Consumer medicine information

Moviprep

Macrogol 3350; Potassium chloride; Sodium chloride; Sodium sulfate; Ascorbic acid; Sodium ascorbate

BRAND INFORMATION

Brand name

Moviprep

Active ingredient

Macrogol 3350; Potassium chloride; Sodium chloride; Sodium sulfate; Ascorbic acid; Sodium ascorbate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Moviprep.

What is in this Leaflet

This leaflet answers some common questions about Moviprep powder for oral solution.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Moviprep is used for

Moviprep is a type of medicine called a bowel preparation. It makes your bowels clean so that they are ready for examination or surgery. Moviprep works by emptying the contents of your bowels, so you should expect to have lots of watery bowel movements.

Moviprep is a lemon flavoured powder contained in four sachets. There are two large sachets (Sachet A) and two small sachets (Sachet B). You need all of these for one treatment.

Moviprep is intended for adults (18 years of age and older), including the elderly, before any clinical procedure that needs a clean bowel.

Ask your doctor if you have any questions about why this medicine has been recommended for you.

Before you take Moviprep

When you must not take it

Do not take Moviprep:

  • if you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of Moviprep (listed in ‘Product Description’)
  • if you have a blockage in your intestine (gut)
  • if you have an opening in the wall of your stomach or bowel (bowel perforation)
  • if you experience problems with food and fluid emptying from your stomach (gastric retention)
  • if you have paralysis of the gut (this often happens after an operation to the abdomen)
  • if you suffer from phenylketonuria. This is a hereditary inability of the body to use a particular amino acid. Moviprep contains aspartame, a source of phenylalanine
  • if your body is unable to produce enough glucose-6- phosphate dehydrogenase
  • if you have severe inflammatory bowel disease, like ulcerative colitis, Crohn’s disease, or toxic megacolon
  • if you are very dehydrated

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, seek medical advice.

Before you start to take it

Make sure you are not dehydrated before the use of any bowel preparation. If you develop significant vomiting, or signs of fluid loss (dehydration) tell your doctor, see ‘Side Effects’ section.

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor, pharmacist or nurse before taking Moviprep if any of the points below apply to you. If you:

  • have an allergy to any of the ingredients in Moviprep
  • have heart problems and/or heart rhythm problems
  • have kidney problems
  • have problems with swallowing
  • have a tendency to regurgitate swallowed drink, food or acid from the stomach.
  • have heart failure or heart disease including high blood pressure, irregular heartbeats or palpitations.
  • have thyroid disease
  • are dehydrated
  • have a decreased level of consciousness, unless you have suitable medical supervision
  • are on a restricted sodium or restricted potassium diet.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you are breastfeeding. It is not known if Moviprep passes into your breast milk. You and your doctor should decide if you should take Moviprep while breastfeeding.

If you have not told your doctor about any of the above, tell him/her before you start taking Moviprep.

Taking other medicines

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines (e.g. oral contraceptives, diuretics, calcium channel blockers, corticosteroids), as well as any you get without a prescription from your pharmacy, supermarket or health food shop.

Don’t take oral medicines within one hour (i.e. includes one hour before administration, as well as during administration and one hour after administration) of taking Moviprep, as they may be flushed through without working properly. Contraceptive cover from the oral contraceptive pill is likely to be incomplete if it is taken at any time during the process of bowel cleansing with Moviprep. Therefore an alternative method of contraception should be used for the length of the cycle when MOVIPREP is taken.

If you have insulin-dependent diabetes, talk to your doctor before you take Moviprep. Once you start taking Moviprep, you can only drink the clear fluids (listed under ‘Moviprep with food and drink’) so you will need to adjust your insulin dose.

Your doctor may tell you to temporarily stop some medicines before your procedure. Follow their advice.

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

Moviprep with food and drink

Your doctor may ask you to change your diet a few days before the procedure, for example, asking you to avoid high-fibre foods. When taking Moviprep you should continue to drink plenty of clear fluids. The fluid content of Moviprep does not replace your regular fluid intake.

Examples of clear fluids are water, clear soups, herbal tea, black tea or coffee (without milk), soft drinks/diluted cordials and clear fruit juices (without pulp).

Important: Do not drink alcohol, milk, anything coloured red or purple (e.g. blackcurrant juice) or any other drinks containing pulp material. Do not eat while taking Moviprep until after your clinical procedure.

