Summary of Product Characteristics
last updated on the eMC:
21/07/2011
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 21/07/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 09-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Lactation information updated in line with MHRA guidance:
Lactation: Limited pharmacokinetic data demonstrate
very low concentrations in breast milk (see section 5.2). Although these
concentrations seem to be clinically irrelevant, the use of Enalapril Maleate
Tablets in breastfeeding is not recommended for preterm infants and for the
first few weeks after delivery, because of the hypothetical risk of
cardiovascular and renal effects and because there is not enough clinical
experience. In the case of an older infant, the use of Enalapril Maleate
Tablets in a breast-feeding mother may be considered if this treatment is
necessary for the mother and the child is observed for any adverse effect.
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Updated on 27/05/2010 and displayed until 21/07/2011
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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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| Date of revision of text on the SPC: |
| 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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