This information is intended for use by health professionals
|Macrogol 3350||13.125 g|
|Sodium Chloride||0.3507 g|
|Sodium Hydrogen Carbonate||0.1785 g|
|Potassium Chloride||0.0466 g|
|Hydrogen Carbonate (Bicarbonate)||17 mmol/l|
Excipients with known effect
Each sachet contains:
- 25 mg potassium
- 187 mg sodium
- 0.76 mg sorbitol (E420)For a full list of excipients, see section 6.1.
Chronic constipationA 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.
Faecal impactionAdults, 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.
Administration:Each sachet should be dissolved in 125 ml water.
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.
This medicine contains 0.63 mmol (25 mg) potassium per sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
This medicinal product contains 187 mg sodium per sachet, equivalent to 9.35% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
When used to treat chronic constipation, the maximum daily dose of this product is equivalent to 28.05% of the WHO recommended maximum daily intake for sodium.
CosmoCol Orange Lemon and Lime Flavour is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
This medicine contains 0.76mg sorbitol (E420) in each sachet.
Immune System Disorders:Allergic reactions, including anaphylactic reaction. Other symptoms of allergic reactions include dyspnoea, urticaria and pruritus.
Gastro-intestinal Disorders: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 or search for MHRA Yellow Card in the Google Play or Apple App Store.