Updated on 26 January 2022
File name
1.3.1 SmPC - IE764 CCDSv07 Suicidality - Clean (1)_1643212882.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 November 2021
File name
IE-Frisium-PIL (1)_1636726561.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 12 July 2021
File name
Frisium 10mg tablets PIL_1574334350_1626106581.pdf
Reasons for updating
- XPIL Removed
Updated on 06 July 2020
File name
Frisium 10mg tablets PIL_1574334350.pdf
Reasons for updating
- XPIL Removed
Updated on 06 July 2020
File name
Frisium 10mg tablets PIL_1574334350.pdf
Reasons for updating
- XPIL Removed
Updated on 21 November 2019
File name
Frisium 10mg tablets SmPC_1574334434.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 November 2019
File name
Frisium 10mg tablets PIL_1574334350.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
Updated on 31 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 31 January 2018
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 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
Section 4.4 added under Risks from concomitant use of opioids and benzodiazepines:
· Concomitant use of Frisium and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Frisium with opioids should be reserved for patients for whom alternative treatment options are not possible.
· If a decision is made to prescribe Frisium concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible (see also general dose recommendation in section 4.2).
· The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their environment to be aware of these symptoms (see section 4.5).
Section 4.5 added under Opioids
· The concomitant use of sedative medicines such as benzodiazepines or related drugs such as Frisium with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dosage and duration of concomitant use should be limited (see section 4.4).
Section 4.8 removed under Skin and subcutaneous tissue disorders
· Photosensitivity reaction
Section 4.8 removed under General disorders and administration site conditions
· 46
Updated on 07 August 2017
Reasons for updating
- 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 5.3 - Preclinical safety data
- 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 27 July 2017
File name
PIL_8372_171.pdf
Reasons for updating
- New PIL for new product
Updated on 27 July 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 06 November 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 16 October 2015
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 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
Elderly: Doses of 10-20 mg daily in anxiety may be used in the lederly and debilitated who are usually more sensitive to the effects of psychoactive agrents. Treatment requires low initial doses and gradual dose increments under careful observations.
The administration of tablets.
4.4 Special Warnings and Special Preacutions for Use
Alcohol, tolerance, dependence, psychiatric and 'paradoxical' reactions, respiratory depression, reneal and hepatic impairment, muscle weakness, depression, elderly patients and CYP2C19 poor metabolizers updated.
4.5 Interactions with out Medicinal Products and other forms of Interactions
Not recommended with alcohol, central nervous system depressqant drugs, anticonvulsants, narcotic analgesics, muscle relaxants, CYP2C19 inhibitors, CYP 2D6 substrates updated.
4.6 Fertility, Pregnancy and Lactation updated
4.8 Undesirable Effects
Nervous system disorders, psychiatric disorders, eye disorders,
respiratory, thoracic and mediastinal disorders, gastrointenstinal disorders, skin and subcutaneous tissue disorders, metabolism and nutrition disorders, general disorders updated.
5.2 Pharmacokinetic Properties
Absorption, distrubution, metabolism and elimination updated.
Updated on 11 August 2015
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 30 April 2013
Reasons for updating
- Change of licence holder
- Change to date of revision
Updated on 02 May 2012
Reasons for updating
- Change of contraindications
- Change to dosage and administration
Updated on 16 April 2012
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 01 April 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 14 February 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 14 October 2010
Reasons for updating
- Change to improve clarity and readability
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 June 2010
Reasons for updating
- Improved electronic presentation
Updated on 07 August 2008
Reasons for updating
- Change to improve clarity and readability
- Change of manufacturer
Updated on 12 June 2008
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 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 24 August 2007
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
Updated on 18 December 2006
Reasons for updating
- Improved electronic presentation
Updated on 07 December 2005
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 April 2005
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 March 2005
Reasons for updating
- Improved electronic presentation
Updated on 21 March 2005
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 16 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)