Last Updated on eMC 14-04-2016 View medicine  | Allergan Ltd Contact details

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.

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-03-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



In section 7 (Marketing Authorisation Holder) - the MAH name and address have been amended, following the completion of MAH transfer procedure from Warner Chilcott UK Limited to Allergan Pharmaceuticals International Limited.

In section 8 (Marketing Authorisation Number(s) - the Warner Chilcott UK Limited MA number - PL 10947/0015 has been replaced with the Allergan Pharmaceuticals International Limited MA number - PL 45496/0005.

In section 9 (Date of first authorisation/renewal of the authorisation)  the date format has been changed as follows: from 3.6.94 / 21.05.2002 to 3rd June 1994 / 21st May 2002

In section 10 (Date of revision of the text) - the date of revision of the text is March 2016

Reasons for adding or updating:

  • 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:08-06-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



IA, C.I.z To register an update to SPC Section 4.8 and the leaflet according to the MHRA wording to be implemented in-line with the ADR statement.

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:01-11-2010

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-11-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



6.6  Special precautions for disposal

 

Read the instructions carefully before using 'Asacol' Foam Enema for the first time.

 

Before using the enema for the first time, thoroughly mix the contents by shaking the can vigorously for 15 seconds. Rest for about 30 seconds, and then shake the can vigorously for another 15 seconds.

 

Also, before using the enema for the first time, remove the safety tag from under the dome.

 

Push the plastic applicator firmly on to the spout of the can and align the notch beneath the dome with the spout.

 

Hold the can in the palm of one hand with the dome pointing downwards.  This product must only be dispensed when the can is upside down, with the dome nearest to the ground.  (If the can is not upside down the foam will not come out properly.)

 

You may find that the easiest way to use the enema is to raise one foot on to a firm surface, such as a stool or chair, and insert the applicator into the rectum as far as is comfortable.  You can apply a lubricating jelly to the tip of the applicator for comfort if you wish.

 

To administer a dose, fully depress the dome once and release it.  The foam will not come out of the can until you release the dome.  To administer a second dose, press and release the dome again.  Wait for 15 seconds before withdrawing the applicator.

 

Note: the can will only work when held with the dome pointing down.

 

Remove the applicator and dispose of it in one of the plastic bags provided.  Do not flush it down the toilet.

 

Before using the enema again, mix the contents of the can by shaking vigorously for 5 seconds only, before continuing to use enema as instructed above.

 

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:01-05-2010

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-05-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



7.  Marketing Authorisation Holder

Warner Chilcott UK Limited

Old Belfast Road,

Millbrook Road,

Larne,

County Antrim,

BT40 2SH

 

 

8.  Marketing Authorisation Number

 

PL 10947/0015

 

10.  Date of  (Partial) Revision of Text

 

May 2010

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Addition of separate SPCs covering individual presentations