When a pharmaceutical company changes an SPC or PIL, 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.
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
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
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
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
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.