Summary of Product Characteristics
last updated on the eMC:
13/11/2009
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.
Updated on 13/11/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 28-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3: Deletion of 'lactation' as a contraindication.
Section 4.6: Revised information on pregnancy and lactation, in line with PhVWP wording.
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Updated on 21/06/2008 and displayed until 13/11/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 12-Aug-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 10/06/2008 and displayed until 21/06/2008
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 10 date of revision of the text
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.2 - Posology and method of administration
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 12-Aug-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections 2, 4.2, 4.3, 4.5, 4.7, 6.4: Standard statements updated in line with QRD template as part of MA Renewal.
Section 4.4: (i) Revised statement related to the risk of hyperkalaemia, in line with other AIIRA products. (ii) Statement re pregnancy added as per PhVWP recommendations on the use of ACE inhibitors and AIIRAs during pregnancy.
Section 4.6: Statement re pregnancy added as per PhVWP recommendations on the use of ACE inhibitors and AIIRAs during pregnancy.
Section 4.8: (i) 'Hyperkalaemia' added to Undesirable Effects section, in line with post-marketing data. (ii) Addition of general warning re rhabdomyolysis.
Section 6.1: Excipient names updated.
Sections 9, 10: Renewal date/Date of revision of text updated to '12 August 2007'.
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Updated on 26/09/2007 and displayed until 10/06/2008
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 Posology and Method of Administration: Revised statement re use in patients with hepatic impairment.
Section 4.4 Special Warnings and Special Precautions for Use: Revised statement re use in patients with hepatic impairment.
Section 5.2 Pharmacokinetic Properties: Additional statement on hepatic impairment.
Section 10 Date of Revision of Text Amended to July 2007
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Updated on 14/11/2006 and displayed until 26/09/2007
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 Amended statement with regard to the Elderly: No adjustment of dosage is generally required in elderly patients. If up-titration to the maximum dose of 40 mg daily is required, blood pressure should be closely monitored. Renal impairment: Cross-reference to Section 4.4.
Section 4.4 Addition of lactose statement.
Section 4.8 Additional information on special populations: In elderly patients the frequency of hypotension is slightly increased from rare to uncommon.
Section 5.2 Pharmacokinetics in special populations - Elderly: Amended statement.
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Updated on 26/09/2006 and displayed until 14/11/2006
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 7. Marketing Authorisation Holder has been changed from Sankyo Pharma UK Ltd to Daiichi Sankyo UK Ltd; new Company Address.
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Updated on 05/09/2005 and displayed until 26/09/2006
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Reasons for adding or updating:
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Removal of Black Triangle
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Updated on 22/09/2004 and displayed until 05/09/2005
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Reasons for adding or updating:
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Addition of joint SPC covering all presentations
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