MOVIPREP, powder for oral solution

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/06/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 11/4/2019

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Norgine Limited

Norgine Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Dantrium Capsules 100mg Active Ingredients Dantrolene Sodium
Medicine Name Dantrium Capsules 25mg Active Ingredients Dantrolene Sodium
Medicine Name Dantrium Intravenous 20 mg Powder for Solution for Injection Active Ingredients Dantrolene Sodium
Medicine Name MOVICOL 13.8g sachet, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Medicine Name Movicol Liquid Orange Flavour Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name MOVICOL PAEDIATRIC PLAIN 6.9g sachet, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name MOVIPREP Orange, powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name MOVIPREP, powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name NORMACOL Granules Active Ingredients Sterculia
Medicine Name NORMACOL PLUS Granules Active Ingredients Frangula, Sterculia
Medicine Name Plenvu powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name TARGAXAN 550mg film-coated tablets Active Ingredients Rifaximin
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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 21 June 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 11 April 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 11 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 be renewed (B)

Updated on 31 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 31 August 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company

Section 4.2 posology update to include the procedure conducted when you are put under general anaesthesia and without general anaesthesia

Updated on 24 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 August 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product contains

Updated on 4 April 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 12 May 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 11 May 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change due to harmonisation of SPC

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

Free text change information supplied by the pharmaceutical company

The following changes have been made:

Section 2 - Update to the statement re the excipients

Section  4.2 – the inclusion of the word clinical before procedure through the various paragraphs

Section 4.7 – update to the comment regarding effect on ability to drive and use machines

Section 4.8 – clarification on the definition of the frequencies for reporting adverse effects

Section 5.3 – inclusion of additional information on reproductive toxicology studies

Section 10 – date of revision of the text

 

Minor editorial changes have been made through the document.

 

 

Updated on 22 October 2015 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Change to improve clarity and readability
  • Change to section 4.2 - Posology and method of administration
  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company

The following changes have been made.

 

Section 2         - addition of the title – ‘Excipients with known affect’

 

Section 4.2         - an additional dosing option has been added to include the option of ‘two litres in the morning of the clinical procedure’. Further information around the dosing has been added.

-information around the method of administration has been added.

 

Section 4.3      - statement about the hypersensitivity to excipients has been aligned with QRD wording.

 

Section 4.4      - addition of the sentence ‘ The fluid content of Moviprep when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained’

-addition of statements regarding those at risk of arrhythmia

-addition of statements regarding the content of absorbable sodium, potassium and aspartame in relation to at risk patients.

 

Section 4.6      - general information added about use in pregnancy and breastfeeding.

 

Section 4.8      - the addition of the adverse event  arrhythmia, to cardiac disorders

- the order of some adverse events has been amended

- addition of the statement  ‘Dehydration may occur as a result of diarrhoea and/or vomiting.’

-  addition of information regarding adverse event reporting.

 

Section 6.6      - information added to the precautions for disposal

 

General            - the spelling of Sulphate has been changed from Sulphate and Sulfate throughout.

- MOVIPREP uppercase text has been changed to lowercase text throughout.

 

Updated on 15 October 2015 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
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 9 July 2013 SmPC

Reasons for updating

  • 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

In section 4.8,  Adverese reactions: Hypokalemia was added to  Investigation, as follwos: 'Electrolytes disturbances including blood bicarbonate decreased, hyper and hypocalcaemia, hypophosphataemia, hypokalemia and hyponatraemia (the latter two disturbances occurs more commonly in patients taking concomitant medication affecting the kidneys such as ACE inhibitors and diuretics) and changes in the blood chloride levels.'

Updated on 5 July 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 5 December 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1; MOVIPREP, powder for oral solution - 'in sachets' has been removed

 

Section 6.4: removal of 'store in original package'

 

Section 9; Date of last renewal: 18th January 2011 (added)


Section 10: July 2011

Updated on 1 December 2011 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 13 August 2010 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

4.8, 5.1 and 5.3.

As with other macrogol containing products, allergic reactions including rash, urticaria, pruritus, angioedema and anaphylaxis are a possibility.

Data from clinical studies are available in a population of 825 patients treated with MOVIPREP in which undesirable effect data were actively elicited.  Additionally,  adverse events reported in postmarketing are included.

 

The electrolytes present in the formulation and the supplementary clear liquid intake are included to prevent clinically significant variations of sodium, potassium or water, and thus reduce dehydration risk.


No studies have been carried out on the genotoxicity, carcinogenicity or toxic effect on reproduction with this product.

Updated on 30 July 2010 PIL

Reasons for updating

  • Change to packaging

Updated on 6 April 2010 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Legal category now correctly stated as POM.

Updated on 25 April 2007 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 April 2007 SmPC

Reasons for updating

  • New SPC for new product

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