1. Name Of The Medicinal Product
MOVICOL-Half 6.9g sachet, powder for oral solution
2. Qualitative And Quantitative Composition
Each sachet of MOVICOL-Half contains the following active ingredients:
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The content of electrolyte ions per sachet when made up to 62.5 ml of solution is as follows:
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For excipients, see 6.1.
3. Pharmaceutical Form
Powder for oral solution.
Free flowing white powder.
4. Clinical Particulars
4.1 Therapeutic Indications
Chronic Constipation
For the treatment of chronic constipation in adults, adolescents and the elderly.
Faecal Impaction
For resolving faecal impaction in adults, adolescents and the elderly Faecal impaction is defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by physical or radiological examination of the abdomen and rectum.
4.2 Posology And Method Of Administration
Chronic Constipation
A course of treatment for constipation with MOVICOL-Half does not normally exceed two 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 elderly
2 - 6 sachets daily in divided doses, according to individual response.
For extended use, the dose can be adjusted down to 2 - 4 sachets daily.
Faecal Impaction
Adults, adolescents and elderly
A course of treatment for faecal impaction with MOVICOL-Half does not normally exceed 3 days.
Dosage is 16 sachets daily, all of which should be consumed within a 6 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 patient follows an appropriate bowel management programme to prevent reimpaction.
This dosage regimen is based on one clinical trial.
Children (below 12 years of age): Not recommended.
Patients with impaired cardiovascular function
For the treatment of faecal impaction the dose should be divided so that no more than four sachets are taken in any one hour.
Patients with renal insufficiency
No dosage change is necessary for treatment of either constipation or faecal impaction.
Administration
Each sachet should be dissolved in 62.5ml water. For use in faecal impaction the correct number of sachets can be reconstituted in advance and kept covered and refrigerated for up to 6 hours. For example 16 sachets can be made up into one 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.
Known hypersensitivity to any of the active substances or 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 fluid/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) MOVICOL-Half 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
Medication in solid dose form taken within one hour of administration of large volumes of macrogol preparations may be flushed from the gastrointestinal tract and not absorbed.
Clinical interactions with other drugs have been reported extremely rarely. No specific reactions with individual drugs or classes of drugs have been observed.
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.
4.6 Pregnancy And Lactation
There is no experience of the use of MOVICOL-Half 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
There is no effect on the ability to drive and use machines.
4.8 Undesirable Effects
Reactions related to the gastrointestinal tract are the most common to occur. These may include:
Abdominal pain
Nausea
Borborygmi
Diarrhoea
Abdominal distension
Vomiting
Flatulence
Anal discomfort
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-Half. Mild diarrhoea usually responds to dose reduction.
Allergic reactions, including anaphylaxis. Other symptoms of allergic reactions include pruritus, urticaria and dyspnoea.
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
ATC code: A06A D
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 comparative studies have not been performed with other treatments (e.g. enemas). In a non-comparative study in 27 adult patients, MOVICOL 13.8g 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 in the use of MOVICOL in chronic constipation have shown that the dose needed to produce normal formed stools tends to reduce over time. Many patients respond to between 2-4 sachets of MOVICOL-Half per 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 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 macrogols that provide evidence of safety at the recommended therapeutic dose.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Acesulfame K (E950)
Lime and Lemon Flavour
6.2 Incompatibilities
None are known.
6.3 Shelf Life
The shelf life of the sachets is 3 years.
Discard any solution not used within 6 hours.
6.4 Special Precautions For Storage
Sachet: Do not store above 25°C.
Solution: Store at 2 - 8ºC (refrigerated and covered)
6.5 Nature And Contents Of Container
6.9g sachets contained in boxes of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Norgine Limited
Chaplin House
Widewater Place
Moorhall Road, Harefield
UXBRIDGE, Middlesex
UB9 6NS, United Kingdom
8. Marketing Authorisation Number(S)
PL 00322/0080
9. Date Of First Authorisation/Renewal Of The Authorisation
16th October 2002
10. Date Of Revision Of The Text
Approved: January 2009
Legal Category: P
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