Summary of Product Characteristics
last updated on the eMC:
14/12/2011
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 14/12/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 07-Dec-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Tp update sections 1, 2, 3, 4.4, 4.6, 5.1, 6.1, 6.6 and 9 of the SPC in line with current regulatory guidance. The labelling is also revised as a result of the updates.
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Updated on 01/12/2011 and displayed until 14/12/2011
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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| Date of revision of text on the SPC: 28-Mar-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 3 - "oral solution" changed to "elixir"
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Updated on 30/03/2011 and displayed until 01/12/2011
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 28-Mar-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3 Contraindications
Phenergan should not be used in patients in coma or suffering from CNS depression of any cause.
Phenergan should not be given to patients with a known hypersensitivity to promethazine or to any of the excipients.
Promethazine is contraindicated for use in children less than two years of age because of the potential for fatal respiratory depression.
Phenergan should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.
The elixir contains hydrogenated glucose syrup and is not suitable for diabetics.
Section 4.4 Special Warnings and Precautions for use
The following wording has been added to section 4.4:-
If you have diabetes, you should be aware that although Phenergan Elixir does contain carbohydrates , which the body will convert into small amounts of sugar . The maximum 25ml single dose of Phenergan Elixir is equivalent to approximately 5 grams of sugar, or one teaspoon of sugar/sugar lump. Taking this amount of Phenergan Elixir is unlikely to affect the control of your diabetes or require you to increase your diabetes medication.
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Updated on 06/01/2009 and displayed until 30/03/2011
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Oct-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 8 - change of marketing authorisation number
Section 9 - changed to October 2008 from July 1988/June 2003
Section 10 - changed to October 2008 from December 2007
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Updated on 21/01/2008 and displayed until 06/01/2009
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 12/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.1 Change to Excipient labelling
6.1 List of excipients
Maltitol liquid, Citric acid anhydrous (E330), Sodium citrate (E331), Ascorbic acid (E300), Sodium sulphite anhydrous (E221), Sodium metabisulphite (E223), Sodium benzoate (E211), Orange juice flavour 510844E, Caramel (E150), Acesulfame potassium (E950), Purified water.
Section 10 - change to date of revision
10 Date of Revision of The Text
10 December 2007
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Updated on 18/09/2007 and displayed until 21/01/2008
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 6.1 - List of Excipients
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3 (Contrainidications): Information regarding use in children has been updated:
'Promethazine is contraindicated for use in children less than two years of age because of the potential
for fatal respiratory depression.'
Section 4.4 (Special warnings and precautions for use): The following statement has been added:
'Patients with rare hereditary problems of fructose intolerance should not take this medicine.'
Section 4.8 (Undesirable effects): Urticaria, rash and pruritis added.
Section 6.1 (List of excipients): Excipietns changed from BP monograph to equivalent EP monograph standards
Section 7 (Marketing Authorisation Holder): change in MA Holder's details
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Updated on 26/08/2005 and displayed until 18/09/2007
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 29/09/2004 and displayed until 26/08/2005
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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