Lioresal 10mg Tablets
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 10 September 2024
File name
Lioresal tabs 10mg REGPIL PF24-0094 clean September 24.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 4 - possible side effects
Updated on 10 September 2024
File name
Lioresal 10mg Tabs REGSPC PF24-0094 clean September 2024.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
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 April 2022
File name
Lioresal tabs 10mg REGPIL PF21-0201 Jan 2022 clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 28 January 2022
File name
Lioresal 10mg Tabs REGSPC PF21-0201 Jan 2022 clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 January 2022
File name
Lioresal tabs 10mg REGPIL PF21-0201 Jan 2022 clean.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
Updated on 30 November 2020
File name
Lioresal tabs 10mg REG PIL PF20-0175 TBI 27.5.2021IPHA.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 30 November 2020
File name
Lioresal 10 mg Tablets PILsept 2019clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 30 November 2020
File name
Lioresal 10mg Tabs REG SPC PF20-0175 November 2020 Clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 November 2019
File name
Lioresal 10 mg Tablets PILsept 2019clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 25 November 2019
File name
Lioresal 10mg Tabs REG SPC PF19-0179 clean October 2019.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 November 2019
File name
Lioresaltabs933459_IE_LFT_PF18-0205_IPHA.pdf
Reasons for updating
- XPIL Updated
Updated on 25 November 2019
File name
Lioresal 10 mg Tablets PILsept 2019clean.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 November 2019
File name
Lioresaltabs933459_IE_LFT_PF18-0205_IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 11 November 2019
File name
Lioresal 10mg Tabs REG SPC PF19-0179 clean October 2019signed.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 April 2019
File name
Lioresal_Tabs_REG_SPC_PF18-0205_IPHA.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 April 2019
File name
Lioresal_Tabs_REG_SPC_PF18-0205_IPHA.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 November 2018
File name
Lioresaltabs933459_IE_LFT_PF18-0205_IPHA.pdf
Reasons for updating
- Change to marketing authorisation holder
Updated on 16 July 2018
File name
Lioresal_Tabs_REG_SPC_PF18-0205clean.docx
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
MAT transfer
Updated on 03 May 2018
File name
Lioresal_Tabs_REG_SPC_PF17-0023_March2018.docx
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 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 December 2014
File name
PIL_8514_294.pdf
Reasons for updating
- New PIL for new product
Updated on 22 December 2014
Reasons for updating
- Change of manufacturer
- Change to side-effects
Updated on 15 October 2014
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 October 2014
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 4.6 - 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2 has been updated to include the sentence: Excipient with known effect: 61.0 mg wheat starch per tablet.
Section 4.2 has been revised to include a statement on discontinuation of treatment and to change to dosage from "3 divided doses" to "between 2 and 4 divided doses". A paragraph on "hepatic impairment" and on "patients with spastic states of cerebral origin" have bee included.
Section 4.4 has been revised to include the sentence "Since unwanted effects are more likely to occur, a cautious dosage schedule should beadopted in elderly and patients with spasticity of cerebral origin (see section 4.2 posology and method of administration)."
Section 4.6 has been revised to include information on fertility and women of child-bearing potential.
Section 4.7 has been updated to add statement on "posture and balance".
Section 4.8 has been revised with additional ADRs and information for reporting of ADRs to the HPRA.
Section 4.9 has been updated to remove the section regarding ingestion of activated charcoal.
Section 5.1 has been revised to include a more detailed Mechanism of Action.
Section 5.2 has been updated to add sections on paediacric patients and patients with hepatic and renal impairment.
Section 5.3 has been revised to include information on reproductive toxicity and mutagenicity/carcinogenicity.
Section 4.2 has been revised to include a statement on discontinuation of treatment and to change to dosage from "3 divided doses" to "between 2 and 4 divided doses". A paragraph on "hepatic impairment" and on "patients with spastic states of cerebral origin" have bee included.
Section 4.4 has been revised to include the sentence "Since unwanted effects are more likely to occur, a cautious dosage schedule should beadopted in elderly and patients with spasticity of cerebral origin (see section 4.2 posology and method of administration)."
Section 4.6 has been revised to include information on fertility and women of child-bearing potential.
Section 4.7 has been updated to add statement on "posture and balance".
