MOVIPREP, powder for oral solution

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 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 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 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

Other medicines and Moviprep

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 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

What MOVIPREP contains

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

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:

Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany,

Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and United Kingdom (Northern Ireland): Moviprep.

Sweden: Movprep

This leaflet was last revised in September 2021 November 2022.

6. Contents of the pack and other information

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
 Or
 Recipharm Höganäs AB, Sporthallsvägen 6, Höganäs, 263 34, Sweden.
 

This leaflet was last revised in  April 2021

4.4     Special warnings and precautions for use

Diarrhoea is an expected effect resulting from the use of Moviprep.

Moviprep should be administered with caution to fragile patients in poor health or patients with serious clinical impairment such as:

- impaired gag reflex, or with a tendency to aspiration or regurgitation

- impaired consciousness

- severe renal insufficiency (creatinine clearance <30 mL/min)

- cardiac impairment (NYHA grade III or IV)

- those at risk of arrhythmia, for example those on treatment for cardiovascular

  disease or who have thyroid disease

- dehydration

- severe acute inflammatory bowel disease

The presence of dehydration should be corrected before the use of Moviprep.

The fluid content of Moviprep when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.

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.

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 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 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       

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 if you have any of the following:

•    you need to thicken 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 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 with food and drink

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

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

This leaflet was last revised in  April 2021

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

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

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

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.

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

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.

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.

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.