LYRICA Capsules
*Company:
Upjohn EESVStatus:
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 09 September 2024
File name
ie-mt-xi-pl-Lyrica-Art 61(3) - clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 01 July 2024
File name
SmPC - h-0546-clean CDS -IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 20 May 2024
File name
ie-mt-xi-pl-Lyrica-trade dress-clean-Medis & PSUSA.pdf
Reasons for updating
- Addition of manufacturer
Updated on 07 March 2024
File name
PIL.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 07 March 2024
File name
SmPC - 003042192-Clean-trade dress -IE.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 19 December 2023
File name
Patient Information Leaflet - 003067906 -clean-PSUSA-IE_MT_NI_19 Dec 2023 Lyrica.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 19 December 2023
File name
Summary of Product Characteristics - 003042192-Clean-PSUSA -IE-19 Dec 2023 Lyrica.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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)
Updated on 23 March 2023
File name
Patient Information Leaflet - 003067906.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
Updated on 02 August 2022
File name
DEC202208790-V_Adv SPC LY 49_0 Hard Capsules IE clean.pdf
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
To implement the wording related to the cases of abuse and dependence in patients without a history of substance disorder, following procedures EMEA/H/C/000546/LEG/057 and EMEA/H/C/003880/LEG/009, resulting from EMEA/H/C/PSUSA/00002511/202101.
Updated on 02 August 2022
File name
DEC202209105-V_Adv PIL LY 47_0 Hard Capsules IE UK (NI) - clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 02 August 2022
File name
DEC202208790-V_Adv PIL LY 46_0 Hard Capsules IE UK (NI) clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 June 2022
File name
DEC202207134-V_Adv SPC LY 48_0 Hard Capsules IE clean_.pdf
Reasons for updating
- 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
The SPC has been updated as follows:
The Lyrica and Pregabalin Pfizer SmPCs are being updated to reflect new data on suicidal ideation in sections 4.4 and 4.8.
Updated on 20 June 2022
File name
DEC202207134-V_Adv PIL LY 45_0 Hard Capsules IE UK (NI) clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 16 June 2022
File name
Adv SPC LY 47_1 Hard Capsules IE clean.pdf
Reasons for updating
- 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
The SPC has been updated as follows:
The Lyrica and Pregabalin Pfizer SmPCs are being updated to add TEN in sections 4.4 and 4.8.
Updated on 16 June 2022
File name
Adv PIL LY 44_0 Hard Capsules IE UK (NI) clean.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 - date of revision
Updated on 28 February 2022
File name
Adv PIL LY 42_1 Hard Capsules IE UK (NI) clean_.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Updated on 15 December 2021
File name
Adv SPC LY 45_0 Hard Capsules IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: Section 4.6 of the SmPC has been updated concerning the risks of pregabalin treatment during pregnancy. In addition, section 4.4 has been updated to highlight that pregabalin should not be used during pregnancy. |
Updated on 15 December 2021
File name
Adv PIL LY 42_0 Hard Capsules IE clean .pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 24 November 2021
File name
DEC202115103-V_Adv SPC LY 44_0 Hard Capsules IE clean .pdf
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
The SPC has been updated as follows: Addition of parkinsonism in Section 4.8 - Table 2
Updated on 24 November 2021
File name
DEC202115103-V_Adv PIL LY 41_0 Hard Capsules IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 April 2021
File name
DEC202104513-V_Adv PIL LY 39_2 Hard Capsules IE - clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 07 April 2021
File name
DEC202104513-V_Adv SPC LY 43_1 Hard Capsules IE - clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Update to Section 5.1 of the SPC following completion of a paediatric study (A0081105)
Updated on 07 April 2021
File name
DEC202104513-V_Adv PIL LY 39_2 Hard Capsules IE - clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 27 November 2020
File name
DEC202050877-V_Adv SPC LY 42_1 Hard Capsules IE clean.pdf
Reasons for updating
- 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)
Updated on 27 November 2020
File name
DEC202050877-V_Adv PIL LY 38_1 Hard Capsules IE clean.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 - date of revision
Updated on 16 October 2020
File name
DEC202048978-V_Adv SPC LY 41_1 Hard Capsules IE-clean.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4: Special warnings and precautions for use has been updated to include the Sodium content warning
Section 4.8: Undesirable effects has been updated to include updates to Paediatric population data
Section 5.1 Pharmacodynamic properties has been updated to include updates to Paediatric population data
Section 10: DATE OF REVISION OF THE TEXT has been updated to align with the EU annex approval date.
