PICOPREP Powder for Oral Solution

FERRING PHARMACEUTICALS PRIVATE LIMITED

FERRING PHARMACEUTICALS PRIVATE LIMITED

Therapeutic

Prescription Only

POWDER, FOR SOLUTION

**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.