Astellas Pharma Ltd

·         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 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.

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

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’