Summary of Product Characteristics
last updated on the eMC:
18/04/2011
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 18/04/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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: 13-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 7 the address of the MAH, Astellas Pharma Ltd., has been updated following a move to new premises. This entails the address changing from Lovett House, Lovett Road, Staines, TW18 3AZ, United Kingdom to 3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, United Kingdom.
In section 10 the last revision date of the text has been revised to correspond with this move to new premises as detailed in Section 7. This date is updated to 13th December 2010.
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Updated on 13/10/2009 and displayed until 18/04/2011
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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 5.2 - Pharmacokinetic Properties
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 21-Sep-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.8 - now set out in table format, with the following changes:
Headache: from Common to Uncommon
Syncope: from Uncommon to Rare
Angiodema: from Very Rare to Rare
Abnormal ejaculation and Asthenia: from Common to Uncommon
5.2 - fourth paragraph - addition of "XL" after the name "Flomaxtra"
6.3 - extension of shelf life from 2 years to 3 years
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Updated on 01/11/2006 and displayed until 13/10/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 date of revision of the text
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Addition of Legal Category
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| Date of revision of text on the SPC: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4 Special warnings and precautions for use – The following paragraphs have been added-
The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. IFIS may lead to increased procedural complications during the operation. The initiation of therapy with tamsulosin in patients for whom cataract surgery is scheduled is not recommended.
Discontinuing tamsulosin 1-2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping of therapy prior to cataract surgery has not yet been established.
During pre-operative assessment, cataract surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with tamsulosin in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.
4.8 Undesirable effects
General disorders – The following paragraph has been added –
During cataract surgery a small pupil situation, known as Intraoperative Floppy Iris Syndrome (IFIS), has been associated with therapy of tamsulosin during post-marketing surveillance (see also section 4.4).
5.2 Pharmacokinetic properties
The heading ‘Excretion’ has been changed to ‘Elimination’
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Updated on 05/01/2006 and displayed until 01/11/2006
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 12/08/2005 and displayed until 05/01/2006
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Reasons for adding or updating:
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