Nasobec 50 Micrograms Aqueous Nasal Spray

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Beclometasone dipropionate

Tilgjengelig fra:

Teva B.V.

ATC-kode:

R01AD01

INN (International Name):

Beclometasone dipropionate

Dosering :

50 microgram(s)

Legemiddelform:

Nasal spray, suspension

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

beclometasone

Autorisasjon status:

Marketed

Autorisasjon dato:

1999-03-04

Informasjon til brukeren

1
NASOBEC
TM 50 MICROGRAMS AQUEOUS NASAL SPRAY
BECLOMETASONE DIPROPIONATE
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

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.
IN THIS LEAFLET:
1.
WHAT NASOBEC IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NASOBEC
3.
HOW TO USE NASOBEC
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE NASOBEC
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT NASOBEC IS AND WHAT IT IS USED FOR
Nasobec contains beclometasone dipropionate, which belongs to a group
of medicines called corticosteroids.
Your medicine has anti-inflammatory properties.
Nasobec is used to prevent and treat:

Inflammation in the lining of your nose (rhinitis) due to seasonal
allergies, such as hayfever

Inflammation in the lining of your nose (rhinitis) due to year round
(perennial) allergies, such as animal
allergies.
Nasobec can also be used to delay the recurrence of polyps after a
nasal polypectomy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NASOBEC
DO NOT USE NASOBEC IF YOU:

are allergic (hypersensitive) to beclometasone dipropionate or any of
the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Nasobec if you:

suffer from or have a history of tuberculosis

suffer from a lowered resistance to disease (immunosuppression)

have an infection in your nose

have been taking steroids for a long time

are switching to Nasobec from any systemic steroid treatments.
Contact your doctor if you experience blurred vi

Preparatomtale

Health Products Regulatory Authority
15 January 2022
CRN00CQVS
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nasobec 50 Micrograms Aqueous Nasal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg spray contains 50 micrograms beclometasone dipropionate.
Excipients: contains benzalkonium chloride solution 0.02 microlitres.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, suspension.
A white opaque suspension, free from any visible matter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prophylaxis and treatment of perennial and seasonal allergic
rhinitis including hay fever and vasomotor rhinitis.
Nasobec is indicated in adults and children aged six years and over.
Nasobec can significantly delay the recurrence of nasal polyps after
nasal polypectomy. Where polyps do recur, Nasobec can
suppress their increase in size.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children over six years old_: Two sprays twice daily into
each nostril (400 mcg/day) is the recommendeddosage. It
may be preferable for some patients to administer a single spray into
each nostril three or four times daily. Once control has
been established it may be possible to maintain control with fewer
sprays. Dosage should be adjusted in each individual case
to the lowest dose that achieves effective control of the symptoms.
The maximum daily dose of 400 mcg (eight sprays) should not normally
be exceeded.
It should be made clear to patients that full therapeutic benefit will
only be achieved after a few days treatment.
_Elderly_: Dosage as for adults.
_Paediatric population:_
The safety and efficacy of Nasobec in children aged less than six
years old has not been established.
Method of administration
For administration by the intranasal route only.
4.3 CONTRAINDICATIONS
Hypersensitivity to beclomethasone dipropionate or any of the
excipients listed in section 6.1.
Health Products Regulatory Authority
15 January 2022
CRN00CQVS
Page 2 of 5
4.4 SPECIA