Besonin Aqua Nasal Spray 64mcgdose

Country: Malaysia

Language: English

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

Active ingredient:

BUDESONIDE

Available from:

RIGEL PHARMA SDN. BHD.

INN (International Name):

BUDESONIDE

Units in package:

1units Units

Manufactured by:

Synmosa Biopharma Corporation

Patient Information leaflet

BESONIN AQUA NASAL SPRAY 64MCG/DOSE
Budesonide 64mcg/dose
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET
1. What Besonin Aqua is used for
2. How Besonin Aqua works
3. Before you use Besonin Aqua
4. How to use Besonin Aqua
5. While you are using it
6. Side effects
7. Storage and Disposal of Besonin Aqua
8. Product Description
9. Manufacturer and Product Registration
Holder
10. Date of Revision
WHAT BESONIN AQUA IS USED FOR
Besonin Aqua is used for running nose,
nasal congestion, sneezing and/or itching
in the nose caused by allergy and also for
so-called vasomotor rhinitis where the
cause may be e.g. smoke or perfume.
Besonin Aqua is also used for polyps in
the nose and after surgery for polyps in
order to reduce the risks of the
development of new polyps.
HOW BESONIN AQUA WORKS
Besonin Aqua is a cortisone preparation
that suppresses inflammation and allergic
reactions in the nose.
BEFORE YOU USE BESONIN AQUA
_- When you must not use it_
Do not use Besonin Aqua if you are
allergic (hypersensitive) to budesonide or
to any of the other ingredients of Besonin
Aqua.
_- Before you start to use it _
Take special care with Besonin Aqua

avoid Besonin Aqua coming into
contact with the eyes. If you get it in
your eyes, rinse them immediately
with water.

talk to your doctor before you start
using Besonin Aqua if you have any
of the following conditions:
-
fungal or herpes infection in the nose
-
tuberculosis
-
severe liver disease
Long-term treatment with high doses can
cause serious cortisone side effects. In
children this may manifest itself as
retarded growth.
_- Taking other medicines_
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
HOW TO USE BESONIN AQUA
_ _
_- How much to use _
Always use Besonin Aqua exactly as
your doctor has told you. You should
check with your doctor or pharmacist if
you are not sure.
If you have seasonal allergic rhinitis (hay
fever), you should try to star

Summary of Product characteristics

BESONIN AQUA NASAL SPRAY 64MCG/DOSE
budesonide
Nasal spray, suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.05 ml) contains budesonide 64 micrograms.
PRODUCT DESCRIPTION
Besonin Aqua Nasal Spray is a metered‐dose, manual‐pump spray
formulation containing a
micronized suspension of budesonide in an aqueous medium. It appears
as a white to almost white
suspension.
THERAPEUTIC INDICATIONS
Seasonal allergic and allergic/non‐allergic perennial rhinitis.
Treatment of nasal polyps. Prevention of
nasal polyps after polypectomy.
DOSAGE AND METHOD OF ADMINISTRATION
The posology must be adjusted individually.
_Rhinitis _
Adults and children from 6 years: The recommended initial dose is 256
micrograms daily. The dose
can be administered once daily in the morning or divided into two
administrations, morning and
evening. This means 128 micrograms (2 X 64 micrograms) into each
nostril in the morning or 64
micrograms into each nostril morning and evening.
No further effect has been seen with doses higher than 256 micrograms
per day.
For elderly patients the posology is the same as for adults.
When the desired clinical effect has been achieved, the dose should be
reduced to the lowest
amount that is needed to control the symptoms. A dose of 32 micrograms
in each nostril in the
morning may be sufficient for some patients.
In some patients relief of symptoms is already obtained within 5 – 7
hours after the start of
treatment. The full effect is only obtained after several days of
treatment (in rare cases not until
after 2 weeks). Treatment of seasonal rhinitis should therefore start
before exposure to the
allergens.
In case of severe nasal congestion an initial addition of a
vasoconstrictor may be required.
Supplementary treatment may sometimes be necessary in order to
counteract possible ocular
symptoms caused by the allergy.
_Symptomatic treatment and prevention of nasal polyps _
The recommended dose is 256 micrograms daily. The dose may be
administered once daily in the
morning or divided into two adminis