Manerix 150 mg Film-coated Tablets

  • Name:

    Manerix 150 mg Film-coated Tablets

  • Company:
    info
  • Active Ingredients:

    Moclobemide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/06/18

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Summary of Product Characteristics last updated on medicines.ie: 14/6/2019

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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1 - 0 of 95 items.Total: Infinity pages

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 14 June 2019 SmPC

Reasons for updating

  • Change to improve clarity and readability

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

Updated on 29 June 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Marketing Authorisation Holder Transfer from Meda Health Sales Ireland Limited to Mylan IRE Healthcare Limited

Updated on 29 June 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 May 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 May 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

In section 4.2: Information regarding the posology has been updated. Method of administration has been added.

In section 5.1: The pharmacotherapeutic group has been added. The ATC code has been added.

In section 5.2: Information regarding absorption has been added. Update has been made to information regarding distribution. Information regarding metabolism and elimination has been added. Information for pharmacokinetics in special populations has been added.

In section 5.3: Preclinical safety data information has been added.

In section 10: The date of revision has been changed.

Updated on 6 May 2015 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.2: Information regarding the posology has been updated. Method of administration has been added.

In section 5.1: The pharmacotherapeutic group has been added. The ATC code has been added.

In section 5.2: Information regarding absorption has been added. Update has been made to information regarding distribution. Information regarding metabolism and elimination has been added. Information for pharmacokinetics in special populations has been added.

In section 5.3: Preclinical safety data information has been added.

In section 10: The date of revision has been changed.

Updated on 4 November 2014 SmPC

Reasons for 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 4.6 - 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
  • 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

In section 4.3: Additional contraindications have been added

In section 4.4: warnings regarding the use of antidepressants in those suffering from schizophrenic and schizoaffective psychoses, the use of St John’s wart, increased risk of suicide and hyponatremia has been added

In section 4.5: Interaction with other medicinal products and other forms of interaction has been expanded.

In section 4.6: Additional information regarding pregnancy and lactation has been added

In section 4.7: Text has been reworded

In section 4.8: the structure of this section has been changed and ADR reporting has been added

In section 4.9: Information regarding the signs and management of overdose has been added

In section 10: the date of revision has changed

Updated on 4 November 2014 PIL

Reasons for 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 4.6 - 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
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.3: Additional contraindications have been added

In section 4.4: warnings regarding the use of antidepressants in those suffering from schizophrenic and schizoaffective psychoses, the use of St John’s wart, increased risk of suicide and hyponatremia has been added

In section 4.5: Interaction with other medicinal products and other forms of interaction has been expanded.

In section 4.6: Additional information regarding pregnancy and lactation has been added

In section 4.7: Text has been reworded

In section 4.8: the structure of this section has been changed and ADR reporting has been added

In section 4.9: Information regarding the signs and management of overdose has been added

In section 10: the date of revision has changed

Updated on 13 January 2012 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 2; the quantitative value of lactose monydrate has been added
in section 10; the date of revision has been added

Updated on 13 January 2012 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

In section 2; the quantitative value of lactose monydrate has been added
in section 10; the date of revision has been added

Updated on 7 November 2011 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

In section 3; the word Roche has been removed from the tablets

Updated on 7 November 2011 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Free text change information supplied by the pharmaceutical company

In section 3; the word Roche has been removed from the tablets

Updated on 18 March 2011 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

In section 7: the address of the MAH hs changed
In section 10: the date of revision has changed to Feb 2011

Updated on 18 March 2011 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 7: the address of the MAH hs changed
In section 10: the date of revision has changed to Feb 2011

Updated on 7 January 2011 PIL

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 7 January 2011 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided