MINOCIN SA

  • Name:

    MINOCIN SA

  • Company:
    info
  • Active Ingredients:

    Minocycline Hydrochloride Dihydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/02/19

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Summary of Product Characteristics last updated on medicines.ie: 12/2/2019

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

Company Products

Medicine NameActive Ingredients
Medicine Name ALDARA 5% CREAM Active Ingredients Imiquimod
Medicine Name Ancotil 2.5g/250ml Solution for Infusion Active Ingredients Flucytosine
Medicine Name Brufen 400mg film-coated Tablets Active Ingredients Ibuprofen
Medicine Name Brufen 600mg film-coated tablets Active Ingredients Ibuprofen
Medicine Name Brufen Paediatric 100mg/5ml Oral Suspension Active Ingredients Ibuprofen
Medicine Name Brufen Retard 800mg prolonged release tablets Active Ingredients Ibuprofen
Medicine Name Calvidin 600mg/400IU Chewable Tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Cibacen 10mg Film Coated Tablet Active Ingredients Benazepril Hydrochloride
Medicine Name Cibacen 5mg Film Coated Tablets Active Ingredients Benazepril Hydrochloride
Medicine Name Clozaril 100mg Tablets Active Ingredients Clozapine
Medicine Name Clozaril 25mg Tablets Active Ingredients Clozapine
Medicine Name Colifoam 10% w/w Rectal Foam Active Ingredients Hydrocortisone Acetate
Medicine Name Colofac 135mg Tablets Active Ingredients Mebeverine Hydochloride
Medicine Name Creon 10000 Gastro-resistant Capsules Active Ingredients Pancreatin
Medicine Name Creon 25000 Gastro-resistant Capsules Active Ingredients Pancreatin
Medicine Name Creon for Children 5000 Gastro-resistant Granules Active Ingredients Pancreatin
Medicine Name Cyklokapron 500mg Tablets Active Ingredients Tranexamic Acid
Medicine Name Dalmane 15mg Hard Capsules Active Ingredients Flurazepam monohydrochloride
Medicine Name Dalmane 30mg Hard Capsules Active Ingredients Flurazepam monohydrochloride
Medicine Name Desunin 4000IU Tablets Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name Desunin 800IU Tablets Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name DIFFLAM 3% CREAM Active Ingredients Benzydamine Hydrochloride
Medicine Name DIFFLAM ORAL RINSE Active Ingredients Benzydamine Hydrochloride
Medicine Name DIFFLAM SPRAY Active Ingredients Benzydamine Hydrochloride
Medicine Name Dona 1500mg Powder for Oral Solution Active Ingredients Glucosamine Sulfate, Sodium Chloride
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 13 February 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 February 2019 SmPC

Reasons for updating

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

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

Updated on 25 June 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 25 June 2015 SmPC

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In Section 4.8 : ADR statement has been added
In Section 10 : Date of revision is changed

Updated on 25 June 2015 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In Section 4.8 : ADR statement has been added
In Section 10 : Date of revision is changed

Updated on 9 May 2013 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)

Free text change information supplied by the pharmaceutical company

·         In section 6.3: the shelf-life has been increased from 18 months to 24 months

·         In section 10: the date of revision has changed

Updated on 9 May 2013 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

·         In section 6.3: the shelf-life has been increased from 18 months to 24 months

·         In section 10: the date of revision has changed

Updated on 27 April 2012 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 3; the description of the pellets have changes
in section 10; the date of revision has changes

Updated on 27 April 2012 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 3; the description of the pellets have changes
in section 10; the date of revision has changes

Updated on 7 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 change of the MAH has changed
In section 10: the date of revison has changed to Feb 2011

Updated on 7 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 change of the MAH has changed
In section 10: the date of revison has changed to Feb 2011

Updated on 22 December 2010 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 2; reference to the soya content as a component of the printing ink has been removed
In section 3: reference to the ink on the capusle has been removed
In section 6.1: the excipients for the ink have been removed as there is no longer ink embossing on the capsules
In section 10: the date of revision has been changed to September 2008

Updated on 22 December 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • 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; reference to the soya content as a component of the printing ink has been removed
In section 3: reference to the ink on the capusle has been removed
In section 6.1: the excipients for the ink have been removed as there is no longer ink embossing on the capsules
In section 10: the date of revision has been changed to September 2008

Updated on 28 August 2007 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 2
First sentence revised to read 'Each capsule contains 100mg of minocycline (equivalent to 116mg of minocycline hydrochloride as the dehydrate salt).'
 
Section 4.5
Updated in line with company prescribing information to include interaction with sytemic retinol and other systemic retinoids
 
Section 4.8
Updated in line with company prescribing information to include tooth discolouration as an adverse event.

Updated on 28 August 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2
First sentence revised to read 'Each capsule contains 100mg of minocycline (equivalent to 116mg of minocycline hydrochloride as the dehydrate salt).'
 
Section 4.5
Updated in line with company prescribing information to include interaction with sytemic retinol and other systemic retinoids
 
Section 4.8
Updated in line with company prescribing information to include tooth discolouration as an adverse event.

Updated on 16 August 2005 PIL

Reasons for updating

  • 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 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Updated on 16 August 2005 SmPC

Reasons for updating

  • 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 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Updated on 16 November 2004 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients

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

Updated on 16 November 2004 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients

Updated on 25 May 2004 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Updated on 25 May 2004 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • 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 20 November 2003 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 20 November 2003 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Updated on 10 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 10 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie