Movicol - Half 6.9g Sachet Powder For Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
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 substances:
6.563g 175.4 mg
89.3 mg
23.3 mg
Macrogol 3350 Sodium Chloride Sodium Bicarbonate Potassium Chloride
The content of electrolyte ions per sachet when made up to 62.5 ml of solution is as follows:
65 mmol/l 53 mmol/l 5.4 mmol/l 17 mmol/l
Sodium
Chloride
Potassium
Bicarbonate
For 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
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
Posology
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.
Method of 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 Contra-indications
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 listed in section6.1.
4.4 Special warnings and precautions for use
The fluid content of MOVICOL Half when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.
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.
The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by MOVICOL-Half (see section 4.5).
4.5 Interactions 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.
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-Half (see section 4.4).There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.
4.6 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 Half 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 Half 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
There is no effect on the ability to drive and use machines.
4.8 Undesirable effects
Reactions related to the gastrointestinal tract occur the 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-Half. Mild diarrhoea usually responds to dose reduction.
The frequency of the adverse effects is not known as it cannot be estimated from the available data.
|
System Organ Class |
Adverse Event |
|
Immune system disorders |
Allergic reactions, including anaphylactic reactions, dyspnoea and skin reactions (see below). |
|
Skin and subcutaneous tissue disorders |
Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema. |
|
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 and anorectal 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
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 controlled 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, 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, 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 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 2-8°C (in a refrigerator 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
None.
7 MARKETING AUTHORISATION HOLDER
Norgine 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
16/10/2002 / 18/03/2009
10 DATE OF REVISION OF THE TEXT
31/03/2016