Section 4.8 has been revised with additional ADRs and information for reporting of ADRs to the HPRA.
Section 4.9 has been updated to remove the section regarding ingestion of activated charcoal.
Section 5.1 has been revised to include a more detailed Mechanism of Action.
Section 5.2 has been updated to add sections on paediacric patients and patients with hepatic and renal impairment.
Section 5.3 has been revised to include information on reproductive toxicity and mutagenicity/carcinogenicity.
Updated on 20 February 2013
Reasons for updating
- Change due to user-testing of patient information
Updated on 14 December 2011
Reasons for updating
- Change to warnings or special precautions for use
Updated on 29 August 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 2, additional detail about excipients has been included.
In section 4.1, information relating to paediatric population has been added
In section 4.2, section has been updated due to the paediatric indication.
In section 4.4, new information on renal impairment, abrupt withdrawal and paediatric population have been added.
In section 4.6, information on withdrawal reaction has been included.
In section 4.8, "urticaria" has been added as a hepatobiliary disorder (frequency unknown).
In section 4.9, new information added: convulsions, EEG changes (burst suppression pattern and triphasic waves), or cardiac arrhythmias. Haemodialysis (sometimes unscheduled) may be useful in severe poisoning associated with renal failure (see section 4.4 Special warnings and precautions for use).
In section 6.1, E numbers have been added for relevant excipients.
In section 6.2, the following statement has been added:This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
In section 6.3, the following statement has been added: After dilution, the product may be stored at roomtempe
In section 6.4, storage conditions have been updated.
In section 6.6, reference to storage at room temperature for up to 14 days has been removed.
In section 4.1, information relating to paediatric population has been added
In section 4.2, section has been updated due to the paediatric indication.
In section 4.4, new information on renal impairment, abrupt withdrawal and paediatric population have been added.
In section 4.6, information on withdrawal reaction has been included.
In section 4.8, "urticaria" has been added as a hepatobiliary disorder (frequency unknown).
In section 4.9, new information added: convulsions, EEG changes (burst suppression pattern and triphasic waves), or cardiac arrhythmias. Haemodialysis (sometimes unscheduled) may be useful in severe poisoning associated with renal failure (see section 4.4 Special warnings and precautions for use).
In section 6.1, E numbers have been added for relevant excipients.
In section 6.2, the following statement has been added:This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
In section 6.3, the following statement has been added: After dilution, the product may be stored at room
In section 6.4, storage conditions have been updated.
In section 6.6, reference to storage at room temperature for up to 14 days has been removed.
Updated on 14 July 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.9 - Overdose
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 2 it states: Each tablet contains 10 mg baclofen and 61.0 mg wheat starch .For a full list of excipients, see section 6.1
In section 3, the following text has been added in relation to the scoreline: to facilitate breaking of the tablet for ease of swallowing. The tablet can be divided into equal doses.
In section 4.2 the dosing for adults and children has been updated as well as for patients with renal impairment and elderly.
In section 4.4 new sub-headings have been added and a new section on renal impairment included.
In section 4.5 the last paragraph has been removed as this was duplicate information.
In section 4.9 new information on haemodialysis has been added as well as some additional symptoms of overdose.
In section 6.4 the storage conditions have been updated to include reference to protection from moisture.
In section 6.5 reference is included to the fact that not all pack sizes may be marketed.
In section 4.2 the dosing for adults and children has been updated as well as for patients with renal impairment and elderly.
In section 4.4 new sub-headings have been added and a new section on renal impairment included.
In section 4.5 the last paragraph has been removed as this was duplicate information.
In section 4.9 new information on haemodialysis has been added as well as some additional symptoms of overdose.
In section 6.4 the storage conditions have been updated to include reference to protection from moisture.
In section 6.5 reference is included to the fact that not all pack sizes may be marketed.
Updated on 14 July 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to information about pregnancy or lactation
- Change to dosage and administration
Updated on 25 September 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 May 2006
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 be renewed (B)
Updated on 04 May 2006
Reasons for updating
- Change to packaging
Updated on 16 May 2005
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
- Change to section 9 - Date of renewal of authorisation
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 September 2004
Reasons for updating
- Improved electronic presentation
Updated on 25 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 29 August 2003
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)