Ezede Oral Solution 1mgml

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

LORATADINE

Dostupné z:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (Medzinárodný Name):

LORATADINE

Počet v balení:

120 ml; 90 ml; 60 ml

Výrobca:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Príbalový leták

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
_ _
___________________________________________________________________________________________________________________________
_
_ _
1
WHAT IS IN THIS LEAFLET
1.
What is Ezede` Oral Solution used for
2.
How Ezede` Oral Solution works
3.
Before you use Ezede` Oral Solution
4.
How to use Ezede` Oral Solution
5.
While you are using Ezede` Oral Solution
6.
Side effects
7.
Storage and Disposal of Ezede` Oral Solution
8.
Product Description
9.
Manufacturer and Product Registration Holder
10.
Date of Revision
_ _
11.
Serial number
_ _
WHAT IS EZEDE` ORAL SOLUTION USED FOR
Relieves allergic conditions, such as:
•
nose
allergy
(sneezing,
itchy,
runny
and blocked nose, watery eyes)
•
skin allergy (swelling, red, scaly, flaky
and itchy skin)
HOW EZEDE` ORAL SOLUTION WORKS
Loratadine
is
the
antihistamine
which
prevents the release of histamine due to
allergic reaction. Histamine is a chemical
substance that released in the body as part
of an allergic reaction.
BEFORE YOU USE EZEDE` ORAL SOLUTION
_When you must not use it _
•
Do not use Ezede` Oral Solution if you
are allergic to any ingredients in this
medicine.
•
Do not use it for children below 2
years
old.
Safety
and
efficacy
of
Loratadine has not been established in
children younger than 2 years of age.
_ _
_Before you start to use it _
Tell your doctor or pharmacist before using
Ezede` Oral Solution if you:
•
are pregnant or plan to pregnant.
•
are
breast-feeding
or
plan
to
start
breast-feeding.
•
have liver or kidney problems.
•
have difficulty in digesting sugar.
_Using other medicines _
Tell your doctor or pharmacist if you are
taking or having recently taken any other
medicines. This includes any medicines
which you have bought without a
prescription.
HOW TO USE EZEDE` ORAL SOLUTION
_How much to use _
•
_Adults and children above 12 years old _
10ml (2 teaspoons) once daily.
•
_Children 6 to 12 years old_
Body weight >30kg: 10ml (2
teaspoons) once daily.
Body weight <30kg: 5ml (1 teaspoo

Súhrn charakteristických

EZEDE`
ORAL SOLUTION 1MG/ML
COMPOSITION
Each 5ml contains Loratadine 5mg.
Sodium Benzoate 0.1%w/v as preservative.
PHARMACODYNAMICS
Loratadine is a long-acting, non-sedating H
1
-antagonist antihistamine with no significant
antimuscarinic activity.
PHARMACOKINETICS
Loratadine is rapidly absorbed from the gastrointestinal tract after
oral doses, peak plasma
concentrations being attained in about 1 hour. Bioavailability is
increased and time to peak
plasma concentrations is delayed when taken with food.
Loratadine undergoes extensive metabolism. The major metabolite,
desloratadine has
potent antihistaminic activity. Reported mean elimination half-lives
for loratadine
and desloratadine are 8.4 and 28 hours respectively.
Loratadine is about 98% bound to plasma proteins and desloratadine is
less extensively
bound. Most of the dose is excreted equally in the urine and faeces,
mainly in the form of
metabolites.
INDICATIONS
Loratadine is indicated for the relief of symptoms associated with
allergic rhinitis, such as
sneezing, nasal discharge (rhinorrhea) and itching, as well as ocular
itching and burning.
Nasal and ocular signs and symptoms are relieved rapidly after oral
administration.
Loratadine is also indicated for relief of symptoms and signs of
chronic urticaria and other
allergic dermatologic disorders.
DOSAGE AND ADMINISTRATION
For oral use only.
Given as a single daily dose, with or without food.
•
Adults and Children 12 years of age and over: Two 5 ml spoonfuls (10
mg) once
daily.
•
Children 6 to 12 years of age:
Body Weight >30 kg: Two 5 ml spoonfuls (10 mg) syrup once daily.
Body Weight <30 kg: One 5 ml spoonful (5 mg) syrup once daily.
•
Children 2 to 6 years of age:
Body Weight >30 kg: Two 5 ml spoonfuls (10 mg) syrup once daily.
Body Weight <30 kg: One 5 ml spoonful (5 mg) syrup once daily.
Safety and efficacy of Loratadine has not been established in children
younger than
2 years of age.
Patients with severe liver impairment should be administered a lower
initial dose
because they may have reduced