Stalevo 50 mg/12.5 mg/200 mg film-coated tablets
*Company:
Orion Pharma (Ireland) LtdStatus:
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 17 February 2022
File name
Stalevo 50 Package leaflet IE Jan 2022.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
The following are the major changes to the PIL:
Section 2: What you need to know before you take Stalevo
Under ‘Stalevo contains sucrose’, added
-
- “This medicine contains less than 1 mmol (23 mg) sodium per maximum recommended daily dose, that is to say essentially ‘sodium-free’.”
Updated on 17 February 2022
File name
Stalevo SPC IE Jan 2022.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Following has changed:
Section 2: Qualitative And Quantitative Composition
- To 150 mg/37.5 mg/200 mg under Excipients with known effect, added the words “…and 2.6 mg sodium as a constituent of an excipient.”
Section 4.4: Special warnings and precautions for use
Added following paragraphs:
- Stalevo 150 mg/37.5 mg/200 mg contains 2.6 mg sodium per tablet. The maximum recommended daily dose (10 tablets) contains 26 mg sodium, equivalent to 1.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
- Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg, 175 mg/43.75 mg/200 mg and 200 mg/50 mg/200 mg film-coated tablets contain less than 1 mmol (23 mg) sodium per maximum recommended daily dose, that is to say essentially ‘sodium-free’.
Updated on 09 December 2020
File name
Stalevo 50 Package leaflet IE Nov2020.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Additional site of manufacture added to section 6 of the leaflet.
Updated on 09 December 2020
File name
Stalevo SPC IE Nov 2020.pdf
Reasons for updating
- 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
Date of revision of text updated, no other updates.
Updated on 15 May 2020
File name
Stalevo 50 Package leaflet IE.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Representative offices contact details for Malta and Bulgaria updated
Updated on 06 September 2019
File name
Stalevo 50 Package leaflet July19 IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
The package leaflet has been updated with information relating to what patients and their families should do if addiction-like symptoms are developed and what the side-effects of this may be.
Updated on 06 September 2019
File name
Stalevo SPC July 2019 IE.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 be renewed (B)
Free text change information supplied by the pharmaceutical company
The Summary of product characteristics for Stalevo has been updated to include information on Dopamine Dysregulation Syndrome (DDS):
Section 4.4 is updated to state: Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with carbidopa/levodopa. Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS.
Section 4.8 is updated to state: Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with carbidopa/levodopa. Affected patients show a compulsive pattern of dopaminergic drug misuse above doses adequate to control motor symptoms, which may in some cases result in severe dyskinesias.
Updated on 02 January 2019
File name
Stalevo 50 Package leaflet Dec18 IE.pdf
Reasons for updating
- Change in co-marketing arrangement
Updated on 20 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 February 2018
File name
PIL_7821_452.pdf
Reasons for updating
- New PIL for new product
Updated on 20 February 2018
Reasons for updating
- Change to section 6 - date of revision
Updated on 07 January 2016
Reasons for updating
- Change of distributor details
Updated on 04 February 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 18 December 2013
Reasons for updating
- Change to date of revision
Updated on 25 January 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 10 September 2010
Reasons for updating
- Change to side-effects
Updated on 25 June 2010
Reasons for updating
- Change to date of revision
Updated on 08 April 2010
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 01 October 2009
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 20 May 2009
Reasons for updating
- Joint PIL superseded by PILs for individual presentations
Updated on 27 September 2007
Reasons for updating
- Change to side-effects
Updated on 13 February 2007
Reasons for updating
- Change to date of revision
Updated on 24 May 2006
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 17 August 2004
Reasons for updating
- Change to further information section
Updated on 05 August 2004
Reasons for updating
- New PIL for medicines.ie