STRIGOL ORANGE FLAVOUR

Posology Chronic constipation The usual starting dose is 1 sachet daily for children aged 2 to 6 years, and 2 sachets daily for children aged 7 – 11 years. The dose should be adjusted up or down as required to produce regular soft stools.

If the dose needs increasing this is best done every second day. The maximum dose needed does not normally exceed 4 sachets a day. Treatment of children with chronic constipation needs to be or a prolonged period (at least 6 – 12 months).

However, safety and efficacy of Compound Macrogol Paediatric has only been proved for a period of up to three months. Treatment should be stopped gradually and resumed if constipation recurs. Faecal impaction A course of treatment for faecal impaction with Compound Macrogol Paediatric is for up to 7 days as follows: Daily dosage regimen: Number of Compound Macrogol Paediatric sachets Age (years) Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 5 - 11 4 6 8 10 12 12 12 The daily number of sachets should be taken in divided doses, all consumed within a 12 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 child follows an appropriate bowel management program to prevent reimpaction (dosing for prevention of re-impaction should be as for patients with chronic constipation; see above).

Compound Macrogol Paediatric is not recommended for children below five years of age for the treatment of faecal impaction, or in children below two years of age for the treatment of chronic constipation. For patients of 12 years and older it is recommended to use Compound Macrogol Paediatric.

Patients with impaired cardiovascular function:

There are no clinical data for this group of patients. Therefore Compound Macrogol Paediatric is not recommended for treating faecal impaction in children with impaired cardiovascular function.

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 Compound Macrogol Paediatric.

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 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).

Immune system disorders Not known Angioedema, dyspnoea, rash, erythema, urticaria and pruritus. Metabolism and nutrition disorders Not known Dehydration, electrolytes disorders (hypokalemia, hyponatraemia, hyperkalaemia) Nervous system disorders Not known Headache.

Very common Abdominal pain, borborygmi. Common Diarrhoea vomiting, nausea, anal discomfort. Uncommon Abdominal distension, flatulence. Gastrointestinal disorders 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/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The fluid content of Compound Macrogol Paediatric when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. Avoid mixing PEG laxatives and starch-based thickeners in patients with dysphagia, considered at risk of aspiration.

Diagnosis of faecal impaction/faecal loading of the rectum should be confirmed by the physical or radiological examination of the abdomen and rectum. g. oedema, shortness of breath, increasing fatigue, dehydration and cardiac failure have been reported in adults when using preparations containing macrogol.

If this occurs Compound Macrogol Paediatric should be stopped immediately, electrolytes measured, and any abnormality should be treated appropriately. When used in high doses to treat faecal impaction this medicinal product should be administered with caution to patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness.

g. the elderly, patients with impaired hepatic or renal function or patients taking diuretics) and electrolyte control should be considered. Compound Macrogol Paediatric solution when reconstituted has no calorific value. 5). 11 mg) of potassium per sachet.

This should be taken into consideration if the patient takes more than one sachet daily and has reduced kidney function, or is on a controlled potassium diet. 4 mg sodium (main component of cooking/table salt) per sachet. 6% of the recommended maximum daily dietary intake of sodium for an adult.

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. 1.