Two-day split dosing schedule and day before dosing schedule
Your doctor will give advice on what you can eat the day before the procedure. Once you start taking Moviprep, you can’t eat any food, you can only drink clear fluids.

Morning only dosing schedule
Do not eat any food after 6 pm the evening before your procedure. You may only drink clear fluids from this time. No breakfast is allowed on the morning of the clinical procedure.

Your Doctor may give you additional dietary advice which you should follow.

How to take Moviprep

Unless your doctor has given you different instructions, please follow these dosage and dietary instructions. This will help you get the best results from Moviprep. Check with your doctor, pharmacist or nurse if you are not sure what to do.

Before you take Moviprep, please read carefully the following instructions. You need to know:

  • When to take Moviprep
  • How to prepare Moviprep
  • How to drink Moviprep
  • What you should expect to happen

When to take Moviprep

Your doctor may prescribe the two-day split dosing schedule, the morning only dosing schedule or the day before dosing schedule, depending on the time of your clinical procedure.

Your doctor will tell you which dosing schedule to follow. Your treatment with Moviprep must be completed before your clinical procedure.

You take this treatment as divided doses, as described below (the times given are only suggestions; your doctor may tell you different times).

Two-day split dosing schedule
Dose 1.
Drink 1000 mL of Moviprep in the evening (at approximately 6pm) before the clinical procedure, followed by an extra 500 mL of clear fluid

Dose 2. Drink 1000 mL of Moviprep (at approximately 6am) on the morning of the clinical procedure, followed by an extra 500 mL of clear fluid.

Morning only dosing schedule
Dose 1.
Drink 1000 mL of Moviprep on the morning (at approximately 5 am) of the clinical procedure, followed by an extra 500 mL of clear fluid.

Dose 2. Drink 1000 mL of Moviprep at the time your doctor told you, followed by an additional 500 mL of clear fluid.

Day before dosing schedule
Dose 1.
Drink 1000 mL of Moviprep in the evening (at approximately 6pm) before the clinical procedure, followed by an extra 500 mL of clear fluid.

Dose 2. Drink 1000 mL of Moviprep later the same evening, at the time your doctor told you to, followed by an extra 500 mL of clear fluid.

Your doctor will tell you which dosing schedule to follow.

How to prepare Moviprep Dose 1

  • Open one clear bag and remove Sachets A and B
  • Add the contents of BOTH sachet A and B to a measuring container that holds1 litre.
  • Add water (not chilled) into the container up to the 1 litre mark and stir until all the powder has dissolved and the MOVIPREP solution is clear or slightly hazy. This may take up to 5 minutes.

You can prepare Moviprep solution before you need to drink it, and store it in the fridge. It may be easier to drink if chilled. DO NOT add any other ingredients to the doses.

How to drink Moviprep Dose 1

Drink the first 1000 mL of Moviprep solution over one to two hours. Try and drink a glassful every 10-15 minutes.

Drink an extra 500 mL of clear fluid. You can alternate the clear fluid with the MOVIPREP if you wish. Water, clear soup, diluted cordial/clear fruit juice (without pulp), herbal tea, black tea or coffee (without milk) are all suitable.

How to prepare Moviprep Dose 2

  • When you are ready, prepare the second litre of MOVIPREP solution made up with the contents of the Sachets A and B from the remaining bag. Follow the instructions for Dose 1 (above).

How to drink Moviprep Dose 2

Drink the second 1000 mL of Moviprep solution over one to two hours. Try and drink a glassful every 10-15 minutes.

Drink an extra 500 mL of clear fluid. You can alternate the clear fluid with the MOVIPREP if you wish. Water, clear soup, diluted cordial/clear fruit juice (without pulp), herbal tea, black tea or coffee (without milk) are all suitable.

In addition to Moviprep and the 500 mL clear fluid with each dose, you can drink extra clear fluid as needed to avoid thirst. Drinking clear fluids will help prevent fluid loss (dehydration). You must stop drinking all fluids at least 2 hours before your clinical procedure. Your doctor should tell you your ‘NIL BY MOUTH’ time.

What you should expect to happen

When you start drinking the Moviprep solution, it is important that you stay close to a toilet. At some point, you will start to experience watery bowel movements. This is quite normal and indicates that the Moviprep solution is working. You may have stomach area bloating before you have your first bowel movement.

