BRICANYL TURBOHALER

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Nusipirk tai dabar

Pakuotės lapelis Pakuotės lapelis (PIL)
06-07-2018
Prekės savybės Prekės savybės (SPC)
17-11-2015

Veiklioji medžiaga:

TERBUTALINE SULFATE

Prieinama:

AstraZeneca UK Limited

ATC kodas:

R03AC03

INN (Tarptautinis Pavadinimas):

TERBUTALINE SULFATE

Dozė:

500 Mcg/Acutuation

Vaisto forma:

Powder for Inhalation

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

terbutaline

Autorizacija statusas:

Marketed

Leidimo data:

1989-02-07

Pakuotės lapelis

                                619083-A01
11-04-18
PS13298
AZL045A
6642
N/A
VS
Bricanyl Turbuhaler 0.5mg Leaflet:
Patient IE
Black
Technical Info
Profile
BODY TEXT SIZE
11.0 pt
SMALLEST TEXT SIZE
6.0 pt
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.
Other medicines and Bricanyl Turbohaler
Tell your doctor or pharmacist if you are taking,
have recently take
                                
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Prekės savybės

                                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 Sulfate.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation Powder.
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
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.
Older people:
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.
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.
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 the requirements for additional
therapy (including increased
dosages of anti-inflammatory medication).
Severe exacerbations of asthma should be treated as an emergency in
the
usual manner.
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