MOVIPREP ORANGE

Posology Adults and Older People A course of treatment consists of two litres of Moviprep Orange. 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.

A litre of Moviprep Orange consists of one 'sachet A' and one 'sachet B' dissolved together in water to make one litre of 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 Orange to complete the course.

This course of treatment can be taken either as divided or as 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 Orange in the evening before and one litre of Moviprep Orange in the early morning of the day of the clinical procedure. Ensure consumption of Moviprep Orange 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 of Moviprep Orange in the evening before the clinical procedure or two litres of Moviprep Orange in the morning of the clinical procedure. Ensure consumption of Moviprep Orange 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 Orange in the evening before and one litre of Moviprep Orange in the early morning of the day of the clinical procedure. Ensure consumption of Moviprep Orange 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 of Moviprep Orange in the evening before the clinical procedure or two litres of Moviprep Orange in the morning of the clinical procedure. Ensure consumption of Moviprep Orange has finished at least two hours before the start of the clinical procedure.

Ensure consumption of any clear fluids has finished at least one hour before the clinical procedure. Patients should be advised to allow for appropriate time to travel to the colonoscopy unit. No solid food should be taken from the start of the course of treatment until after the clinical procedure.

Paediatric population Not recommended for use in children below 18 years of age, as Moviprep Orange has not been studied in the paediatric population. Method of administration The route of administration is oral use. A litre of Moviprep Orange consists of one sachet A and one sachet B dissolved together in water to make a one litre solution.

Precautions to be taken before handling or administering the medicinal product. 6.

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. The frequency of adverse reactions to Moviprep Orange is defined using the following convention: Very common ( 1/10) Common ( 1/100 to < 1/10) Uncommon (1/1,000 to < 1/100) Rare ( 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) System Organ Class Frequency Adverse Drug Reaction Immune system disorders Not known Allergic reaction including anaphylactic reaction, dyspnoea and skin reactions (see below).

Metabolism and Nutrition Disorders Not known Electrolyte disturbances including blood bicarbonate decreased, hyper and hypocalcaemia, hypophosphataemia, hypokalaemia and hyponatremia and changes in the blood chloride levels. Dehydration Psychiatric Disorders Common Sleep disorder.

Nervous System Disorders Not known Convulsions associated with severe hyponatraemia, seizures. Cardiac Disorders Not known Transient increase in blood pressure. Arrhythmia, palpitations Very common Abdominal pain, nausea, abdominal distension, anal discomfort.

Common Vomiting, dyspepsia. Uncommon Dysphagia. Gastrointestinal Disorders Not known Oesophageal rupture (Boerhaave syndrome), flatulence, retching. Hepatobiliary disorders Uncommon Abnormal liver function testsSkin and Subcutaneous Tissue Disorders Not known Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema.

Very common Malaise, pyrexia Common Rigors, thirst, hunger. General Disorders and Administration Site Conditions Uncommon Discomfort. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store.

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

The fluid content of Moviprep Orange 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 patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section

g. gastroparesis) - ileus - phenylketonuria (due to presence of aspartame) - glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate) - toxic megacolon which complicates very severe inflammatory conditions of the intestinal tract including Crohn’s disease and ulcerative colitis.

Do not use in unconscious patients