Molipaxin 150mg Film-Coated Tablets

  • Name:

    Molipaxin 150mg Film-Coated Tablets

  • 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

  • New PIL for new product

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 16 October 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 10 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 12 April 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 21 April 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

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

Free text change information supplied by the pharmaceutical company

Addition of pharmaceutical form to product name

Updated on 19 April 2011 PIL

Reasons for updating

  • Change of trade or active ingredient name

Updated on 22 November 2010 PIL

Reasons for updating

  • Change of manufacturer

Updated on 15 October 2010 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

Section 4.2 - Recommended dosage for hepatic and renal impairment now included.

Section 4.3 - Contraindications now include 'alcohol intoxification and intoxication with hypnotics' & 'acute myocaridal infarction'

Section 4.4 - Additional information added on special warnings and precautions for use

Section 4.5 - Additional information added on 'Interactions with other medicinal products and other forms of interactions'

Section 4.6 - Further information included on Pregnancy and Lactation

Section 4.7 - Trazodone has minor or moderate influence on the ability to drive and use machines. Patients should be cautioned against the risks of driving or operating machinery until they are sure they are not affected by drowsiness, sedation, dizziness, confusional states, or blurred vision.

Section 4.8 - Updated to MedRA System Organ Class

Section 4.9 - Information on the management of overdose with Trazodone.

Updated on 19 August 2009 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 10 July 2009 SmPC

Reasons for 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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.4 - Additionl information on QT interval prolongation.
Section 4.5 - Additionl information on QT interval prolongation.
Section 4.8 - Revision of information on undesirable effects (cardiac disorders, priapism, blood picture, fluid status).

Updated on 18 November 2008 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 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

Update section 4.4 and 4.8 of SPC

Updated on 13 May 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 19 December 2006 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Update section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Update section 10 - Date of Revision

Updated on 19 December 2006 PIL

Reasons for updating

  • Change of licence holder

Updated on 30 January 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 January 2006 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Updated on 10 November 2005 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 18 May 2005 SmPC

Reasons for updating

  • New SPC for medicines.ie

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