PICOPREP POWDER FOR ORAL SOLUTION [SIN14303P]

Product Info

PICOPREP POWDER FOR ORAL SOLUTION

[SIN14303P]

4.1 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 4.4 regarding open colorectal surgery – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration
Posology
Adults (including elderly):
(if the procedure is scheduled for the afternoon, it is recommended that the Split Dosing regimen should be used):

SPLIT DOSING REGIMEN (evening-before and day of the procedure)
The first PICOPREP sachet (see Method of Administration section below for reconstitution guidance) 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 late afternoon/ evening (e.g. 5:00 to 9:00PM), followed by at least 5 x 250 ml drinks of clear liquids (not only water), 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 3 x 250 ml drinks of clear liquids (not only water), spread over several hours

• Clear liquids (not only water) may be consumed until 2 hours before the time of the procedure

or

DAY-BEFORE DOSING Regimen (evening-before the procedure only)
The first PICOPREP sachet (see Method of Administration section below for reconstitution guidance) 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 5 x 250 ml drinks of clear liquids (not only water), 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 3 x 250 ml drinks of clear liquids (not only water), spread over several hours

• Clear liquids (not only water) may be consumed until 2 hours before the time of the procedure.

Method of administration
Route of administration: Oral

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 PICOPREP dosing whilst the effects of PICOPREP persist (see section Posology). Apart from the liquid intake together with the treatment regimen (PICOPREP + additional liquids), a normal, thirst driven intake of clear liquids is recommended.

Clear liquids should include a variety of soft drinks, clear soup, tea, coffee (without milk, soy or cream), fruit juice without pulp, and water. Liquid intake should not be restricted to only drinking water.

Directions for reconstitution in adults (including elderly):
Reconstitute the PICOPREP 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.

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

4.3 Contraindications

• Hypersensitivity to the active substances or to any excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• 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.