If you follow these instructions, your bowel will be clean, and this will help you to have a successful clinical procedure. You should allow sufficient time after your bowel movements have subsided to travel to the clinic/ hospital.

If you forget to take it

If you forget to take Moviprep as instructed, take it as soon as you realise you have not taken it and contactyour doctor, pharmacist or nurse for advice before the clinical procedure. It is important that you have allowed sufficient time to complete your course of Moviprep in order to ensure your bowel is fully cleaned at least 2 hours before the clinical procedure.

If you have any other questions on the use of this medicine, ask your doctor, pharmacist or nurse.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia or 0800 764 766 in New Zealand) for advice, or go to the Accident and Emergency department at the nearest hospital, if you think that you or anyone else may have taken too much Moviprep.

While you are using Moviprep

Things you must do

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

Things you must not do

Do not use Moviprep for any other conditions unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Side effects

Tell a doctor or pharmacist as soon as possible if you do not feel well while you are using Moviprep.

All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not. Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask a doctor or pharmacist to answer any questions that you may have.

It is normal to get diarrhoea when you take Moviprep. If you do not have a bowel movement within 6 hours of taking Moviprep, stop the intake and contact your doctor immediately.

As with other medicines there is a small risk of serious allergic reactions. Stop taking Moviprep and tell your doctor immediately or go to the Accident & Emergency department of your nearest hospital if you notice any of the following side effects, as these may be symptoms of a severe allergic reaction:

  • extreme fatigue
  • palpitations
  • sudden or severe itching, skin rash, hives
  • shortness of breath, asthma, wheezing
  • swelling of your face, lips or tongue (which may make swallowing or breathing difficult), ankles or other part of your body

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

Very common side effects (may affect more than 1 in 10 people):

Abdominal pain, abdominal distension, tiredness, feeling generally unwell, soreness of the anus, nausea and fever.

Common side effects (may affect up to 1 in 10 people):

Hunger, problems sleeping, dizziness, headache, vomiting, indigestion, thirst and chills.

Uncommon side effects (may affect up to 1 in 100 people):

Discomfort, difficulties swallowing, and changes to tests of liver function.

The following side effects have sometimes been seen but it is not known how often they occur because the frequency cannot be estimated from the available data: flatulence (wind), temporary increase in blood pressure, irregular heart rhythm or palpitations, dehydration, retching (straining to vomit), very low blood sodium levels that can cause convulsions (fits) and changes to the levels of salts in the blood such as decreased bicarbonate, increased or decreased calcium; increased or decreased chloride and decreased phosphate. Blood potassium and sodium levels could also decrease.

If you are over 65 years of age, you may have an increased chance of getting side effects.

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

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Storage

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not use this medicine after the expiry date which is stated on the sachets and carton, after “EXP”. The expiry date refers to the last day of that month. Please note that the expiry dates may be different for each of the sachets and carton.

Before use, store Moviprep sachets below 25°C. After you have dissolved Moviprep in the water, the solution may be stored (keeping covered) at or below 25°C. It may also be stored in the refrigerator (2°C to 8°C). Do not keep it for more than 24 hours.

Do not store Moviprep or any other medicines in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

What Moviprep contains

Sachet A contains the following active substances:

Macrogol 3350100 g

Sodium sulfate7.5 g

Sodium chloride 2.691 g

Potassium chloride 1.015 g

Sachet A also contains 233 mg of aspartame (E951).

Sachet B contains the following active substances:

Sodium ascorbate 5.9 g

Ascorbic acid4.7g

The inactive ingredients in Moviprep are: lemon flavour (containing lemon oil, lime oil, citral, xanthan gum, maltodextrin and Vitamin E), and the sweeteners aspartame and potassium acesulfame.

The complete treatment contains 8.4 g of sodium and 1.1 g of potassium

Supplier

Moviprep is supplied in Australia by:

Norgine Pty Ltd
Suite 3.10, Building A
20 Rodborough Road
Frenchs Forest NSW 2086
AUSTRALIA
Phone: 1800 766 936
www.norgine.com.au

Moviprep is supplied in New Zealand by:

Pharmacy Retailing (NZ) Ltd
Trading as Healthcare Logistics
58 Richard Pearse Drive
Mangere, Auckland
Phone: (09) 918 5100
Medical Enquiries 0800 404 178

This Leaflet was prepared in July 2022 and updated in May 2023.

