Rosemont Pharmaceuticals Limited

Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE

Telephone: +44 (0)113 244 1400
Fax: +44 (0)113 246 0738
WWW: http://www.rosemontpharma.com
Customer Care direct line: +44 (0)800 919 312

Out of Hours Telephone: +44 (0)7836 557 879
Out of Hours contact: pharmacovigilance@rosemontpharma.com

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Summary of Product Characteristics last updated on the eMC: 05/07/2010

SPC	Amitriptyline Hydrochloride 50mg/5ml Oral Solution

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.

Updated on 05/07/2010 and displayed until Current

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: 11-Jun-2010
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
In section 4.8 (Undesirable effects) an update has been made to include increased risk of bone fractures from studies in patients 50 years of age and over. In section 10 (Date of partial revision of the text) the date has been updated to 11/06/2010.

Updated on 11/04/2008 and displayed until 05/07/2010

Reasons for adding or updating:
Change to section 1 -Name of the Medicinal product Change to section 4.4 - Special warnings and precautions for Use Change to section 4.8 - Undesirable Effects Change to section 6.1 - List of Excipients Change to section 10 date of revision of the text
Date of revision of text on the SPC: 03/2008
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section1: re-arranged name to conform to current legislation Section 4.4: Warnings on suicide Section 4.8: Added suicide Section 6.1: Expanded fruit cup flavour to inlude Carmoisine E122 Section 10: Updated

Updated on 11/04/2007 and displayed until 11/04/2008

Reasons for adding or updating:
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction Change to section 10 date of revision of the text
Date of revision of text on the SPC: 03/2007
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 4.5: Added St John’s Wort may decrease plasma levels of amitriptyline.Amitriptyline may increase levels of thioridazine leading to cardiac side effects.

Updated on 10/04/2007 and displayed until 11/04/2007

Reasons for adding or updating:
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction Change to section 10 date of revision of the text Pending awaiting re-submission
Date of revision of text on the SPC: 03/2007
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 4.5: Added: "St John’s Wort may decrease plasma levels of amitriptyline. Amitriptyline may increase levels of thioridazine leading to cardiac side effects."