Risperdal 0.5, 1, 2, 3, 4 and 6 mg film-coated tablets

  • Name:

    Risperdal 0.5, 1, 2, 3, 4 and 6 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Risperidone

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/10/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 28/10/2019

Click on this link to Download PDF directly

Janssen Sciences Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Caelyx pegylated liposomal 2mg/ml concentrate for solution for infusion Active Ingredients Doxorubicin hydrochloride
Medicine Name CONCERTA XL 18 mg prolonged-release tablets Active Ingredients Methylphenidate Hydrochloride
Medicine Name Concerta XL 27mg Active Ingredients Methylphenidate Hydrochloride
Medicine Name Concerta XL 36 mg prolonged-release tablets Active Ingredients Methylphenidate Hydrochloride
Medicine Name Dacogen 50 mg powder for concentrate for solution for infusion. Active Ingredients Decitabine
Medicine Name Daktacort 2% 1% Cream Active Ingredients Hydrocortisone, Miconazole nitrate
Medicine Name DARZALEX 20 mg/mL concentrate for solution for infusion. Active Ingredients Daratumumab
Medicine Name Durogesic DTrans 100 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 12 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 25 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 50 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 75 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans Transdermal Patch Active Ingredients Fentanyl
Medicine Name Edurant 25mg film-coated tablets Active Ingredients Rilpivirine Hydrochloride
Medicine Name Erleada 60 mg film coated tablets Active Ingredients Apalutamide
Medicine Name Evra transdermal patch Active Ingredients Ethinylestradiol, Norelgestromin
Medicine Name Gyno-Daktarin 20 mg/g vaginal cream Active Ingredients Miconazole nitrate
Medicine Name Gyno-Pevaryl Once 150mg vaginal pessary Active Ingredients Econazole Nitrate
Medicine Name Haldol Decanoate Active Ingredients Haloperidol decanoate
Medicine Name IMBRUVICA 140 mg, 280 mg, 420 mg and 560 mg film-coated tablets Active Ingredients Ibrutinib
Medicine Name Intelence 200 mg tablets Active Ingredients Etravirine
Medicine Name Invega 3 mg, 6mg, 9mg, 12mg prolonged-release tablets Active Ingredients Paliperidone
Medicine Name Lyrinel XL 5mg & 10mg prolonged release tablets Active Ingredients Oxybutynin Hydrochloride
Medicine Name PARIET 10 mg gastro-resistant tablets Active Ingredients Rabeprazole Sodium
Medicine Name PARIET 20 mg gastro-resistant tablets Active Ingredients Rabeprazole Sodium
1 - 0 of 57 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 28 October 2019 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 28 October 2019 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 20 August 2019 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 12 April 2019 SmPC

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)

Updated on 3 April 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 6 November 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 5 November 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 5 November 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 November 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 November 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 November 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 November 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 November 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 September 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 27 September 2018 SmPC

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 - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 September 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 September 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 September 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 September 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 September 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 September 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 September 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 September 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 September 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 21 August 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 August 2018 SmPC

Reasons for updating

  • 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 4.8 – addition of ADRs: somnambulism and sleep related eating disorder (frequency rare)

Updated on 5 July 2018 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 5 July 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • 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

4.4     Special warnings and precautions for use

Excipients

The film‑coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapptotal lactase deficiency or glucose‑galactose malabsorption should not take this medicine. (Pertains only to the film‑coated tablets.)

 

4.8     Undesirable effects

Addition of somnambulism and sleep-related eating disorder as ADRs under SOC Psychiatric disorders with rare frequency.

Updated on 15 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 May 2018 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Change from individual to joint SmPC

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

All Risperdal film-coated tablet SmPCs merged into one document.

Date of latest renewal updated.

Dimensions of tablet added to Section 3.

Updated on 23 April 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 23 April 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 6 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 1 July 2015 PIL

Reasons for updating

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

Updated on 1 July 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 May 2015 PIL

Reasons for updating

  • Change to further information section
  • Deletion of a pack size

Updated on 29 April 2015 PIL

Reasons for updating

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

Updated on 26 February 2014 PIL

Reasons for updating

  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 12 November 2013 PIL

Reasons for updating

  • Change to further information section
  • Deletion of a pack size

Updated on 6 November 2013 PIL

Reasons for updating

  • Change to storage instructions

Updated on 4 September 2013 PIL

Reasons for updating

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

Updated on 24 July 2013 PIL

Reasons for updating

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

Updated on 22 April 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration

Updated on 15 November 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 30 July 2012 PIL

Reasons for updating

  • Change to storage instructions
  • Change to further information section

Updated on 9 March 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 17 May 2011 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 5 April 2011 PIL

Reasons for updating

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

Updated on 31 August 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change due to user-testing of patient information
  • Addition of joint PIL covering all presentations

Updated on 26 July 2010 PIL

Reasons for updating

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

Updated on 18 December 2009 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 14 July 2009 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information
  • Changes to therapeutic indications

Updated on 16 September 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 19 October 2007 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions

Updated on 22 February 2007 PIL

Reasons for updating

  • Change to side-effects
  • Changes to therapeutic indications

Updated on 20 February 2007 PIL

Reasons for updating

  • Change to side-effects
  • Changes to therapeutic indications

Updated on 22 August 2006 PIL

Reasons for updating

  • Change to side-effects

Updated on 26 May 2005 PIL

Reasons for updating

  • Change to dosage and administration
  • Change to drug interactions
  • Change to warnings or special precautions for use
  • Change to, or new use for medicine

Updated on 27 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie