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Mercury Pharma Group
No. 1 Croydon, 12 - 16 Addiscombe Road, Croydon, Surrey, CR0 0XT, UK
Telephone: +44 (0)208 588 9100
Fax: +44 (0)208 686 0807
WWW: http://www.mercurypharma.com
Medical Information Direct Line: 08700 70 30 33
Medical Information e-mail: medicalinformation@mercurypharma.com
Customer Care direct line: +44 (0)208 588 9273
Medical Information Fax: +44 (0)208 686 0807

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 23/11/2011
SPC Triptafen Tablets

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 23/11/2011 and displayed until Current
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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   19-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4- Special warnings and precauitons for use
Section 4.5- Interactions with other medicinal products and other forms of interactions
Section 4.6- Pregnancy and lactation
Section 4.8- Undesirable effects
Updated on 09/02/2011 and displayed until 23/11/2011
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
Date of revision of text on the SPC:   03-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 has been updated with additional special warnings including excipient warnings for lactose and sucrose
Section 4.5 has been updated with additional interactions including those with anticholingeric agents and sympathomimetric agents
Updated on 21/09/2010 and displayed until 09/02/2011
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   10-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.6 has been updated to include further information on breast-feeding i.e. Triptafen is detectable in breast milk. Because of the potential for serious adverse reactions in infacts from Triptafen,  a decision should be made whether to discontinue breast-feeding or to discontinue the drug
Updated on 24/08/2010 and displayed until 21/09/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   23-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


update to section 4.8 of the SPC for implementation of Tricyclic anti-depressants (TCA) and risk of bone fracture warnings as per MHRA request to MA holders
Updated on 29/04/2010 and displayed until 24/08/2010
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  amitriptyline hydrochloride
  perphenazine