Ventolin 2mg/5ml Oral Solution

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

SALBUTAMOL

Διαθέσιμο από:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Φαρμακολογική κατηγορία (ATC):

R03AC02

INN (Διεθνής Όνομα):

SALBUTAMOL 2 mg/5ml

Φαρμακοτεχνική μορφή:

ORAL SOLUTION

Σύνθεση:

SALBUTAMOL 2 mg/5ml

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2005-09-12

Φύλλο οδηγιών χρήσης

1
GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN 2 MG/5 ML ORAL SOLUTION
SALBUTAMOL (AS 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet
IN THIS LEAFLET:
1
What Ventolin Oral Solution is and what it is used for
2
What you need to know before you take Ventolin Oral Solution
3
How to take Ventolin Oral Solution
4
Possible side effects
5
How to store Ventolin Oral Solution
6
Contents of the pack and other information
Ventolin 2 mg/5 ml Oral Solution (called ‘Ventolin Oral Solution’
in this leaflet) contains a
medicine called salbutamol. This belongs to a group of medicines
called fast acting
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 Oral Solution is used to treat breathing problems in adults,
adolescents and children
with asthma, bronchitis and emphysema.
DO NOT TAKE VENTOLIN ORAL SOLUTION:
•
if you are allergic (hypersensitive) to salbutamol sulfate or any of
the other ingredients of
Ventolin Oral Solution (listed in Section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before taking Ventolin Oral
Solution if:
•
you have high blood pressure
•
you are diabetic
•
you have an overactive thyroid gland
•
you have a history of heart problems such as an irregular or fast
heartbeat or angina
•
you suffer from acute severe asthma (your doctor may need to carry out
blood tests to
monitor the amount of potassium in yo

Αρχείο Π.Χ.Π.

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ventolin 2mg/5ml Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of solution contains 2mg salbutamol as salbutamol sulfate.
Excipient with known effect:
Sodium benzoate, benzyl alcohol, propylene glycol
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
A clear, colourless to pale straw coloured liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ventolin Oral Solution is indicated for the treatment or prevention of
bronchospasm. It
provides short acting bronchodilation in reversible airways
obstruction due to asthma and
chronic obstructive pulmonary disease (COPD) such as chronic
bronchitis and emphysema.
Ventolin Oral Solution is indicated in adults, adolescents and
children aged 2 to 12 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (over 18 years) _
10 to 20 ml of Oral Solution (4 to 8 mg salbutamol) three or four
times daily.
_Paediatric Population _
Children aged 2 to 6 years: 2.5 to 5 ml of Oral Solution (1 to 2 mg
salbutamol) three or four
times daily.
Children aged 6 to 12 years: 5 ml of Oral Solution (2 mg salbutamol)
three or four times
daily.
Children aged over 12 years: 5 to 10 ml of Oral Solution (2 to 4 mg
salbutamol) three or four
times daily.
_Special patient groups _
In elderly patients or in those known to be unusually sensitive to
beta-adrenergic stimulant
drugs, it is advisable to initiate treatment with 5ml of oral solution
(2 milligram salbutamol)
three or four times per day.
2
Method of Administration
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Increasing use of beta-2 agonists may be a sign of worsening asthma.
Under these conditions
a reassessment of the patient's therapy plan may be required and
concomitant
glucocorticosteroid therapy should be considered.
As there may be adverse effects associated with excessive dosing, the
dosage or frequency of
administration should only be increased on medical advice.
4.3
CON