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.
Previously combined SPC changed to individual SPC
Section 5.3 Preclinical safety data
The sentence: “All of the doses associated with the teratogenic, embryotoxic effects in animals were maternally toxic and several times the recommended maximum dose for humans” was changed to “). All of the doses associated with the teratogenic, embryotoxic or fetotoxic effects in animals were maternally toxic and several times the recommended maximum dose for humans.”.
Section 7, and section 8 have been changed to:
7. Marketing Authorisation Holder
Bayer Limited
The Atrium
Blackthorn Road
Dublin 18
8. Marketing Authorisation Number
Adalat LA 20mg Film-Coated Tablet PA 1410/25/5
Adalat LA 30mg Film-Coated Tablet PA 1410/25/6
Adalat LA 60mg Film-Coated Tablet PA 1410/25/7
Section 4.9, paragraph on Clinical Effects/Symptoms has been re-written and the following deleted:
1. Cardiac effects may include heart block, AV dissociation and asystole
2. Other toxic effects include nausea, vomiting, drowsiness, dizziness, confusion, lethargy, flushing
The treatment section, ‘use Ipecacuanha should be given to children’ and ‘Activated charcoal should be given in 4-hourly doses of 25g for adults, 10g for children. Blood pressure, ECG, central arterial pressure, pulmonary wedge pressure, urea and electrolytes should be monitored’ has also been deleted.
Section 6.6 heading has been updated to "Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product" and in section 9 the IMB added "Date of first authorisation" and "Date of last renewal" rather than just the actual dates. These were purely IMB changes made in the new schedules. It seems to be a new schedule template. Following information from eIPHA, we have had to revert to the original title for this section only, for the purposes of eIPHA only (section 6.6).