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1. Movicol Liquid Orange Flavour Concentrate For Oral Solution
2. Movicol Liquid Orange Flavour Concentrate For Oral Solution

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

MOVICOL Liquid Orange flavour, concentrate for oral solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 25 ml of MOVICOL Liquid Orange flavour contains the following active ingredients:

Macrogol 3350    13.125 g

Sodium chloride    0.3507 g

Sodium hydrogen carbonate    0.1785 g

Potassium chloride    0.0466 g

The concentration of electrolyte ions present when a 25 ml dose is made up to 125 ml of solution is as follows:

Sodium    65 mmol/l

Chloride    53 mmol/l

Potassium    5.4 mmol/l

Hydrogen carbonate    17 mmol/l

This corresponds to the following amount of each electrolyte in each diluted dose of 125 ml:

Sodium    8.125 mmol

Chloride    6.625 mmol

Potassium    0.675 mmol

Hydrogen carbonate    2.125 mmol

Excipients:

74.5 mg ethyl alcohol per 25 ml

11.3 mg methyl parahydroxybenzoate (E218) per 25 ml

5.6 mg ethyl parahydroxybenzoate (E214) per 25 ml

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Concentrate for oral solution. Clear, colourless liquid

CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of chronic constipation.

4.2 Posology and method of administration

A course of treatment for constipation with MOVICOL Liquid Orange flavour does not normally exceed 2 weeks, although this can be repeated if required. As for all laxatives, prolonged use is not usually recommended. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced by regular constipating medication in particular opioids and antimuscarinics.

Adults, adolescents and the elderly: 25 ml diluted in 100 ml of water 1-3 times daily in divided doses, according to individual response.

For extended use, the dose can be adjusted down to 1 or 2 doses per day of 25 ml diluted in 100 ml of water.

Children : MOVICOL Liquid Orange flavour is not recommended for use in children below the age of 12 years. Alternative MOVICOL products are available for children.

Patients with renal insufficiency: No dosage change is necessary for the treatment of constipation.

Faecal Impaction: MOVICOL Liquid Orange flavour is not recommended for use for the treatment of faecal impaction (see section 4.4). Alternative MOVICOL products are available for the treatment of faecal impaction.

Administration

The product must not be taken undiluted and may only be diluted in water. For instructions on dilution of the product before administration, see section 6.6.

Contraindications

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn’s disease and ulcerative colitis and toxic megacolon.

Hypersensitivity to the active substances or to any of the excipients.

4.4 Special warnings and precautions for use

Mild adverse drug reactions are possible as indicated in Section 4.8. If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) MOVICOL Liquid Orange flavour should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately.

The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by MOVICOL Liquid Orange flavour (see section 4.5).

This medicinal product contains 8.125 mmol of sodium in each diluted dose of 125 ml. The sodium content of MOVICOL Liquid Orange flavour should be taken into consideration when administering the product to patients on a controlled sodium diet.

This medicinal product contains 45.6 mg of benzyl alcohol in each diluted dose of 125 ml. The maximum recommended daily dose (MRD)(25ml diluted in 100ml of water taken three times a day) contains 136.8mg of benzyl alcohol. The Acceptable Daily Intake (ADI) of benzyl alcohol is 5 mg/kg body weight. The maximum daily dose (25 ml diluted in 100 ml of water 1-3 times daily) should not be exceeded.

This product contains ethyl (E214) and methyl (E218) parahydroxybenzoates which may cause allergic reactions, possibly delayed.

4.5 Interaction with other medicinal products and other forms of interaction

Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water.

There is a possibility that the absorption of other medicinal products could be transiently reduced during use with MOVICOL Liquid Orange flavour (see section 4.4). There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.

Fertility, pregnancy and lactation

Pregnancy

There are limited amount of data from the use of MOVICOL in pregnant women. Studies in animals have shown indirect reproductive toxicity (see section 5.3). Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible.

