Daiichi Sankyo Ireland Ltd

Section 2 Qualititative and quantitative composition: Statement revised in line with updated regulatory requirements.

Section 4.2 Posology and method of administration: Statement revised in line with updated regulatory requirements.

Section 4.3 Contraindications: Statement revised in line with updated regulatory requirements.

Section 4.4 Special warnings and precautions for use: Hyperkalaemia:  Class labelling update - revised statement related to the risk of hyperkalaemia, in line with all other AIIRA products. Pregnancy: Class labelling update.

Section 4.5 Interaction with other medicinal products and other forms of interaction: Statement revised in line with updated regulatory requirements.

Section 4.6 Pregnancy and lactation: Class labelling update.

Section 4.7 Effects on ability to drive and use machines: Statement revised in line with updated regulatory requirements.

Section 4.8 Undesirable effects: Hyperkalaemia added in line with post-marketing data. Addition of general warning re rhabdomyolysis.

Section 6.6 List of excipients: Updated.

Section 9 Date of renewal of authorisation: Updated to 12 August 2007.

Section 10 Date of revision of text: Updated to June 2008.

Section 4.2, Hepatic Impairment:  Amended statement - 'No adjustment of dosage recommendations is required for patients with mild hepatic impairment.  In patients with moderate hepatic impairment, an initial dose of 10 mg olmesartan medoxomil once daily is recommended and the maximum dose should not exceed 20 mg once daily.  Close monitoring of blood pressure and renal function is advised in hepatically-impaired patients who are already receiving diuretics and/or other antihypertensive agents.  There is no experience of olmesartan medoxomil in patients with severe hepatic impairment, therefore use is not recommended in this patient group (see 4.4 and 5.2).  Olmesartan medoxomil should not be used in patients with biliary obstruction (see 4.3).'

 

Section 4.4, Hepatic Impairment:  Amended statement:  'There is no experience in patients with severe hepatic impairment and therefore use of olmesartan medoxomil in this patient group is not recommended (see section 4.2 for dosage recommendations in patients with mild or moderate hepatic impairment).'

 

 

Section 4.2 Posology and Method of Administration - Elderly statement has been revised to state:  'No adjustment of dosage is generally required for elderly patients (see below for dose recommendations in patients with renal impairment).  If up-titration to the maximum dose of 40 mg daily is required, blood pressure should be closely monitored.'  Renal Impairment - 'see 4.4, 5.2'.

 

Section 4.4 Special warnings and precautions for use - Other:  Addition of lactose warning.

 

Section 4.8 Undesirable Effects - Additional wording:  'Additional information on special populations:  In elderly patients the frequency of hypotension is slightly increased from rare to uncommon.'

 

Section 5.2 Pharmacokinetic properties - Elderly, addition of:  'This may be at least in part related to a mean decrease in renal function in this gorup of patients.'