Summary of Product Characteristics
last updated on the eMC:
27/02/2008
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 27/02/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.8 - Undesirable Effects
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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: 06/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 (Qualitative and quantitative composition) quantity of lactose monohydrate has been added to each tablet.
Section 4.8 (Undesirable effects) tabulated to show the frequencies of undesirable effects.
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Updated on 16/11/2006 and displayed until 27/02/2008
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 Interaction with other medicinal products and other forms of interaction
Changed from: As with other antihypertensive agents, the antihypertensive effect of candesartan may be attenuated by non-steroidal anti-inflammatory drugs such as indomethacin.
Changed to: When Angiotensin II receptor antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (>3g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
As with ACE inhibitors, concomitant use of Angiotensin II receptor antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
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Updated on 13/01/2005 and displayed until 16/11/2006
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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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 5.1 - Pharmacodynamic Properties
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Change to section 10 (date of (partial) revision of the text
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Addition of new strength
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Change in co-marketing arrangement
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Updated on 05/07/2004 and displayed until 13/01/2005
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 15/08/2003 and displayed until 05/07/2004
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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 4.9 - Overdose
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Change to section 5 - Pharmacological Properties
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 20/09/2002 and displayed until 15/08/2003
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 10 (date of (partial) revision of the text
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Updated on 11/07/2001 and displayed until 20/09/2002
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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