Reminyl Oral Solution
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 October 2022
File name
ie-pl-os-Reminyl-Aug22.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 21 October 2022
File name
ie-spc-os-Reminyl-18.10.22.pdf
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 MAH address details have been revised.
Updated on 09 December 2021
File name
ie_Reminyl_PL 4 mg per ml-Oct 2021.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The updated PIL includes the following:
- change of Marketing Authorisation Holder from Shire Pharmaceuticals Ireland Limited to Takeda Pharmaceuticals International AG Ireland Branch
- CCDS related changes - to add 'extrapyramidal disorder' as an adverse drug reaction to Summary of Product Characteristics (SPC) section 4.8 Undesirable effects under the System Organ Class (SOC) Nervous System Disorders with a frequency category assigned as 'Uncommon'.
- A consequent update is proposed to the existing warning in SPC section 4.4 subsection Nervous system disorders together with a new cross-reference to section 4.8. The package leaflet has been updated in alignment with the proposed changes to the SPC.
- Editorial change without impact on the content: Some QRD formatting changes and very minor punctuation changes have been made
- Date of revision: October 2021
Updated on 09 December 2021
File name
ie_Reminyl_SPC 4 mg per ml-26.11.2021.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 updated SmPC includes the following:
- change of Marketing Authorisation Holder from Shire Pharmaceuticals Ireland Limited to Takeda Pharmaceuticals International AG Ireland Branch
- CCDS related changes - to add 'extrapyramidal disorder' as an adverse drug reaction to Summary of Product Characteristics (SPC) section 4.8 Undesirable effects under the System Organ Class (SOC) Nervous System Disorders with a frequency category assigned as 'Uncommon'.
- A consequent update is proposed to the existing warning in SPC section 4.4 subsection Nervous system disorders together with a new cross-reference to section 4.8. The package leaflet has been updated in alignment with the proposed changes to the SPC.
- Editorial change without impact on the content: Some QRD formatting changes and very minor punctuation changes have been made
Updated on 12 March 2021
File name
ie-pil-reminyl-solution-TIA-077-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 12 March 2021
File name
ie-spc-reminyl-solution-IA-077-clean (003).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 4.4 (Special warnings and precautions for use) the following text has been added: There have been reports of QTc prolongation in patients using therapeutic doses of galantamine and of torsade de pointes in association with overdoses (see section 4.9). Galantamine should therefore be used with caution in patients with prolongation of the QTc interval, in patients treated with drugs affecting the QTc interval, or in patients with relevant pre-existing cardiac disease or electrolyte disturbances.
Updated on 06 November 2020
File name
ie-pl-reminyl-oral-solution-IB-074-clean-July2020.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 06 November 2020
File name
ie-spc-reminyl-oral-solution-IB-074-clean-29Oct2020.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 4.4 Special warnings and precautions for use, the following wording has been added: This medicine contains less than 1 mmol (23 mg) sodium per 6 ml of Reminyl 4 mg/ml solution (equivalent to the maximum dose Reminyl per day), that is to say essentially ‘sodium-free’.
In section 4.8 Undesirable effects - Reporting of suspected adverse reactions, the text has been updated to: Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie.
Date of revision of the text: 29th October 2020
Updated on 03 October 2019
File name
PIL, Reminyl, 4mg per ml, Oral Solution, IE, (en) Clean, 28 Mar 2019.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 17 September 2019
File name
ie-PIL Reminyl-4mg per ml Oral Solution-clean-28 Mar 2019.pdf
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
File name
ie-spc-reminyl-4mg.pdf
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) changed to Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland.
Section 8 (Marketing authorisation number) changed to PA1575/003/001.
Updated on 10 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 April 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 April 2017
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
Updated on 10 April 2017
File name
PIL_9350_852.pdf
Reasons for updating
- New PIL for new product
Updated on 10 April 2017
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 30 October 2015
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
Updated on 29 October 2015
Reasons for updating
- Change to date of revision
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 11 February 2015
Reasons for updating
- Change to section 4 - Clinical particulars
- Change to section 4.1 - Therapeutic indications
- 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 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 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral solution contains 4 mg galantamine (as hydrobromide).
Excip
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Because no data are available on the use of galantamine in patients with severe hepatic (Child-Pugh score greater than 9) and severe renal (creatinine clearance less than 9 ml/min) impairment, galantamine is contraindicated in these populations. Galantamine is contraindicated in patients who have both significant renal and hepatic dysfunction.
Updated on 02 February 2015
Reasons for updating
- Change to side-effects
Updated on 18 September 2013
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
Seizures*
*Class-related effects reported with acetylcholinesterase-inhibitor antidementia drugs include convulsions/seizures (see 4.4 Nervous system disorders)
Updated on 18 September 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 26 June 2012
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 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
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 08 July 2011
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
Updated on 13 July 2010
Reasons for updating
- Change to storage instructions
- Change to date of revision
- Removal/change of distributor
Updated on 07 July 2010
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 November 2009
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 02 November 2009
Reasons for updating
- Change to side-effects
Updated on 18 August 2008
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 13 November 2007
Reasons for updating
- Change to drug interactions
- Correction of spelling/typing errors
Updated on 07 November 2007
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 September 2007
Reasons for updating
- Correction of spelling/typing errors
Updated on 14 July 2006
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
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 5.1 - Pharmacodynamic properties
- 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 23 February 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 14 January 2005
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 August 2004
Reasons for updating
- Change in co-marketing arrangement
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 February 2004
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)