Oxis Turbohaler 12mcg *
Pharmacy Only: Prescription

Updated on 19 January 2023

File name

63c90ea84987c.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 16 March 2020

File name

ie-spc-oxis-ema-excipient-qrd-update-RSP 19 0004_1584362911.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 16 March 2020

File name

ie-pl-oxis-12-ema-excipient-qrd-update-RSP 19 0006_1584362852.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 17 January 2019

File name

20190114-Package Leaflet-ie-oxis-tbh-12-brexitmahtransfer-rsp 18 0074_1547725491.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation number

Updated on 17 January 2019

File name

20190114-spc-ie-oxis-tbh- 6 12-brexitmahtransfer-rsp 18 0074_1547725268.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 has been updated to reflect the MAH transfer.

Updated on 17 January 2019

File name

20190114-spc-ie-oxis-tbh- 6 12-brexitmahtransfer-rsp 18 0074_1547725241.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 has been updated to reflect the MAH transfer.

Updated on 17 January 2019

File name

20190114-spc-ie-oxis-tbh- 6 12-brexitmahtransfer-rsp 18 0074_1547725209.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 has been updated to reflect the MAH transfer.

Updated on 04 May 2018

File name

20180424 PIL Oxis 12 UIM RSP 17 0134 (SE) FMD & PIL update (1).pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 07 July 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 July 2016

File name

PIL_14144_373.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 July 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2: updated quantitative composition of excipient Lactose monohydrate

Section 4.2: updated posology of Oxis Turbohaler 6

Section 4.4: update to header in line with QRD

Section 4.4: editorial update to Lactose intolerance

Section 4.5: updated spelling of ‘formoterol’

Section 4.8: update to side effects

Section 5.2: editorial update to ‘absorption’ and ‘elimination’ of product

Section 8: editorial update

Section 9: update to header in line with QRD

Section 10: updated date of revision

Updated on 07 July 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 16 March 2015

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

-Section 2 lactose quantity and QRD update
-Section 4.1 QRD update

-section 4.2 QRD update

-section 4.3 QRD update

-section 4.4 lactose quantity and QRD update

-section 4.6 QRD update and addition of fertility information

-section 4.7 QRD update

-section 4.8 QRD update and reporting of ADR statement

-section 4.9 QRD update

-section 5.1 QRD update

-section 5.2 updated information on absorption, QRD update and information on linearity/non-linearity added.

-section 5.3 deletion of information on high systemic exposure

-section 6.4 amendments to storage conditions

-section 6.6 removal of disposal information.

-section 10- update to revision date

Updated on 13 March 2015

Reasons for updating

  • Change to storage instructions
  • Change to date of revision
  • Change to appearance of the medicine
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 23 July 2013

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change of special precautions for disposal

Updated on 24 August 2011

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 07 October 2010

Reasons for updating

  • Change to side-effects
  • Change to drug interactions

Updated on 27 September 2010

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



Section 4.4

Change and additional text penultimate paragraph:

Oxis Turbohaler 6 contains lactose monohydrate, 445.5 micrograms per delivered dose (corresponding to 594 micrograms per metered dose). Oxis Turbohaler 12 contains lactose monohydrate, 441 micrograms per delivered dose (corresponding to 588 micrograms per metered dose). This amount does not normally cause problems in lactose intolerant people.  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase or glucose-galactose malabsorption should not take this medicine.

 

Section 4.5

additional text penultimate paragraph:

The bronchodilating effects of formoterol can be enhanced by anticholinergic drugs.

 

Section 4.8

Side effect under ‘Investigations’ ‘very rare’  moved to ‘Cardiac disorders’ ‘very rare’

Prolongation of QTc interval

 

Hyperkalemia removed as a rare side effect under the heading Metabolic and nutrition disorders

 

Section 10

Revision date of text: 3rd September 2010

Updated on 20 February 2009

Reasons for updating

  • New PIL for new product

Updated on 09 January 2008

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2

Additional new text:

Excipient: Lactose monohydrate 450 micrograms per delivered dose (corresponding to 600 micrograms per metered dose).

 

Section 4.2

Additional new text after first paragraph

Oxis Turbohaler is not recommended for use in children below 6 years due to insufficient data on safety and efficacy.

 

Change of text under COPD for Oxis 6 & 12

 

Special patient groups: There are no special dosing requirements for elderly patients.  There are no data available for use of Oxis Turbohaler in patients with hepatic or renal impairment (see also section 5.2).

 

Section 4.3

Change of text

Hypersensitivity to formoterol or to lactose (which contains small amounts of milk proteins).

 

Section 4.4

New text first paragraph

Oxis Turbohaler should not be used (and is not sufficient) as the first treatment for asthma.

 

New text third paragraph

Although Oxis Turbohaler may be introduced as add-on therapy when inhaled corticosteroids do not provide adequate control of asthma symptoms, patients should not be initiated on Oxis Turbohaler during an acute severe asthma exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with Oxis Turbohaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Oxis Turbohaler. Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Oxis Turbohaler. Regular review of patients as treatment is stepped down is important. The lowest effective dose of Oxis Turbohaler should be used.

 

Change to text fifth paragraph

Frequent need of medication (i.e. prophylactic treatment e.g. corticosteroids and long-acting b2-agonists) for the prevention of exercise-induced bronchoconstriction several times every week, despite an adequate maintenance treatment, can be a sign of suboptimal asthma control, and warrants a reassessment of the asthma therapy and an evaluation of the compliance.

 

Additional sentence to tenth paragraph

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase or glucose-galactose malabsorption should not take this medicine.

 

Section 4.6

Change of text first sentence of first paragraph

There are no adequate data from the use of formoterol in pregnant women.

 

Additional text last sentence of first paragraph

The potential risk for human is unknown.

 

Section 4.7

Change of text

Oxis Turbohaler has no influence on the ability to drive and use machines.

 

Section 4.8

Change to format of table

 

Section 5.2

Additional text last paragraph

Special populations:

The effect of decreased liver or kidney function on the pharmacokinetics of formoterol and the pharmacokinetics in the elderly is not known. As formoterol is primarily eliminated via liver metabolism an increased exposure can be expected in patients with severe liver cirrhosis.

 

Section 6.1

Additional text

Lactose monohydrate (which contains milk proteins).

 

Section 6.4

Change of text

Do not store above 30°C. Keep the container/cap tightly closed.

 

Section 6.6

Additional text

Any unused product or waste material should be disposed of in accordance with the local requirements.

 

Section 10
New revision date of text: 19th December 2007

Updated on 07 August 2007

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 Section 4.4

New text first paragraph:
 
Oxis Turbohaler should not be used (and are not sufficient) as the first treatment for asthma.

Deletion of text:

Oxis Turbohaler should not be initiated to treat a severe asthma exacerbation.

Additional new text third paragraph:

Although Oxis Turbohaler may be introduced as add-on therapy when inhaled corticosteroids do not provide adequate control of asthma symptoms, patients should not be initiated on Oxis Turbohaler during an acute severe asthma exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with Oxis Turbohaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Oxis Turbohaler. Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Oxis Turbohaler. Regular review of patients as treatment is stepped down is important. The lowest effective dose of Oxis Turbohaler should be used.

Section 10

New revision date of text: 11 August 2006

Updated on 21 January 2005

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 15 November 2004

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 19 July 2004

Reasons for updating

  • Change to joint SPC covering all presentations

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 19 August 2003

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 23 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)