Pico-Salax

/ Ferring Pharmaceuticals

Directions for reconstitution: The contents of one sachet should be reconstituted in a cup of water (approximately 150ml) and stirred for 2-3 minutes until the solution becomes an off-white, cloudy liquid with a faint odour of orange.
Adults (including the elderly): One sachet reconstituted in water as directed, taken before 8 am on the day before the procedure. Second sachet 6 to 8 hours later.
Children:
1 – 2 years: one measuring spoon full (equivalent to ¼ sachet ) in the morning,
one measuring spoon full (equivalent ¼ sachet) in the afternoon.
2 – 4 years: two measuring spoons full (equivalent ½ sachet in the morning,
two measuring spoons full (equivalent ½ sachet) in the afternoon.
4 – 9 years: 1 sachet morning, ½ sachet afternoon.
9 and above: adult dose.
A low residue diet is recommended on the day prior to the procedure. A clear liquid diet is recommended on the day of the procedure. To avoid dehydration it is important to follow the liquid intake recommendation as advocated together with the PICOLAX dosing whilst the effects of PICOLAX persist. Apart from
the liquid intake together with the treatment regimen (PICOLAX + additional liquids), a normal, thirst driven intake of clear liquids is recommended.
Clear liquids should include a variety of fruit juice without pulp, soft drinks, clear soup, tea, coffee (without milk, soy or cream) and water. Do not drink only water.

To clean the bowel prior to X-ray examination or endoscopy or surgery.

– Hypersensitivity to the active substances or to any of the excipients.
– Congestive cardiac failure
– Gastric retention
– Gastro-intestinal ulceration
– Toxic colitis
– Toxic megacolon
– Ileus
– Nausea and vomiting
– Acute surgical abdominal conditions such as acute appendicitis
– Known or suspected gastro-intestinal obstruction or perforation.
– Severe dehydration
– Rhabdomyolysis
– Hypermagnesemia
– Active inflammatory bowel disease
– In patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases.

Because a clinically relevant benefit of bowel cleansing prior to elective, open colorectal surgery could not be proven, bowel cleansers should only be administered before bowel surgery if clearly needed. The risks of the treatment should be carefully weighed against possible benefits and needs depending on surgical procedures performed.
An insufficient or excessive oral intake of water and electrolytes could create clinically significant abnormalities, particularly in less fit patients. In this regard patients with low body weight, children, the elderly, debilitated individuals and patients at risk of hypokalaemia or hyponatremia may need particular attention. Prompt corrective action should be taken to restore fluid/electrolyte balance in patients with signs or symptoms of hypokalaemia or hyponatremia.
Drinking only water to replace the fluid losses may lead to electrolyte imbalance, which may in severe cases lead to complications such as seizures and coma. In rare cases, this medicinal product can cause severe or life-threatening electrolyte problems or impaired renal function in fragile or debilitated patients.
Few episodes of severe hypermagnesaemia have been reported following the use of Picoprep. In the majority of the cases this occurred in association with other factors (e.g. renal impairment or concomitant medication).
Care should also be taken in patients with recent gastro-intestinal surgery, renal impairment,
heart disease or inflammatory bowel disease.
Use with caution in patients on drugs that might affect water and/or electrolyte balance e.g. diuretics, corticosteroids, lithium.
This medicinal product may modify the absorption of regularly prescribed oral medication and should be used with caution e.g. there have been isolated reports of seizures in patients on antiepileptics, with previously controlled epilepsy.
The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and electrolyte imbalance.
For an early time of the day procedure it may be required to take the second dose during the night and possible sleep disturbance may occur.
This medicine contains 5 mmol (or 195 mg) potassium per sachet. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
This medicine contains lactose as a component of the orange flavour. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicinal product should not be used as a routine laxative.

Common: Hypermagnesaemia, headache, nausea and abdominal pain.
See prescribing information for full details.

As a purgative, PICO SALAX increases the gastrointestinal transit rate. The
absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives, anti-diabetics, antibiotics) may therefore be modified during the treatment period. Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, should be taken at least 2 hours before and not less than 6 hours after administration of PICO SALAX to avoid chelation with magnesium.
The efficacy of PICO SALAX is lowered by bulk-forming laxatives.
Care should be taken with patients already receiving drugs which may be associated with hypokalaemia (such as diuretics or corticosteroids, or drugs where hypokalaemia is a particular risk i.e. cardiac glycosides). Caution is also advised when PICO SALAX is used in patients on NSAIDs or drugs known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine as these drugs may increase the risk of water retention and/or electrolyte imbalance.

Pregnancy: As picosulfate is a stimulant laxative, for safety measure, it is preferable to avoid the use of PICO SALAX during pregnancy.
Breastfeeding: There is no experience with the use of PICO SALAX in nursing mothers. However, due to the pharmacokinetic properties of the active ingredients, treatment with PICO SALAX may be considered for females who are breastfeeding.

Overdosage would lead to profuse diarrhoea. Treatment is by general supportive measures and correction of fluid and electrolyte balance.