Frisium Tablets *

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Legal 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

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

TII C.I.4 Update to SmPC 4.4, 4.6, 4.8, 5.3following CCDS v4

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

4.2 Posology and Method of Administation

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

Section 6.3 updated to reduce the shelf-life from 5 to 3 years.

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

Sections 4.2 & 4.3 have been updated regarding Paediatric Indications in line with Article 45 EU work-sharing procedure report

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

To bring in line with the core safety data sheet

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

The changes were made as a result of a renewal, and to bring the SPC in line with the core safety data sheet

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

Update sections  4.4, 4.5, 4.8, 9, 10

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

Update Section 7 - change MAH to sanofi-aventis Ireland Ltd.
Section 10 - Date of revision

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)