SUNADINE SYRUP 5MG5ML

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

LORATADINE

Tersedia dari:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nama Internasional):

LORATADINE

Unit dalam paket:

60 ml; 100 ml; 120 ml; 1000 ml; 100 ml mL; 120 ml mL; 60 ml mL

Diproduksi oleh:

SUNWARD PHARMACEUTICAL SDN. BHD.

Selebaran informasi

SUNADINE TABLET 10MG /
SUNADINE SYRUP 5MG/5ML
Loratadine (10mg, 5mg/5ml) 1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What Sunadine Tablet/Syrup is used for
2. How Sunadine Tablet/Syrup works
3. Before you use Sunadine Tablet/Syrup
4. How to use Sunadine Tablet/Syrup
5. While you are using it
6. Side effects
7. Storage and Disposal of Sunadine Tablet/
Syrup
8. Product Description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT SUNADINE TABLET/SYRUP IS USED FOR
It
is
used
to
relieve
symptoms
associated
with;

seasonal allergic rhinitis (such as sneezing,
stuffy nose, and throat itchy due to inflam-
mation of the mucous membrane inside the
nose and throat).

long
term
hives
(associated
with
skin
swelling, redness, itchiness, patches).

other skin allergic disorders due to certain
allergens.
HOW SUNADINE TABLET/SYRUP WORKS
The active
ingredient
in the medicine is
Loratadine.
Loratadine
is
anti-histamine
which
work
by
blocking
a
certain
natural
substance (histamine) that your body makes
during an allergic reaction.
BEFORE YOU USE SUNADINE TABLET/SYRUP
_- When you must not use it _
Do not take Sunadine Tablet/Syrup if you are
hypersensitivity
to
Loratadine
or
any
ingredients listed at the end of this leaflet.
_- Before you start to use it _
Talk to your doctor before taking Sunadine
Tablet/Syrup, if you have:

liver problem

kidney problem

glaucoma
(increased
pressure
inside
the
eye).

difficulty in urination due to enlargement of
prostate gland.

epilepsy (fits).
_Pregnancy and breastfeeding _
You should check with your doctor if you are
pregnant
or
think
you
may
be
pregnant,
planning to become pregnant or if you are
breastfeeding. Loratadine have been detected
in breast milk. It is not recommended for
pregnant women and nursing mothers unless
the expected benefit outweighs any potential
risks.
_Children _
Use with caution and on doctor's/pharmacist's
advice in children younger than 2 years of age
Safety and effectiveness in childre

Karakteristik produk

SUNADINE TABLET 10MG/
SUNADINE SYRUP 5MG/5ML
Tablet : Loratadine 10mg / tablet
Syrup : Loratadine 5mg / 5ml
FURTHER INFORMATION CONCERNING THIS DRUG CAN BE OBTAINED FROM YOUR
FAMILY PHYSICIAN
/ LOCAL GENERAL PRACTITIONER / PHARMACIST.
Manufacturer & Product Registration Holder:
SUNWARD PHARMACEUTICAL SDN. BHD.
No. 9, 11 & 17, Jalan Kempas 4,
Taman Perindustrian Tampoi Indah,
81200 Johor Bahru, Johor, Malaysia.
CL673A-R10
Revision Date: 21/10/2022
Children 2-6 years of age:
Body weight > 30kg
Body weight ≤ 30kg
Category
Adults and children 12 years
of age and over:
Two 5ml spoonful (10mg) syrup once daily.
One 5ml spoonful (5mg) syrup once daily.
One tablet (10mg)/Two 5ml spoonful (10mg) syrup once daily.
Half a tablet (5mg)/One 5ml spoonful (5mg) syrup once daily.
One tablet (10mg)/Two 5ml spoonful (10mg) syrup once daily.
Dose
Children 6-12 years of age:
Body weight > 30kg
Body weight ≤ 30kg
PRODUCT DESCRIPTION:
Tablet : Oval, white, convex, film-coated tablet with single score on
one side only.
Syrup : A clear, colourless syrup with peach flavour.
PHARMACODYNAMICS:
Antihistamines (loratadine) diminish or abolish the main actions of
histamine in the body by competitive,
reversible blockade of histamine receptor sites on tissues. Histamines
H
1
-receptors are responsible for
vasodilatation, increased capillary permeability, flare and itch
reactions in the skin, and to some extent for
contraction of smooth muscle in the bronchi and gastrointestinal
tract.
Loratadine is a long-acting tricyclic antihistamine with selective
peripheral histamine H
1
-receptor
antagonistic activity. Studies have been shown that neither loratadine
nor its metabolites readily cross the
blood-brain barrier. It has higher affinity for the peripheral rather
than the central nervous system
H
1
-receptors. Hence, less problem of daytime sedation for those who have
to drive or operate machinery.
PHARMACOKINETICS:
It is rapidly absorbed from the gastrointestinal tract after oral
administration. The peak plasma concentration is
being attai