When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
The main changes are to sections 4.2, 4.3, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2 for the following reasons:
- Implementation of the EU Guideline on Summary of Product Characteristics (SmPC) and QRD formatting template
- A material change occurs in section 4.8, due to the altered way of estimating adverse reaction frequencies described in the new SmPC guideline.
- Adaptation of information on the active substance amlodipine to be in line with the current EU Core Safety Profile (CSP) for amlodipine.
Update to section 6.3: Shelf life updated from 3 years to 48 months
4.3 Contraindications
Lactation contra-indication removed
4.6 Pregnancy and lactation
Pregnancy – minor changes to the wording.
Lactation – Wording amended to remove contra-indication.
New statement added: Because no information is available regarding the use of olmesartan and amlodipine during breast-feeding, Konverge is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.