ALLOR (LORATADINE ORAL SOLUTION 5MG5ML USP)

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

LORATADINE

Disponible depuis:

UNIMED SDN BHD

DCI (Dénomination commune internationale):

LORATADINE

Unités en paquet:

60 ml

Fabriqué par:

XL Laboratories Pvt. Ltd.

Notice patient

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
ALLOR (LORATADINE ORAL SOLUTION
5MG/5ML USP)
Loratadine (5mg/5ml)
WHAT IS IN THIS LEAFLET
1.
What ALLOR is used for
2.
How ALLOR works
3.
Before you use ALLOR
4.
How to use ALLOR
5.
While you are using it
6.
Side effects
7.
Storage
and Disposal of
ALLOR
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ALLOR IS USED FOR
Allor is used to relieve the
symptoms of hayfever (allergic
rhinitis) in adults and children
over the age of 2 years, which
include:
•
sneezing
•
irritated, runny or blocked nose
•
itchy, red and watering eyes
It is also used to relieve the
symptoms of skin allergies in
adults and children (over the age
of 2 years), which include:
•
rash, itching and urticaria
(hives)
HOW ALLOR WORKS
Allor belongs to a group of
medicines called antihistamines.
It works by counteracting the
effects of histamine which is
produced naturally by your body's
defence system, but may be over-
produced in allergic reactions
BEFORE YOU USE ALLOR
-
_When you must not use it _
Do not use ALLOR if:
•
allergic to loratadine, or any of
the
other
ingredients
of
this
medicine
•
pregnant or planning to become
pregnant.
•
breast-feeding, as loratadine can
pass into breast milk.
-
_Before you start to use it _
You must tell your healthcare
professional if you:
•
you have severe liver problems
•
you have a hereditary intolerance
to some sugars.
Allor should not be taken for 48
hours before a skin test, since it
may affect the results.
_Pregnancy and breastfeeding _
Do not take this medicine if you are
pregnant or if you are breast-
feeding
_Children _
Do not give Allor to children
younger than 2 years old.
-
_Taking other medicines _
Tell your doctor or pharmacist if
you are taking, have recently taken
or might take any other medicines,
including medicines obtained
without a prescription.
There are some medicines which
may increase the risk of side-
effects.
Especially, tell your doctor if you
are taking any of the

Résumé des caractéristiques du produit

Size: 165x120 mm
c. Paediatric population
In clinical trials in a paediatric population children aged 2 through
12 years, common
adverse reactions reported in excess of placebo were headache (2.7%),
nervousness
(2.3%), and fatigue (1%).
DRUG INTERACTION:
When administered concomitantly with alcohol, Loratadine Oral Solution
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.
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).
Paediatric population
Interaction studies have only been performed in adults.
STORAGE CONDITON:
0
Store at temperatures not exceeding 30 C.
Jauhkan daripada capaian kanak-kanak.
Keep out of reach of children.
This medicinal product contains sucrose; patients with rare hereditary
problems of
fructose
intolerance,
glucose-galactose
malabsorption
or
sucrase-isomaltase
insufficiency should not take this medicine
PREGNANCY:
_Pregnancy_
A large amount of data on pregnant women (more than 1000 exposed
outcomes)
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 Loratadine
Oral Solution
during pregnancy.
_Breast-feeding_
Loratadine is excreted in breast milk, therefore the use of loratadine
is not
recommended in breast-feeding women.
_Fertility_
There are no data available on male and female fertility.
ADVERSE EFFECTS:
a. Summary of the safety profile
In clinical trials involving adults and adolescents in a range of
indications including AR
and CIU, at the recommended dose of 10mg daily, adverse reactions with
loratadine
were reported in 2% of pati