COSMOCOL PAEDIATRIC

Posology Chronic constipation Children aged 2 to 6 years: starting dose of 1 sachet daily. Children aged 7 to 11 years: starting dose of 2 sachets daily. Adjust dose as required to produce regular, soft stools. Introduce dose increases every other day.

Normal maximum dose is 4 sachets daily. Doses may be reduced or temporarily omitted in cases of loose stools. Treatment of children with chronic constipation needs to be for a prolonged period (at least 6 - 12 months). However, safety and efficacy of CosmoCol Paediatric has only been proved for a period of up to 3 months.

Treatment should be stopped gradually and resume if constipation recurs. Faecal impaction A course of treatment with CosmoCol Paediatric takes up to 7 days, as follows: Daily dose regimen Number of CosmoCol Paediatric sachets Age Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 5 – 11 years 4 6 8 10 12 12 12 Take the daily number of sachets as divided doses over a 12 hour period.

Stop treatment once disimpaction has occurred. Passage of a large volume of stools indicates disimpaction. After disimpaction, it is recommended that the child follows an appropriate bowel management program to prevent reimpaction (dosage for prevention of recurrence follows dosage for chronic constipation; see above).

CosmoCol Paediatric is not recommended for children below 5 years of age for the treatment of faecal impaction, or in children under 2 years of age for the treatment of chronic constipation. For patients of 12 years of age and above, it is recommended to use Cosmocol.

Patients with impaired cardiovascular function There are no clinical data in this group of patients. Use of CosmoCol Paediatric for the treatment of faecal impaction is not recommended in children with impaired cardiovascular function.

Patients with renal impairment There are no clinical data in this group of patients. Use of CosmoCol Paediatric for the treatment of faecal impaction is not recommended in children with renal insufficiency. 5 ml (quarter of a glass) of water.

The correct number of sachets may be reconstituted in advance and kept covered and refrigerated for up to 24 hours. For example, for use in faecal impaction, 12 sachets can be made up into 750 ml of water.

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 Paediatric.

In the treatment of chronic constipation, diarrhoea or loose stools normally respond to a reduction in dose. Diarrhoea, abdominal distension, anorectal 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 reactions listed below is defined using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1000); and very rare (<1/10,000); not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse Event Immune system disorders Rare Allergic reactions, including anaphylactic reaction. Not known Dyspnoea and skin reaction (see below) Skin and subcutaneous tissue disorders Not known Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema.

Metabolism and nutrition disorders Not known Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia. Nervous system disorders Not known Headache. Gastrointestinal disorders Very common Abdominal pain, borborygmi. Common Diarrhoea, vomiting, nausea and anorectal discomfort.

Uncommon Abdominal distension, flatulence. Not known Dyspepsia and peri-anal inflammation. General disorders and administration site conditions Not known 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. uk or search for MHRA Yellow Card in the Google Play or Apple App Store.

The fluid content of CosmoCol Paediatric when re-constituted 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.

g. oedema, shortness of breath, increasing fatigue, dehydration and cardiac failure. If these symptoms occur, stop treatment with CosmoCol Paediatric immediately. Measure electrolytes and treat any abnormality with appropriate counter measures.

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

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory bowel diseases such as Crohn's disease, ulcerative colitis and toxic megacolon. 1.