Compound Macrogol Oral Powder Sugar Free

1. Name Of The Medicinal Product

Compound Macrogol Oral Powder Sugar Free.

2. Qualitative And Quantitative Composition

Each sachet contains the following quantitative composition of active ingredients:

Macrogol 3350	13.125g
Sodium Chloride	350.7mg
Sodium Hydrogen Carbonate	178.5mg
Potassium Chloride	46.6mg

The content of electrolyte ions per sachet following reconstitution in 125ml of water is equivalent to:

Sodium	65mmol/l
Chloride	53mmol/l
Hydrogen Carbonate (Bicarbonate)	17mmol/l
Potassium	5.4mmol/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. Compound Macrogol Oral Powder Sugar Free 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

Compound Macrogol Oral Powder Sugar Free is for oral use.

Chronic Constipation:

A course of treatment for chronic constipation with Compound Macrogol Oral Powder Sugar Free 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 Compound Macrogol Oral Powder Sugar Free 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

Compound Macrogol Oral Powder Sugar Free is contraindicated in intestinal obstruction or perforation caused by functional or structural disorder of the gut wall, ileus and in patients with severe inflammatory conditions of the intestinal tract (e.g. ulcerative colitis, Crohn's disease and toxic megacolon).

Hypersensitivity to the active substances or any of the excipients.

4.4 Special Warnings And Precautions For Use

The faecal impaction diagnosis should be confirmed by appropriate physical or radiological examination of the rectum and abdomen.

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) Compound Macrogol Oral Powder Sugar Free should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known interactions of Compound Macrogol Oral Powder Sugar Free with other medicinal products. However, macrogol 3350 raises the solubility of medicinal products that are soluble in alcohol and mainly insoluble in water. It is a theoretical possibility that absorption of these drugs could be reduced transiently. Therefore, other medicines should not be taken orally for one hour before and for one hour after taking Compound Macrogol Oral Powder Sugar Free.

4.6 Pregnancy And Lactation

There is no experience with the use of Compound Macrogol Oral Powder Sugar Free during pregnancy and lactation and it should not be used during pregnancy and lactation unless clearly necessary.

4.7 Effects On Ability To Drive And Use Machines

Compound Macrogol Oral Powder Sugar Free has no influence on the ability to drive and use machines.

4.8 Undesirable Effects

Immune System Disorders:

Allergic reactions are possible.

Gastro-intestinal Disorders:

Potential gastro-intestinal effects that may occur include abdominal distension and pain, borborygmi and nausea. Mild diarrhoea may also occur, but normally resolves after dose reduction.

4.9 Overdose

Severe distension or pain can be treated using nasogastric aspiration. Vomiting or diarrhoea may induce extensive fluid loss, possibly leading to electrolyte disturbances that should be treated appropriately.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Osmotically acting laxatives.

ATC code: A06A D65

Macrogol 3350 induces a laxative effect through its osmotic action in the gut. This product also contains electrolytes to ensure that there is no overall gain or loss of water, potassium or sodium.

Clinical studies using the listed active substances for the treatment of chronic constipation have shown that the dose required to produce normally formed stools tends to decrease over time. For most patients, the maintenance dose will be one to two sachets per day (adjusted according to individual response).

Comparative studies in faecal impaction using active controls (e.g. enemas) have not been performed. However, results from a non-comparative study have shown that, from a population of 27 adult patients, the listed combination of active substances cleared faecal impaction in 12/27 (44%) patients after one day's treatment, increasing to 23/27 (85%) following two days' treatment and 24/27 (89%) recovered at the end of three days.

5.2 Pharmacokinetic Properties

Macrogol 3350 is virtually unabsorbed from the gastro-intestinal tract and is excreted, unaltered, in faeces. Any macrogol 3350 that enters the systemic circulation is excreted in urine.

5.3 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 weight macrogols that provide evidence of safety at the recommended therapeutic dose.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Acesulfame Potassium (E950)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Sachet: Two years.

Reconstituted solution: Six hours.

6.4 Special Precautions For Storage

Sachet: Store below 25°C.

Reconstituted solution: Store covered in a refrigerator (2°C to 8°C).

6.5 Nature And Contents Of Container

The sachet is composed of paper, low density polyethylene and aluminium.

Sachets are packed in cartons of 2, 8, 10, 20, 30, 50 and 100.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Galen Limited

Seagoe Industrial Estate

Craigavon

BT63 5UA

UK

8. Marketing Authorisation Number(S)

PL 21590/0088.

9. Date Of First Authorisation/Renewal Of The Authorisation

01 May 2008

10. Date Of Revision Of The Text

09 January 2009