DuoResp Spiromax 320microgramsdose 9microgramsdose dry powder inhaler

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Budesonide; Formoterol fumarate dihydrate

Available from:

Teva UK Ltd

ATC code:

R03BA02

INN (International Name):

Budesonide; Formoterol fumarate dihydrate

Dosage:

400microgram/1dose ; 12microgram/1dose

Pharmaceutical form:

Inhalation powder

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

VMP not recommended to prescribe - patient training required

Product summary:

BNF: 03020000; GTIN: 5017007013525

Patient Information leaflet

57
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DUORESP SPIROMAX 320 MICROGRAMS/9 MICROGRAMS, INHALATION POWDER
(budesonide/formoterol fumarate dihydrate)
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
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What DuoResp Spiromax is and what it is used for
2.
What you need to know before you use DuoResp Spiromax
3.
How to use DuoResp Spiromax
4.
Possible side effects
5.
How to store DuoResp Spiromax
6.
Contents of the pack and other information
1.
WHAT DUORESP SPIROMAX IS AND WHAT IT IS USED FOR
DuoResp Spiromax contains two different active substances: budesonide
and formoterol fumarate dihydrate.

Budesonide belongs to a group of medicines called
‘corticosteroids’ also known as ‘steroids’. It
works by reducing and preventing swelling and inflammation in your
lungs and helps you to breathe
more easily.

Formoterol fumarate dihydrate belongs to a group of medicines called
‘long-acting β
2
adrenoceptor
agonists’ or ‘bronchodilators’. It works by relaxing the muscles
in your airways. This will help to
open the airways and help you to breathe more easily.
DUORESP SPIROMAX IS INDICATED FOR USE IN ADULTS 18 YEARS OF AGE AND
OLDER ONLY.
DUORESP SPIROMAX IS NOT INDICATED FOR USE IN CHILDREN, 12 YEARS OF AGE
AND YOUNGER OR ADOLESCENTS,
13 TO 17 YEARS OF AGE.
Your doctor has prescribed this medicine to treat asthma or chronic
obstructive pulmonary disease (COPD).
ASTHMA
When used for asthma, your doctor will prescribe DuoResp Spiromax
together with a separate ‘reliever

Summary of Product characteristics

OBJECT 1
DUORESP SPIROMAX 320 MICROGRAMS/9
MICROGRAMS INHALATION POWDER
Summary of Product Characteristics Updated 16-Jun-2017 | Teva Pharma
B.V.
1. Name of the medicinal product
DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder
2. Qualitative and quantitative composition
Each delivered dose (the dose that leaves the mouthpiece of the
Spiromax) contains 320 micrograms of
budesonide and 9 micrograms of formoterol fumarate dihydrate.
This is equivalent to a metered dose of 400 micrograms budesonide and
12 micrograms of formoterol
fumarate dihydrate.
Excipient(s) with known effect:
Each dose contains approximately 10 milligrams of lactose (as
monohydrate) .
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Inhalation powder.
White powder.
White inhaler with a semi-transparent wine red mouthpiece cover.
4. Clinical particulars
4.1 Therapeutic indications
DuoResp Spiromax is indicated in adults 18 years of age and older
only.
Asthma
DuoResp Spiromax is indicated in the regular treatment of asthma,
where use of a combination (inhaled
corticosteroid and long-acting β
2
adrenoceptor agonist) is appropriate:
- in patients not adequately controlled with inhaled corticosteroids
and “as needed” inhaled short-acting
β
2
adrenoceptor agonists.
or
- in patients already adequately controlled on both inhaled
corticosteroids and long-acting β
2
adrenoceptor agonists.
COPD
Symptomatic treatment of patients with COPD with forced expiratory
volume in 1 second (FEV
1
) < 70%
predicted normal and a history of repeated exacerbations, who have
significant symptoms despite regular
therapy with long-acting bronchodilators.
4.2 Posology and method of administration
DuoResp Spiromax is indicated in adults 18 years of age and older
only.
DuoResp Spiromax is not indicated for use in children, 12 years of age
and younger or adolescents, 13 to
17 years of age.
Posology
_Asthma _
DuoResp Spiromax is not intended for the initial management of asthma.
DuoResp Spiromax is not an appropriate treatment for th