Compound Macrogol 6.9g Powder For Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Compound Macrogol 6.9 g powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of contains the following active ingredients:
Macrogol 3350 6.563g
Sodium chloride 175.4 mg
Sodium hydrogen carbonate 89.3 mg Potassium chloride 23.3 mg
The content of electrolyte ions per sachet when made up to 62.5 ml of solution is as follows:
Sodium 65 mmol/l
Chloride 53 mmol/l
Hydrogen carbonate 17 mmol/l
Potassium 5.4 mmol/l
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
Free flowing white powder.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of chronic constipation in children 2 to 11 years of age.
For the treatment of faecal impaction in children from the age of five years, defined as refractory constipation with faecal loading of the rectum and/or colon.
Chronic constipation
The usual starting dose is 1 sachet daily for children aged 2 to 6 years, and 2 sachets daily for children aged 7 - 11 years. The dose should be adjusted up or down as required to produce regular soft stools. If the dose needs to be increased this is best done every second day. The maximum dose needed does not normally exceed 4 sachets a day.
Treatment of children with chronic constipation needs to be or a prolonged period (at least 6 - 12 months). However, safety and efficacy have only been proved for a period of up to three months. Treatment should be stopped gradually and resumed if constipation recurs.
Faecal impaction
A course of treatment for faecal impaction is for up to 7 days as follows:
Daily dosage regimen:
|
Number of sachets | |||||||
|
Age (years) |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
Day 7 |
|
5 - 11 |
4 |
6 |
8 |
10 |
12 |
12 |
12 |
The daily number of sachets should be taken in divided doses, all consumed within a 12 hour period. The above dosage regimen should be stopped once disimpaction has occurred. An indicator of disimpaction is the passage of a large volume of stools. After disimpaction it is recommended that the child follows an appropriate bowel management program to prevent reimpaction (dosing for prevention of re-impaction should be as for patients with chronic constipation; see above).
Compound Macrogol 6.9g powder for oral solution is not recommended for children below five years of age for the treatment of faecal impaction, or in children below two years of age for the treatment of chronic constipation.
Patients with impaired cardiovascular function: There are no clinical data for this group of patients. Therefore this medicinal product is not recommended for treating faecal impaction in children with impaired cardiovascular function.
Patients with renal insufficiency: There are no clinical data for this group of patients. Therefore this medicinal product is not recommended for treating faecal impaction in children with impaired renal function.
Administration
Each sachet should be dissolved in 62.5 ml (quarter of a glass) of water. The correct number of sachets may be reconstituted in advance and kept covered and refrigerated for up to 24 hours. For example, for use in faecal impaction, 12 sachets can be made up into 750 ml 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 faecal impaction/faecal loading of the rectum should be confirmed by the physical or radiological examination of the abdomen and rectum.
Rarely symptoms indicating shifts of fluid/electrolytes e.g. oedema, shortness of breath, increasing fatigue, dehydration and cardiac failure have been reported in adults when using preparations containing macrogol. If this occurs treatment should be stopped immediately, electrolytes measured, and any abnormality should be treated appropriately.
When used in high doses to treat faecal impaction this medicinal product should be administered with caution to patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness.
When reconstituted the solution has no calorific value.
The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by Compound Macrogol 6.9g powder for oral solution (see section 4.5).
4.5 Interaction with other medicinal products and other forms of interaction
Medicinal products in solid dose form taken within one hour of administration of large volumes of macrogol preparations (as used when treating faecal impaction) may be flushed from the gastrointestinal tract and not absorbed.
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 concomitant administration of this product (see section 4.4). There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products e.g. anti-epileptics.
There are no data on the use of this medicinal product during pregnancy and lactation and it should only be used if considered essential by the physician.
4.7 Effects on ability to drive and use machines
Compound Macrogol 6.9g powder for oral solution has no influence on the ability to drive and use machines.
4.8 Undesirable effects
The frequency of the adverse reactions listed below 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).
Reactions related to the gastrointestinal tract are the most common to occur. They may include:
Chronic Constipation Indication:
Immune system disorders:
Rare: allergic reactions, including anaphylaxis.
Other symptoms of allergic reactions include pruritis, urticaria and dyspnoea. Gastrointestinal disorders:
Very common: abdominal pain, borborygmi, diarrhoea or loose
stools which normally respond to a reduction in dose.
Common: nausea, mild vomiting, abdominal distension,
flatulence, perianal inflammation and soreness.
Faecal Impaction Indication:
Immune system disorders:
Rare: allergic reactions, including anaphylaxis.
Other symptoms of allergic reactions include pruritis, urticaria and dyspnoea.
Gastrointestinal disorders:
Very common: mild vomiting, abdominal distension and pain
which are attributable to the expansion of the contents of the intestinal tract, perianal inflammation and soreness.
Vomiting may be resolved if the dose is reduced or delayed.
borborygmi, nausea and mild diarrhoea.
Common:
These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacological effects of this medicinal product.
4.9 Overdose
Severe abdominal 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.
In an open study of macrogol with electrolytes in chronic constipation, weekly defaecation frequency was increased from 1.3 at baseline to 6.7, 7.2 and 7.1 at weeks 2, 4 and 12 respectively. In a study comparing macrogol with electrolytes and lactulose as maintenance therapy after disimpaction, weekly stool frequency at the last visit was 9.4 (SD 4.46) in the macrogol with electrolytes group compared with 5.9 (SD 4.29). In the lactulose group 7 children re-impacted (23%) compared with no children in the macrogol with electrolytes group.
For the indication of faecal impaction comparative studies have not been performed with other treatments (e.g. enemas). In a non-comparative study in 63 children, macrogol with electrolytes (paediatric version) cleared the faecal impaction in the majority of patients within 3 - 7 days of treatment. For the 5 -11 years age group the average total number of sachets of macrogol with electrolytes (paediatric version) required was 47.2.
5.2 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, 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)
Lemon Flavour (contains acacia gum (E414) and flavouring)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
30 months.
Reconstituted solution: 24 hours
6.4 Special precautions for storage
Reconstituted solution: Store at 2-8°C.
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, 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Any unused solution should be discarded within 24 hours.
7 MARKETING AUTHORISATION HOLDER
TEVA UK Limited Brampton Road,
Hampden Park,
Eastbourne,
East Sussex BN22 9AG UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 00289/1637
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/01/2011
10 DATE OF REVISION OF THE TEXT
01/08/2013