Updated to reflect the MAH transfer

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

-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

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

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

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