Summary of Product Characteristics
last updated on the eMC:
07/06/2010
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 07/06/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
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: 05-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| The text in italics has been added:
Section 4.5:
NSAIDs (including COX-2 inhibitors) and ACE inhibitors exert an additive effect on the increase in serum potassium, and may result in a deterioration of renal function. These effects are usually reversible. Rarely, acute renal failure may occur, especially in patients with compromised renal function such as the elderly or patients who are volume-depleted including those on diuretic therapy.
Section 4.8:
Endocrine disorders
Not known: syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Date of revision of text has been changed
|
|
Updated on 02/11/2009 and displayed until 07/06/2010
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
