Stalevo 125 mg/31.25 mg/200 mg film-coated tablets

  • Name:

    Stalevo 125 mg/31.25 mg/200 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Carbidopa, Entacapone, Levodopa

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/09/19

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Summary of Product Characteristics last updated on medicines.ie: 6/9/2019

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Orion Pharma (Ireland) Ltd

Orion Pharma (Ireland) Ltd

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Medicine NameActive Ingredients
Medicine Name Bufomix Easyhaler 160 micrograms/4.5 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Bufomix Easyhaler 320 micrograms/9 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Bufomix Easyhaler 80 micrograms/4.5 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
Medicine Name Comtess Active Ingredients Entacapone
Medicine Name Dexdor 100 micrograms/ml concentrate for solution for infusion Active Ingredients Dexmedetomidine hydrochloride
Medicine Name Divigel 0.1% Gel Active Ingredients Estradiol Hemihydrate
Medicine Name Fareston Active Ingredients Toremifene Citrate
Medicine Name Indivina Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 1 mg/2.5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 1 mg/5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Indivina 2 mg/5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Methotrexate 10mg tablets Active Ingredients Methotrexate
Medicine Name Methotrexate 2.5mg tablet Active Ingredients Methotrexate
Medicine Name Stalevo 100 mg/25 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 200 mg/50 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Toilax micro enema suspension Active Ingredients Bisacodyl
Medicine Name Veramil 120 mg Film-coated Tablets Active Ingredients verapamil hydrochloride
Medicine Name Veramil 40 mg Film-coated Tablets Active Ingredients verapamil hydrochloride
Medicine Name Veramil 80 mg Film-coated Tablets Active Ingredients verapamil hydrochloride
1 - 0 of 24 items.Total: Infinity pages

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 6 September 2019 PIL

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 6 September 2019 SmPC

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 2 January 2019 PIL

Reasons for updating

  • Change in co-marketing arrangement

Updated on 20 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 20 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 February 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 7 January 2016 PIL

Reasons for updating

  • Change of distributor details

Updated on 4 February 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 18 December 2013 PIL

Reasons for updating

  • Change to date of revision

Updated on 25 January 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 10 September 2010 PIL

Reasons for updating

  • Change to side-effects

Updated on 25 June 2010 PIL

Reasons for updating

  • Change to date of revision

Updated on 8 April 2010 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to side-effects
  • Change to date of revision

Updated on 17 November 2009 PIL

Reasons for updating

  • New PIL for medicines.ie