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Shire Pharmaceuticals Ireland Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland,
Telephone: +353 1 429 7700
Fax: +353 1 429 7701
Medical Information Direct Line: 1 800 818 016
Medical Information e-mail: MedInfoIE@shire.com
Customer Care direct line: +44 (0)1256 894 107
Summary of Product Characteristics last updated on medicines.ie: 18/09/2013
SPC Reminyl Oral Solution

When a pharmaceutical company changes an SPC or PIL, 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 18/09/2013 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03-Sep-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

The folowing section has been updated, Section 4.8-Undesirable effects, SOC-Nervous system disorder, uncommon:

Seizures*

*Class-related effects reported with acetylcholinesterase-inhibitor antidementia drugs include convulsions/seizures (see 4.4 Nervous system disorders)
Updated on 26/06/2012 and displayed until 18/09/2013
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-Jun-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


  • Formatting changes to headings, changing bold, italic headers to normal text underlined and some minor typo corrections.
  • Section 4.2 (Posology and method of administration), section on children re-worded to "Paediatric population, There is no relevant use of galantamine in the paediatric population".
  • Section 4.8 (undesirable effects), The following text has been amended "The table below reflects data obtained with Reminyl in seven placebo-controlled, double blind clinical trials (N=4457), five open-label clinical trials (N=1454), and from postmarketing spontaneous reports. The most commonly reported adverse drug reactions were nausea (25%) and vomiting (13%). They occurred mainly during titration periods, lasted less than a week in most cases and the majority of patients had one episode. Prescription of anti-emetics and ensuring adequate fluid intake may be useful in these instances. "Hypersensitivity" was also added as an uncommon side effect under SOC "Immune system disorders".
  • Section 10 (Date of revision), Approval date of 20th June 2012 added.

 

Updated on 08/07/2011 and displayed until 26/06/2012
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-Jun-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change of shelf life from 2 years to 3 years
Updated on 07/07/2010 and displayed until 08/07/2011
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   18-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Update in renewal including addition of E216 and E218 where appropriate in Exceipients ( Section 6.1)
Updated on 04/11/2009 and displayed until 07/07/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   19-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.8 updated to list MedDRA-coded ADRs rather than WHOART-coded Adverse Events (AEs). For oral solution only Section 6.5 Reference to HDPE pipette case removed.
Updated on 07/11/2007 and displayed until 04/11/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to name of manufacturer
  • Change to section 5 - Pharmacological properties
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Reasons for update:
 
Update in line with QRD template, changes to precautions and warnings e.g. gastrointestinal disorders, nervous system disorders, surgical and medical procedures, interactions, undesirable effects, overdose, pharmacological properties, Renewal of Marketing Authorisation
Updated on 26/10/2005 and displayed until 07/11/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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
  • Change to section 10 - Date of revision of the text
Updated on 14/01/2005 and displayed until 26/10/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
Updated on 09/08/2004 and displayed until 14/01/2005
Reasons for adding or updating:
  • Change in co-marketing arrangement
  • Correction of spelling/typing errors
Updated on 17/02/2004 and displayed until 09/08/2004
Reasons for adding or updating:
  • Change to section 6.6 - Special precautions for disposal and other handling
Updated on 04/07/2003 and displayed until 17/02/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Galantamine Hydrobromide