Lioresal 5mg/5ml Oral Solution
*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 28 January 2022
File name
Lioresal OS REGPIL PF21-0201 Jan 2022 clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 28 January 2022
File name
Lioresal Oral solt REGSPC PF21-0201 clean Jan 2022.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 30 November 2020
File name
Lioresal Oral solt REG PIL PF 20-0175 TBI 27.5.2021.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 30 November 2020
File name
Lioresal Oral solt REG SPC PF 20-0175 November clean 2020.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 be renewed (B)
Updated on 28 November 2019
File name
Lioresal oral solt PF19-0179clean september 2019.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 27 November 2019
File name
Lioresal oral solt PILSeptember 2019clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 25 November 2019
File name
Lioresal Oral solt REG SPC PF 19-0179 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
Lioresal Oral solt REG SPC PF 19-0179 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
Lioresal oral solt PILSeptember 2019clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 11 November 2019
File name
Lioresal Oral solt REG SPC PF 19-0179 clean October 2019.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 11 November 2019
File name
Lioresal Oral Solt REG SPC PF 19-0179 clean October 2019signed.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 April 2019
File name
Reg_SPC_LioresalOralSolt_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
Lioresal LFT OSLN506703_IE_IPHA.pdf
Reasons for updating
- Change to marketing authorisation holder
Updated on 16 July 2018
File name
Reg_SPC_LioresalOralSolt_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 25 May 2018
File name
FINALLioresal Oral Solution26022018.docx
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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 February 2017
File name
PIL_10807_82.pdf
Reasons for updating
- New PIL for new product
Updated on 21 February 2017
Reasons for updating
- Change to section 6 - manufacturer
Updated on 22 December 2014
Reasons for updating
- Change of manufacturer
- Change to warnings or special precautions for use
- 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 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 03 July 2013
Reasons for updating
- Change of manufacturer
Updated on 27 May 2013
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 6.5 has been updated to reflect a new primary packaging container.
Updated on 20 February 2013
Reasons for updating
- Change due to user-testing of patient information
Updated on 07 February 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 01 September 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 4.4 - Special warnings and precautions for use
- 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
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 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 6.1 - List of excipients
- 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 it states: The solution contains 1 mg/1 ml baclofen, 1.4 mg/ml methyl parahydroxybenzoate, 0.14 mg/ml propyl parahydroxybenzoate and 1.62 mg/ml sodium
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 6.1 E numbers have been added for some excipients.
In section 6.2 Incompatabilities included.
In section 6.3 Information on dilution added.
In section 6.4 the storage conditions have been updated to include reference to protection from light.
In section 6.6 reference to storage at room temperature has been removed.
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 6.1 E numbers have been added for some excipients.
In section 6.2 Incompatabilities included.
In section 6.3 Information on dilution added.
In section 6.4 the storage conditions have been updated to include reference to protection from light.
In section 6.6 reference to storage at room temperature has been removed.
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 further information section
Updated on 03 September 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 September 2008
Reasons for updating
- Improved electronic presentation
Updated on 10 April 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 10 March 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 April 2005
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)