BIRESP SPIROMAX budesonide / formoterol (eformoterol) fumarate dihydrate 400 microgram / 12 microgram powder for inhalation dry powder inhaler

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

budesonide, Quantity: 320 microgram; formoterol fumarate dihydrate, Quantity: 9 microgram

Available from:

Teva Pharma Australia Pty Ltd

INN (International Name):

Budesonide,formoterol (eformoterol) fumarate dihydrate

Pharmaceutical form:

Inhalation, powder for

Composition:

Excipient Ingredients: lactose monohydrate

Administration route:

Oral

Units in package:

2 x 60 dose inhalers, 1 x 60 dose inhaler, 3 x 60 dose inhalers

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Asthma: BiResp Spiromax is indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk and exacerbations (see Section 4.2 Dose and method of administration).,BiResp Spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,Chronic Obstructive Pulmonary Disease (COPD): BiResp Spiromax is indicated for the symptomatic treatment of moderate to severe COPD (FEV1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. BiResp Spiromax is not indicated for the initiation of bronchodilator therapy in COPD.

Product summary:

Visual Identification: White or off-white powder in a multi-dose dry powder inhaler; Container Type: Inhaler - dry powder; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-12-19

Patient Information leaflet

BIRESP
® SPIROMAX
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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 BIRESP SPIROMAX?
BIRESP SPIROMAX contains two active ingredients in one inhaler:
budesonide and formoterol (eformoterol) fumarate dihydrate. It is
inhaled into the lungs for the treatment of asthma or Chronic
Obstructive Pulmonary Disease (COPD).
For more information, see Section 1. Why am I using BIRESP SPIROMAX?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BIRESP SPIROMAX?
Do not use if you have ever had an allergic reaction to any medicine
containing formoterol or budesonide 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
BIRESP SPIROMAX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BIRESP SPIROMAX 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 BIRESP SPIROMAX?
•
ASTHMA - Anti-inflammatory reliever only (BIRESP SPIROMAX 200/6) - If
you get asthma symptoms, take 1 inhalation and wait
a few minutes. If you do not feel better, take another inhalation.
•
ASTHMA - Anti-inflammatory reliever plus maintenance therapy (BIRESP
SPIROMAX 200/6) – See above for reliever
instructions. The usual maintenance dose is 2 inhalations per day
(given either as 1 inhalation in the morning and evening or as
2 inhalations in either the morning or evening).
•
ASTHMA - Daily fixed dose maintenance therapy (BIRESP SPIROMAX 200/6
and 400/12) – BIRESP SPIROMAX 200/6 usual
dose is 1-2 inhalations twice a day. BIRESP SPIROMAX 400/12 usual dose
is 2 inhalations twice a day.
•
COPD - The usual dose is 2 inhalatio

Summary of Product characteristics

1
BiResp Spiromax 200/6 & 400/12 V5.0
Based on CCSI 795/05/03/17
AUSTRALIAN PRODUCT INFORMATION – BIRESP
® SPIROMAX
®
(BUDESONIDE/FORMOTEROL (EFORMOTEROL) FUMARATE
DIHYDRATE) DRY POWDER INHALER
1
NAME OF THE MEDICINE
Budesonide
Formoterol (eformoterol) fumarate dihydrate (hereafter referred to as
formoterol).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BiResp Spiromax is available as a multidose inspiratory flow driven,
metered dose dry
powder inhaler (Spiromax). To avoid confusion, BiResp Spiromax is
labelled as the metered
dose of the corresponding monotherapy products budesonide and
formoterol dry powders for
inhalation. The monotherapy products are also labelled as metered
doses. The following
table gives the corresponding dose delivered to the patient.
TABLE 1
BUDESONIDE/
FORMOTEROL
METERED DOSE (ΜG)
CORRESPONDING DOSE DELIVER TO PATIENT (ΜG)
BUDESONIDE
FORMOTEROL
BUDESONIDE
FORMOTEROL
200 / 6
200
6
160
4.5
400 / 12
400
12
320
9
_Excipient(s) with known effect:_ lactose monohydrate
For full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
White or off-white powder in a multi-dose dry powder inhaler.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ASTHMA
BiResp Spiromax is indicated in adults (18 years and older) for the
treatment of asthma, to
achieve overall asthma control, including the relief of symptoms and
the reduction of the risk
and exacerbations (see Section 4.2 Dose and method of administration).
BiResp Spiromax is not indicated in children and adolescents under the
age of 18 years as
the 100/6 dose is not available.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
BiResp Spiromax is indicated for the symptomatic treatment of moderate
to severe COPD
(FEV
1
≤50% predicted normal) in adults with frequent symptoms despite
long-acting
2
BiResp Spiromax 200/6 & 400/12 V5.0
Based on CCSI 795/05/03/17
bronchodilator use, and/or a history of recurrent exacerbations.
BiResp Spiromax is not
indicated for the initiation of bronchodilator therapy in COPD.
4.2
D
OSE AND METHO