RHINOCORT AQUA64MCGDOSE

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BUDESONIDE

Boleh didapati daripada:

JNTL (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

BUDESONIDE

Unit dalam pakej:

10 ml; 01Units Units

Dikeluarkan oleh:

McNeil AB

Risalah maklumat

RHINOCORT AQUA
64MCG/DOSE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Budesonide
WHAT IS IN THIS LEAFLET
1.
What RHINOCORT AQUA is used
for
2.
How RHINOCORT AQUA works
3.
Before you use RHINOCORT AQUA
4.
How to use RHINOCORT AQUA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
RHINOCORT AQUA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT RHINOCORT AQUA IS USED FOR
RHINOCORT AQUA is used to relieves
symptoms of seasonal or perennial allergic
rhinitis (nasal congestion, runny nose,
sneezing and itchy nose). It is also used for
the treatment of allergic rhinoconjuctivitis
(nasal congestion, runny nose, sneezing,
itchy and watery eyes).
RHINOCORT AQUA is also used for
treatment and prevention of nasal polyps
after polypectomy and relieves vasomotor
rhinitis.
HOW RHINOCORT AQUA WORKS
RHINOCORT AQUA is a cortisone
preparation that suppresses inflammation
and allergic reactions in the nose.
BEFORE YOU USE RHINOCORT AQUA
-
_When you must not use it _
Do not use
•
If you are allergy to budesonide
or to any of the other ingredients.
•
If you are pregnant, trying to get
pregnant or think you may be
pregnant.
•
If you are breast-feeding.
-
_Before you start use it _
Consult your doctor if you:
•
are using a steroid medicine for
conditions such as asthma, allergies
or skin rash.
•
have ever been diagnosed with
glaucoma (abnormally high pressure
in the eye), cataract (cloudy areas in
lens of the eye), or have an eye
infection, or if you have diabetes.
•
have or have been exposed to
someone who has tuberculosis,
chicken pox or measles.
•
have severe or frequent nosebleeds,
recent nose ulcers, nose surgery or
have a nose injury that has not healed
•
develop signs or symptoms of an
infection such as persistent fever
_Pregnancy and lactation _
This product should not be used during
pregnancy or lactation. Consult your
doctor before use.
This product may slow the growth rate in
some children when used in combination
with other steroids.
Ta

Ciri produk

1
1.
NAME OF THE MEDICINAL PRODUCT
Rhinocort Aqua, 64 mcg/dose
Budesonide (INN)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Table 1. Dosage Forms and Strengths
Dosage Form
Budesonide Strength
Suspension (Nasal Spray)
64 mcg
3.
PHARMACEUTICAL FORM
Budesonide is formulated for intranasal administration and available
as a nasal spray
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Relieves symptoms of seasonal or perennial allergic rhinitis (nasal
congestion, runny nose, sneezing and itchy nose)
•
Treatment of allergic rhinoconjunctivitis (nasal congestion, runny
nose,
sneezing, itchy nose, itchy and watery eyes)
•
Prevention of allergic rhinitis
UNDER THE SUPERVISION OF A HEALTHCARE PROFESSIONAL
•
Treatment of nasal polyps and prevention of nasal polyps after
polypectomy
•
Relieves symptoms of vasomotor rhinitis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Some symptoms may get better on the first day of treatment. It may
take up to two
weeks of daily use to feel the most symptom relief.
For prevention, start therapy before anticipated exposure to the
allergens
64 MCG PER SPRAY DOSE FORMULATION
ALLERGIC RHINITIS AND VASOMOTOR RHINITIS
2
Adults and Children 12 years and over:
•
Once daily, use up to 2 sprays in each nostril (256 mcg total daily
dose)
while sniffing gently. (Alternatively, total daily dose of 256 mcg may
be
administered in twice daily divided doses of 1 spray in each nostril
in the
morning and evening).
•
Once allergy symptoms improve, reduce dose to 1 spray in each nostril
daily
Children aged 6 to less than 12 years:
•
An adult should supervise use in children under age 12
•
Once daily, use 1 spray in each nostril (total dose 128 mcg) while
sniffing
gently
•
If symptoms do not improve, dose can be increased up to 2 sprays per
nostril (up to 256 mcg total daily dose) (Alternatively, total daily
dose of
256 mcg may be administered in twice daily divided doses of up to 1
spray in each nostril in the morning and evening).
•
Once allergy symptoms improve, reduce dose to 1 spray i