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 to Adalat 5mg SPC 17.02.09
Section: 4.3 Contraindications
Deleted:
Adalat 5mg capsules are contraindicated in pregnancy before week 20 and during breastfeeding (see Sections 4.4, 4.6 and 5.3)
Inserted:
Adalat 5mg should not be administered to women during pregnancy or to nursing mothers (see Sections 4.4, 4.6 and 5.3).
Section 4.4 Special warnings and precautions for use
Information regarding pregnancy and iv magnesium sulphate deleted and changed to:
Whilst nifedipine is contra-indicated in pregnancy, particular care must be exercised when administering nifedipine in combination with i.v. magnesium sulphate to pregnant women.
Section 4.6 Pregnancy and lactation
Text changed to:
Adalat 5 mg is contra-indicated during pregnancy. (See section 4.3. Contraindications).
Adalat 5 mg should not be used by women who intend to get pregnant in the near future.
The safety of Adalat 5 mg for use in human pregnancy has not been established. Evaluation of experimental animal studies has shown reproductive toxicity consisting of embryotoxicity and teratogenic effects at maternally toxic doses.
Adalat 5 mg is contra-indicated in breastfeeding. Nifedipine passes into the breast milk. As there is no experience of possible effects on infants, breastfeeding should first be stopped if nifedipine treatment becomes necessary during the breastfeeding period.
In single cases of in vitro fertilisation calcium antagonists like nifedipine have been associated with reversible biochemical changes in the spermatozoas head section that may result in impaired sperm function. In those men who are repeatedly unsuccessful in fathering a child by in vitro fertilisation, and where no other explanation can be found, calcium antagonists like nifedipine should be considered as possible causes.
10. Date of Revision of Text
Changed to
November 2008
Section 7, Section 8, Section 9 and Section 10 have been changed to:
7. Marketing Authorisation Holder
Bayer Limited
The Atrium
Blackthorn Road
Dublin 18
8. Marketing Authorisation Number
Adalat 5mg PA1410/25/1
Adalat 10mg PA1410/25/2
9. Date of First Authorisation / Renewal of the Authorisation
Adalat 50mg
Date of first authorisation: 26th February 1982
Date of last renewal: 26th February 2007
Adalat 100mg
Date of first authorisation: 25th May 1977
Date of last renewal: 25th May 2007
10. Date of Revision of the Text
January 2008
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.