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

  • Name:

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

  • Company:
    info
  • Active Ingredients:

    Galantamine Hydrobromide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/10/19

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Summary of Product Characteristics last updated on medicines.ie: 26/7/2019

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Shire Pharmaceuticals Ireland Limited

Shire Pharmaceuticals Ireland Limited

Address: Shire Pharmaceuticals Ireland Limited, Block 2, Miesian Plaza, 50-58 Baggot St, Dublin 2, Ireland

Medical Information E-mail: medinfoEMEA@shire.com

Customer Care direct line: 01800837470

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Medicine Name Equasym XL 10, 20 & 30mg Modified Release Capsules Active Ingredients Methylphenidate Hydrochloride
Medicine Name Firazyr 30 mg solution for injection in pre-filled syringe Active Ingredients Icatibant Acetate
Medicine Name Foznol 250mg, 500mg, 750mg & 1000mg Chewable Tablets Active Ingredients Lanthanum Carbonate Hydrate
Medicine Name Intuniv 1mg, 2mg, 3mg, 4mg prolonged-release tablets Active Ingredients Guanfacine hydrochloride
Medicine Name Mezavant XL Active Ingredients Mesalazine
Medicine Name Reminyl Oral Solution Active Ingredients Galantamine Hydrobromide
Medicine Name Reminyl XL 8mg, 16mg and 24 mg prolonged release capsules Active Ingredients Galantamine Hydrobromide
Medicine Name Resolor 1 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Resolor 2 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Tyvense 20mg, 30mg, 40mg, 50mg. 60mg & 70mg Capsules, hard Active Ingredients Lisdexamfetamine dimesylate
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Medicine Name Xagrid 0.5mg hard capsule Active Ingredients Anagrelide hydrochloride
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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 3 October 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 September 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Removal of alternative manufacturer and updated revision date

Updated on 26 July 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)

Free text change information supplied by the pharmaceutical company

Section 7 (marketing authorisation holder) has been changed to Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower, Dublin 2, Ireland. 

Section 8 (marketing authorisation numbers) have been changed to PA1575/003/005-007.

Updated on 12 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 12 April 2017 SmPC

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Addition of adverse reaction to section 4.8  (atrioventricular block complete) as a rare adverse reaction and revision of related warning in section 4.4 of the SmPC.

Updated on 10 April 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 April 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 30 October 2015 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update to the galantamine SmPC to introduce warnings on serious skin reactions

Updated on 29 October 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to warnings or special precautions for use

Updated on 11 February 2015 SmPC

Reasons for updating

  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines

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

Free text change information supplied by the pharmaceutical company

Multiple sections updated :

Updated on 2 February 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 18 September 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 18 September 2013 SmPC

Reasons for updating

  • 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 not be renewed (A)

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 June 2012 SmPC

Reasons for 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

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

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 22 June 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 8 September 2010 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to further information section

Updated on 8 September 2010 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

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 13 July 2010 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision
  • Removal/change of distributor

Updated on 7 July 2010 SmPC

Reasons for updating

  • 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)

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 4 November 2009 SmPC

Reasons for updating

  • 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 4.8 updated to list MedDRA-coded ADRs rather than WHOART-coded Adverse Events (AEs).

Updated on 2 November 2009 PIL

Reasons for updating

  • Change to side-effects

Updated on 18 August 2008 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information
  • Change of special precautions for disposal
  • Change to improve clarity and readability

Updated on 28 April 2008 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Correction of spelling/typing errors

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

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 13 November 2007 PIL

Reasons for updating

  • Change to drug interactions
  • Change to improve clarity and readability

Updated on 7 November 2007 SmPC

Reasons for 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

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

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 September 2007 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 14 July 2006 PIL

Reasons for updating

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

Updated on 26 October 2005 SmPC

Reasons for 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

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

Updated on 17 June 2005 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 June 2005 SmPC

Reasons for updating

  • New SPC for new product

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