MOVIPREP Orange, powder for oral solution

The ingredients of MOVIPREP Orange are contained in two separate sachets.

Sachet A contains the following active substances:

Sachet B contains the following active substances:

The concentration of electrolyte ions when both sachets are made up to one litre of solution is as follows:

This product contains 0.175 g of aspartame and 0.120g of glucose per sachet A.

For a full list of excipients, see section 6.1.

Powder for oral solution.

Free flowing white to off-white powder in Sachet A.

Free flowing white to light brown powder in Sachet B.

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 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 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 Orange.

This course of treatment can be taken:

either divided as 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, or two litres of MOVIPREP Orange in the evening preceding 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 colonoscopy.

No solid food should be taken from the start of the course of treatment until after the clinical procedure.

Children: Not recommended for use in children below 18 years of age, as MOVIPREP Orange has not been studied in the paediatric population.

Do not use in patients with known or suspected:

- gastrointestinal obstruction or perforation

- disorders of gastric emptying (e.g. gastroparesis)

- ileus

- phenylketonuria (due to presence of aspartame)

- glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate)

- hypersensitivity to the active substances or to any of the excipients

- toxic megacolon which complicates severe inflammatory conditions of the intestinal tract including Crohn's disease and ulcerative colitis.

Do not use in unconscious patients.

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)

- dehydration

- severe acute inflammatory disease

The presence of dehydration should be corrected before the use of MOVIPREP Orange.

Semi-conscious patients or patients prone to aspiration or regurgitation should be closely observed during administration, especially if this is via a nasogastric route. If patients develop any symptoms indicating shifts of fluid/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, cardiac failure), plasma electrolytes should be measured and any abnormality treated appropriately.

In debilitated fragile patients, patients with poor health, those with clinically significant renal impairment and those at risk of electrolyte imbalance, the physician should consider performing a baseline and post-treatment electrolyte and renal function test.

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 Orange and should consult their doctor.

Patients with rare glucose-galactose malabsorption should not take this medicine.

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.

There are no adequate data from the use of MOVIPREP Orange in pregnant or breastfeeding women.

MOVIPREP Orange should not be used during pregnancy or lactation unless clearly necessary.

MOVIPREP Orange has no influence on the ability to drive and use machines.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Very common 1/10;

Common 1/100, < 1/10;

Uncommon 1/1,000, < 1/100;

Rare 1/10,000, < 1/1,000;

Very rare < 1/10,000.

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.

As with other macrogol containing products, allergic reactions including rash, urticaria, oedema and anaphylaxis are a possibility.

Data from clinical studies are available in a population of 591 patients treated with MOVIPREP in which undesirable effect data were actively elicited.

In case of gross accidental overdosage, where diarrhoea is severe, conservative measures are usually sufficient; 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.

Pharmacotherapeutic group: A06A D

Macrogol 3350, sodium sulphate and high doses of ascorbic acid exert an osmotic action in the gut, which induce 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 as well as the supplementary clear liquid intake ensure that there are no clinically significant variations of sodium, potassium or water, and thus no dehydration risk.

Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the gastro-intestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine

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 absorbed dose. For oral doses between 30 and 180 mg an amount of about 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.

After high oral doses of ascorbic acid and when plasma concentrations exceed 14 mg/litre, the absorbed ascorbic acid is mainly eliminated unchanged in the urine.

Pre-clinical studies provide evidence that macrogol 3350, ascorbic acid and sodium sulphate have no significant systemic toxicity potential.

Aspartame (E951)

Acesulfame Potassium (E950)

Orange flavour (containing natural flavouring substances and preparations, maltodextrin, dextrose)

Not applicable

Sachets: Do not store above 25°C.

Reconstituted solution: Store below 25°C. The solution may be refrigerated.

Keep the solution covered

A paper / low density polyethylene / aluminium / low density polyethylene sachet containing 112 g of powder ('sachet A') and a paper / low density polyethylene / aluminium / low density polyethylene sachet containing 11 g of powder ('sachet B'). Both sachets are contained in a transparent bag. One pack of MOVIPREP Orange contains a single treatment of two bags.

Pack sizes of 1, 10, 40, 80, 160 and 320 packs of a single treatment. Hospital packs of 40 single treatments. Not all pack sizes may be marketed.

Reconstitution of MOVIPREP Orange 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 in water, MOVIPREP Orange consumption may begin immediately or if preferred it may be cooled before use.

Norgine Pharmaceuticals Limited

Widewater Place, Moorhall Road

Harefield, UB9 6NS

UK

PL 20011/0006

06/08/2010

06/08/2010