Bricanyl Turbohaler 500 micrograms per metered dose, inhalation powder

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Terbutaline sulfate

Available from:

AstraZeneca AB

ATC code:

R03AC; R03AC03

INN (International Name):

Terbutaline sulfate

Dosage:

500 Mcg/Acutuation

Pharmaceutical form:

Inhalation powder

Therapeutic area:

Selective beta-2-adrenoreceptor agonists; terbutaline

Authorization status:

Marketed

Authorization date:

1989-02-07

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRICANYL
® TURBOHALER
® 500 MICROGRAMS PER METERED DOSE, INHALATION
POWDER
terbutaline sulfate
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.
WHAT IS IN THIS LEAFLET
1. What Bricanyl Turbohaler is and what it is used for
2. What you need to know before you use Bricanyl Turbohaler
3. How to use Bricanyl Turbohaler
4. Possible side effects
5. How to store Bricanyl Turbohaler
6. Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU USE BRICANYL TURBOHALER
DO NOT USE BRICANYL TURBOHALER:
•
If you are allergic to terbutaline.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Bricanyl Turbohaler if:
•
You have diabetes. If so, you may need some extra blood sugar tests
when you start using
Bricanyl Turbohaler.
•
You have a heart problem.
•
You have an overactive thyroid gland.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before
using Bricanyl Turbohaler.
Page 2 of 7
OTHER MEDICINES AND BRICANYL TURBOHALER
Tell your doctor or pharmacist if you are taking, have recently taken
or migh

Summary of Product characteristics

Health Products Regulatory Authority
18 January 2023
CRN00DC3S
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 delivered dose contains:
Terbutaline sulfate 400 micrograms (which corresponds to 500
micrograms metered dose).
Excipients with known effect
Bricanyl Turbohaler 500 micrograms/dose: each delivered dose contains
approximately 400 micrograms of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder.
A white inhaler comprising a blue turning grip, an integral dose
indicator and a white cover.
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
Posology
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.
Method of administration
Instructions for use and cleaning are provided in the Patient
Information Leaflet, which can be found in each pack.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance (terbutaline) or to any of
the excipients listed in section 6.1.
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. For further
information see section 4.9.
Patients who are prescribed regular anti-inflammatory therapy should
be advised to continue taking their anti-inflammatory
medi