Molipaxin 50mg Capsules

  • Name:

    Molipaxin 50mg Capsules

  • Company:
    info
  • Active Ingredients:

    Trazodone Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/06/19

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Summary of Product Characteristics last updated on medicines.ie: 11/5/2015
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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 20 June 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 11 May 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 11 May 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 4.4 updated to include:

Severe hepatic disorders with potential fatal outcome have been reported with trazodone use (see adverse reaction section).  Patients should be instructed to report immediately signs such as asthenia, anorexia, nausea, vomiting, abdominal pain or icterus to a physician.  Investigations including clinical examination and biological assessment of liver function should be undertaken immediately and withdrawal of trazodone therapy be considered.


Section 4.8: Hepato-biliary disorders updated to include:

Severe hepatic disorders such as hepatitis/fulminant hepatitis, hepatic failure with potential fatal outcome.


New paragraph on the reporting of suspected adverse reactions included.

Updated on 1 May 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 1 May 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 September 2014 PIL

Reasons for updating

  • Change of manufacturer

Updated on 12 September 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects

Updated on 2 September 2013 SmPC

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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Core Safety Profile updates:-

Section 4.2 updated:
- The Elderly: reworded regarding dosage.
- Children: reworded

Section 4.3: Pregnancy deleted

Section 4.4 updated as per highlighted text:
- The Elderly: 
Elderly patients are more often more sensitive to antidepressants, in particular may more often experience orthostatic hypotension, somnolence and other anticholinergic effects of trazodone. 
Paragraph relating to this change deleted from later in the section.

Paragraph 'Close supervision' last word changed from 'persist' to 'present'.

Section 4.8 table:
'Immune system disorders' and 'Endocrine disorders' - reformatted.

Section 4.9:

Single brief convulsions do not require treatment.  Control frequent or prolonged convulsions with intravenous diazepam (0.1 – 0.3mg/kg/bodyweight) or lorazepam (4mg in an adult and 0.5mg/kg in a child).  If these measures do not control the fits, an intravenous infusion of phenytoin may be useful.  Give oxygen and correct acid base and metabolic disturbances as required.


Updated on 23 July 2013 SmPC

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

Type IAINB.II.f.1 a variation to reduce the shelf life from 60months to 36 months.

Updated on 12 April 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 2 May 2012 PIL

Reasons for updating

  • Change to further information section

Updated on 13 April 2012 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

Section 6.1 has been updated due to the change of supplier ink used in the imprint of the capsules

Updated on 22 November 2010 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 3 July 2009 PIL

Reasons for updating

  • New PIL for medicines.ie