Updated on 16 October 2020
File name
DEC202048978-V_Adv PIL LY 37_1 Hard Capsules IE-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 09 June 2020
File name
DEC202037863_Adv PIL LY 36_0 Hard Capsules IE-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Joint PIL superseded by individual PILs
Updated on 09 June 2020
File name
DEC202037863_Adv SPC LY 40_0 Hard Capsules IE-clean.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Due to the spilt of the joint SPC/PIL, Section 4.8: Undesirable effects has been updated to reflect market specific ADR reporting information
Section 7: MARKETING AUTHORISATION HOLDER has been updated FROM: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium TO: Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den Ijssel, Netherlands
Section 10: DATE OF REVISION OF THE TEXT has been updated to align with the EU annex approval date.
Updated on 01 April 2020
File name
DEC202020758_Adv SPC LY 39_0 Hard Capsules UK & IE - Clean.pdf
Reasons for updating
- 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 SPC has been updated as follows:
Section 10: DATE OF REVISION OF THE TEXT has been updated to align with the EU annex approval date.
Updated on 01 April 2020
File name
DEC202020758 Adv PIL LY 35_0 Hard Capsules UK IE - Clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 13 January 2020
File name
Adv SPC LY 38_1 Hard Capsules UK & IE-clean.pdf
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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
In section 4.4, Special warnings and precautions for use, a section is added to include information on concomitant use with opioids.
The following statement is added to section 4.4 of the SPC, under ‘concomitant use with opioids’
This increased risk was observed at low doses of pregabalin (≤ 300 mg, aOR 1.52 [95% CI, 1.04 – 2.22]) and there was a trend for a greater risk at high doses of pregabalin (> 300 mg, aOR 2.51 [95% CI 1.24 – 5.06]).
In section 4.5, Interaction with other medicinal products and other forms of interaction, information on opioids is added.
Updated on 13 January 2020
File name
Adv PIL LY 34_1 Hard Capsules UK & IE-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 19 November 2019
File name
DEC201964569_Adv PIL LY 33_0 Hard Capsules UK & IE.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 28 May 2019
File name
DEC201926912_Adv PIL LY 32_1 Hard Capsules UK & IE - Clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 28 May 2019
File name
DEC201926912_Adv SPC LY 37_1 Hard Capsules UK & IE - Clean.pdf
Reasons for updating
- 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 May 2019
File name
DEC201925204_Adv PIL LY 31_1 Hard Capsules UK & IE - Clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 16 May 2019
File name
DEC201925204_Adv SPC LY 36_1 Hard Capsules UK & IE - Clean.pdf
Reasons for updating
- 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
The SPC has been updated as follows:
Section 6.5 and 10 - updated to remove 2x56 bundle pack information and changed date of revision of text to 05/2019.
Updated on 27 March 2019
File name
DEC201915676_Adv SPC LY 35_2 Hard Capsules UK & IE - Clean.pdf
Reasons for updating
- 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 03 August 2018
File name
Adv PIL LY 30_0 Hard Capsules UK IE-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 August 2018
File name
Adv SPC LY 34_0 Hard Capsules UK IE-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
The SPC has been updated as follows|;
SECTION 7 – Change to MAH
SECTION 4.8: To add ADR statement ‘or search for MHRA Yellow Card in the Google Play or Apple App Store’
SECTION 10 – Date of revision of text
Updated on 12 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 January 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 January 2018
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
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 December 2017
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Hi All
Following error below, note that eMC and medicines.ie should not have been updated.
Please revert and update eMC and medicines.ie with previous version, see attachments.
KR
Nathalie
Updated on 24 November 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- SPC submitted in error
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
Type II – Art 46 - update Section 4.8 Undesirable effects and Section 5.1 Pharmacodynamic properties of the pregabalin SmPC to reflect the availability of information |
Updated on 13 July 2017
File name
PIL_9215_408.pdf
Reasons for updating
- New PIL for new product
Updated on 13 July 2017
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
Updated on 13 July 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 March 2017
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 March 2017
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 18 November 2016
Reasons for updating
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: - Update of section 4.9 of the SmPC to add information about seizures. The Package leaflet is updated accordingly
|
Updated on 23 June 2016
Reasons for updating
- 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 21 June 2016
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 26 June 2015
Reasons for updating
- Removal/change of distributor
Updated on 27 April 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Updated paediatric information in sections 4.2, 4.8, 5.1 and 5.2 as requested after assessment of studies A0081074 & A0081075 submitted as post authorisation measures under Article 46 and Article 45.Updated on 26 January 2015
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 January 2015
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 03 September 2014
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 06 August 2014
Reasons for updating
- 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 31 July 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 29 May 2014
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 6.5 & 8 to add a new pack size of a 70 day pack for Lyrica 75mg capsules
Updated on 22 May 2014
Reasons for updating
- Introduction of new pack/pack size
Updated on 04 March 2014
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
Updates to section 4.8 of the SPC to update the frequency categories for ADRs in the Lyrica SPC based on the all-causality adverse events clinical trial dataset
Updated on 27 February 2014
Reasons for updating
- Change to side-effects
Updated on 04 December 2013
Reasons for updating
- 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 November 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 30 April 2013
Reasons for updating
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
To remove the sentence " In overdose up to 15 g no unexpected reactions were reported" and to add a reference to cases of coma.(SPC Section 4.9 Overdose).