Australian Registration No. AUST R 155398

MOVIPREP, NORGINE and the sail logo are registered trademarks of the Norgine group of companies.

Published by MIMS June 2023

BRAND INFORMATION

Brand name

Moviprep

Active ingredient

Macrogol 3350; Potassium chloride; Sodium chloride; Sodium sulfate; Ascorbic acid; Sodium ascorbate

Schedule

S3

 

1 Name of Medicine

Macrogol 3350, sodium chloride, sodium sulfate, potassium chloride, ascorbic acid and sodium ascorbate.

2 Qualitative and Quantitative Composition

Sachet A.

Macrogol 3350 100 g, sodium sulfate 7.5 g, sodium chloride 2.691 g, potassium chloride 1.015 g.

Sachet B.

Ascorbic acid 4.7 g, sodium ascorbate 5.9 g.
The concentration of electrolyte ions when both sachets are made up to 1 litre of solution is sodium 181.6 mmol/L (of which not more than 56.2 mmol is absorbable), sulfate 52.8 mmol/L, chloride 59.8 mmol/L, potassium 14.2 mmol/L, ascorbate 56.5 mmol/L.
Contains aspartame. Phenylketonurics are warned that this product contains aspartame (phenylalanine). See Section 4.3 Contraindications.
The complete treatment contains 8.4 g of sodium and 1.1 g of potassium. See Section 4.4 Special Warnings and Precautions for Use.
For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for oral solution.

4 Clinical Particulars

4.1 Therapeutic Indications

For bowel cleansing prior to any clinical procedure requiring a clean bowel, e.g. bowel endoscopy, lower gastrointestinal tract radiology or digestive tract surgery.

4.2 Dose and Method of Administration

A course of treatment consists of two litres of Moviprep.
It is strongly recommended that patients also drink a further one litre of clear liquid to prevent them from feeling thirsty and becoming dehydrated. "Clear liquids" include: water, clear soup, tea or coffee without milk or non-dairy creamer, all of the following liquids which are not coloured red or purple: fruit juices without pulp, carbonated and non-carbonated soft drinks, fruit flavoured cordials.

Note.

Patients should not drink anything coloured red or purple.
A litre of Moviprep consists of one "Sachet A" and one "Sachet B" dissolved together in water to make a one litre solution. The reconstituted solution should be drunk over a period of one to two hours. This process should be repeated with a second litre of Moviprep to complete this course.
This course of treatment can be taken either as divided (split) or single doses and timing is dependent on whether the clinical procedure is conducted with or without general anaesthesia as specified below:

For procedures conducted under general anaesthesia.

1. Divided doses: one litre of Moviprep in the evening before and one litre of Moviprep in the early morning of the day of the procedure. Ensure consumption of Moviprep as well as any other clear fluids has finished at least two hours before the start of the clinical procedure.
2. Single dose: two litres in the evening preceding the clinical procedure or two litres in the morning of the clinical procedure. Ensure consumption of Moviprep as well as any other clear fluids has finished at least two hours before the start of the clinical procedure.

For procedures conducted without general anaesthesia.

1. Divided doses: one litre of Moviprep in the evening before and one litre of Moviprep in the early morning of the day of the procedure. Ensure consumption of Moviprep as well as any other clear fluids has finished at least one hour before the start of the clinical procedure.
2. Single dose: two litres in the evening preceding the clinical procedure or two litres in the morning of the clinical procedure. Ensure consumption of Moviprep as well as any other clear fluids has finished at least one hour before the start of the clinical procedure.
Patients should be advised to allow for appropriate time to travel to the colonoscopy unit.
For patients taking the divided dose or the 2 litre dose taken the evening before the procedure, no solid food or liquids (other than the clear fluids listed above) should be taken from the start of the course of Moviprep treatment until after the clinical procedure.
For patients taking the 2 litre dose in the morning of the procedure, no solid food or liquids (other than the clear fluids listed above) should be taken from 6 pm the night before the procedure until after the clinical procedure.
Reconstitution of Moviprep in water may take up to 5 minutes and is best performed by adding the powder to the mixing vessel first followed by the water. The patient should wait until all the powder has dissolved before drinking the solution.
After reconstitution, the Moviprep solution may be used immediately or if preferred may be cooled before use. The reconstituted solution should be used within 24 hours.

