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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 XL 8mg, 16mg and 24mg prolonged release capsules

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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • 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 08/09/2010 and displayed until 26/06/2012
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   30-Aug-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Change to names of excipients, excipients used in the printing ink on the capsules, and change in definition from pellets to granules
Updated on 07/07/2010 and displayed until 08/09/2010
Reasons for adding or updating:
  • 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:   23-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change in dates following renewal. 8mg Capsules date of revision of text is 18-Jun-2010; 16mg and 24mg date of revision of text is 23-Jun-2010 following a pack size variation that does not affect IPHA marketed data.
Updated on 04/11/2009 and displayed until 07/07/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
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).
Updated on 28/04/2008 and displayed until 04/11/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The following nformation on how to switch to Reminyl XL prolonged release capsules from Reminyl tablets or Reminyl oral solution have now been added to Section 4.2 Posology and method of administration:
 

Switching to Reminyl XL prolonged release capsules from Reminyl tablets or Reminyl oral solution

 

It is recommended that the same total daily dose of galantamine is administered to patients. Patients switching to the once-daily regimen should take their last dose of Reminyl tablets or oral solution in the evening and start Reminyl XL prolonged release capsules once daily the following morning.

Updated on 07/11/2007 and displayed until 28/04/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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:   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, interactions, undesirable effects, overdose, pharmacological properties, Renewal of Marketing Authorisations
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 10 - Date of revision of the text
Updated on 02/06/2005 and displayed until 26/10/2005
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Galantamine Hydrobromide