Bricanyl Turbohaler 500 micrograms per metered dose, inhalation powder

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

TERBUTALINE SULFATE

Fáanlegur frá:

Imbat Limited

ATC númer:

R03AC; R03AC03

INN (Alþjóðlegt nafn):

TERBUTALINE SULFATE

Skammtar:

500 Mcg/Acutuation

Lyfjaform:

Powder for Inhalation

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Selective beta-2-adrenoreceptor agonists; terbutaline

Leyfisstaða:

Authorised

Leyfisdagur:

2012-08-03

Vara einkenni

Health Products Regulatory Authority
19 November 2019
CRN009GHC
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bricanyl Turbohaler 500 micrograms per metered dose, inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 500 micrograms terbutaline sulphate.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
_Product imported from United Kingdom_:
Multi-dose breath-actuated metered dose powder inhaler. White to
off-white spherical particles which break into a fine
powder on inhalation.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Terbutaline is a selective beta
2
-adrenergic agonist recommended for the relief and prevention of
bronchospasm in bronchial
asthma and in chronic bronchitis and other bronchopulmonary disorders
in which bronchospasm is a complicating factor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and Children:
One inhalation (500 micrograms) (metered dose) as required. Not more
than 4 inhalations should be necessary in any 24 hour
period.
ELDERLY:
Dosage as for adults.
Instructions for use and cleaning are provided in the Patient
Information Leaflet, which can be found in each pack.
4.3 CONTRAINDICATIONS
Bricanyl preparations are contra-indicated in patients with a history
of sensitivity to terbutaline sulphate.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients should be instructed in proper use and their inhalation
technique checked regularly.
With each inhalation a fraction of the delivered dose will be
deposited in the oral cavity. To minimize unnecessary systemic
exposure to terbutaline, the patients should be advised to, when
possible, rinse their mouth after each use.
If a previously effective dosage regimen no longer gives the same
symptomatic relief, the patient should urgently seek further
medical advice.
Health Products Regulatory Authority
19 November 2019
CRN009GHC
Page 2 of 5
Consideration should be given to the requirements for additional
therapy (including increased dosage