Updated on 26 February 2013
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of the sub heading in Section 4.5 of the SPC from Ethanol, lorazepam, oxycodone to CNS influencing medical products
Updated on 26 February 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 02 February 2012
Reasons for updating
- Change to side-effects
Updated on 30 November 2011
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
Updated on 21 November 2011
Reasons for updating
- 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
Updated on 08 November 2011
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 June 2011
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
Updated on 24 June 2011
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 15 September 2010
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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Administrative changes to sections 4.2, 4.4, 4.5, 4.6, 4.7, 4.8 & 5.1 of the SPC
Addition of text on fertility to sections 4.6 and 5.1 of the SPC
Updated on 13 September 2010
Reasons for updating
- Change to instructions about overdose
- Change to drug interactions
Updated on 01 July 2010
Reasons for updating
- 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 June 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 13 May 2010
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4:
- Addition of anxiety as a discontinuation symptom
- Addition of possible paralytic ileus when pregabalin is co-administered with drugs known to reduce lower gastrointestinal tract function to section 4.4 (CDS has it under drug interactions rather than warning/precautions).
Section 4.8:
- Addition of anxiety as a discontinuation symptom
Updated on 12 May 2010
Reasons for updating
- Change to warnings or special precautions for use
Updated on 08 March 2010
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
The addition of malaise and aggressions as ADRs with unknown frequency to section 4.8 of the SPC.
Updated on 01 March 2010
Reasons for updating
- Change to side-effects
Updated on 15 September 2009
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 undesirable effect
Removal of side effects emanating from clinical trial data from trials for indications for which Lyrica is not indicated.
Updated on 04 September 2009
Reasons for updating
- Change to side-effects
Updated on 03 September 2009
Reasons for updating
- Change to side-effects
Updated on 07 January 2009
Reasons for updating
- 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
Section 4.4 - Addition of vision loss and suicidal ideation information
Section 4.8 - Addition of vision loss information
Updated on 07 January 2009
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 24 April 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 22 April 2008
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Addition of information on hypersensitivity reactions, including cases of angioedema and visual changes
4.8 Addition of angioedema & Keratitis as new adverse events and visual field defect
described under eye disorders
5.1 Addition of clinical trial data for visual changes
Updated on 25 March 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 19 March 2008
Reasons for updating
- 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
1) Strengthening of Congestive Heart Failure wording in section 4.4 of the SmPC and addition of urinary retention to section 4.8 of the SmPC
2) Addition of Stevens Johnson Syndrome (SJS) to section 4.8 of the SmPC
Updated on 27 July 2007
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
- Change to section 4.9 - Overdose
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 Addition of post marketing reports of consciousness, confusion and mental impairment
Section 4.5 Addition of interaction with CNS depressant medication and effects of ethanol & lorazepam
Section 4.8 Addition of loss of consciousness, mental impairment and headache
Section 6.5 Addition of 100 hard capsule PVC/Aluminium blister pack (non-perforated)
Section 8 – Addition of further license numbers
Updated on 27 July 2007
Reasons for updating
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change due to harmonisation of patient information leaflet
Updated on 14 June 2007
Reasons for updating
- Change to further information section
Updated on 16 February 2007
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 07 February 2007
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to MA holder contact details
Updated on 25 September 2006
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 September 2006
Reasons for updating
- Change to how the medicine works
Updated on 21 August 2006
Reasons for updating
- Change to warnings or special precautions for use
Updated on 17 August 2006
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
Updated on 14 August 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 8 - MA number
- 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)
Updated on 12 June 2006
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 21 April 2006
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- 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)
Updated on 21 April 2006
Reasons for updating
- Change to how the medicine works
- Change to drug interactions
- Change to warnings or special precautions for use
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to side-effects
- Change to storage instructions
- Change to further information section
- Change to date of revision
- Correction of spelling/typing errors
Updated on 05 January 2006
Reasons for updating
- Change to side-effects
Updated on 21 December 2005
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 August 2005
Reasons for updating
- Change to packaging
Updated on 20 July 2005
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 July 2005
Reasons for updating
- Correction of spelling/typing errors
Updated on 16 May 2005
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 November 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 16 November 2004
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 October 2004
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)