Rhinocort Aqua 64 nasal spray

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Budesonide

제공처:

Waymade Healthcare Plc

ATC 코드:

R01AD05

INN (국제 이름):

Budesonide

복용량:

64microgram/1dose

약제 형태:

Spray

관리 경로:

Nasal

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 12020100

환자 정보 전단

RHINOCORT
® AQUA, 64 MICROGRAMS, NASAL SPRAY
(budesonide)
PATIENT INFORMATION LEAFLET
Your medicine is known by the above name but will be referred to as
Rhinocort Aqua throughout this leaflet
IN THIS LEAFLET:
1) What Rhinocort Aqua is and what it is used for
2) What you need to know before you use Rhinocort Aqua
3) How to use Rhinocort Aqua
4) Possible side effects
5) How to store Rhinocort Aqua
6) Contents of the pack and other information
1) WHAT RHINOCORT AQUA IS AND WHAT IT IS USED FOR
Rhinocort Aqua contains a medicine called budesonide. This belongs to
a
group of medicines called corticosteroids.
•
Corticosteroids help to reduce and prevent inflammation.
•
Rhinocort Aqua is used to treat the symptoms of allergies, such as hay
fever, and rhinitis (inflammation inside the nose). Symptoms may
include sneezing, a runny, itchy or blocked nose.
•
Regular use of this nasal spray can reduce inflammation in the nose
and help prevent these symptoms.
•
It is also used to treat small growths inside the nose (nasal polyps).
You must talk to a doctor if you do not feel better or if you feel
worse
after 14 days.
2) WHAT YOU NEED TO KNOW BEFORE YOU USE RHINOCORT AQUA
This medicine is suitable for most people but a few people should not
use
it. If you are in any doubt, talk to your doctor or pharmacist.
DO NOT USE RHINOCORT AQUA:
•
If you have ever had a bad reaction to budesonide or any of the other
ingredients of this medicine (listed in section 6).
•
If you are under 18 years of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Rhinocort Aqua if:
•
You have had recent nose ulcers or nose surgery or you have a
nose injury that hasn’t healed properly.
•
You get heavy or frequent nose bleeds.
•
You have TB (tuberculosis), a chest infection, chicken pox or
measles, or you have been in contact with somebody who has
TB, chicken pox or measles.
•
You have ever had glaucoma (increased pressure in the eye), or
cataracts.
•
You have an eye infection.
•
You have diabetes.
•
Y

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rhinocort® Aqua 64 micrograms, nasal spray
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation contains: Budesonide 64 micrograms (1.28 mg/ml).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Nasal spray, suspension
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Seasonal and perennial allergic rhinitis and vasomotor rhinitis.
Treatment of nasal
polyps
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Dosage should be individualised.
RHINITIS (ADULTS INCLUDING THE ELDERLY)
Recommended
start dose
Once daily dosing
Twice daily dosing
256 micrograms
per day
Two applications of
64 micrograms into
each nostril each
morning
One application of 64
micrograms into each
nostril morning and
evening
If good effect is achieved, one application of 64 micrograms into each
nostril each morning.
Treatment of seasonal rhinitis should, if possible, start before
exposure to the
allergens. Treatment can be continued for up to 3 months_._
The dose should be titrated to the lowest dose at which effective
control of
symptoms is achieved.
NASAL POLYPS (ADULTS INCLUDING THE ELDERLY)
Recommended
dose
Once daily dosing
Twice daily dosing
256 micrograms
per day
Not applicable
One application of 64
micrograms into each
nostril morning and
evening.
RHINITIS AND NASAL POLYPS
The patient should be informed that the full effect of Rhinocort is
not achieved
until after a few days treatment.
Patients should be reminded of the importance of taking this medicine
regularly.
If symptoms are not controlled, or persist for longer than 2 weeks of
treatment,
medical advice must be sought.
PAEDIATRIC POPULATION: There are insufficient data to recommend the
use of
this medicine in children and adolescents under 18 years of age.
METHOD OF ADMINISTRATION
For nasal inhalation.
For further details on how to administer the medicine, see Section
6.6.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
4