AXCEL LORATADINE SYRUP

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

LORATADINE

Доступна з:

KOTRA PHARMA (M) SDN. BHD.

ІПН (Міжнародна Ім'я):

LORATADINE

Одиниць в упаковці:

60 ml; 100 ml

Виробник:

KOTRA PHARMA (M) SDN. BHD.

інформаційний буклет

AXCEL LORATADINE SYRUP
Loratadine (5mg/5ml)
_ _
1
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What Axcel Loratadine Syrup is
used for.
2.
How
Axcel
Loratadine
Syrup
works.
3.
Before you use Axcel Loratadine
Syrup.
4.
How
to
use
Axcel
Loratadine
Syrup.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Loratadine Syrup.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT
AXCEL
LORATADINE
SYRUP IS USED FOR
Axcel Loratadine Syrup is used for
the
relief
of
symptoms
associated
with
allergic
rhinitis
(inflammation
of the mucous membrane inside the
nose)
for
example
sneezing,
nasal
discharge (rhinorrhea) and itching, as
well as ocular (eye) itching burning,
chronic urticaria (a raised, itchy rash
on
the
skin)
and
other
allergic
dermatologic (skin) disorders.
HOW
AXCEL
LORATADINE
SYRUP WORKS
Loratadine is a long-acting tricyclic
antihistamine
with
selective
peripheral
histamine
H1-receptor
antagonist
activity.
It
works
by
blocking
the
action
of
one
of
the
body's natural chemicals known as
histamine. Histamine is responsible
for many of the symptoms caused by
allergies.
BEFORE
YOU
USE
AXCEL
LORATADINE SYRUP
_When you must not use it _
Do not take Axcel Loratadine Syrup
if:
•
If
you
are
allergic
or
hypersensitive to any ingredients
in Axcel Loratadine Syrup.
•
If
it
is
not
prescribed
by
a
qualified
doctor
or
pharmacist
for you.
•
Do
not
take
Axcel
Loratadine
Syrup if you are pregnant, trying
to get pregnant or think you may
be pregnant.
•
Do
not
take
Axcel
Loratadine
Syrup if you are breast-feeding.
Loratadine is excreted in breast
milk.
Ask
your
doctor
or
pharmacist
for
advice
before
taking any medicine.
_Before you start to use it _
Tell your doctor if you:
•
If
you
are
allergic
to
any
medicines, food and dyes.
•
If
you
are
taking
any
other
medicines
(including
those
not
prescribed by your doctor).
•
If
you
have
severe
liver
impairment.
Use in children:
Safety and efficacy of loratadine in
children be

Характеристики продукта

PRECAUTION:
Patients
with
severe
liver
impairment
should
be
administered a lower initial dose because they may have
reduced clearance of loratadine; an initial dose of 5mg
once daily or 10mg every other day is recommended.
Unsuitable for phenylketonurics.
_Use in Pregnancy and Lactation:_
Safe use of loratadine during pregnancy has not been
established; therefore use only if potential benefit justifies
potential risk to the fetus. Since loratadine is excreted in
breast milk and because of the increased risk of loratadine
for infants, particularly newborns and premature infants, a
decision should be made whether to discontinue nursing or
discontinue the drug.
_Use in Children:_
Safety and efficacy of loratadine in children < 2 years have
not yet been established.
SIDE EFFECTS:
The incidence of adverse effects associated with loratadine
has been comparable to that of placebo. In controlled
paediatric clinical trials, the incidence of treatment-related
headache, sedation and nervousness, which were rarely
reported events, was similar to placebo.
DRUG INTERACTIONS:
When administered concomitantly with alcohol, loratadine
has no potential effects as measured by psychomotor
performance studies. Increase in plasma concentrations of
loratadine has been reported with concomitant use of
ketoconazole, erythromycin or cimetidine in controlled
clinical trials, but without clinically significant changes
(including electrocardiographic). Other drugs known to
inhibit hepatic metabolism should be co-administered with
caution
until
definitive
interaction
studies
can
be
completed. Plasma concentration for loratadine may be
increased by amprenavir.
OVERDOSAGE AND TREATMENT:
To date overdosage has not occurred with loratadine. A
single acute ingestion of 160mg produced no adverse
effects. In the event of overdosage, treatment which should
be started immediately, is symptomatic and supportive.
The patients should be induced to vomit even if emesis
has occurred spontaneously. Pharmacologically-induced
vomiting
by
the
administration
of