Benacort 64micrograms nasal spray

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Budesonide

Available from:

McNeil Products Ltd

ATC code:

R01AD05

INN (International Name):

Budesonide

Dosage:

64microgram/1dose

Pharmaceutical form:

Spray

Administration route:

Nasal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12020100; GTIN: 3574661373461

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
THIS MEDICINE IS AVAILABLE WITHOUT
PRESCRIPTION. ALWAYS USE THIS MEDICINE
EXACTLY AS DESCRIBED IN THIS LEAFLET OR
AS YOUR PHARMACIST HAS TOLD YOU.
■
Keep this leaflet. You may need to
read it again.
■
Ask your pharmacist if you need more
information or advice.
■
If you get any side effects, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet.See section 4.
■
You must talk to a doctor if you do not
feel better or if you feel worse after
14 days.
WHAT IS IN THIS LEAFLET
1.
What Benacort™ is and what it is
used for
2.
What you need to know before you
use Benacort™
3.
How to use Benacort™
4.
Possible side effects
5.
How to store Benacort™
6.
Contents of the pack and other
information
1. WHAT BENACORT™ IS AND
WHAT IT IS USED FOR
This nasal spray contains a medicine
called budesonide. This belongs to a
group of medicines called corticosteroids.
■
Corticosteroids help to dampen down
and prevent inflammation.
■
This nasal spray is used to treat
inflammation in the nose that can
occur as a result of an allergy to
things such as pollen. The
inflammation causes the nose to be
blocked and results in sneezing, these
are typical symptoms of hay fever.
■
Regular use of this nasal spray over
several days can reduce inflammation
in the nose and help prevent these
symptoms.
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 BENACORT™
DO NOT USE BENACORT™:
■
If you are allergic to budesonide or
any of the other ingredients of this
medicine (listed in section 6).
■
If you are under 18 years of age.
Do not use this nasal spray if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
using it.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
using Benacort™ if:
■
You have an infection of your nose o

Summary of Product characteristics

OBJECT 1
BENACORT 64 MICROGRAMS NASAL SPRAY
Summary of Product Characteristics Updated 10-Jan-2018 | McNeil
Products Ltd
1. Name of the medicinal product
Benacort 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 (nasal spray).
4. Clinical particulars
4.1 Therapeutic indications
Prevention and treatment of seasonal allergic rhinitis (hay fever).
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
OR
If good effect is achieved, one
application of 64 micrograms
One application of 64 micrograms into each
nostril morning and evening
The minimum dose should be used at which effective control of symptoms
is maintained. The patient
should be informed that the full effect of Benacort is not achieved
until after a few days treatment.
Treatment of seasonal rhinitis should, if possible, start before
exposure to the allergens. If symptoms are
not controlled, or persist for longer than 2 weeks of treatment,
medical advice must be sought.
Concomitant treatment may sometimes be necessary to counteract eye
symptoms caused by the allergy.
Benacort should not be used continuously for longer than 3 months
without consulting your doctor or
pharmacist.
Patients should be reminded of the importance of taking this medicine
regularly.
The dose should be titrated to the lowest dose at which effective
control of symptoms is achieved.
PAEDIATRIC POPULATION: This spray should not be used in children and
adolescents under 18 years of age.
There is insufficient data to recommend the use of Benacort in
children.
METHOD OF ADMINISTRATION
For nasal inhalation.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
li