COSMOCOL LEMON AND LIME FLAVOUR

Posology Chronic constipation A course of treatment for chronic constipation with CosmoCol Lemon and Lime Flavour powder for oral solution does not normally exceed 2 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 antimuscarincs.

Adults, adolescents and the elderly: 1-3 sachets daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 sachets daily.

Children below 12 years old:

Not recommended. Alternative products are available for children.

Patients with renal insufficiency:

No dosage change is necessary.

Faecal impaction 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. 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 two 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. Method of administration CosmoCol Lemon and Lime Flavour powder for oral solution is for oral use. Each sachet should be dissolved in 125 ml water.

For use in faecal impaction 8 sachets may be dissolved in 1 litre of water.

8. g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) CosmoCol Lemon and Lime Flavour powder for oral solution should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately.

5). 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. 5. 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.

35% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 05% of the WHO recommended maximum daily intake for sodium. CosmoCol Lemon and Lime Flavour is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

61 mg sorbitol (E420) in each sachet. 5 Interaction with other medicinal products and other forms of interaction Macrogol 3350 raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water.

4). g. anti-epileptics. Therefore, other medicines should not be taken orally for one hour before, during and for one hour after taking CosmoCol Lemon & Lime. CosmoCol Lemon and Lime Flavour powder for oral solution may result in a potential interactive effect if used with starch-based food thickeners.

The macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems. 6 Fertility, pregnancy and lactation Pregnancy There are limited amount of data from the use of CosmoCol Lemon & Lime Flavour in pregnant women.

3). Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible. CosmoCol Lemon & Lime Flavour 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.

CosmoCol Lemon & Lime Flavour can be used during breast-feeding. Fertility There are no data on the effects of CosmoCol Lemon & Lime Flavour on fertility in humans. 3). 7 Effects on ability to drive and use machines Cosmocol Lemon and Lime Flavour powder for oral solution has no influence on the ability to drive and use machines.

8 Undesirable effects Reactions related to the gastrointestinal tract occur 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 CosmoCol Lemon and Lime Flavour powder for oral solution.

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. 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.

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The fluid content of CosmoCol Lemon & Lime Flavour when reconstituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. Confirm diagnosis of faecal impaction / faecal loading of the rectum by physical or radiological examination of the abdomen and rectum.

8. g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) CosmoCol Lemon and Lime Flavour powder for oral solution should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately.

5). 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. In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section

g. ulcerative colitis, Crohn's disease and toxic megacolon). 1.