Beconase 50mcg Nasal Spray Suspension

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

BECLOMETASONE DIPROPIONATE

Доступна с:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

код АТС:

R01AD01

ИНН (Международная Имя):

BECLOMETASONE DIPROPIONATE 50 µg

Фармацевтическая форма:

NASAL SPRAY, SUSPENSION

состав:

BECLOMETASONE DIPROPIONATE 50 µg

Тип рецепта:

POM

Терапевтические области:

NASAL PREPARATIONS

Статус Авторизация:

Withdrawn

Дата Авторизация:

2006-11-01

тонкая брошюра

1
Package Leaflet: Information for the user
BECONASE
NASAL SPRAY, SUSPENSION
BECLOMETASONE DIPROPIONATE
50 MICROGRAM
Beclometasone diproriate as monohydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
Contact your doctor if your situation worsens or if your situation
does not improve in 3-4 days.
•
If you get any of the side effects, talk to your doctor or pharmacist.
This includes any possible
side effects not listed in the leaflet. See section 4.
See the newest leaflet on www.indlaegsseddel.dk
WHAT IS IN THIS LEAFLET
:
1. What Beconase is and what it is used for
2. What you need to know before you use Beconase
3. How to use Beconase
4. Possible side effects
5. How to store Beconase
6. Contents of the pack and other information
1
WHAT BECONASE IS AND WHAT IT IS USED FOR
Beconase nasal spray contains a hormone, which prevents swelling and
irritation of the nose because
of allergy with itching, clogged and/or running nose.
Beconase nasal spray can be used for preventing hayfever and the
year-round cold.
If your doctor said that you must use Beconase for something else, you
must always follow the
doctor’s directions.
Contact your doctor if your situation worsens or if your situation
does not improve within 3-4 days.
2
WHAT YOU NEED TO KNOW BEFORE YOU BEGIN USING BECONASE
DO NOT USE BECONASE IF:
•
you are allergic to beclometasone dipropionate or any of the other
ingredients of this medicine
(listed in section 6).
Contact your doctor if you experience blurred vision or other visual
disturbances.
OTHER MEDICINES AND BECONASE
Please tell your doctor or the pharmacy staff if you are taking or
have recently taken any other
medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Beconase and your doctor
may wish to monitor you
carefully if you are taking these m

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Beconase
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1
dose
contains
beclomethasone
dipropionate
monohydrate
equal
to
50
micrograms Beclomethasone Dipropionate.
Excipient which the health worker should be aware of
Benzalkonium Chloride (see section 4.4)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Nasal spray, suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Preventive, local steroid treatment of hayfever, year-round rhinitis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE
Adults above 18
0.1 mg (2 sprays) in each nostril 2 twice daily.
Maximal daily dose 400 micrograms (8 sprays).
Must be used every day for maximal effect.
The effect occurs within 12-25 hours – after use some times – and
full
effect after 3-4 days.
Administration
Only for intranasal use.
Beconase should not be used for children without a doctor’s
direction.
Should not be used for more than 3 months without a doctor’s
direction.
Shake before use.
4.3
CONTRA-INDICATIONS
Hypersensitivity to the active substance or any of the excipients
listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Infection in the nasal passages and sinuses should be treated
appropriately but
are not a specific contraindication for treatment with Beconase.
Caution should be shown by changing to Beconase from systemic steroid
treatment if there is suspicion of reduced adrenal cortical function.
Systemic effects of nasal corticosteroids may occur, particularly at
high doses
prescribed for prolonged periods. These effects are much less likely
to occur
than with oral corticosteroids and may vary in individual patients and
between
different corticosteroid preparations. Potential systemic effects may
include
Cushing’s
syndrome,
Cushingoid
features,
adrenal
suppression,
growth
retardation in children and adolescents, cataract, glaucoma and more
rarely, a
range
of
psychological
or
behavioural
effects
including
psychomotor
hyperactivity, sleep disorde