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.
Changes following transfer of MAH from Bayer plc to Bayer Ltd.
Adalat retard 10 mg tablets.
Adalat Retard 10 mg Prolonged-Release tablets
Adalat retard 10 mg tablets: One film-coated, prolonged-release tablet contains 10 mg nifedipine.
Adalat retard 20 mg tablets: One film-coated, prolonged-release tablet contains 20 mg nifedipine.
Excipients: Lactose monohydrate 10.00 mg per tablet.
ADRs listed under ¡°common¡± were observed with a frequency below 3% with the exception of oedema (9.9%) and headache (3.9%). ADRs derived from post marketing reports (status:15 Feb 2006) are printed in bold italic.
Clinical
Description
Common >1% to <10%
Uncommon
>0.1% to <1%
Rare >0.01% to <0.1%
Very Rare
<0.01%
Adverse drug reactions (ADRs) based on placebo-controlled studies with nifedipine sorted by CIOMS III categories of frequency (clinical trial data base: nifedipine n=2,661; placebo n=1,486; status: 22 Feb 2006 and the ACTION study: nifedipine n=3,825; placebo n=3,840) are listed below: ADRs listed under ¡°common¡± were observed with a frequency below 3% with the exception of oedema (9.9%) and headache (3.9%). ADRs derived from post marketing reports (status: 31 Mar 2006) are printed in bold italic.
Common ¡Ý1% to <10%
¡Ý0.1% to <1%
Rare ¡Ý0.01% to <0.1%
August 2008
Changes have been made to Section 4.2, Section 4.5, Section 4.8, Section 4.9, Section 5.1, Section 5.2 and Section 5.3.
Section 10. Date of Revision of the Text has been changed to
“April 2007”
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.