Stalevo 200 mg/50 mg/200 mg film-coated tablets *
Pharmacy Only: Prescription

Updated on 17 February 2022

File name

Stalevo 200 Package leaflet IE Jan 2022_1645101383.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:

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_1645100863.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

The following are the major changes:

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 SPC IE Nov 2020_1607533838.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 09 December 2020

File name

Stalevo 200 Package leaflet IE Nov2020_1607533665.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 15 May 2020

File name

Stalevo 200 Package leaflet IE_1589552854.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 200 Package leaflet July19 IE_1567771782.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_1567771724.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 200 Package leaflet IE Dec 18_1546440445.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_14016_131.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 17 December 2013

Reasons for updating

  • Change to date of revision

Updated on 30 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

  • Addition of separate PILs covering individual presentations

Updated on 16 April 2009

Reasons for updating

  • New PIL for medicines.ie