4.3 Contraindications

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, gastric retention, and severe inflammatory conditions of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic megacolon. Phenylketonuria (due to the presence of aspartame), glucose-6-phosphodehydrogenase deficiency (patients may be at risk of acute haemolysis due to the presence of ascorbate), known hypersensitivity to any of the active substances or to any of the excipients. Do not use in unconscious patients, or patients with severe dehydration.

4.4 Special Warnings and Precautions for Use

The fluid content of Moviprep when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.
Diarrhoea is an expected effect resulting from the use of Moviprep.
Moviprep should be administered with caution to frail or debilitated patients in poor health.
Moviprep should be used with caution in patients with:
impaired gag reflex, with the possibility of regurgitation or aspiration, or with diminished levels of consciousness;
moderate or severe renal insufficiency (creatinine clearance < 30 mL/min);
cardiac failure (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;
pre-existing serum electrolyte disturbance.
In debilitated fragile patients, patients with poor health, those with clinically significant renal impairment, arrhythmia and those at risk of electrolyte imbalance, the physician should consider performing a baseline and post-treatment electrolyte, renal function test, and ECG as appropriate.
There have been rare reports of serious arrhythmias including atrial fibrillation associated with the use of ionic osmotic laxatives for bowel preparations. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbance.
Patients with insulin-dependent diabetes should consult their physician prior to use of Moviprep. Only liquids should be consumed during usage of Moviprep, therefore insulin dosing should be balanced accordingly.
The presence of dehydration should be corrected before the use of Moviprep.
Semi-conscious patients or patients prone to aspiration or regurgitation should be closely monitored during administration, especially if administered via nasogastric tube.
If patients develop any symptoms indicating arrhythmia or shifts of fluid/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, or cardiac failure) plasma electrolytes should be measured, ECG monitored and any abnormality treated appropriately.
If a patient experiences severe bloating, abdominal distension, or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate.

Ischaemic colitis.

Post-marketing cases of ischaemic colitis, including serious cases, 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.
This medicine contains 363.2 mmol (8.4 g) sodium per course of treatment. This should be taken into consideration by patients on a sodium controlled diet (see Section 2 Qualitative and Quantitative Composition). Only a proportion of sodium is absorbed, (see Section 5.2 Pharmacokinetic Properties).
This medicine contains 28.4 mmol (1.1 g) potassium per course of treatment. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet (see Section 2 Qualitative and Quantitative Composition).
Contraceptive cover from the oral contraceptive pill is likely to be incomplete if it is taken at any time during the process of bowel cleansing with Moviprep (an hour before the first dose of Moviprep until after the investigation). Therefore an alternative method of contraception should be used for the length of the cycle when Moviprep is taken.

Use in the elderly.

Use with caution in elderly or debilitated patients.

Paediatric use.

The safety and efficacy of Moviprep has not been studied in the paediatric population, therefore it is not recommended for use in children below 18 years.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Oral medication should not be taken within one hour of administration of Moviprep (i.e. includes one hour before administration, as well as during administration and one hour after administration), as it may be flushed from the gastrointestinal tract and not absorbed.
Specific consideration should be given to sustained release formulations and products with a narrow therapeutic window. Please see Section 4.4 Special Warnings and Precautions for Use for advice on oral contraceptives.
Moviprep may have a potential interactive effect when 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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B1)
Pregnancy Category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.
There is no experience of the use of Moviprep during pregnancy. Moviprep should only be used if considered essential by the physician.
There is no experience of the use of Moviprep during lactation. Moviprep should only be used if considered essential by the physician.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Diarrhoea is an expected outcome of bowel preparation.
Due to the nature of the intervention, undesirable effects occur in the majority of patients during the process of bowel preparation. Whilst these vary between preparations, nausea, vomiting, bloating, abdominal pain, anal irritation and sleep disturbance commonly occur in patients undergoing bowel preparation. Dehydration may occur as a result of diarrhoea and/or vomiting.
As with other bowel cleansing products containing macrogol, allergic reactions including rash, urticaria, pruritus, dyspnoea, angioedema and anaphylaxis have been reported.
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 post-marketing are included.
The frequency of adverse reactions to Moviprep is defined using the following convention: Very common ≥ 1/10 (≥ 10%); Common ≥ 1/100, < 1/10 (≥ 1%, < 10%); Uncommon ≥ 1/1,000, < 1/100 (≥ 0.1%, < 1%); Rare ≥ 1/10,000, < 1/1,000 (≥ 0.01%, < 0.1%); Very rare < 1/10,000 (< 0.01%); Not known (cannot be estimated from the available data). See Table 1.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicine is important. It allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

