Easyhaler Beclometasone 200micrograms/dose dry powder inhaler

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Beclometasone dipropionate

Saadav alates:

Orion Pharma (UK) Ltd

ATC kood:

R03BA01

INN (Rahvusvaheline Nimetus):

Beclometasone dipropionate

Annus:

200microgram/1dose

Ravimvorm:

Inhalation powder

Manustamisviis:

Inhalation

Klass:

No Controlled Drug Status

Retsepti tüüp:

Caution - AMP level prescribing advised

Toote kokkuvõte:

BNF: 03020000; GTIN: 6432100004642

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Easyhaler
®
Beclometasone 200 micrograms/dose inhalation powder
BECLOMETASONE DIPROPIONATE
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 Easyhaler
®
Beclometasone is and what it is used for
2.
What you need to know before you use Easyhaler
®
Beclometasone
3.
How to use Easyhaler
®
Beclometasone
4.
Possible side effects
5.
How to store Easyhaler
®
Beclometasone
6.
Contents of the pack and other information
1. WHAT EASYHALER
® BECLOMETASONE IS AND WHAT IT IS USED FOR………
Easyhaler
®
Beclometasone is packed in an inhaler called Easyhaler. Beclometasone
dipropionate belongs to a
group of medicines called corticosteroids (often just called
steroids). A very small dose of steroid is needed
when it is inhaled. This is because it is inhaled straight to your
lungs. Easyhaler
®
Beclometasone works by
reducing swelling and irritation in the lungs. They have what is
called an ‘anti-inflammatory action’.
Easyhaler
®
Beclometasone helps to prevent asthma in people who need regular
treatment. This is why they are
sometimes called ‘preventers’. They need to be used regularly,
every day.
Easyhaler
®
Beclometasone will not help treat sudden asthma attacks where you feel
breathless.
•
A different medicine is used for treating sudden attacks (called a
‘reliever’).
•
If you have more than one medicine, be careful not to confuse them.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE EASYHALER
® BECLOMETASONE
DO NOT USE EASYHALER
® BECLOMETASONE IF Y

Toote omadused

OBJECT 1
EASYHALER BECLOMETASONE 200 MICROGRAMS/DOSE
INHALATION POWDER
Summary of Product Characteristics Updated 05-Apr-2017 | Orion Pharma
(UK) Limited
1. Name of the medicinal product
Easyhaler® Beclometasone 200 micrograms/dose inhalation powder
2. Qualitative and quantitative composition
Name of active ingredient
Amount in metered dose
Amount in delivered dose
Beclometasone dipropionate
200 micrograms
180 micrograms
Excipient with known effect: Lactose monohydrate
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Inhalation powder administered from multidose powder inhaler.
4. Clinical particulars
4.1 Therapeutic indications
Beclometasone dipropionate given by inhalation offers preventative
treatment for asthma. It provides
effective anti-inflammatory action in the lungs with a lower incidence
and severity of adverse effects than
those observed when corticosteroids are administered systemically. It
also offers preventive treatment of
asthma.
Easyhaler® Beclometasone 200 micrograms/dose is indicated in the
following:
Adults Prophylactic management in:
Mild asthma (PEF values greater than 80% predicted at baseline with
less than 20% variability):
Patients requiring intermittent symptomatic bronchodilator asthma
medication on a regular basis.
Moderate asthma (PEF values 60-80% predicted at baseline with 20-30%
variability):
Patients requiring regular asthma medication and patients with
unstable or worsening asthma despite
prophylactic therapy or bronchodilator alone.
Severe asthma (PEF values less than 60% predicted at baseline with
greater than 30% variability):
Patients with severe chronic asthma. On transfer to high dose inhaled
beclometasone dipropionate, many
patients who are dependent on systemic corticosteroids for adequate
control of symptoms may be able to
reduce significantly or eliminate their requirement for oral
corticosteroids.
4.2 Posology and method of administration
Easyhaler® Beclometasone 200 micrograms/dose is for oral inhalation
use only.
Patients should be made awa