Ventolin Syrup

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

SALBUTAMOL

Dostupno od:

Glaxo Wellcome UK Limited

ATC koda:

R03AC02

INN (International ime):

SALBUTAMOL

Farmaceutski oblik:

SYRUP

Sastav:

SALBUTAMOL 2 mg/5ml

Tip recepta:

POM

Područje terapije:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Status autorizacije:

Authorised

Datum autorizacije:

2005-09-12

Uputa o lijeku

Reason for Update:

Update in-line with QRD Version 09   
MHRA Approval Date: 29/10/2014 
Text Date: 04/12/13 
Text Issue No.: 3 Draft No.: 1 
SPC Issue No 4 Draft No 2 

1 
GSK LOGO 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
VENTOLIN
®
 SYRUP 
SALBUTAMOL SULFATE 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING 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, nurse 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, nurse or pharmacist. This includes any 
possible
side effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET:  
1 
What Ventolin Syrup is and what it is used for  
2 
What you need to know before you take Ventolin Syrup  
3 
How to take Ventolin Syrup   
4 
Possible side effects  
5 
How to store Ventolin Syrup 
6 
Contents of the pack and other information  

1  
WHAT VENTOLIN SYRUP IS AND WHAT IT IS USED FOR  
Ventolin Syrup contains a
medicine called salbutamol. This belongs to a group
of medicines 
called bronchodilators.  

  Bronchodilators help the airways in
your lungs to stay open. This makes it easier for air 
to get in and out. 

  They help to relieve chest tightness, wheezing and cough. 

Ventolin Syrup is used to treat breathing problems in people with
asthma and similar 
conditions. The syrup is used
when children and adults cannot use an inhaler device. 

2 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENTOLIN SYRUP  
DO NOT TAKE VENTOLIN 

Svojstava lijeka

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1. NAME OF THE MEDICINAL PRODUCT
Ventolin
Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 2 mg Salbutamol (as Salbutamol Sulfate BP).
Excipient with known effect:
Sodium
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Syrup
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ventolin syrup is indicated in adults, adolescents and children aged 2
to 12
years.
Salbutamol is a selective beta-2 adrenoceptor agonist providing
short-acting
(4-6 hour) bronchodilatation in reversible airways obstruction.
Ventolin syrup
can be used in the management of asthma, bronchospasm and/or
reversible
airways obstruction.
Relief of bronchospasm in bronchial asthma of all types.
Ventolin syrup is suitable oral therapy for children and adults who
are unable
to use an inhaler device.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral
Adults
Page 2 of 9
The minimum starting dose is 2mg three times a day given as 5ml syrup.
The
usual effective dose is 4mg (10ml syrup) three or four times a day,
which may
be increased to a maximum of 8mg (20ml syrup) three or four times a
day if
adequate bronchodilation is not obtained.
Elderly
In elderly patients or in those known to be unusually sensitive to
beta-
adrenergic stimulant drugs, it is advisable to initiate treatment with
the
minimum starting dose.
Paediatric Population
2 - 6 years: the minimum starting dose is 1mg as 2.5ml of syrup three
times
daily. This may be increased to 2mg as 5ml of syrup three or four
times daily.
6-12 years: the minimum starting dose is 2mg as 5ml syrup three times
daily.
This may be increased to four times daily.
Over 12 years: the minimum starting dose is 2mg three times daily
given as
5ml syrup. This may be increased to 4mg as 10ml syrup three or four
times
daily.
Ventolin is well tolerated by children so that, if necessary, these
doses may be
cautiously increased to the maximum dose.
For lower doses the syrup may be diluted with freshly pr