In case of gross accidental overdosage, where diarrhoea is severe, conservative measures are usually sufficient, generous amounts of fluid should be given. Further information on the latest overdosage treatment can be obtained by contacting the following Poisons Information Centres: 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Macrogol 3350, sodium sulfate and high doses of ascorbic acid exert an osmotic action in the gut, which induces a laxative effect. Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is a propulsive colonic transportation of the softened stools. The electrolytes present in the formulation and the supplementary clear liquid intake are included to prevent clinically significant variations in sodium, potassium or water, and therefore reduce dehydration risk.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the gastrointestinal tract.
Ascorbic acid is absorbed mainly at the small intestine level by a mechanism of active transport, which is sodium dependent and saturable. There is an inverse relationship between the ingested dose and the percentage of the dose absorbed. For oral doses between 30 and 180 mg an amount of 70-85% of the dose is absorbed. Following oral intake of up to 12 g ascorbic acid, it is known that only 2 g is absorbed.

Excretion.

Any macrogol 3350 that is absorbed is excreted via the urine.
After high oral doses of ascorbic acid and when plasma concentrations exceed about 15 mg/L, the absorbed ascorbic acid is mainly eliminated unchanged in the urine.
The pharmacokinetics of Moviprep have not been studied in patients with renal or hepatic insufficiency.
Osmotically-acting bowel preparations lead to a copious diarrhoea, resulting in extensive elimination of most of the product via the faeces. They can also lead to changes in electrolyte balance in the body, often with depletion of sodium and potassium, the additional sodium and potassium included in the Moviprep formulation help to balance the electrolytes. While some absorption of sodium takes place, the bulk of sodium is expected to be excreted in the faeces as the sodium salts of sulfate and ascorbate, the osmotic active ingredients included in the Moviprep composition.

5.3 Preclinical Safety Data

Preclinical studies show that macrogol 3350, ascorbic acid, and sodium sulfate have no significant systemic toxicity potential.
Both sodium chloride and potassium chloride are present at a similar level to normal daily intake from the diet.

Genotoxicity.

No studies have been carried out on the genotoxicity of the product.
However, available data on macrogols of relevant size did not identify any potential genotoxicity or reproductive toxicity.
Sodium sulfate showed negative results in genotoxicity and reproductive toxicity studies.
Ascorbic acid showed negative results in assessments of genotoxicity and reproductive toxicity.

Carcinogenicity.

No studies have been carried out on the carcinogenicity of the product.
However, available data on macrogols of relevant size did not identify any potential carcinogenicity toxicity.
Ascorbic acid showed negative results in assessments of carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Aspartame, acesulfame potassium, and lemon flavour (contains maltodextrin, citral, lemon oil, lime oil, xanthan gum, vitamin E).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

Sachets.

Shelf life 3 years.

Reconstituted solution.

24 hours.

6.4 Special Precautions for Storage

Sachets.

Store below 25°C.

Reconstituted solution.

Store below 25°C, or store in refrigerator. Keep solution covered.

6.5 Nature and Contents of Container

One pack of Moviprep contains a single treatment of two bags. Each bag contains one Sachet A containing 112 g of powder, and one Sachet B containing 11 g of powder.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Macrogol 3350.


Ascorbic acid.

C6H8O6.

Sodium chloride.

NaCl.

Sodium sulfate.

Na2SO4.

Potassium chloride.

KCl.

Sodium ascorbate.

NaC6H7O6.

CAS number.

Ascorbic acid.

50-81-7.

Macrogol 3350.

25322-68-3.

Sodium chloride.

7647-14-5.

Sodium sulfate.

7757-82-6.

Potassium chloride.

7447-40-7.

Sodium ascorbate.

134-03-2.

7 Medicine Schedule (Poisons Standard)

Schedule 3 - Pharmacist Only Medicine.

Summary Table of Changes