Last Updated on eMC 04-04-2016 View medicine  | Takeda UK 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 10 - Date of revision of the text

Date of revision of text on the SPC:01-04-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Change to section

Details of change

7. Marketing Authorisation Holder

ERT  Text in blue removed:

 

Sucampo Pharma Europe, Ltd.

99 Park Drive

Milton Park

Abingdon

Oxfordshire

OX14 4RY

United  Kingdom

 

Updated text in red:

 

Takeda UK Limited

Building 3,

Glory Park,

Glory Park Avenue,

Wooburn Green,

BUCKS,

HP10 0DF

UK

 

8. Marketing Authorisation Number(s)

Text in Text in blue removed:

 

               PL 21341/0003

 

Updated text in red:

 

                PL 16189/0030

 

10. Date of revision of the text

Text in Text in blue removed:

 

15 January 2016

 

Updated text in red:

 

1 April 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:15-01-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

In section 4.8 (undesirable effects), ischaemic colitis and hypotension have been added.

In section 10 (date of last revision), the date has been updated to 15 January 2016

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
  • Addition of black triangle

Date of revision of text on the SPC:13-08-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

The SPC has been changed following a mututal recognition procedure with some additional EU member states.

  • throughout the SPC, the term 'Amitiza' has been replaced by the name of the active substance 'lubiprostone'
  • in section 2 (qualitative and quantitative composition), the amount of the excipient sorbitol liquid has been added
  • in section 4.1 (therapeutic indication), wording has been slightly simplified
  • in section 4.2 (posology and method of administration), treatment duration has been changed from '2 weeks'  to '2-4 weeks', and a statement that efficacy beyond this time has not been demonstrated in placebo-controlled studies
  • in section 4.4 (special warnings and precautions), a paragraph has been added to recommend treatment for not longer than 4 weeks and that treatment should be discontinued if no effect is seen after 2 weeks
  • in section 4.6 (fertility, pregnancy and lactation), wording has been changed that lubiprostone should not be used during pregnancy and in women of childbearing potential not using contraception. The paragraph on fertility has been slighly simplified.
  • in section 5.1 (pharmacodynamic properties), the description of the open-label long-term study has been slightly revised
  • in section 6.1 (list of excipients), the detailed composition of the black ink on the capsule has been added
  • in section 6.4 (special precaution for storage), in addition to protect the capsules from moisture, it should also be protected from light
  • in section 10 (date of revision of the text), the date has been updated
  • a black triangle symbol has been added as needs to be done for all new molecules. This was initially forgotten.

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:10-10-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The Medicines Healthcare products Regulatory Agency (MHRA) has not yet accepted the changes made in the previous revision and requested the marketing authorisation holder to cease the last version and revert back to the version of 1 October 2013.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
  • Addition of black triangle

Date of revision of text on the SPC:18-03-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



All changes described below have been changed in the course of a mutual recognition procedure with 8 other EU member states.

  • In section 2 (qualitative and quantitative composion), amount of excipient sorbitol - less than 10 mg - has been added.
  • In section 4.1 (therapeutic indication), "Amitiza" has been replaced by "Lubiprostone", and "...and associated symptoms..." has been deleted.
  • In section 4.2 (posology and method of administration), "Amitiza" has been replaced by "Lubiprostone". Furthermore, a course of treatment has been changed from 2 to "2 to 4" weeks, and the follwoing sentence has been added: "Efficacy beyond 4 weeks has not been demonstrated in placebo-controlled studies (see section 5.1). Treatment with lubiprostone should be stopped if there is no response after at least 2 weeks."
  • In section 4.3 (contraindications), "Amitiza" has been replaced by "Lubiprostone".
  • In section 4.4 (special warnings and precautions), "Amitiza" has been replaced by "Lubiprostone", and the following paragraph has been added: "The efficacy of lubiprostone beyond 4 weeks has not been dmonstrated in placebo-controlled trials (see section 5.1). Therefore, a course of treatment with lubiprostone should not exceed 4 weeks. Treatment should be stopped if there is no response to lubiprostone after at least 2 weeks.
  • In section 4.6 (fertility, pregnancy and lactation), "Amitiza" has been replaced by "Lubiprostone", a paragraph in the "pregnancy" subsection has been revised to "Lubiprostone should not be used during pregnancy and in women of childbearing potential not using contraceptives," and in the "fertility" subsection the words "...at oral doses of up to 1000 micrograms/kg/day..." have been deleted but a reference to section 5.3 has been added.
  • In section 4.8 (undesirable effects), "Amitiza" has been replaced by "Lubiprostone".
  • In section 4.9 (overdose), "Amitiza" has been replaced by "Lubiprostone".
  • In section 5.1 (pharmacodynamic properties), "Amitiza" has been replaced by "Lubiprostone", and the second last paragraph on long-term use has been reworded to "Four open-labelled, long-term studies were conducted in patients with chronic idiopathic constipation. Except for one study, Lubiprostone was used on an as need basis. The chosen Lubiprostone dose was 24 micrograms twice daily. These studies comprised 1087 patients who were treated for 24 (one study) or 48 weeks. These studies demonstrated that Lubiprostone decreases abdominal bloating, abdominal discomfort, and constipation severity of the chosen treatment period."
  • In section 6.1 (list of excipients), "Ink composition" has been changed to "Black ink composition", and Ammonium hydroxide" has beed deleted.
  • In section 6.4 (special precaution for storge), protection against light has been added.
  • In section 10 (date of last revision), the date 18 March 2015 is provided.
  • At the beginning of the SPC, a black triangle statement has been added

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC:01-10-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



  • In section 6.5 (nature and contents of container) '56 capsules are contained in each bottle' has changed to '28 or 56 capsules are contained in each bottle.'
  • In section 7 (marketing authorization holder) The Sucampo Pharma Europe, Ltd. UK registered office address has changed to 99 Park Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RY, UNITED KINGDOM

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO