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.
Store in the original package. Keep blister in the outer carton. Do not store above 25°C. was amended to: Store in the original package. Keep blister in the outer carton. Do not store above 30°C. New date if revision of text: December 2011
Store in the original package. Keep blister in the outer carton. Do not store above 30°C. New date if revision of text: December 2011
Changes to Adalat 10mg SPC 17.02.09, BSP08126
Section: 4.3 Contraindications
Deleted:
Adalat 10mg capsules are contraindicated in pregnancy before week 20 and during breastfeeding (see Sections 4.4, 4.6 and 5.3)
Inserted:
Adalat 10mg 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 10 mg is contra-indicated during pregnancy. (See section 4.3. Contraindications).
Adalat 10 mg should not be used by women who intend to get pregnant in the near future.
The safety of Adalat 10 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 10 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