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Boehringer Ingelheim Limited Consumer Healthcare
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 399
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.com
Customer Care direct line: +44 (0)1344 741 186
Medical Information Fax: +44 (0)1344 741 298

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 21/03/2012
SPC Flomax Relief MR

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 21/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Mar-2012
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 Special Warnings and Precautions for Use

Two new paragraphs before the Additional warnings … sub-heading have been added to this section (regarding inhibitors of CYP3A4).

 

Section 4.5 Interaction with other Medicinal Products and other forms of Interaction

What was previously the fourth paragraph of this section (regarding interactions at the level of hepatic metabolism being seen during in vitro studies with liver microsomal fractions) has been deleted from this section.

 

Four new paragraphs (now the fifth to eighth ones) have been added to this section.


Section 4.9 Overdose

What was previously the first paragraph of this section (regarding acute overdose and acute hypotension, vomiting and diarrhoea) has been deleted from this section.

 

A new sub-heading (and corresponding text) entitled Symptoms has been added to this section.

 

A new sub-heading title (Treatment) has been added to what is now the second paragraph of this section.

 

Section 5.2 Pharmacokinetic Properties

The word hydrochloride has been added after the word tamsulosin in the first and second paragraphs of this section.

 

A new (now third) paragraph has been added to the Biotransformation sub-heading of this section (regarding in vitro results with CYP3A4 and CYP2D6). 
Updated on 08/03/2012 and displayed until 21/03/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Mar-2012
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3 Contraindications

The text …, including drug-induced angioedema, has been added to the first paragraph of this section.

 

Section 4.4 Special Warnings and Precautions for Use

The second paragraph of this section (regarding Intraoperative Floppy Iris Syndrome) has been updated with both text being deleted from (regarding cataract surgery) and added to (regarding risk of eye complications).

 

The third and fourth paragraphs of this section have both had text added (regarding cataract surgery).  The word hydrochloride has been added after the word tamsulosin in the first sentence of the third paragraph of this section.

 

Section 4.5 Interaction with other Medicinal Products and other forms of Interaction

A new first paragraph has been added to this section (regarding interaction studies having been performed in adults only).

 

The word nifedipine has been deleted from what is now the second paragraph of this section (after the word enalapril in the first sentence).


Section 4.8 Undesirable effects

The table in this section has been updated as follows:

 

postural hypotension has been replaced with orthostatic hypotension in the Uncommon column.

Stevens-Johnson syndrome has been added to the Very rare column.

ejaculation disorders has been added to the Common column.

abnormal ejaculation has been deleted from the Uncommon column.

A new, final paragraph regarding Post-marketing experience has been added to this section.

 

Section 10 Date of Revision of the Text

The date has been updated from 03 December 2009 to March 2012. 
Updated on 27/01/2010 and displayed until 08/03/2012
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  tamsulosin hydrochloride