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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

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Summary of Product Characteristics last updated on the eMC: 19/04/2012
SPC Trazodone 150mg 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 19/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   30-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4:
Use in children and adolescents under 18.

Trazodone should not be used in children and adolescents under 18 years old. Suicidal behaviour (suicidal attempt and suicidal planning) and hostility (essentially aggressiveness, opposing behavior and anger) has been observed in a clinical study on children and adolescents treated with antidepressant more frequently than with placebo. Moreover, long-term safety data on children and adolescents regarding growth, maturation and cognitive and behavioral development are not available. Trazodone should be administered with caution with patients of porphyria urinary retention.

Section4.7: Some additional warnings about the use of Trazodone while driving and using machines has been added.

Section 4.8: Some new side-effects have been added and the symptoms have been arranged according to frequency and SOC. 
Updated on 23/08/2010 and displayed until 19/04/2012
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
Date of revision of text on the SPC:   02-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.3 hypersensivity to excipients has been added.

In section 4.4. new sprecial warnings have been added such as Trazodone should be administered with caution in patients of thyroid disease, psychosis/mania, the elderly, close angle glaucoma, anaesthesia, porphyria and urinary retention.

In section 4.5 the interactions have been re-arranged according to their class. The interactions are as per current clinical knowledge.

In section 4.8 the following side effects have been added: serotonin syndrome, convulsions, Neuroleptic malignant syndrome,  hyponatraemia.
Updated on 12/01/2010 and displayed until 23/08/2010
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

 
  trazodone hydrochloride