RILAST RAPIHALER budesonide / formoterol fumarate dihydrate 100/3 pressurised metered dose inhaler

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

budesonide, Quantity: 80 microgram; formoterol fumarate dihydrate, Quantity: 2.25 microgram

Available from:

AstraZeneca Pty Ltd

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: apaflurane; macrogol 1000; povidone

Administration route:

Inhalation

Units in package:

120 doses

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Asthma Rilast Rapihaler is indicated in adults and adolescents (12 years and older), for the treatment of asthma to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see Section 4.2 Dose and method of administration). Chronic obstructive pulmonary disease (COPD) Rilast Rapihaler 200/6 is indicated for the symptomatic treatment of moderate to severe COPD (FEV1 < or = 50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. is not indicated for the initiation of bronchodilator therapy in COPD.

Product summary:

Visual Identification: Contents held in metal can fitted with plastic valve. After evaporation of the propellant a residue remains which is free from visible contaminants. The external & internal can and valve surfaces are free from corrosion and significant defects.; Container Type: Inhaler - Metered Dose; Container Material: Other plastic laminate/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-12-06

Patient Information leaflet

RILAST RAPIHALER™
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING RILAST RAPIHALER?
Rilast Rapihaler contains two active ingredients in one inhaler:
budesonide and formoterol (eformoterol) fumarate dihydrate. Rilast
Rapihaler is used for treatment of asthma in adults and adolescents
(12 years and over) or Chronic Obstructive Pulmonary Disease
(COPD) in adults (18 years and over).
For more information, see Section 1. Why am I using Rilast Rapihaler?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RILAST RAPIHALER?
Do not use if you have ever had an allergic reaction to any medicine
containing budesonide or formoterol, or any of the ingredients
listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Rilast Rapihaler? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Rilast Rapihaler and affect how it
works. A list of these medicines is in Section 3. What if I am
taking other medicines? in the full CMI.
4.
HOW DO I USE RILAST RAPIHALER?
•
Rilast Rapihaler should be inhaled into your lungs through the mouth.
•
Follow all directions given to you by your doctor or pharmacist.
More instructions can be found in Section 4. How do I use Rilast
Rapihaler? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RILAST RAPIHALER?
THINGS YOU
SHOULD DO
•
If you have an Asthma Action Plan agreed with your doctor, follow it
closely at all times.
•
Have your reliever medicine available at all times. As advised by your
doctor, this may be your Rilast
Rapihaler 100/3 or another reliever medicine.
•
Rinse your mouth out with water after taking your daily morning and/or
evening dose of Rilast Rapihaler
and spit this

Summary of Product characteristics

1 of 20
AUSTRALIAN PRODUCT INFORMATION
RILAST RAPIHALER
™
(BUDESONIDE/FORMOTEROL (EFORMOTEROL) FUMARATE DIHYDRATE)
PRESSURISED INHALATION
1
NAME OF THE MEDICINE
Budesonide
Formoterol (eformoterol) fumarate dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rilast Rapihaler is a pressurised metered dose inhaler (pMDI). For
ease of reference, formoterol,
formoterol fumarate or formoterol fumarate dihydrate have been used
throughout the rest of this
document.
The following strengths are registered:
•
_Rilast Rapihaler 100/3: _
Each delivered dose (the dose that leaves the mouthpiece) contains as
active constituents: budesonide 80 μg/inhalation and formoterol 2.25
μg/inhalation.
•
_Rilast Rapihaler 200/6: _
Each delivered dose (the dose that leaves the mouthpiece) contains as
active constituents: budesonide 160 μg/inhalation and formoterol 4.5
μg/inhalation.
To avoid confusion, Rilast Rapihaler is labelled as metered dose like
Rilast Turbuhaler
®
. The
following table gives the corresponding dose delivered to the patient.
TABLE 1
RILAST RAPIHALER
METERED DOSE (

G)
CORRESPONDING DOSE DELIVERED TO PATIENT (

G)*
BUDESONIDE
FORMOTEROL
BUDESONIDE
FORMOTEROL
100/3
100
3
80
2.25
200/6
200
6
160
4.5
_* doses referred to in budesonide/formoterol fixed dose combination
publications _
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Inhalation, pressurised.
2 of 20
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASTHMA
Rilast Rapihaler is indicated in adults and adolescents (12 years and
older), for the treatment of
asthma to achieve overall asthma control, including the relief of
symptoms and the reduction of the
risk of exacerbations (see Section 4.2 Dose and method of
administration).
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Rilast Rapihaler 200/6 is indicated for the symptomatic treatment of
moderate to severe COPD
(FEV
1
≤50% predicted normal) in adults with frequent symptoms despite
long-acting bronchodilator
use, and/or a history of recurrent exacerb