Last Updated on eMC 13-07-2016 View medicine  | AstraZeneca UK Limited 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.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:28-06-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2: updated quantitative composition of excipient Lactose monohydrate

Section 4.4: editorial update to Lactose intolerance

Section 4.6: updated spelling of ‘foetus’

Section 4.8: update to side effects

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

Section 10: updated date of revision

Reasons for adding or updating:

  • 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 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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
  • 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

Date of revision of text on the SPC:20-03-2015

Legal Category:POM

Black Triangle (CHM): NO

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

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • 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

Date of revision of text on the SPC:09-08-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



SPC Changes – Oxis 6mcg

 

Section 2

Second paragraph, 450 micrograms is now 445  micrograms and 600 micrograms is now 594 micrograms.

 

Section 4.4

Changes to 9th and 10th 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 445.5 micrograms per delivered dose (corresponding to 594 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,

 

Cardiac disorders

Common

Palpitations

Uncommon

Tachycardia

Rare

Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles.

Very rare

Angina pectoris, Prolongation of QTc interval

Gastrointestinal disorders

Rare

Nausea

Immune system disorders

Rare

Hypersensitivity reactions, e.g. bronchospasm, exanthema, urticaria, pruritus

Metabolic and nutrition disorders

Rare

Hypokalemia

Very rare

Hyperglycemia

Musculoskeletal, connective tissue and bone disorders

Uncommon

Muscle cramps

Nervous system disorders

Common

Headache, tremor

Very rare

Taste disturbances, dizziness

Psychiatric disorders

Uncommon

Agitation, restlessness, sleep disturbances

Vascular disorders

Very rare

Variations in blood pressure

 

 

Section 10

9 August 2010


Reasons for adding or 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. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:10-11-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



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-

10th March 2007

 

Section 10:

 

Change of date-

10th November 2008

Reasons for adding or updating:

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

Date of revision of text on the SPC:01-08-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4

 

Additional new text added to 2nd paragraph.

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.

Reasons for adding or updating:

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

Reasons for adding or updating:

  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Reasons for adding or updating:

  • Change to section 6. 4 - Special Precautions for Storage

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied