SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

LAXAGOL ORANGE FLAVOUR powder for oral solution

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet of LAXAGOL ORANGE FLAVOUR contains the following active ingredients:

Macrogol 3350	13.125 g
Sodium chloride	350.7 mg
Sodium bicarbonate (Sodium hydrogen carbonate)	178.5 mg
Potassium chloride	46.6 mg

The content of electrolyte ions per sachet when made up to 125 ml of solution is as follows:

Sodium	65 mmol/l
Chloride	53 mmol/l
Potassium	5.4 mmol/l
Bicarbonate (Hydrogen carbonate)	17 mmol/l
For a full list of excipients, see Section 6.1.

3    PHARMACEUTICAL FORM

Powder for oral solution. Single-dose sachet containing a free flowing white powder.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the treatment of chronic constipation. LAXAGOL ORANGE FLAVOUR is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon.

4.2 Posology and method of administration

Chronic constipation

A course of treatment for constipation with LAXAGOL 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: 1 -3 sachets daily in divided doses, according to individual response.

For extended use, the dose can be adjusted down to 1 or 2 sachets daily. Children below 12 years old: Not recommended.

Faecal impaction

A course of treatment for faecal impaction with LAXAGOL ORANGE FLAVOUR does not normally exceed 3 days.

Adults, adolescents and the elderly: 8 sachets daily, all of which should be consumed within a 6 hour period.

Children below 12 years old: Not recommended.

Patients with impaired cardiovascular function: For the treatment of faecal impaction the dose should be divided so that no more than 2 sachets are taken in any one hour.

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

Administration

Each sachet should be dissolved in 125 ml water. For use in faecal impaction 8 sachets may be dissolved in 1 litre of water.

4.3 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 ingredients or to any of the excipients.

4.4 Special warnings and precautions for use

Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.

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) LAXAGOL 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 LAXAGOL ORANGE FLAVOUR (see section 4.5).

LAXAGOL ORANGE FLAVOUR contains 0.68mmol (26mg) of potassium per sachet. This should be taken into consideration if more than one sachet is taken daily and for those patients that have reduced kidney function, or are on a controlled potassium diet.

LAXAGOL ORANGE FLAVOUR contains 8.13mmol (187mg) of sodium per sachet. This should be taken into consideration for patients on a controlled sodium diet.

The orange flavouring used in LAXAGOL ORANGE FLAVOUR may contain sulphites. This may rarely cause severe hypersensitivity reactions and bronchospasm.

4.5 Interaction with other medicinal products and other forms of interaction

No clinical interactions with other medicinal products have been reported. Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water. There is therefore a theoretical possibility that the absorption of such medicinal products could be transiently reduced. Therefore, other medicines should not be taken orally for one hour before and one hour after taking LAXAGOL ORANGE FLAVOUR.

There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.

4.6 Pregnancy and lactation

Pregnancy

There are limited amount of data from the use of macrogol 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.

LAXAGOL ORANGE FLAVOUR 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.

LAXAGOL ORANGE FLAVOUR can be used during breast-feeding.

Fertility

There are no data on the effects of LAXAGOL ORANGE FLAVOUR 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

LAXAGOL 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 occurs as a consequences of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacological effects of LAXAGOL ORANGE FLAVOUR. Mild diarrhoea usually responds to dose reduction.

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

System Order Class	Adverse Event
Immune system disorders	Allergic reactions, including anaphylaxis, angioedema, dyspnoea, rash, erythema, urticaria, and pruritus.
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.

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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

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 defaecation. 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.

For the indication of faecal impaction controlled comparative studies have not been performed with other treatments (e.g. enemas). In a non-comparative study in 27 adult patients, the listed combination of active substances cleared the faecal impaction in 12/27 (44%) after 1 day's treatment; 23/27 (85%) after 2 days' treatment and 24/27 (89%) at the end of 3 days.

Clinical studies using the listed active substances in the treatment of 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 a day, but this dose should be adjusted depending on individual response.

5.2 Pharmacokinetic properties

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

Preclinical safety data

Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential, although no tests of its effects on reproduction or genotoxicity have been conducted.

There are no long-term animal toxicity or carcinogenicity studies involving macrogol 3350, although there are toxicity studies using high levels of orally administered high molecular macrogols that provide evidence of safety at the recommended therapeutic dose.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Acesulfame potassium(E950)

Orange flavour

(Orange flavour contains the following constituents: nature-identical flavouring substances, flavouring preparations, natural flavouring substances, maltodextrin, acacia gum and ascorbic acid).

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

2 years.

Reconstituted solution: 6 hours.

6.4    Special precautions for storage

Sachet: Do not store above 25°C.

Reconstituted solution: Store at 2 - 8°C (in a refrigerator and covered).

6.5    Nature and contents of container

Sachet: laminate consisting of four layers: low density polyethylene, aluminium, low density polyethylene and paper.

Pack sizes: boxes of 2, 8, 20, 30, 50 or 100 sachets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused solution should be discarded within 6 hours.

7    MARKETING AUTHORISATION HOLDER

Auden Mckenzie (Pharma Division) Ltd.

Mckenzie House Bury Street Ruislip Middlesex HA47TL UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 17507/0221

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/01/2013

10    DATE OF REVISION OF THE TEXT

17/05/2016