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.
1. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Pyrrolidone Carboxylate 2.50% w/w Excipients: Contains cetostearyl alcohol 4%w/w Contains hydroxybenzoates (parabens) approximately 1%w/w: methyl (E218), ethyl (E214), propyl (E216) and butyl parahydroxybenzoates For full list of excipients see Section 6.1. 4.1 Undesirable effects Rarely a non serious allergic type reaction may be experienced, e.g. rash. 6.1 List of excipients Isopropyl Myristate Liquid paraffin Sodium Lactate Cetomacrogol Emulsifying Wax (contains cetostearyl alcohol and macrogol cetostearyl ether) Myristyl Myristate Cetomacrogol 1000 Hydroxybenzoates (Parabens): methyl (E218), ethyl (E214), propyl (E216) and butyl parahydroxybenzoates Phenoxyethanol Purified water 6.1 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product Any unused product or waste materials should be disposed of in accordance with local requirements
Sodium Pyrrolidone Carboxylate 2.50% w/w
Excipients:
Contains cetostearyl alcohol 4%w/w
Contains hydroxybenzoates (parabens) approximately 1%w/w: methyl (E218), ethyl (E214), propyl (E216) and butyl parahydroxybenzoates
For full list of excipients see Section 6.1.
4.1 Undesirable effects Rarely a non serious allergic type reaction may be experienced, e.g. rash. 6.1 List of excipients Isopropyl Myristate Liquid paraffin Sodium Lactate Cetomacrogol Emulsifying Wax (contains cetostearyl alcohol and macrogol cetostearyl ether) Myristyl Myristate Cetomacrogol 1000 Hydroxybenzoates (Parabens): methyl (E218), ethyl (E214), propyl (E216) and butyl parahydroxybenzoates Phenoxyethanol Purified water 6.1 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product Any unused product or waste materials should be disposed of in accordance with local requirements
Rarely a non serious allergic type reaction may be experienced, e.g. rash. 6.1 List of excipients Isopropyl Myristate Liquid paraffin Sodium Lactate Cetomacrogol Emulsifying Wax (contains cetostearyl alcohol and macrogol cetostearyl ether) Myristyl Myristate Cetomacrogol 1000 Hydroxybenzoates (Parabens): methyl (E218), ethyl (E214), propyl (E216) and butyl parahydroxybenzoates Phenoxyethanol Purified water 6.1 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product Any unused product or waste materials should be disposed of in accordance with local requirements
6.1 List of excipients Isopropyl Myristate Liquid paraffin Sodium Lactate Cetomacrogol Emulsifying Wax (contains cetostearyl alcohol and macrogol cetostearyl ether) Myristyl Myristate Cetomacrogol 1000 Hydroxybenzoates (Parabens): methyl (E218), ethyl (E214), propyl (E216) and butyl parahydroxybenzoates Phenoxyethanol Purified water
Isopropyl Myristate
Liquid paraffin
Sodium Lactate
Cetomacrogol Emulsifying Wax (contains cetostearyl alcohol and macrogol cetostearyl ether)
Myristyl Myristate
Cetomacrogol 1000
Hydroxybenzoates (Parabens): methyl (E218), ethyl (E214), propyl (E216) and butyl parahydroxybenzoates
Phenoxyethanol
Purified water
6.1 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product Any unused product or waste materials should be disposed of in accordance with local requirements
Any unused product or waste materials should be disposed of in accordance with local requirements