Summary of Product Characteristics
last updated on the eMC:
23/04/2012
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 23/04/2012 and displayed until Current
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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 4.5 - 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 4.9 - Overdose
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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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| Date of revision of text on the SPC: 05-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| · In section 4.4 (Special warnings and precautions for use) the warning is updated in relation to IFIS and a warning added in relation to concomitant use CYP3A4-inhibiting drugs.
· In section 4.5 (Interaction with other medicinal products and other forms of interaction) information is added in relation to concomitant use CYP3A4-inhibiting drugs. Also the statement concerning nifidipine having no effect when concomitantly administered with tamsulosin is removed and a statement concerning concomitant administration of tamsulosin hydrochloride with paroxetine is added (albeit that it there is not considered to be any clinically relevant impact).
· In section 4.8 (Undesirable effects) the table has been updated to include abnormal ejaculation and Stevens-Johnson syndrome, with hypotension qualified now as ‘orthostatic hypotension’. Also the following sentence is added to the foot of this section after the table of undesirable events:- “Post-marketing experience: In addition to the adverse events listed above, atrial fibrillation, arrhythmia, tachycardia and dyspnoea have been reported in association with tamsulosin use. Because these spontaneously reported events are from the worldwide post marketing experience, the frequency of events and the role of tamsulosin in their causation cannot be reliably determined.”
· In section 4.9 (Overdose) the information is updated to reflect current data.
· In section 5.2 (Pharmacokinetic properties) information concerning the impact of food when taking the product is updated. Also information to the effect that in vitro results suggest CYP3A4 and CYP2D6 are involved in metabolism is added.
· In section 10 (Date of revision of the text) the date of last revision of the SmPC is updated.
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Updated on 18/04/2011 and displayed until 23/04/2012
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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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