Moviprep 112 g Powder for Oral solution

MOVIPREP is indicated for bowel cleansing prior to any clinical procedures requiring a clean bowel e.g. bowel endoscopy or radiology.

Adults and elderly
A course of treatment consists of two litres of MOVIPREP. It is strongly recommended that one litre of clear liquid, which may include water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk is also taken during the course of treatment.
This course of treatment can be taken either as divided or single doses and timing is dependent on whether the clinical procedure is conducted with or without general anaesthesia.

The course of treatment can be taken either as:
u2022 Divided doses: one litre of MOVIPREP in the evening before and one litre of MOVIPREP in the early morning of the day of the clinical procedure.
u2022 Single dose: two litres of MOVIPREP in the evening preceding the clinical procedure or two litres of MOVIPREP in the morning of the clinical procedure.
For procedures conducted under general anaesthesia, 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 ensure consumption of MOVIPREP as well as any other clear fluids has finished at least one hour before the start of the clinical procedure when taken as a divided dose and two hours when take as a single dose.
Patients should be advised to allow for appropriate time to travel to the colonoscopy unit. There should be at least one hour between the end of intake of fluid (MOVIPREP or clear liquid) and the start of the colonoscopy. No solid food should be taken from the start of the course of treatment until after the clinical procedure.
Paediatric population
The safety and efficacy of MOVIPREP in children below 18 years has not yet been established.

Method of administration
For oral administration. A litre of MOVIPREP consists of one Sachet A and one Sachet B dissolved together in one litre of water. This reconstituted solution should be drunk over a period of one to two hours. This should be repeated with a second litre of MOVIPREP to complete this course. 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. Reconstituted solution is a clear to hazy, colourless to yellow solution when dissolved in one litre of water. After reconstitution in water, MOVIPREP consumption may begin immediately or if preferred it may be cooled before use.

MOVIPREP is contraindicated in:
u2022 Patients with hypersensitivity to macrogol, sodium sulphate anhydrous, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid or to any of the excipients in MOVIPREP (see section 6.1).
u2022 Gastrointestinal obstruction or perforation.
u2022 Disorders of gastric emptying (e.g. gastroparesis).
u2022 Ileus.
u2022 Phenylketonuria (due to presence of aspartame).
u2022 Glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate).
u2022 Toxic megacolon which complicates severe inflammatory conditions of the intestinal tract including Crohnu2019s disease and ulcerative colitis.
u2022 Do not use in unconscious patients.

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 (see section 4.3),
- severe renal insufficiency (creatinine clearance < 30 ml/min),
- cardiac impairment (NYHA grade III or IV),
- those at risk of cardiac arrhythmias, 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 the nasogastric route.
If patients develop any symptoms indicating dysrhythmia or shifts of fluid/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, cardiac failure), plasma electrolytes should be measured, ECG monitored, and any other abnormality treated appropriately. In debilitated fragile patients, patients with poor health, those with clinically significant renal impairment, dysrhythmias and those at risk of electrolyte imbalance, the medical practitioner should consider performing a baseline and post-treatment electrolyte, renal function test and ECG as appropriate. There have been rare reports of serious dysrhythmias including atrial fibrillation associated with the use of ionic osmotic laxatives for bowel preparation. These occurred predominantly in patients with underlying cardiac risk factors and electrolyte disturbances.
If patients experience symptoms such as severe bloating, abdominal distention, abdominal pain or any other reaction which makes it difficult to continue the preparation, they may slow down or temporarily stop consuming MOVIPREP and should consult their doctor.
Excipients
MOVIPREP contains 363,2 mmol (8,4 g) sodium per course of treatment. This should be taken into consideration by patients on a controlled sodium diet. Only a proportion of sodium is absorbed.
MOVIPREP 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.
MOVIPREP contains 0,233 g aspartame in each 112 g sachet A. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

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

Pregnancy
There are no data on the use of MOVIPREP during pregnancy and MOVIPREP should only be used if considered essential by the doctor.
Breastfeeding
There are no data on the use of MOVIPREP during lactation and it should only be used if considered essential by the doctor.
Fertility
There are no data on the effects of MOVIPREP on fertility.

MOVIPREP may cause dizziness. Patients experiencing dizziness should be advised to refrain from driving or using machines.

a) Summary of the safety profile
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 macrogol containing products, allergic reactions including rash, urticaria, pruritus, dyspnoea, 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 post-marketing are included.
b) Tabulated list of adverse reactions

System organ class
Frequent
Less frequent
Frequency unknown (cannot be estimated from the available data)
Immune system disorders
Allergic reaction including anaphylactic reaction, dyspnoea, skin reactions
Metabolism and nutrition disorders
Hunger
Hypophosphataemia
Electrolyte disturbances including blood bicarbonate decreased, hyper- and hypo- calcaemia, hypophosphataemia, hypokalaemia and hypornatraemia and changes in the blood chloride levels, dehydration.
Psychiatric disorders
Sleep disorder
Nervous system disorders
Dizziness
Headache
Convulsions associated with severe hyponatraemia.
Cardiac disorders
Transient increase in blood pressure, arrhythmia, palpitations.
Gastrointestinal disorders
Abdominal pain, nausea, abdominal distension, anal discomfort, vomiting, dyspepsia
Dysphagia
Flatulence, retching.
Hepato-biliary disorders
Abnormal liver function tests.
Skin and subcutaneous tissue disorders
Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema.
General disorders and administrative site conditions
Malaise, thirst, rigors, pyrexia, hunger
Discomfort
Investigations
Decreased blood bicarbonate, decreased blood calcium, hypercalcaemia, blood chloride decreased/increased, decreased blood phosphorous
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to: SAHPRA: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088

Symptoms
In case of gross accidental overdosage, where diarrhoea is severe, conservative measures are usually sufficient.
Treatment
Generous amounts of fluid, especially fruit juices, should be given. In the rare event of overdose provoking severe metabolic derangement, intravenous rehydration may be used.