Easyhaler Salbutamol sulfate 100micrograms/dose dry powder inhaler

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Salbutamol

זמין מ:

Orion Pharma (UK) Ltd

קוד ATC:

R03AC02

INN (שם בינלאומי):

Salbutamol

כמות:

100microgram/1dose

טופס פרצבטיות:

Inhalation powder

מסלול נתינה (של תרופות):

Inhalation

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 03010101; GTIN: 6432100007957

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
EASYHALER SALBUTAMOL SULFATE
100 AND 200 MICROGRAMS/DOSE INHALATION POWDER
Salbutamol sulfate (salbutamol)
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, pharmacist or
asthma nurse.
• 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 Easyhaler Salbutamol is and what it is used for
2. What you need to know before you use Easyhaler Salbutamol
3. How to use Easyhaler Salbutamol
4. Possible side effects
5. How to store Easyhaler Salbutamol
6. Contents of the pack and other information
1. WHAT EASYHALER SALBUTAMOL IS AND WHAT IT IS USED FOR
WHAT IS EASYHALER SALBUTAMOL?
Easyhaler Salbutamol is a “reliever” inhaler. The active
ingredient is salbutamol, an asthma
medicine, which opens up the airways. Salbutamol has a quick effect
and a short duration of
action (4 to 6 hours).
WHAT IS EASYHALER SALBUTAMOL USED FOR?
Salbutamol is used to relieve symptoms of asthma and other asthma-like
conditions such as chest
tightness, wheezing and coughing in adults and children aged 4 years
and over. It is also used for
prevention of asthma symptoms brought on by exercise or a known
allergen exposure that cannot
be avoided.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE EASYHALER SALBUTAMOL
DO NOT USE EASYHALER SALBUTAMOL:
• if you are allergic to salbutamol or the other ingredient of this
medicine (listed in section 6),
which is lactose (which contains small amounts of milk protein)
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before using Easyhaler
Salbutamol if you have any of
the following:
• any diseases a

מאפייני מוצר

OBJECT 1
EASYHALER SALBUTAMOL 100MCG
Summary of Product Characteristics Updated 04-Oct-2016 | Orion Pharma
(UK) Limited
1. Name of the medicinal product
Easyhaler Salbutamol Sulfate 100 micrograms per actuation inhalation
powder
2. Qualitative and quantitative composition
Metered dose delivery 100 mcg of Salbutamol per actuation as
Salbutamol Sulfate Ph.Eur.
Excipient with known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
White or almost white odourless powder intended for respiratory use by
oral inhalation
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of asthma attacks and exacerbations of asthma in
adults and children aged 4 years
and over. Prevention of exercise-induced bronchospasm or before
exposure to a known unavoidable
allergen challenge. Symptomatic treatment of broncho-asthma and other
conditions associated with
reversible airways obstruction.
Salbutamol provides a short-acting bronchodilation with fast onset of
action in reversible airways
obstruction due to asthma.
Easyhaler Salbutamol Sulfate should be used to relieve symptoms when
they occur and to prevent them in
those circumstances recognised by the patient to precipitate an attack
(e.g. before exercise or unavoidable
allergen exposure).
Salbutamol is valuable as a rescue medication in mild, moderate or
severe asthma, provided that reliance
on it does not delay the introduction and use of regular inhaled
corticosteroid therapy.
Easyhaler Salbutamol Sulfate is indicated in adults, adolescents and
children aged 4 to 11 years.
4.2 Posology and method of administration
Posology
_Adults and Older people_:
For the relief of acute bronchospasm and for managing intermittent
episodes of asthma, one inhalation
(100 micrograms) may be administered as a single starting dose; this
may be increased to two inhalations
(200 micrograms) if necessary.
To prevent exercise-induced bronchospasm _or allergen bronchospasm_
two inhalations (200 micrograms)
should be taken before _challen