Section 4.4 and 4.8 of SmPC and Section 2 and 4 are updated as per the PRAC recommendation received for Macrogol, Procedure no.: PSUSA/00010705/202401.

Section 10 updated due to change in revision date

Section 4.4 and 4.8 of SmPC and Section 2 and 4 are updated as per the PRAC recommendation received for Macrogol, Procedure no.: PSUSA/00010705/202401.

Section 10 updated due to change in revision date

Section 4.4 and 4.8 of SmPC and Section 2 and 4 are updated as per the PRAC recommendation received for Macrogol, Procedure no.: PSUSA/00010705/202401.

Section 10 updated due to change in revision date

4.5    Interaction with other medicinal products and other forms of interaction

The interaction of Moviprep Orange with other medicinal products has not been studied. Theoretically, Mmedicinal products taken orally (e.g. oral contraceptive pill) one hour before, during and one hour after Moviprep Orange administration may be flushed from the gastrointestinal tract unabsorbed. The therapeutic effect of drugs with a narrow therapeutic index or short half-life may be particularly affected.

10.    DATE OF REVISION OF THE TEXT

             May 2024 January 2023

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Sachet A contains the following active substances:

Macrogol 3350 100g

Sodium sulfate anhydrous 7.500g

Sodium chloride 2.691g

Potassium chloride 1.015g

Sachet B contains the following active substances:

Ascorbic acid 4.700g

Sodium ascorbate 5.900g

The concentration of electrolyte ions when both sachets are made up to one litre of solution is as follows:

Sodium 181.6mmol/L (of which not more than 56.2 mmol is absorbable)

Sulfate 52.8mmol/L

Chloride 59.8mmol/L

Potassium 14.2mmol/L

Ascorbate 29.8 56.5mmol/L

4.5       Interaction with other medicinal products and other forms of interaction

Oral medication should not be taken within one hour of administration of Moviprep Orange as it may be flushed from the gastro-intestinal tract and not absorbed. Medicinal products taken orally (e.g. oral contraceptive pill) one hour before, during and one hour after Moviprep Orange administration may be flushed from the gastrointestinal tract unabsorbed. The therapeutic effect of drugs with a narrow therapeutic index or short half-life may be particularly affected.

Moviprep Orange may result in a potential interactive effect if used with starch-based food thickeners. The Macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.

10.      DATE OF REVISION OF THE TEXT

08 April 2021 January 2023

4.4     Special warnings and precautions for use

Semi-conscious patients or patients prone to aspiration or regurgitation should be closely observed during administration, especially if this is via a nasogastric route.

In people with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section 4.5.

If patients develop any symptoms indicating arrhythmia or shifts of fluid/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, cardiac failure), plasma electrolytes should be measured, ECG monitored and any abnormality treated appropriately.

4.5     Interaction with other medicinal products and other forms of interaction

Oral medication should not be taken within one hour of administration of Moviprep Orange as it may be flushed from the gastro-intestinal tract and not absorbed. The therapeutic effect of drugs with a narrow therapeutic index or short half-life may be particularly affected.

MOVIPREP Orange may result in a potential interactive effect if used with starch based food thickeners. Macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.

10.     DATE OF REVISION OF THE TEXT

13 Jan 2020   08 April 2021

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

 The following sections have been updated:

 Section 2:

 If you experience sudden abdominal pain or rectal bleeding when taking Moviprep Orange for bowel preparation, contact your doctor or seek medical advice immediately.

 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.

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

The MOVIPREP Orange SmPC  has been updated following the approval of the renewal application.

The only changes that have been made are a change to the ‘date of first authorisation/renewal of the authorisation’ and a change to the ‘date of revision of the text’.

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.

SMPC changes are as follows:

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.