BRICANYL TURBOHALER 500 Microgram Powder for Inhalation

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Preparatomtale Preparatomtale (SPC)
25-05-2024

Aktiv ingrediens:

TERBUTALINE SULFATE

Tilgjengelig fra:

B & S Healthcare

INN (International Name):

TERBUTALINE SULFATE

Dosering :

500 Microgram

Legemiddelform:

Powder for Inhalation

Resept typen:

Product subject to prescription which may be renewed (B)

Autorisasjon status:

Authorised

Autorisasjon dato:

0000-00-00

Informasjon til brukeren

                                PACKAGE LEAFLET: INFORMATION FOR THE USER 
 
BRICANYL
®
 TURBOHALER
®
 500MICROGRAMS PER METERED DOSE, 
INHALATION POWDER 
(terbutaline sulphate) 
 
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS 
MEDICINE. 
• 
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. Do not pass it on 
to others. It may harm them, even if their symptoms are the 
same as yours. 
• 
If any of the side effects get serious, or if you notice any side 
effects not listed in this leaflet, please tell your doctor or 
pharmacist. 
 
The name of your medicine is “Bricanyl
®
 Turbohaler
®
 
500micrograms per metered dose, inhalation powder”
but will be 
referred to as “Bricanyl Turbohaler“ throughout this leaflet. 
 
IN THIS LEAFLET: 
1.  What Bricanyl Turbohaler is and what it is used for 
2.  Before you use Bricanyl Turbohaler 
3.  How to use Bricanyl Turbohaler 
4.  Possible side effects 
5.  How to store Bricanyl Turbohaler 
6.  Further information 
 
1.  WHAT BRICANYL TURBOHALER IS AND WHAT IT IS USED FOR 
 
Bricanyl Turbohaler is an inhaler. It contains a medicine
called 
terbutaline. This belongs to a group of medicines called ‘beta-
agonists’. These work by relaxing certain muscles and
opening up 
the airways in the lungs. 
 
Bricanyl Turbohaler is used for asthma and other breathing 
problems where you have a tight chest and difficulty breathing. 
 
2.   BEFORE YOU USE BRICANYL TURBOHALER 
 
DO NOT USE BRICANYL TURBOHALER IF: 
 
• 
You are allergic (hypersensitive) to terbutaline or any of the 
other ingredients of Bricanyl Turbohaler (listed in Section 6: 
Further information). 
 
TAKE SPECIAL CARE WITH BRICANYL TURBOHALER 
 
Check with your doctor or pharmacist before using Bricanyl 
Turbohaler if: 
• 

                                
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Preparatomtale

                                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 UK:_
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 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. Consideration should be given to th
                                
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