AstraZeneca UK Limited

SPC Changes – Oxis 12mcg

Section 2

Second paragraph, 450 micrograms is now 441 micrograms and 600 micrograms is now 588 micrograms.

Section 4.4

Changes to 10^th and 11^th paragraphs, now reads as,

“As with other inhalation therapy, the potential for paradoxical bronchospasm should be considered. If it occurs, the treatment should be discontinued immediately and alternative therapy started (see section 4.8).

Oxis Turbohaler 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 deficiency or glucose-galactose malabsorption should not take this medicine.”

Section 4.5

New paragraph added before the last paragraph, reads as,

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

Section 4.8

Changes to table, now reads as,

Section 10

9 August 2010

Section 2, paragraph 2:

Addition of text-

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

Section 4.2, paragraph 2:

Addition of text-

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

Section 4.2, under heading ‘COPD’, paragraph 3:

Change of text-

‘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:

Addition of text-

‘(which contains small amounts of milk proteins).’

Section 4.4, paragraph 5:

Change of text-

‘Frequent need of medication (i.e. prophylactic treatment e.g. corticosteroids and long-acting β₂-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.’

Section 4.4, paragraph 10:

Addition of text-

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

Section 4.4, paragraph 11:

Deletion of text-

‘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 metabolism an increased exposure can be expected in patients with severe liver cirrhosis.’

Section 4.6, paragraph 1:

Addition of text-

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

‘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:

Addition of table of adverse reactions

Addition of text-

‘The excipient lactose contains small amounts of milk proteins. These may cause allergic reactions.’

Section 5.2, paragraph 5:

Addition of text-

‘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:

Addition of text-

‘(which contains milk proteins).’

Section 6.6:

Addition of text-

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

Section 9:

Change of date-

10^th March 2007

Section 10:

Change of date-

10^th November 2008 

Section 4.4

Paragraph 1 is new text.

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

Additional new text added to paragraph 2

Asthmatic patients who require therapy with long acting b₂-agonists, should also receive optimal maintenance anti-inflammatory therapy with corticosteroids. Patients must be advised to continue taking their anti-inflammatory therapy after the introduction of Oxis Turbohaler even when symptoms decrease. Should symptoms persist, or treatment with b₂-agonists need to be increased, this indicates a worsening of the underlying condition and warrants a reassessment of the maintenance therapy. 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 a severe asthma exacerbation, 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 remained 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.