Summary of Product Characteristics
last updated on the eMC:
18/08/2009
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 18/08/2009 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 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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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: 19-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 3
Change of text:
Pink/lavender or white opaque capsules containing propranolol hydrochloride in a prolonged release formulation.
Section 4.5
Change of text 2nd paragraph to include amiodarone:
Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have potentiating effect on atrial-conduction time and induce negative inotropic effect.
Section 4.8
Revised table.
Section 10
Change of revision date to 19 May 2009
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Updated on 18/07/2007 and displayed until 18/08/2009
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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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: 06/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.3 Shelf Life
Old Text 5 years New Text 3 years.
6.4 Special Precautions for storage
Old text Store below 30°C, protected from light and moisture. New text Store below 25°C, protected from light and moisture.
Section 10
New revision date of text: 21 June 2007
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Updated on 03/12/2004 and displayed until 18/07/2007
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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Change to section 3 - pharmaceutical form
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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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 6.2 - Incompatibilities
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 15/06/2004 and displayed until 03/12/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 13/12/2002 and displayed until 15/06/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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