemia.
If hypercalcaemia occurs,
the dosage should be reduced or the treatment
withdrawn temporarily,
depending on the
degree of
hypercalcaemia.
The risk of
hypercalcaemia needs
to be considered particularly during concomitant
treatment with Vitamin D preparations.
I
R
I
S
H
M