Almogran 12.5 mg Film-coated tablet

Product Information *

  • Company:

    Almirall Limited
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

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

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 19 January 2021

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Updated with sodium content and warning - essentially sodium free.

Updated on 19 January 2021

Reasons for updating

  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

Updated with excipient warning for sodium content and warning - essentially sodium free.

Updated on 21 January 2020

Reasons for updating

  • 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

Date of revision Feb 2016

Updated on 20 January 2020

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Date of revision updated to Jan 2019

Updated on 20 July 2015

Reasons for updating

  • New SPC for new product

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

Updated on 20 July 2015

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 3 - replacement of description of printed blue A with engraved A.

 

Section 6.1 - removal of printing inks for blue A.

Updated on 16 July 2015

Reasons for updating

  • New PIL for new product

Updated on 16 July 2015

Reasons for updating

  • Change of inactive ingredient
  • Change to appearance of the medicine

Updated on 14 July 2015

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

In Section 4.8:
Addition of side effect with frequency unknown: intestinal ischemia.

Update of name of Competent Authority in Ireland to HPRA.

Updated on 09 July 2015

Reasons for updating

  • Change to side-effects

Updated on 12 May 2015

Reasons for updating

  • 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 4.8
Adddition of AEs with frequency not known.

Immune system disorders:
hypersensitivity reactions including angioedema, anaphalactic reactions

Eye disorders
Visual impairment, vision blurred.  However visual disorders occure dureint a migraine attach.

Section 4.9
Deletion of: No case of overdose has been reported.

Updated on 08 May 2015

Reasons for updating

  • Change to name of manufacturer

Updated on 25 September 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - 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

QRD template changes to the heading and referral to full list of excipents in section 2 and section 4.3.
Serotonin syndrome warning - section 4.4
Clarification of SSRI interaction - section 4.5
QRD template change to heading in section 4.6
Adverse events tabulated in section 4.8
Date of revision 02/2012

Updated on 18 September 2012

Reasons for updating

  • Change of trade or active ingredient name
  • Change of inactive ingredient
  • Change to warnings or special precautions for use

Updated on 03 June 2011

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

In section 4.4 the SPC has been harmonised with other European triptan procedures
In section 4.5 the potential interaction with serotonin noradrenaline reuptake inhibitors (SNRI's) has been added
In section 4.8 the addition of seizure, category frequency not known

Updated on 02 June 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to name of manufacturer

Updated on 28 March 2011

Reasons for updating

  • Improved electronic presentation

Updated on 03 July 2009

Reasons for updating

  • Addition of separate SPCs covering individual presentations

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 26 March 2009

Reasons for updating

  • New PIL for medicines.ie