Summary of Product Characteristics
last updated on the eMC:
26/01/2011
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 26/01/2011 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 4.5 - Interaction with other medicinal products and other forms of interaction
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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: 20-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SPC Changes
Half Inderal LA capsules 80mg
Section 4.2
Additional text in first paragraph, now reads as,
“For oral administration. The capsule must not be chewed, but swallowed whole to ensure a prolonged release action.”
Section 4.5
Additional second paragraph, reads as,
“Simultaneous administration of rizatriptan and propranolol can cause an increased rizatriptan AUC and Cmax by approximately 70-80%. The increased rizatriptan exposure is presumed to be caused by inhibition of first-passage metabolism of rizatriptan through inhibition of monoamine oxidase-A. If both drugs are to be used, a rizatriptan dose of 5 mg has been recommended.”
Section 10
20th January 2011
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Updated on 18/08/2009 and displayed until 26/01/2011
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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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