PICO-SWIFT POWDER FOR ORAL SOLUTION [SIN17163P]

Product Info

PICO-SWIFT POWDER FOR ORAL SOLUTION

[SIN17163P]

THERAPEUTIC INDICATIONS
To clean the bowel prior to X-ray examination or endoscopy.
To clean the bowel prior to surgery when judged clinically necessary (see section Special Warnings and Precautions for Use regarding open colorectal surgery – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Route of administration: Oral

A low residue diet is recommended on the day prior to the hospital 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 PICO-SWIFT dosing whilst the effects of PICO-SWIFT persist (see section Posology). Apart from the liquid intake together with the treatment regimen (PICO-SWIFT + 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.

Posology
Directions for reconstitution:
Reconstitute the Sodium Picosulfate powder right before each administration. Do not prepare the solution in advance. Reconstitute the contents of one sachet in a cup of water (approximately 150ml). Stir for 2–3 minutes, the solution should now become an off-white, cloudy liquid with a faint odour of orange. Drink the solution. If it becomes warm, wait until it cools sufficiently to drink.

Adults (including the elderly):
(if the procedure is scheduled for the afternoon, it is recommended that the Split-Dose regimen should be used):

Split-Dose Regimen (evening-before and day of the procedure)
The first PICO-SWIFT sachet is taken the night before the procedure, and the second is taken the next day, in the morning prior to the procedure.
On the day before the procedure – 1 sachet:

• The first reconstituted sachet is taken in the evening (e.g. 5:00 to 9:00 PM), followed by at least five 250 ml drinks of clear liquids, spread over several hours.

On the day of the procedure – 1 sachet:

• The second reconstituted sachet is taken in the morning (5–9 hours before the procedure), followed by at least three 250 ml drinks of clear liquids, spread over several hours.

• Clear liquids may be consumed until 2 hours before the time of the procedure.

or

Day-Before Regimen (evening-before the procedure only)
The first PICO-SWIFT sachet is taken in the afternoon or early evening and the second is taken approximately 6 hours later, the night before the procedure.
On the day before the procedure – 2 sachets:

• The first reconstituted sachet is taken in the afternoon or early evening (e.g. 4:00 to 6:00PM), followed by at least five 250 ml drinks of clear liquids, spread over several hours.

• The second reconstituted sachet is taken in the late evening (e.g., 10:00PM to 12:00AM), followed by at least three 250 ml drinks of clear liquids, spread over several hours.

• Clear liquids may be consumed until 2 hours before the time of the procedure.

Paediatric population:
The safety and efficacy of Sodium picosulfate in paediatric patients has not been established.

CONTRAINDICATIONS

• Hypersensitivity to any of the ingredients of the product

• 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.