Neupro 2mg/24hr Transdermal Patch

  • Name:

    Neupro 2mg/24hr Transdermal Patch

  • Company:
    info
  • Active Ingredients:

    Rotigotine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/08/18

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 2/8/2018

Click on this link to Download PDF directly

UCB (Pharma) Ireland Limited

UCB (Pharma) Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Briviact 10 mg/ml solution for injection/infusion Active Ingredients Brivaracetam
Medicine Name Briviact 10mg/ml oral solution Active Ingredients Brivaracetam
Medicine Name Briviact film-coated tablets Active Ingredients Brivaracetam
Medicine Name Cimzia 200 mg solution for injection in pre-filled pen Active Ingredients Certolizumab Pegol
Medicine Name Cimzia 200 mg solution for injection in pre-filled syringe Active Ingredients Certolizumab Pegol
Medicine Name Keppra 100 mg/ml oral solution Active Ingredients Levetiracetam
Medicine Name Keppra 1000 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 100mg/ml concentrate for solution for infusion Active Ingredients Levetiracetam
Medicine Name Keppra 250 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 500 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 750 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Neupro 1mg/24hr and 3 mg/24 hTransdermal Patch Active Ingredients Rotigotine
Medicine Name Neupro 2mg/24hr Transdermal Patch Active Ingredients Rotigotine
Medicine Name Neupro 4 mg/24hr, 6 mg/24hr, 8 mg/24hr Transdermal Patch Active Ingredients Rotigotine
Medicine Name Tylex 30mg/500mg Hard Capsules Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Vimpat 10 mg/ml solution for infusion Active Ingredients lacosamide
Medicine Name Vimpat 10 mg/ml syrup Active Ingredients lacosamide
Medicine Name Vimpat 50 mg, 100 mg, 150 mg, 200 mg film-coated tablets Active Ingredients lacosamide
Medicine Name Xyrem 500mg/ml oral solution Active Ingredients Sodium oxybate
Medicine Name Xyzal 0.5mg/ml oral solution Active Ingredients Levocetirizine dihydrochloride
Medicine Name Xyzal 5mg Tablets Active Ingredients Levocetirizine dihydrochloride
Medicine Name Xyzal 5mg/ml Oral Drops, Solution Active Ingredients Levocetirizine dihydrochloride
Medicine Name Zirtek Allergy Relief 10 mg film-coated tablets (OTC) Active Ingredients Cetirizine Dihydrochloride
Medicine Name Zirtek Oral Solution Active Ingredients Cetirizine Dihydrochloride
Medicine Name Zirtek Plus Decongestant 5mg/120mg Prolonged Release Tablets Active Ingredients Cetirizine Dihydrochloride, Pseudoephedrine Hydrochloride
1 - 0 of 26 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 2 August 2018 PIL

Reasons for updating

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

Updated on 2 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

Change concerning a linguistic Review - Dropped Head Syndrome and additional changes 

4.8 Undesirable effect- Tabulated list of adverse reactions; Section 10- Date of revision of the text

Updated on 17 January 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 17 January 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

 

Changes were made to the following sections:

Section 4.2: Changes to duration of pressing during the application of the patch.

 Section 6.5: amendment to reflect the change of design from cardboard to plastic and to change an existing pack-size.

Updated on 1 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 December 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for

Updated on 16 October 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

In the section 7.0 (Marketing Authorisation Holder) address is updated

Updated on 16 October 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 26 June 2017 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

To include the 14 pack size in the section 6. 5.

Updated on 23 June 2017 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents

Updated on 13 December 2016 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 15 November 2016 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 15 March 2016 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

5.1 Pharmacodynamic properties

 

Reference to a skin adhesion study has been included.

 

6.3 Shelf life

 

The shelf life has increased to 30 months (from 2 years).

 

6.4 Special precautions for storage

 

The storage conditions have been updated to “Do not store above 30°C” (previously 25°C).

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

The date of last renewal has been added: 22 January 2016

 

10. DATE OF REVISION OF THE TEXT

 

The date of revision has been added: 02/2016

Updated on 10 March 2016 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision
  • Change to dosage and administration

Updated on 12 February 2016 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

 

Changes were made to the following sections:

Section 4.1: Editorial changes

Section 4.2: Editorial changes and removal of a sentence about the case where a patch fall off.

Section 4.4:Changes to the syncope and augmentation sub-sections.

Section 4.8: Addition of  new side effects, and changing in the frequency for already registered side effects. The section 'Description of selected adverse reactions' has also been edited.

 Section 5.1: Addition of an 'augmentation sub-section'.

Section 6.1: Editorial changes

Section 6.5: Deletion of registered pack-sizes

Section 6.6: Editorial changes

Updated on 11 February 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Deletion of a pack size

Updated on 30 June 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 25 September 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to improve clarity and readability

Updated on 17 February 2012 PIL

Reasons for updating

  • Change to instructions about overdose

Updated on 13 May 2011 PIL

Reasons for updating

  • Change to further information section

Updated on 2 March 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of special precautions for disposal

Updated on 31 August 2010 PIL

Reasons for updating

  • New PIL for medicines.ie