This information is intended for use by health professionals
CosmoCol Orange Lemon and Lime Flavour powder for oral solution
Each sachet contains the following quantitative composition of active ingredients:
| Macrogol 3350
|| 13.125 g
| Sodium Chloride
|| 0.3507 g
| Sodium Hydrogen Carbonate
|| 0.1785 g
| Potassium Chloride
|| 0.0466 g
The content of electrolyte ions per sachet following reconstitution in 125 ml of water is equivalent to:
|| 65 mmol/l
|| 53 mmol/l
| Hydrogen Carbonate (Bicarbonate)
|| 17 mmol/l
|| 5 mmol/l
For a full list of excipients, see section 6.1.
Powder for oral solution
Single-dose sachet containing a free flowing white powder.
For the treatment of chronic constipation.
For resolving faecal impaction. Faecal impaction is defined as refractory constipation with faecal loading in the rectum and/or colon confirmed by physical or radiological examination of the abdomen and rectum.
CosmoCol Orange Lemon and Lime Flavour is for oral use.
A course of treatment for chronic constipation with CosmoCol Orange Lemon and Lime Flavour does not normally exceed 2 weeks, although this can be repeated if required. As for all laxatives, prolonged use is not usually recommended.Adults, adolescents and the elderly:
1-3 sachets daily in divided doses, according to individual response.Children below 12 years old:
Not recommended.Patients with renal insufficiency:
No dosage change is necessary.
Adults, adolescents and the elderly:
A course of treatment for faecal impaction does not normally exceed 3 days.
Dosage is 8 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.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 four sachets are taken in any one hour.Patients with renal insufficiency:
No dosage change is necessary for the treatment of either constipation or faecal impaction.
Each sachet should be dissolved in 125 ml water.
CosmoCol Orange Lemon and Lime Flavour 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.
Confirm diagnosis of faecal impaction / faecal loading of the rectum by physical or radiological examination of the abdomen and rectum.
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) CosmoCol Orange Lemon and Lime Flavour should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately.
When using high doses of this medicine to treat faecal impaction, use caution in patients with impaired gag reflex, reflux oesophagitis or reduced levels of consciousness.
The lemon lime flavour in CosmoCol Orange Lemon and Lime Flavour contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Macrogol 3350 raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water. It is a theoretical possibility that absorption of these drugs could be reduced transiently.
There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.
There is no experience with the use of CosmoCol Orange Lemon and Lime Flavour during pregnancy and lactation and it should only be used if considered essential by the physician.
CosmoCol Orange Lemon and Lime Flavour has no influence on the ability to drive and use machines.
Reactions related to the gastrointestinal tract are the most common to occur.
Immune System Disorders:
Allergic reactions, including anaphylactic reaction. Other symptoms of allergic reactions include dyspnoea, urticaria and pruritus.
Potential gastro-intestinal effects that may occur include abdominal distension and pain, anal discomfort, flatulence, vomiting, borborygmi and nausea.
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 CosmoCol Orange Lemon and Lime Flavour.
In the treatment of chronic constipation, diarrhoea or loose stools normally respond to a reduction in dose.
Diarrhoea, abdominal distension, anal discomfort and mild vomiting are more often observed during the treatment for faecal impaction. Vomiting may be resolved if the dose is reduced or delayed.
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
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.
Pharmacotherapeutic group: Osmotically acting laxatives.
ATC code: A06A D65
Macrogol 3350 induces a laxative effect through its osmotic action in the gut. It 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.
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. Many patients, respond to between one and two sachets a day, but this dose should be adjusted depending on individual response.
Macrogol 3350 is virtually unabsorbed from the gastro-intestinal tract and is excreted, unaltered, in faeces. Any macrogol 3350 that is absorbed is excreted via the urine.
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.
Colloidal anhydrous silica
(Orange flavour contains: flavouring substances and flavouring preparations, maltodextrin, acacia gum, alpha-tocopherol)
Lemon lime flavour
(Lemon lime flavour contains: flavouring preparations, maltodextrin, mannitol, gluconolactone, sorbitol (E420), acacia gum, colloidal anhydrous silica)
Reconstituted solution: 24 hours
Sachet: Do not store above 25 °C.
Reconstituted solution: Store covered in a refrigerator (2 °C to 8 °C).
The sachet is composed of paper, ethylene / methacrylic acid co-polymer and aluminium.
Sachets are packed in cartons of 20, 30, 50, 60 (2x30) and 100 (2x50).
Not all pack sizes may be marketed.
After 24 hours, any unused solution should be discarded.
Stirling Anglian Pharmaceuticals Ltd
Hillington Park Inovation Centre
1 Ainslie Road