Becotide Evohaler 250 micrograms, Pressurised Inhalation Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BECLOMETASONE DIPROPIONATE

Available from:

PCO Manufacturing Ltd.

ATC code:

R03BA; R03BA01

INN (International Name):

BECLOMETASONE DIPROPIONATE

Dosage:

250 microgram(s)

Pharmaceutical form:

Pressurised inhalation, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Glucocorticoids; beclometasone

Authorization status:

Authorised

Authorization date:

2007-10-19

Patient Information leaflet

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
BECOTIDE
® EVOHALER
®
50 AND 250 MICROGRAMS
PRESSURISED INHALATION SOLUTION
(Beclometasone dipropionate)
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 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 Becotide Evohaler is and what it is used for
2.
What you need to know before you use Becotide Evohaler
3.
How to use Becotide Evohaler
4.
Possible side effects
5.
How to store Becotide Evohaler
6.
Contents of the pack and other information
1.
WHAT BECOTIDE EVOHALER IS AND WHAT IT IS USED FOR
Becotide contains the active substance beclometasone dipropionate.
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.
Becotide works by reducing swelling and irritation in the lungs. It
has what is called an
'anti-inflammatory action'.
Becotide helps to prevent asthma attacks in people who need regular
treatment. This
is why it is sometimes called a 'preventer'. It needs to be used
regularly, every day.
Becotide 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.
Becotide is supplied to you in an inhaler. You breathe the medicine
directly into your
lungs.
Becotide contains norflurane. This is less harmful to the environment
than older
inhalers. Older inhalers

Summary of Product characteristics

Health Products Regulatory Authority
15 March 2019
CRN008WK7
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Becotide Evohaler 250 micrograms, Pressurised Inhalation Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One metered dose contains 250 micrograms of Beclometasone
Dipropionate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised Inhalation, Solution
_Product imported from Italy and Spain:_
Pressurised aluminium container closed with a metering valve
containing a pressurised inhalation solution.
4 CLINICAL PARTICULARS
As per PA1077/042/009
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/042/009.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Norflurane (Hydrofluoroalkane (HFA) 134a)
Ethanol Anhydrous
Glycerol
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C. The canister contains a pressurised liquid.
Do not expose to temperatures higher than 50°C. Do not
pierce the canister.
Protect from frost and direct sunlight. Do not refrigerate or freeze.
As with most inhaled medications in pressurised canisters, the
therapeutic effect of this medication may decrease when the
canister is cold.
6.5 NATURE AND CONTENTS OF CONTAINER
Health Products Regulatory Authority
15 March 2019
CRN008WK7
Page 2 of 2
The inhaler comprises an aluminium can fitted with a metering valve,
plastic actuator and dust cap. Each canister contains 200
metered doses.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Patients should be carefully monitored in the proper use of their
inhaler.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PP