Buscopan Ampoules

Product Information *

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 12 February 2021

File name

Leaflet - Buscopan Ampoules - clean_1613134206.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 01 October 2020

File name

1.3.2 Mockup PIL PL04425-0707_Cropped_1601540354.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 30 April 2020

File name

1.3.2 Mockup PIL PL04425-0707_Cropped_1588230148.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

- Update on the Possible Side effects Sub-section of 'Other side effects'  (Section 4 - Possible Side Effects effects) 

Updated on 16 April 2020

File name

1.3.1.1 SmPC Ampoules_1587041540.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to reflect update on Company Core Data Sheet (CCDS) - Version 1, which consisted in:

- Update on the Sub-section adverse events frequency presentation (Section 4.8 - Undesirable effects) 

- Update on the Adverse Reactions Sub-section of 'Skin and subcutaneous tissue disorders'  (Section 4.8 - Undesirable effects) 

Updated on 11 November 2019

File name

Bus.Amps 04425_0707 PIL_1573496595.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 16 October 2019

File name

Busc. Amps. Approved SPC_1571238572.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 September 2019

File name

B10b-E-SPC-25_1568121384.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to section 6.3 Shelf life - shelf life is now 36 months

Updated on 17 November 2017

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.3 - Contraindications
This section has been updated/reordered to align with the current Company Core Data Sheet.  The information has been bulleted and the previous first two paragraphs deleted.  The information relating to hypersensitivity has been revised in line with EU SPC guidance at the request of the HPRA.

Section 4.9 - Overdose
A minor editorial correction has been made for clarity (in line with the Company Core Data Sheet).  The text "should be considered" has been added to the Therapy paragraph. 

Section 10 - Date of Revision of the Text
This has been updated from August 2017 to November 2017.

Updated on 17 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 November 2017

File name

PIL_15404_244.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 November 2017

Reasons for updating

  • Correction of spelling/typing errors

Updated on 15 August 2017

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 (Marketing Authorisation Holder) has been amended.  Boehringer Ingelheim Limited details have been replaced by sanofi-aventis Ireland Ltd details.

Section 8 (Marketing Authorisation Number) has been amended.  PA 7/16/2 has been replaced by PA 540/181/1.

Section 10 (Date of Revision of the Text) has been amended from February 2017 to August 2017.

Updated on 11 August 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 21 February 2017

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 (Special Warnings and Precautions for Use) has been revised to align with the Company Core Data Sheet (CCDS) and to incorporate wording requested by the MHRA relating to risk in patients with isachaemic heart disease.

Section 10 (Date of Revision of the Text) has been updated from July 2014 to February 2017.

Updated on 17 February 2017

Reasons for updating

  • Correction of spelling/typing errors

Updated on 08 August 2014

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 Undesirable Effects

Details regarding the reporting of suspected adverse reactions have been added to the end of this section.

 

Section 10 Date of Revision of the Text

The date has been amended from June 2012 to July 2014.

Updated on 07 August 2014

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 02 July 2012

Reasons for updating

  • New PIL for medicines.ie

Updated on 28 June 2012

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 has been amended.

Section 4.4 has been updated to include the following paragraph:
In case severe, unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting, or blood in stool, appropriate diagnostic measures are needed to investigate the etiology of the symptoms.
Section 4.5 has been updated.

Section 4.6 has been extensively updated.

Section 4.7 has been extensively updated.

Section 4.8 has been updated.

Section 5.2 has been extensively amended.

Section 5.3 has been amended.

A minor editorial update has also been made to section 4.3 and section 10 – date of revision of the text has also been updated to June 2012

Updated on 26 November 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.9 - Overdose
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 – Qualitative and Quantitative Composition


Previous wording:
For excipients, see 6.1

 

Updated wording: For a full list of excipients, see section 6.1


Section 4.9 – Overdose


Previous wording:
In addition, appropriate supportive measures should be used as required.

 

Updated wording: In addition, appropriate supportive measures should be used.

 

Section 9 – Date of Renewal of the Authorisation

 

1 April 2009

 

Section 10: Date of revision of the text

 

October 2009

Updated on 08 October 2009

Reasons for 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 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



Details of main changes

Section 4.3

In addition, Buscopan should not be used in patients with a known sensitivity to hyoscine butylbromide or any other component of the product.

Buscopan should not be used in patients who have demonstrated prior hypersensitivity to hyoscine butylbromide or any other component of the product.

The following text has been added:

Buscopan ampoules should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.

 

 

Section 6.6

Heading has been re-worded. 

 

 

 

 

Section 4.5

The anticholinergic effect of tricyclic antidepressants, antihistamines, quinidine, amantadine, phenothiazines, butyrophenones and disopyramide may be intensified by Buscopan.

The anticholinergic effect of drugs such as tricyclic antidepressants, antihistamines, quinidine, amantadine, phenothiazines, butyrophenones, disopyramide and other anticholinergics (e.g. tiotropium, ipratropium) may be intensified by Buscopan.

Section 4.8

Undesirable effects have been re-formatted.

Updated on 03 May 2006

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 January 2006

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 July 2005

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 30 May 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)