HALON

País: Malásia

Língua: inglês

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

Ingredientes ativos:

LORATADINE

Disponível em:

Prestige Pharma Sdn Bhd

DCI (Denominação Comum Internacional):

LORATADINE

Unidades em pacote:

100 Tablets; 300 Tablets; 500 Tablets

Fabricado por:

T.O. CHEMICALS (1979) LTD.

Folheto informativo - Bula

HALON
_Loratadine_
(10mg)
1
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What
_Halon_
is used for
2.
How
_Halon_
works
3.
Before you use
_Halon_
4.
How to use
_Halon_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Halon_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _HALON _IS USED FOR
_Halon _
contains the active ingredient
_Loratadine_
. It is used to relief symptoms
of allergic reactions.
HOW _HALON _WORKS
_Halon _
contains
_ Loratadine _
which belong
to a group
of antihistamine compound
that helps to stop histamine from
working in the body. In an allergic
reaction, the body releases histamine.
Histamine causes rashes, sneezing,
itching and other allergic ailments.
_ _
BEFORE YOU USE _HALON_
-
_When you must not use it_
_ _
Do not take
_ Halon _
if you:
_ _
Have ever had allergic reaction to
_ _
_Loratadine _
the active ingredient or to
any other ingredients in this product.
_ _
_ _
_If you are not sure whether you should _
_start taking this medicine, consult your _
_doctor. _
_ _
_PREGNANCY AND LACTATION _ _ _
Do not use
_Halon _
if you are pregnant,
trying to get pregnant or think you may
be pregnant.
Do not use
_Halon _
if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
_ _
-
_Before you start to use it _
Tell your doctor if you have allergies to
any other medicines, food, preservatives
or dyes.
Tell your doctor if you:
•
Have impaired liver function.
•
Are pregnant or think you are
pregnant.
•
Breast feeding or plan to breast
feed.
_Halon_
is not recommended for
children under 2 years of age.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
Some medicines and Halon may
interfere with each other. It is
important to tell your doctor or
pharmacist if you are taking:
•
Antibiotic; eg. Erythromycin to
treat bacterial in

Características técnicas

PLEASE READ CAREFULLY
CONTENT
Each tablet contains 10.0mg of loratadine
DESCRIPTION
A white oval, biplain tablets with bisec-line on one side and the word
“HALON” on the
other.
INDICATIONS
For relief of symptoms associated with allergic conditions.
RECOMMENDED DOSAGE
•
Adult and children over 12 years of age: 1 tablet (10mg) once daily
•
Children 2 – 12 years of age:
i) Body weight ≥ 30kg – 1 tablet (10mg) once daily
ii) Body weight ≤ 30kg – ½ tablet (5mg) once daily
For patients who have difficulties in swallowing the tablet form, the
tablet may be
crushed first and then mixed with a little bit of water for easy
administration.
ROUTE OF ADMINISTRATION
For oral administration.
CONTRAINDICATIONS
Halon is contraindicated in patients who are hypersensitive to
loratadine or to any of its
ingredients.
WARNINGS AND PRECAUTIONS
Halon
tablets
should
be
administered
with
caution
in
patients
with
severe
liver
impairment.
Administration of Halon should be discontinued at least 48 hours
before skin tests since
antihistamines may prevent or reduce otherwise positive reactions to
dermal reactivity
index.
DRUG INTERACTIONS
When administered concomitantly with alcohol, Halon have 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.
Increase in plasma concentrations of loratadine has been reported
after concomitant
use with ketoconazole, erythromycin and cimetidine in controlled
trials, but without
clinically significant changes (including electrocardiographic).
PREGNANCY AND LACTATION
Pregnancy
Large amount of data on pregnant women indicate no malformative nor
feto/neonatal
toxicity of loratadine. Animal studies do not indicate direct or
indirect harmful effects with
respect to reproductive toxicity. As a precautionary measure, it is
preferable to avoid the
use of Halon during pregnancy.
Breast-feeding
Loratadine is excreted