Surmontil 50mg hard capsules

  • Name:

    Surmontil 50mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Trimipramine maleate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/04/19

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Summary of Product Characteristics last updated on medicines.ie: 18/4/2019

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SANOFI

SANOFI

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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 18 April 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 18 April 2019 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.3
 
Hypersensitivity to trimipramine or to one of the constituents of the medicinal product.any of the excipients.
Hypersensitivity to other tricyclic antidepressants.

 

 

4.5 Interaction with other medicinal products and other forms of interaction

Inadvisable combinations:

  • Alcohol:  increased sedative effect of imipramines.  Possible hazard when driving or operating machinery due to impaired alertness.  Concomitant use of alcoholic beverages and alcohol-containing medicines should be avoided.
  • Medicinal products that lower blood pressure, including antihypertensives;
    Increased risk of hypotension, particularly orthostatic hypotension.

Other combinations:

  • Antihypertensives (excluding clonidine and related compounds:  see inadvisable combinations):  increased antihypertensive effect and higher risk of postural hypotension (cumulative effects).

 

  1. 4.6 Pregnancy and lactation
    1.  
      The maintenance of good maternal mental balance throughout pregnancy is desirable.  If a medicinal treatment is required to ensure this balance, it should be started or continued as an effective dose throughout the pregnancy and, if possible, as monotherapy.
       
      In the neonates of mothers treated with an imipramine-like antidepressant at the end of pregnancy, symptoms of intoxication (especially atropine-like) and/or withdrawal have sometimes been described.
       
      Do not use in pregnancy, especially during the first and last trimesters, unless considered essential by the physician.  It is preferable to avoid using trimipramine during pregnancy at any stage.  However, treatment should not be discontinued abruptly to avoid the risk of withdrawal for the mother.  If the initiation or maintenance of treatment with trimipramine during pregnancy is unavoidable, the effects described above should be considered when monitoring the neonate.

 

 

4.8  Undesirable effects
 
erectile dysfunction.impotence.

Hypersensitivity reactions such as skin rash, allergic skin reactions, dermatitis, hyperhidrosis, flushing, facial oedema, angioedema and less commonly anaphylactic  reactions have been reported.

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie www.hpra.ie; Email: medsafety@hpra.ie.

Updated on 19 March 2014 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 19 March 2014 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 - how to report a side effect
  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type II.C.1.4 variation following a Global Labelling Update for Surmontil (GLUv3) which updates sections of the SPC. 

Updated on 14 March 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 March 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions

Updated on 16 April 2013 PIL

Reasons for updating

  • Change of manufacturer

Updated on 26 September 2012 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 updated to include 'T/A SANOFI'

Updated on 13 February 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 2 September 2011 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 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update sections 4.2, 4.3, 4.4, 4.5, 4.8, 5.2 of SPC

Updated on 7 August 2011 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update section 4.4 and 4.8 of SPC in relation to suicide and bone fractures in elderly.

Updated on 18 July 2011 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Improved presentation

Updated on 7 April 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information
  • PIL retired pending re-submission

Updated on 24 August 2009 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Correction of Typographical errors.

Updated on 8 July 2009 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 November 2008 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update section 4.4 and 4.8

Updated on 17 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 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update sections 4.4, 4.8 and 5.1 of SPC

Updated on 21 March 2007 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Updated on 14 March 2006 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 9 February 2006 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 12 December 2005 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 February 2004 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 December 2003 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 not be renewed (A)

Updated on 11 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)