DULCOLAX PICO Oral solution Ref.[8377] Active ingredients: Sodium picosulfate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aventis Pharma Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

Therapeutic indications

Short term relief of constipation.

For the management of constipation of any aetiology.

Posology and method of administration

For oral administration.

The following dosages are recommended to be taken at night to produce evacuation the following morning.

It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools.

The maximum recommended daily dose should not be exceeded.

Adults and children over 10 years of age: One to two 5 ml spoonfuls (5-10 mg) per day.

Children under 10 years of age: Not to be taken by children under 10 years of age without medical advice.

Children aged 4-10 years: Half to one 5 ml spoonful (2.5-5 mg) per day.

Children under 4 years of age: The recommended dosage is 0.25 mg per kilogram body weight per day (1 ml of Dulcolax Pico Liquid contains 1 mg sodium picosulfate).

In the management of constipation, once regularity has restarted dosage should be reduced and can usually be stopped.

Diluent: Can be diluted with purified water.

Overdose

Symptoms

If high doses are taken diarrhoea, abdominal cramps and a clinically significant loss of fluid, potassium and other electrolytes can occur.

Furthermore, cases of colonic mucosal ischaemia have been reported in association with doses of DULCOLAX considerably higher than those recommended for the routine management of constipation.

Laxatives when taken in chronic overdosage may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and renal calculi. Renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described in association with chronic laxative abuse.

Therapy

Within a short time of ingestion, absorption can be minimised or prevented by inducing vomiting or by gastric lavage. Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in the elderly and the young.

Administration of antispasmodics may be of some value.

Shelf life

3 years.

Special precautions for storage

Keep the container in the outer carton.

Nature and contents of container

Amber glass bottles with aluminium ROPP caps.

Pack sizes of 90 and 500 ml.

Amber glass bottles with polypropylene tamper-evident closure with expanded polyethylene (coated with LDPE) liner.

Pack sizes of 100, 250 and 300 ml.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Not applicable.

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