CLARINASE 24HR EXTENDED RELEASE TABLETS

Land: Malaysia

Språk: engelsk

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

Kjøp det nå

Preparatomtale Preparatomtale (SPC)
03-06-2022

Aktiv ingrediens:

PSEUDOEPHEDRINE SULPHATE; LORATADINE

Tilgjengelig fra:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (International Name):

PSEUDOEPHEDRINE SULPHATE; LORATADINE

Enheter i pakken:

10 Tablets

Produsert av:

SAG MANUFACTURING, S.L.U

Preparatomtale

                                Patients wno nave a nistory-of □ifficulty rn- swalTowfng ta1
J1efs-or -
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P
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DI
ATRIC
-
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AGE:
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'
),vho have known upper gastrointestinal narrowing or abnormal
_
:
,
esophageal
peristalsis
should
not
use
this
product
(see
Safety and efficacy of CLARI
NASE 24Hr Tablets in children youngen
:PRECAUTIONS and ADVERSE REACTIONS).
than 12 years of age have not yet been established.
:
:
DRUG INTERACTIONS:
USAGE DURING PREGNANCY AND IN NURSING MOTHERS:
Safe use of CLARINASE 24Hr Tablets during pregnancy has not
been established. Therefore, the product should be used only if the'
potential benefit justifies the potential risk to the fetus.
:
When administered concomitantly with alcohol, loratadine has no
:
pote_
ntiating effect
as measured
by psychomotor performance
,
studies.
:
increase in plasma concentrations of loratadine has been reported
<1fter
concomitant
use
with
ketoconazole,
erythromycin
or
:cimetidine
in
controlled
clinical
trials,
but
without
clinically
�ignificant changes (including electrocardiographic). Other drugs
:
known to inhibit hepatic metabolism should be coadministered with
,
caution until definitive interaction studies can be completed.
When sympathomimetic drugs are given to patients receiving
lnonoamine
oxidase
(MAO)
inhibitors,
hypertensive
reactions,
)ncluding
hypertensive
crisis
may
occur. The
antihypertensive
�fleets of methyldopa, mecamylamine, reserpine and veratrum
�lkalo1ds may be reduced by sympathomimetics. Beta-adrenergic
'
blocking
agents
also
may
interact
with
sympathomimetics.
:
increased
ectopic
pacemaker
activity
can
occur
when
ipseudoephedrine
sulfate
is
used
concomitantly
with
digitalis.
tl,ntacids increase the rate of pseudoephedrine sulfate absorption;
kaolin decreases it.
:DRUG/LABORATORY
TEST
INTERACTIONS:
Antihistamines
should
be
:discontinued
approximately
48
hours
prior
to
skin
testing
,
procedures since these drugs may prevent or diminish otherwise
:
positive reactions to dermal reactivity indicators.
:
The _in vi
                                
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