Ventolin Accuhaler Inhalation Powder 200mcg

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

SALBUTAMOL SULFATE

متاح من:

Glaxo Wellcome UK Limited

ATC رمز:

R03AC02

INN (الاسم الدولي):

SALBUTAMOL SULFATE

الشكل الصيدلاني:

INHALATION POWDER

تركيب:

SALBUTAMOL SULFATE 200 µg

نوع الوصفة الطبية :

POM

المجال العلاجي:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

الوضع إذن:

Authorised

نشرة المعلومات

Reason for update: GDS025 Revised contraindication to specify non-IV
formulations contraindicated in obstetrics + QRD
version 9 + Excipients guidelines
MHRA Approval Date: 09/07/2015
Text Date: 12/03/2015
Text Issue and Draft No: Issue 3 draft 2 annotated
SPC Issue and Draft No.: Issue 3 draft 1
Agile Ref: TBC
- 1 -
GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN
® ACCUHALER
® 200 micrograms
SALBUTAMOL SULFATE
[PRODUCT PICTURE WITH PART DESCRIPTIONS]
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 Accuhaler is and what it is used for
2
What you need to know before you use Ventolin Accuhaler
3
How to use Ventolin Accuhaler
4
Possible side effects
5
How to store Ventolin Accuhaler
6
Contents of the pack and other information
1
WHAT VENTOLIN ACCUHALER IS AND WHAT IT IS USED FOR
Ventolin Accuhaler 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 Accuhaler is used to treat breathing problems in people with
asthma and similar
conditions. This includes relieving and preventing asthma brought on
by exercise or other
“triggers”. These are things, which bring on asthma symptoms in
some people. Common
triggers include house dust, pollen, cats, dogs and cigarette smoke.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ventolin Accuhaler 200 micrograms
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ventolin Accuhaler is a plastic inhaler device containing a foil strip
with 60 regularly spaced
blisters each containing a mixture of 200 micrograms of microfine
salbutamol (as sulfate) and
larger particle lactose.
Excipients with known effect: Contains Lactose monohydrate 12.5
mg/blister (see section 4.4).
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Multi-dose dry powder inhalation device.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ventolin Accuhaler is indicated in adults, adolescents and children
aged 4 to 11 years.
Ventolin Accuhaler can be used in the management of asthma,
bronchospasm and/or reversible
airways obstruction.
Ventolin Accuhaler is particularly suitable for the relief of asthma
symptoms. It should be used to
relieve symptoms when they occur, and to prevent them in those
circumstances recognised by the
patient to precipitate an asthma attack (e.g. before exercise or
unavoidable allergen exposure).
Ventolin Accuhaler is particularly valuable as relief medication in
mild, moderate
or severe asthma, provided that reliance on it does not delay the
introduction and use of regular
inhaled corticosteroid therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ventolin Accuhaler is for inhalation use only. Ventolin Accuhaler is
suitable for many patients
including those who cannot use a metered-dose inhaler successfully.
Adults (including the elderly)_ _
For the relief of acute bronchospasm, 200 micrograms as a single dose.
The maximum daily dose
is 200 micrograms four times a day.
To prevent allergen- or exercise-induced symptoms, 200 micrograms
should be taken
10-15 minutes before challenge.
_ _
Paediatric Population
_ _
_Relief of acute bronchospasm _
Children aged 4 to 11 years 200 micrograms as required.
Children aged 12 years and over: Dose as per adult population.
_Prevention of allergen or exercise-induced bronchospasm _