Compound Macrogol 13.7g Powder For Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Compound Macrogol 13.7 g powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following active ingredients:
Macrogol 3350 13.125 g
Sodium chloride 350.7 mg
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
Hydrogen carbonate 17 mmol/l
Potassium 5.4 mmol/l
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
A white powder.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Compound Macrogol 13.7g powder for oral solution is indicated for the treatment
of chronic constipation and resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon.
4.2 Posology and method of administration
Posology
Chronic constipation
Adults, adolescents and older people: 1 -3 sachets daily in divided doses. Normal dose for most patients is 1-2 sachets per day. Depending on the individual response 3 sachets per day might be needed.
A course of treatment for constipation does not normally exceed 2 weeks, although this can be repeated if required.
For extended use, the lowest effective dose should be used.
Special populations
Paediatric population
Compound Macrogol 13.7g powder for oral solution should not be used in children below 12 years of age. Alternative products are available for children.
Patients with renal insufficiency
No dosage change is necessary for the treatment of chronic constipation.
Faecal impaction
A course of treatment for faecal impaction does not normally exceed 3 days.
Adults, adolescents and older people: 8 sachets daily, all of which should be consumed within a 6 hour period.
Special populations
Paediatric population
Compound Macrogol 13.7g powder for oral solution should not be used in children below 12 years of age. Alternative products are available for children.
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 faecal impaction.
Method of 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. For instructions on dilution of the medicinal product before administration, see section 6.6.
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 substances or to any of the excipients listed in section 6.1.
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.
The cause of constipation should be investigated if daily use of laxatives is necessary. Patients using this preparation should seek medical advice if there is no improvement after two weeks.
Long term use can be necessary in serious chronical or refractory constipation due to i.e. multiple sclerosis (MS) or Parkinson’s disease, or constipation induced by drugs, especially opioides or antimuscarine products.
If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) treatment 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 this medicinal product (see section 4.5).
Paediatric population
There is no clinical data on the use of Compound Macrogol 13.7g powder for oral solution
in children, therefore it should not be used in children below 12 years of age.
4.5 Interaction with other medicinal products and other forms of interaction
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 this medicinal product (see section 4.4).
4.6 Fertility, pregnancy and lactation
Pregnancy:
Compound Macrogol 13.7g powder for oral solution can be used during pregnancy. There is no documented experience from the use of macrogol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal reproductive development, delivery or postnatal development (see section 5.3). As Macrogol has a molecular weight above 3000 da very little if any will be absorbed. Therefore it seems unlikely that the use of this product will cause problems during pregnancy.
Breast-feeding:
Compound Macrogol 13.7g powder for oral solution can be used during breast-feeding.There is no documented experience from the use of macrogol during breastfeeding. Macrogol with a molecular weight above 3000 da will not or hardly be resorbed.
4.7 Effects on ability to drive and use machines
Compound Macrogol 13.7g 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); and 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.
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 the product. Mild diarrhoea usually responds to dose reduction.
|
System Order Class |
Adverse Event |
Frequency (if known) |
|
Immune system disorders |
Allergic reactions, including anaphylaxis, angioedema, dyspnoea, allergic rash, erythema, urticaria and pruritus |
Very rare |
|
Metabolism and nutrition disorders |
Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia |
Not known |
|
Nervous system disorders |
Headache |
Not known |
|
Gastrointestinal disorders |
Abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anal discomfort |
Common |
|
General disorders and administration site conditions |
Peripheral oedema |
Not known |
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 the Yellow Card Scheme at: 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
Mechanism of action
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, macrogol with electrolytes 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 efficacy and safety
Clinical studies in the use of macrogol with electrolytes in 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 gastro-intestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
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
36 months.
Reconstituted solution: 24 hours.
Store in a refrigerator (2°C - 8°C).
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
For storage conditions after reconstitution of the medicinal product, See section 6.3.
6.5 Nature and contents of container
Sachet: laminate consisting of four layers (inner to outer): low density polyethylene, aluminium, low density polyethylene and paper.
Pack sizes: Boxes of 8, 10, 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 24 hours.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
TEVA UK Limited Brampton Road,
Hampden Park,
Eastbourne,
East Sussex BN22 9AG UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 00289/1409
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
31/01/2014
10 DATE OF REVISION OF THE TEXT
31/01/2014