MOVICOL can be used during pregnancy.

Breastfeeding

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Macrogol 3350 is negligible.

MOVICOL can be used during breast-feeding.

Fertility

There are no data on the effects of MOVICOL on fertility in humans. There were no effects on fertility in studies in male and female rats (see section 5.3).

4.7 Effects on ability to drive and use machines

MOVICOL Liquid Orange flavour has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Reactions related to the gastrointestinal tract occur most commonly.

These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of MOVICOL Liquid Orange flavour. Mild diarrhoea usually responds to dose reduction.

The frequency of the adverse events is not known as it cannot be estimated from the available data.

System Order Class	Adverse Event
Immune system disorders	Allergic reactions, including anaphylaxis, angioedema, dyspnoea, rash, erythema, urticaria, and pruritis.
Metabolism and nutrition disorders	Electrolyte disturbances, particularly

	hyperkalaemia and hypokalaemia.
Nervous system disorders	Headache
Gastrointestinal disorders	Abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anal discomfort.
General disorders and administration site conditions	Peripheral oedema

4.9 Overdose

Severe pain or distension can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Osmotically acting laxatives.

ATC code: A06A D65

Macrogol 3350 acts by virtue of its 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 an improved propulsive colonic transportation of the softened stools and a facilitation of the defecation. Electrolytes combined with macrogol 3350 are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted in faecal water without net gain or loss of sodium, potassium and water.

Clinical studies in the use of MOVICOL sachets (parent product) in chronic constipation have shown that the dose needed to produce normal formed stools tends to reduce over time. Many patients respond to between 1 and 2 sachets of powdered MOVICOL a day (one sachet is equivalent to 25 ml of MOVICOL Liquid Orange flavour), but this dose should be adjusted depending on individual response.

Pharmacokinetic properties

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.

5.3 Preclinical safety data

Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential, based on conventional studies of pharmacology, repeated dose toxicity and genotoxicity.

There were no direct embryotoxic or teratogenic effects in rats even at maternally toxic levels that are a multiple of 66 x the maximum recommended dose in humans for chronic constipation and 25 x for faecal impaction.

Indirect embryofetal effects, including reduction in fetal and placental weights, reduced fetal viability, increased limb and paw hyperflexion and abortions, were noted in the rabbit at a maternally toxic dose that was 3.3 x the maximum recommended dose in humans for treatment of chronic constipation and 1.3 x for faecal impaction. Rabbits are a sensitive animal test species to the effects of GI-acting substances and the studies were conducted under exaggerated conditions with high dose volumes administered, which are not clinically relevant. The findings may have been a consequence of an indirect effect of MOVICOL related to poor maternal condition as the result of an exaggerated pharmacodynamic response in the rabbit. There was no indication of a teratogenic effect.

There are long-term animal toxicity and carcinogenicity studies involving macrogol 3350. Results from these and other toxicity studies using high levels of orally administered high molecular weight macrogols provide evidence of safety at the recommended therapeutic dose.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Acesulfame potassium E950 Sucralose E955 Benzyl alcohol

Methyl parahydroxybenzoate E218 Ethyl parahydroxybenzoate E214

Orange flavour (contains flavouring substances, flavouring preparations and ethanol)

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Unopened: 2 years Opened: 30 days

Diluted solution shelf-life: 24 hours

6.4 Special precautions for storage

Bottle: Do not refrigerate or freeze. Diluted solution: Keep solution covered.

6.5 Nature and contents of container

Polyethylene terephthalate bottle with polypropylene - low density polyethylene child-resistant closure with polyethylene liner.

Each carton contains one bottle and a polypropylene measuring cup.

Pack size: 500ml bottle

6.6 Special precautions for disposal

The product should be diluted as follows:

25 ml should be measured out using the dosing cup provided or five 5 ml teaspoonfuls. This should be diluted in 100 ml (approximately half a glass) of water.