Summary of Product Characteristics
last updated on the eMC:
08/03/2012
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 08/03/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 11-Sep-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| change results in a small change in section 6.5 of the SPC to remove the phrase ‘printed’ bottle; there is no change to the bottle composition.
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Updated on 19/01/2011 and displayed until 08/03/2012
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 30-Dec-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Additions highlighted in red text
4.1 Posology and method of administration
Route of administration
Hydromol Bath & Shower Emollient should be used topically and is either added to water or applied to wet skin.
1. For use in the bath
a) Adults/Children and the Elderly:
Add 1—3 capfuls (inner capfuls for 500ml or 1 litre pack sizes) to an 8 inch bath of water. Soak for 10-15 minutes.
b) Infants:
Add ½ to 2 capfuls (inner capfuls for 500ml or 1 litre pack sizes) to a small bath of water.
2. For application to the skin as a sponge bath or in the shower.
Adults and Children and the Elderly:
Pour a small quantity on to a wet sponge or flannel and rub onto wet skin. Rinse and pat dry.
6.6 Special precautions for disposal
Hydromol Bath & Shower Emollient should be used topically and is either added to water or applied to wet skin.
1. For use in the bath
a) Adults/Children and the Elderly:
Add 1—3 capfuls (inner capfuls for 500ml or 1 litre pack sizes) to an 8 inch bath of water. Soak for 10-15 minutes.
b) Infants:
Add ½ to 2 capfuls (inner capfuls for 500ml or 1 litre pack sizes) to a small bath of water.
2. For application to the skin as a sponge bath or in the shower.
Adults and Children and the Elderly:
Pour a small quantity on to a wet sponge or flannel and rub onto wet skin. Rinse and pat dry.
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Updated on 10/12/2009 and displayed until 19/01/2011
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 03-Nov-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5, now includes the 50ml pack size.
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Updated on 29/10/2008 and displayed until 10/12/2009
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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| Date of revision of text on the SPC: 24-Oct-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1: Now reads Hydromol Bath & Shower Emollient
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Updated on 25/09/2006 and displayed until 29/10/2008
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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