Summary of Product Characteristics
last updated on the eMC:
17/08/2009
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 17/08/2009 and displayed until Current
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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: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.2 Posology and method of administration
Oral administration.
Adults & Children over 12 years: 30ml in measuring cup at bedtime.
Elderly patients: Adult dose applies.
4.3 Contraindications
Cardiovascular disorders, thyroid disease, diabetes, monoamine oxidase inhibitor therapy, severe hepatic or
renal insufficiency. Pregnancy. Hypersensitivity to any of the ingredients.
Not to be used in Children under 12 years of age
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Updated on 03/06/2009 and displayed until 17/08/2009
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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: 01-May-2003 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 180ml clear flint glass bottle with wadless polypropylene screw cap or white polypropylene child resistant closure
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Updated on 02/11/2007 and displayed until 03/06/2009
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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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