Summary of Product Characteristics
last updated on the eMC:
04/08/2010
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 04/08/2010 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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Oct-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5: Amber cylindrical glass bottle (pharmaceutical type III) with a high density polyethylene screw thread closure has been changed to Amber cylindrical glass bottle (pharmaceutical type III) with a Crab claw seal (polypropylene) child resistant closure
Section 10: June 2009 has been changed to October 2009
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Updated on 17/08/2009 and displayed until 04/08/2010
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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 4.3 - Contraindications
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| Date of revision of text on the SPC: 08-Jun-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.2 Posology and method of administration
` Adults and children 12 years and over: 3 x 5ml spoonfuls
Repeat every 4 hours as needed.
No more than 6 doses a day
4.3 Contraindications
Not to be used in children under the age of 6 years
Known hypersensitivity to guaifenesin.
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Updated on 14/01/2009 and displayed until 17/08/2009
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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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| Date of revision of text on the SPC: 03-Apr-2006 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Before
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children 12 years and over: 3 x 5ml spoonfuls
Children (6-11 years): 2 x 5ml spoonfuls
Children (2-5 years): 1 x 5ml spoonful
Repeat every 4 hours as needed.
No more than 6 doses a day
After
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children 12 years and over: 3 x 5ml spoonfuls
Children (6-11 years): 2 x 5ml spoonfuls
Children (2-5 years): 1 x 5ml spoonful
Children under 6: Do not take with any other cough and cold medicine. Consult a pharmacist or other healthcare professional for further advice.
Repeat every 4 hours as needed.
No more than 6 doses a day
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Updated on 26/10/2007 and displayed until 14/01/2009
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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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