MOVIPREP, powder for oral solution
- Name:
MOVIPREP, powder for oral solution
- Company:
Norgine Limited
- Active Ingredients:
Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/12/20
(Click to Download)XPIL
Package leaflet: Information for the User
Package leaflet: Information for the User
1. What Moviprep is and what it is used for
1. What Moviprep is and what it is used for
2. What you need to know before you take Moviprep
2. What you need to know before you take Moviprep
3. How to take Moviprep
3. How to take Moviprep
4. Possible side effects
4. Possible side effects
5. How to store Moviprep
5. How to store Moviprep
6. Contents of the pack and other information
6. Contents of the pack and other information
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Norgine Limited
Company Products
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 17 December 2020 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to name of manufacturer
Free text change information supplied by the pharmaceutical company
Manufacturer:
Norgine Limited, New Road, Hengoed, Mid Glamorgan, CF82 8SJ, United Kingdom. Or
Helsinn Birex Pharmaceuticals Ltd., Damastown Mulhuddart, Dublin 15, Ireland.
Or
Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, The Netherlands.
Or
SOPHARTEX, 21 rue du Pressoir, 28500 Vernouillet, France
This leaflet was last revised in November 2020
Updated on 17 December 2020 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to name of manufacturer
Free text change information supplied by the pharmaceutical company
Manufacturer:
Norgine Limited, New Road, Hengoed, Mid Glamorgan, CF82 8SJ, United Kingdom. Or
Helsinn Birex Pharmaceuticals Ltd., Damastown Mulhuddart, Dublin 15, Ireland.
Or
Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, The Netherlands.
Or
SOPHARTEX, 21 rue du Pressoir, 28500 Vernouillet, France
This leaflet was last revised in November 2020
Updated on 5 November 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
The following section shave been updated:
section 4.4:
Ischaemic colitis
Post-marketing cases of ischaemic colitis, including serious, have been reported in patients treated with macrogol for bowel preparation. Macrogol should be used with caution in patients with known risk factors for ischaemic colitis or in case of concomitant use of stimulant laxatives (such as bisacodyl or sodium picosulfate). Patients presenting with sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis should be evaluated promptly.
section 10:
3 November 2020
Updated on 5 November 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to further information section
Free text change information supplied by the pharmaceutical company
Section 2:
If you experience sudden abdominal pain or rectal bleeding when taking Moviprep for bowel preparation, contact your doctor or seek medical advice immediately.
Section 4:
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
IE: HPRA Pharmacovigilance Website: www.hpra.ie.
MT: The national ADR reporting website: www.medicinesauthority.gov.mt/adrportal.
By reporting side effects you can help provide more information on the safety of this medicine.
This leaflet was last revised in November 2020
Other sources of information
If you need the information on this leaflet in an alternative format, such as large print, please ring 00 44 1895 826 606.
Updated on 10 January 2020 SPC
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
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 10 January 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
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 SPC
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 SPC
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 31 August 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
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 SPC
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
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 SPC
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 SPC
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
Updated on 5 July 2013 PIL
Reasons for updating
- Change to side-effects
Updated on 5 December 2011 SPC
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 SPC
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
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 SPC
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
Updated on 25 April 2007 PIL
Reasons for updating
- New PIL for new product
Updated on 24 April 2007 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)