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DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder

Last Updated on eMC 16-Jun-2017 View document  | Teva Pharma B.V. Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 16-Jun-2017 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC: 01-May-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.1

 

Symptomatic treatment of patients with severe COPD with forced expiratory volume in 1 second (FEV1) <

70% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite

regular therapy with long-acting bronchodilators.

 

Added to section 4.4

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

 

Added to section 4.8

Uncommon

Vision, blurred (see also section 4.4)

Updated on 10-Apr-2017 and displayed until 16-Jun-2017

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC: 01-Mar-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 

 

Section 4.1

 

Symptomatic treatment of patients with severe COPD (FEV1 < 750% predicted normal) and a history of

repeated exacerbations, who have significant symptoms despite regular therapy with long-acting

bronchodilators.

 

Added to section 4.4

There are  no  clinical  study  data  on  DuoResp  Spiromax  available  in  COPD  patients  with   a  pre-bronchodilator

FEV1 >50% predicted normal and with a post-bronchodilator FEV1 <70% predicted normal (see section

5.1).

 

Added to section 4.5

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the

risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

 

Added to section 4.6

Fertility

There is no data available on the potential effect of budesonide on fertility. Animal reproduction studies with

formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure (see section

5.3)..No data on fertility are available.

 

Added to section 5.2

Linearity/non-linearity

Systemic exposure for both budesonide and formoterol correlates in a linear fashion to administered dose.

Updated on 27-Sep-2016 and displayed until 10-Apr-2017

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC: 01-Jun-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Added to section 4.4

Pneumonia in patients with COPD

 

An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.

 

There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.

 

Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.

Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.





Added to section 4.8
Infections and infestations - Common - pneumonia (in COPD patients)

Updated on 16-Nov-2015 and displayed until 27-Sep-2016

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 17-Sep-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change of address to MA Holder

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem

The Netherlands

Updated on 22-Sep-2014 and displayed until 16-Nov-2015

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Teva Pharma B.V.

Company image
Address

Field House, Station Approach, Harlow, Essex, CM20 2FB

Medical Information Direct Line

+44(0)207 5407117

Medical Information Fax

+44(0)207 5407349

Stock Availability

0800 590 502

Telephone

+44(0)1977 628500

Customer Care direct line

0800 590 502

Medical Information Fax

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

budesonide, formoterol fumarate dihydrate

Legal categories

POM - Prescription Only Medicine

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