Lorsedin Oral Solution 1mgml

Country: Malaysia

Language: English

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

Active ingredient:

LORATADINE

Available from:

SPG PHARMA (MALAYSIA) SDN BHD

INN (International Name):

LORATADINE

Units in package:

60mL x 1 bottle BOTTLE

Manufactured by:

SIAM BHEASACH CO LTD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LORSEDIN
®
ORAL SOLUTION
Loratadine
(1mg/ml)__________________________________________________________________
_____________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What LORSEDIN® is used
for
2.
How LORSEDIN® works
3.
Before
you
use
LORSEDIN®
4.
How to use LORSEDIN®
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
LORSEDIN®
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT
LORSEDIN®
IS
USED
FOR
LORSEDIN® is used to relief
symptoms
of
sneezing,
runny
nose,
itching;
red,
itchy,
and
watery eyes. It is also indicated
for chronic urticaria (red, raised,
itchy
rash)
and
other
allergic
skin disorder.
HOW LORSEDIN® WORKS
LORSEDIN® belongs to a class
of
medications
called
antihistamines.
It
works
by
blocking
the
action
of
histamines,
a
substance
in
the
body
that
causes
allergic
reaction:
sneezing,
itching,
watery eyes, and running nose.
BEFORE YOU USE LORSEDIN®
-_When you must not use it_
Do not use LORSEDIN® if:


you
are
allergic
to
loratadine
or
any
of
the
ingredients listed under the
_Ingredients _ section of this_ _
leaflet.

-_Before you start to use it_
You
must
tell
your
healthcare
professional if you:

have liver problems

_Pregnancy and breastfeeding_
_:_
Talk to your doctor if you are
pregnant,
might
become
pregnant
or
are
breastfeeding
before taking this medicine.
Loratadine
is
excreted
into
breast
milk
and
due
to
the
increased risk of antihistamine
for
infants,
particularly
new
born
and
premature
infants,
a
decision
should
be
made
whether to discontinue nursing
or discontinue the drug.
-_Taking other medicines_
Tell
your
healthcare
professional
if
you
are
taking
any other medicines, including
medicines that you buy without
a prescription from a pharmacy,
supermarket
or
health
food
shop.
Medications
which
affect
the
liver
should
be
used
with
caution.
HOW TO USE LORSEDIN®
-_How much to take_
_Adults and Chil

Summary of Product characteristics

WARNING AND PRECAUTION :-
Loratadine should be administered with caution in patients with severe
liver
impairment. The administration of Loratadine Products should be
discontinued
at least 48 hours before skin tests since antihistamines may prevent
or reduce
otherwise positive reactions to dermal reactivity index.
Effects on ability to drive and use machines
No impairment occurred in patients receiving loratadine. However,
patients should
be informed that very rarely some people experience drowsiness, which
may affect
their ability to drive or use machines.
ADVERSE DRUG REACTIONS :-
In paediatric population, children aged 2 through 12 years, common
adverse reactions
reported in excess of placebo were headache, nervousness and fatigue.
The most frequent adverse reactions in adults and adolescents were
somnolence,
headache, increased appetite and insomnia. Other adverse reactions
reported very
rarely during the post-marketing period are listed below.
Immune system disorders
Anaphylaxis
Nervous system disorders
Dizziness
Cardiac disorders
Tachycardia, palpitation
Gastrointestinal disorders
Nausea, dry mouth, gastritis
Hepatobiliary disorders
Abnormal hepatic function
Skin and subcutaneous tissue disorders
Rash, alopecia
General disorders and administration site conditions
Fatigue
DRUG INTERACTIONS :-
When administered concomitantly with alcohol, loratadine has no
potentiating
effects as measured by psychomotor performance studies. Potential
interaction
may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in
elevated
levels of loratadine which may cause an increase in adverse events.
SYMPTOMS AND TREATMENT OF OVERDOSE :-
Overdosage with loratadine increase the occurrence of anticholinergic
symptoms.
Somnolence, tachycardia and headache have been reported with
overdoses. In the
event of overdose, general symptomatic and supportive measures are to
be instituted
and maintained for as long as necessary. Administration of activated
charcoal as
a slurry with water may be attempted. Gastric lavage may be
consid