Reasons for adding or updating:

• Change to section 1 - Name of the medicinal product
• 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 6.4 - Special precautions for storage
• Change to section 6.5 - Nature and contents of container
• Change to section 10 - Date of revision of the text
• Change to legal category

Date of revision of text on the SPC: 01-Jun-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Removal of the POM product name 'Buscopan Tablets' (sections 1, 4.1, 4.2, 4.3, 4.4 and 6.4)

Removal of the registered POM pack sizes (section 6.5)

Update of revision date to June 2015 from December 2013 (section 10)

Change to legal category

Reasons for adding or updating:

• Change to section 10 - Date of revision of the text
• Change to section 4.8 - Undesirable effects - how to report a side effect

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

Legal Category:POM, P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8 Undesirable Effects

A new paragraph regarding the reporting of suspected adverse reactions has been added at the end of this section. 

 

Section 10 Date of Revision of the Text

The date has been amended from August 2013 to December 2013.

Reasons for adding or updating:

• Change to section 4.9 - Overdose
• Change to section 10 - Date of revision of the text

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

Legal Category:POM, P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.9 Overdose

In the first sentence of the Therapy sub-heading, the word sulphate has been amended to sulfate at the request of the MHRA following issuing of relevant guidance on 16 May 2013.

 

Section 10 Date of Revision of the Text

The date has been amended from March 2012 to August 2013.

Reasons for adding or updating:

• 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: 22-Mar-2012

Legal Category:POM, P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 Special Warnings and Precautions for Use
A new first paragraph regarding severe, unexplained abdominal pain has been added to this section.

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
Text has been both added to and deleted from the first paragraph of this section, including addition of the following medicines: … and tetra, antipsychotics and atropine-like compounds …

Section 4.8 Undesirable Effects
The word … listed … has been added to the first paragraph of this section.

The word … incidence … has been deleted from the last sentence of the second paragraph of this section.

Update to Immune system disorders

A new final paragraph has been added to this section.

Section 10 Date of Revision of the Text
The date has been amended from February 2012 to March 2012.

Reasons for adding or updating:

• Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC: 24-Feb-2012

Legal Category:POM, P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 Posology and Method of Administration
The following sentence has been added to the section:
“Buscopan Tablets should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.”

Reasons for adding or updating:

• Change to section 5.2 - Pharmacokinetic Properties
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Feb-2012

Legal Category:POM, P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 5.2 Pharmacokinetic Properties
This section has been re-written with new sub-headings and corresponding text regarding Absorption, Distribution and Metabolism and elimination.

Section 10 Date of Revision of the Text
The date has been amended from January 2012 to February 2012.

Reasons for adding or updating:

• Change to section 5.1 - Pharmacodynamic Properties
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Jan-2012

Legal Category:POM, P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 5.1
“As a quaternary ammonium derivative, hyoscine butylbromide does not enter the central nervous system. Therefore, anticholinergic side effects at the central nervous system do not occur.” has been added to section 5.1.

Section 10
Date of revision has been updated to January 2012

Reasons for adding or updating:

• Change to section 4.6 - Pregnancy and Lactation
• Change to section 5.3 - Preclinical Safety Data
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Nov-2011

Legal Category:POM, P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.6
Section on Pregnancy and Lactation has been updated and a statement on Fertility added.

Section 5.3
Pre-clinical safety data – information updated.

Section 10
Date updated to November 2011.

Reasons for adding or updating:

• Change to section 4.7 - Effects on Ability to Drive and Use Machines
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Apr-2011

Legal Category:POM, P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.7 - Effects on Ability to Drive and Use Machines of the SPC has been aligned with CCDS

Section 10 has been revised to April 2011

Reasons for adding or updating:

• Change to section 2 - Qualitative and quantitative composition
• Change to section 4.3 - Contraindications
• Change to section 5.2 - Pharmacokinetic Properties
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Jul-2009

Legal Category:POM, P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2

Revision of the drug substance name from 'hyoscine-N-butylbromide' to 'hyoscine butylbromide'.

 

Section 4.3

Revision of the drug substance name from 'hyoscine-N-butylbromide' to 'hyoscine butylbromide'.

 

Section 5.2

Revision of the drug substance name from 'hyoscine-N-butylbromide' to 'hyoscine butylbromide'.

 

Section 10

Date of revision updated to July 2009

Reasons for adding or updating:

• Change to section 4.8 - Undesirable Effects
• Change to section 10 date of revision of the text
• Change to section 1 -Name of the Medicinal product

Date of revision of text on the SPC: 01-Jul-2008

Legal Category:POM, P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 1 and Legal Category

New Buscopan Cramps name for the P status product included.

Section 4.8

Text has been updated and now includes frequency information.

 

Section 10

Date has been revised to July 2008.

 

Reasons for adding or updating:

• Change to section 4.3 - Contraindications
• Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
• Change to section 6. 6 - Instructions for use, handling and disposal
• Change to section 9 - Date of first Authorisation/renewal of the Authorisation
• Change to section 10 date of revision of the text
• Change to section 4.4 - Special warnings and precautions for Use
• Change to section 8 - MARKETING AUTHORISATION NUMBER(S)

Date of revision of text on the SPC: 01-Apr-2008

Legal Category:POM, P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.3

Removal of hyphen from heading.  From “Contra-Indications” to “Contraindications”.

 

Section 4.4

–        Removal of “Special” from heading.  Heading has changed from “Special Warnings and Special Precautions for Use” to “Special Warnings and Precautions for Use”.

–        Paragraph 4:  Addition of (41.2 mg) after the word “sucrose”.

 

Section 4.5

Paragraph 1: 

–        Addition of “drugs such as” after “The anticholinergic effect of”

–        Removal of “and” and insertion of comma (,) after the word “phenothiazines”

–        Addition of “and other anticholinergics e.g. tiotropium, ipratropium after the word “disopyramide”

 

Section 6.6

Heading change from “Instructions for Use, Handling and Disposal” to “Special Precautions for Disposal”

 

Section 8

Change in heading – deletion of “s” in Numbers(s)

 

Section 9

Addition of “the” in heading ie. “Date of First Authorisation/Renewal of the Authorisation”

 

Section 10

Change of date to April 2008

Reasons for adding or updating:

• Change to section 6.1 - List of Excipients

Date of revision of text on the SPC: 01-Apr-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Reasons for adding or updating:

• Change to section 4.4 - Special warnings and precautions for Use
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Sep-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 addition of statement relating to  sucrose

Reasons for adding or updating:

• Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

• Change to section 4.8 - Undesirable Effects
• Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

• Change to section 4.1 - Therapeutic Indications

Reasons for adding or updating:

• Change to section 3 - pharmaceutical form
• Change to section 4.2 - Posology and Method of Administration
• Change to section 6.1 - List of Excipients
• Change to section 6. 4 - Special Precautions for Storage
• Change to section 6. 5 - Nature and Contents of Container
• Change to section 9 - Date of Renewal of Authorisation
• Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

• Transferred from eMC version 1

Reasons for adding or updating:

• No reasons supplied

Reasons for adding or updating:

• No reasons supplied

Reasons for adding or updating:

• No reasons supplied