MOVIPREP Orange, powder for oral solution

2.            What you need to know before you take Moviprep Orange

Children and adolescents

Moviprep Orange should not be taken by children and adolescents aged below 18 years.

3.            How to take Moviprep Orange

Use in children

Moviprep Orange should not be taken by children aged below 18 years.

When to take Moviprep Orange

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor if you are not sure. Your treatment with Moviprep Orange must be completed before your clinical procedure examination.

 This course of treatment can be taken either as divided or single doses as described below:

 For procedures conducted when you are put to sleep (using general anaesthesia):

 1.       Divided doses: one litre of Moviprep Orange in the evening before and one litre in the early morning of the day of the clinical procedure.

Single dose: two litres of Moviprep Orange in the evening before the clinical procedure or two litres in the morning of the clinical procedure.

For the divided dose and single dose taken in the evening before the clinical procedure, there should be at least one hour between the end of intake of fluid (Moviprep Orange or clear liquid) and the start of the colonoscopy.

For the single dose taken in the morning of the clinical procedure, there should be at least two hours between the end of intake of Moviprep Orange and at least one hour between the end of intake of any clear liquid and the start of the colonoscopy.

 1.       Divided doses: one litre of Moviprep Orange in the evening before and one litre of Moviprep Orange in the early morning of the day of the examination. Ensure consumption of Moviprep Orange as well as any other clear fluids has finished at least two hours before the start of the examination.

 2.Single dose: two litres of Moviprep Orange in the evening before the examination or two litres of Moviprep Orange in the morning of the examination. Ensure consumption of Moviprep Orange as well as any other clear fluids has finished at least two hours before the start of the examination.

 For procedures conducted without the need for putting you to sleep (without using general anaesthesia):

 1.         Divided doses: one litre of Moviprep Orange in the evening before and one litre of Moviprep Orange in the early morning of the day of the examination. Ensure consumption of Moviprep Orange as well as any other clear fluids has finished at least one hour before the start of the examination.

 2.         Single dose: two litres of Moviprep Orange in the evening before the examination or two litres of Moviprep Orange in the morning of the examination. Ensure consumption of Moviprep Orange has finished at least two hours before the start of the examination. Ensure consumption of any clear fluids has finished at least one hour before the examination.

 If you forget to take Moviprep Orange

If you forget to take Moviprep Orange take the dose as soon as you realise you have not taken it. If this is several hours after the time when you should have taken it, contact your doctor or pharmacist for advice. When taking Moviprep Orange as divided doses it is important that you complete your Moviprep Orange preparation at least one hour before your examination (without use of general anaesthesia), or two hours before your examination (with use of general anaesthesia). When taking all your Moviprep Orange on the morning of the examination as a single dose it is important that you complete your Moviprep Orange preparation at least two hours before your examination. It is important that you complete your preparation at least an hour before your clinical procedure when taking Moviprep Orange as divided dose and two hours before your clinical procedure if taking all your Moviprep Orange on the morning of the clinical procedure.

 6.          Contents of the pack and other information

 This leaflet was last revised in November 2022 April 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

2.        What you need to know before you take Moviprep Orange

Other medicines and Moviprep Orange

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking other medicines orally (e.g. oral contraceptive pill), you should not take them at least one hour before, during and one hour after taking Moviprep Orange or at least one hour afterwards because they may be flushed through your digestive system and not work so well.

6.        Contents of the pack and other information

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 56.2mmol is absorbable)

Chloride 59.8mmol/L

Sulfate 52.8mmol/L

Potassium 14.2mmol/L

Ascorbate 29.8 56.5mmol/L

The medicinal product medicine is authorised in the Member States of the EEA European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Country                                 Tradename

Austria                                     MOVIPREP Orange

Belgium                                   MOVIPREP Sinaas/Orange

Denmark                                 MOVIPREP Appelsin

Finland                                     MOVIPREP Appelsini

France                                       MOVIPREP Orange

Germany                                MOVIPREP Orange

Ireland                                       MOVIPREP Orange

Italy                                        MOVIPREP Arancio

Luxembourg                             MOVIPREP Sinaas/Orange

Netherlands                            MOVIPREP Orange

Spain                                      MOVIPREP sabor Naranja

Sweden                                  MOVPREP APELSIN

United Kingdom:                      MOVIPREP Orange

(Northern Ireland)

This leaflet was last revised in April 2021 November 2022.

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

Warnings and precautions

If you are in poor health or have a serious medical condition, you should be particularly aware of the possible side effects listed in section 4. Contact your doctor or pharmacist if you are concerned.

Talk to your doctor or pharmacist before taking Moviprep Orange if you have any of the following:

·    you need to thicken fluids in order to swallow them safely.

·    a tendency to regurgitate swallowed drink, food or acid from the stomach, or if you have problems with swallowing (see also Moviprep Orange with food and drink).

·    kidney disease.

• heart failure or heart disease including high blood pressure,  irregular heartbeats or palpitations.

·    thyroid disease

·    dehydration.

·    acute flare of inflammatory bowel disease (Crohn’s disease or ulcerative colitis).

Moviprep Orange with food and drink

Do not take any solid food from when you start to take Moviprep Orange until after the examination.

If you need to thicken fluids in order to swallow them safely, Moviprep Orange may counteract the effect of the thickener.

This leaflet was last revised in  October 2019 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.