Summary of Product Characteristics
last updated on the eMC:
20/01/2012
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 20/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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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-Jan-2012 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 5.1 Pharmacodynamic Properties
New second and third sentences (regarding the central nervous system) have been added to this section.
Section 10 Date of Revision of the Text
The date has been amended from November 2011 to January 2012.
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Updated on 01/12/2011 and displayed until 20/01/2012
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 5.3 - Preclinical Safety Data
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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-Nov-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.6 Fertility, Pregnancy and Lactation
The text Fertility, has been added to this section’s header.
This section has been completely updated with replacement text added. It now incorporates three separate sub-headings with associated text (Pregnancy, Lactation and Fertility).
Section 5.3 Preclinical Safety Data
This section has been completed updated, with replacement text added.
Section 10 Date of Revision of the Text
The date has been amended from July 2008 to November 2011.
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Updated on 22/06/2011 and displayed until 01/12/2011
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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Change to section 10 date of revision of the text
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 01-May-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.9 Overdose
The words … should be considered have been added after the words … artificial respiration in the first paragraph of the Therapy sub-heading of this section.
Section 10 Date of Revision of the Text
The date has been amended from April 2011 to May 2011.
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Updated on 16/05/2011 and displayed until 22/06/2011
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Reasons for adding or updating:
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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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-Apr-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.7 Effects on Ability to Drive and Use Machines
A new first sentence has been added to this section i.e. No studies on the effects on the ability to drive and use machines have been performed.
Section 10 Date of Revision of the Text
The date has been amended from July 2008 to April 2011.
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Updated on 11/08/2008 and displayed until 16/05/2011
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Reasons for adding or updating:
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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: 01-Jul-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 – Undesirable effects:
The following text has been added as the first paragraph of this section “Many of the undesirable effects can be assigned to the anticholinergic property of Buscopan IBS Relief”.
The text “Not known – incidence cannot be estimated from the available data” has been added to the end of the now second paragraph (beginning “Adverse events have been ranked …”).
The words “Rare”, “Not known” and “Uncommon: skin reactions” have been added to the “Immune system disorders” paragraph.
The word “Uncommon” has been added to the “Gastrointestinal disorders” paragraph.
Section 10 - Revision date:
Revision date updated to July 2008.
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Updated on 11/06/2008 and displayed until 11/08/2008
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Reasons for adding or updating:
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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 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 30-May-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.3 – Contraindications – change “sensitivity” to “hypersensitivity”
Section 4.4 – Warnings – addition of small amount of sucrose in each tablet
Section 4.4 – Change in heading to align with MHRA template
Section 4.5 – Interactions – Addition of anticholinergic drugs (tiotropium and ipratropium)
Section 6.6 – Change of heading to “Special precautions for disposal”
Section 10 - Revision date up-dated to 30 May 2008
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Updated on 18/02/2008 and displayed until 11/06/2008
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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: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.1 removal of palmitic acid from list of excipients
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Updated on 15/08/2007 and displayed until 18/02/2008
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Reasons for adding or updating:
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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: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to date of revision
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Updated on 09/02/2005 and displayed until 15/08/2007
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Reasons for adding or updating:
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