Patient Medication Information: uses, side effects, how to take - Picoflo
ABOUT THIS MEDICATION
What the medication is used for:
PicoFLO is a white powder. It is a very strong purgative (i.e. to empty bowels). PicoFLO is used to cleanse the bowel of faecal matter and secretions prior to x-ray examination, endoscopy or surgery. This product is not intended for routine use as a laxative.
What it does:
Magnesium oxide and citric acid combine together in water (chemical reaction) to form magnesium citrate, which works as an osmotic laxative by drawing water into the bowel to help make the stool soft and more watery. Sodium picosulfate works as a stimulant laxative to increase the bowel movements to move the contents along. Together they work to empty the bowel prior to medical procedures.
When it should not be used:
Do not use PicoFLO if:
You are allergic to sodium picosulfate, magnesium oxide,
citric acid, or to any of the non-medicinal ingredients.
You have any of the following: gastric retention (reduced
ability of the stomach to empty), gastric or intestinal ulcers, appendicitis, gastrointestinal blockage or perforation.
You have ileus (intestinal blockage or failure of normal
movements), toxic colitis (damage to intestinal wall) or toxic megacolon (acute dilatation of the large bowel). In these conditions, transit of the contents of the bowel may be impaired or prevented. Symptoms include nausea, vomiting, diarrhoea, abdominal pain, tenderness or swelling, colicky pain and fever.
- You have congestive cardiac failure (the heart is unable to pump blood efficiently around the body).
- You have severely reduced kidney function.
What the medicinal ingredients are:
Each 16.1 g sachet of PicoFLO contains: 3.5 g magnesium oxide, 12 g citric acid and 10 mg sodium picosulfate; the first two ingredients react and produce magnesium citrate in solution.
What the important non-medicinal ingredients are:
Orange flavour, potassium bicarbonate and saccharin sodium.
What dosage forms it comes in:
PicoFLO is available as a powder to be dissolved in 150 mL (5 oz) of cold water. Each carton contains 2 sachets.
WARNINGS AND PRECAUTIONS
BEFORE you use PicoFLO talk to your doctor or pharmacist if:
- You have recently had gastrointestinal surgery.
- You have a medical condition affecting the heart or kidneys.
- You have inflammatory bowel disease such as ulcerative colitis or Crohn’s disease.
- You are using bulk forming laxatives e.g., bran.
- You have heart problems such as a recent heart attack, irregular or fast heartbeat (arrhythmia), lengthened heart beat (QT prolongation) or angina.
- You have a history of seizures.
- You have an impaired gag reflex.
Pregnancy or Breast-Feeding:
If you are pregnant or are breast-feeding, ask your doctor or pharmacist for advice before taking PicoFLO.
INTERACTIONS WITH THIS MEDICATION
Please inform your doctor or pharmacist if:
- You are taking or have recently taken or used any other medicines - even those that are available without a prescription.
- You are taking anti-epileptics, contraceptives, antibiotics, diabetes medications or cardiac glycosides as they may be affected during treatment with PicoFLO.
- You are taking diuretics, corticosteroids or lithium as these drugs may affect electrolyte balance.
You are taking nonsteroidal anti-inflammatory drugs
(NSAIDs), tricyclic antidepressants, antipsychotic drugs or carbamazapine as these drugs may add to the electrolyte imbalance.
You are taking oral iron preparations in the week before your
colonoscopy.
You are taking constipating drugs (i.e. cholinergics, opioids),
they should be suspended for few days before the procedure.
You are taking tetracycline and fluoroquinolone antibiotics,
digoxin, chlorpromazine or penicillamine they should be taken 2 hours before or not less than 6 hours after taking PicoFLO, to avoid loss of effectiveness of these other medications.
PROPER USE OF THIS MEDICATION
PRE-DOSING INSTRUCTIONS:
If you have special dietary requirements, please discuss this with your doctor.
At least 3 days prior to your procedure:
- Do not consume seeds or nuts due to digestive residue
Do not consume any fresh fruits or raw vegetables (i.e. no
salads) and no multigrain bread
Your doctor will inform you of the dose that you should take. It is important to drink a large glass (250 mL or 8 oz) of clear fluid at one hour intervals during the use of PicoFLO. Unless otherwise directed by your doctor, please follow the directions below.
On the day before your procedure you should have ONLY clear fluids and NO solid food.
ADULT DOSING INSTRUCTIONS:
To prepare each dose of the product, mix the entire powder contents of one sachet with 150 mL or 5 oz of cold water in a cup; stir until the powder is completely dissolved. This may take 2-3 minutes. If the solution becomes hot, let it cool down before drinking it. Following each dose, drink 1.5 to 2 Liters of a variety of clear fluids over 4 hours.
DO NOT DRINK ONLY WATER. You should also drink a balanced electrolyte solution (e.g., Electrolyte Gastro*, Gastrolyte*).
Drinking only water to replace the fluid losses may lead to electrolyte imbalance, particularly to hyponatremia and possibly seizures. A good option is to also drink a balanced electrolyte solution as recommended by a health professional to replace fluid losses.
Recommended clear fluids include any fluid that you can see through, that is not red or purple, such as sports drinks (e.g.,
Gatorade*), fruit juices (e.g., apple, white (not red) cranberry, white (not purple) grape), balanced electrolytes solutions (e.g., Electrolyte Gastro*, Gastrolyte*), clear broth (chicken, vegetable or beef stock with no noodles, meat or vegetables), tea or coffee (black, sweetened to taste, without milk, cream or soy), clear sodas (e.g., ginger ale), Kool-Aid* (not red or purple), plain Jell-O* (not red or purple), Popsicles* (not red or purple), and water.
Diabetics can use a fibre-free supplement/meal replacement.
MORNING COLONOSCOPY: before 12:00 pm (noon)
One day BEFORE your procedure:
1- Take 1 sachet (first dose) in the afternoon or early evening (around 5:00 pm) followed by 6 to 8 cups (250 mL or 8 oz each) of a variety of clear fluids as described above.
2- Take 1 sachet (second dose) in the late evening (around 10:00 pm) followed by 6 to 8 cups (250 mL or 8 oz each) of a variety of clear fluids as described above.
No fluid should be ingested at least 2 hours prior to your procedure.
AFTERNOON COLONOSCOPY: 12:00 pm (noon) or later
1- One day BEFORE your procedure: Take 1 sachet (first dose) in the evening (around 7:00 pm) followed by 6 to 8 cups (250 mL or 8 oz each) of a variety of clear fluids as described above.
2- On the SAME DAY as your procedure: Take 1 sachet (second dose) in the early morning (around 6:00 am), followed by 6 to 8 cups (250 mL or 8 oz each) of a variety of clear fluids as described above.
No fluid should be ingested at least 2 hours prior to your procedure.
In order to replace fluid lost from the body, it is important to drink plenty of clear fluids throughout the treatment with PicoFLO until bowel movements have ceased.
PEDIATRIC DOSING INSTRUCTIONS:
Mix the entire powder contents of one sachet with 150 mL or 5 oz of cold water in a cup; stir until the powder is completely dissolved. This may take 2- 3 minutes. If the solution becomes hot, let it cool down before drinking it.
It is recommended that PicoFLO be given to the child at least 5 to 6 hours before bedtime to avoid interference with sleep. Splitting the two doses over two days is recommended as described below:
Children (1 to 6 years old):
1- One day BEFORE the procedure: Give the child ¼ of the prepared solution (first dose) as per DOSING INSTRUCTIONS in the evening (around 6:00 pm), followed by 1 cup (250 mL or
8 oz) of a variety of clear fluids as described above, every hour while the child is awake.
No solid food should be ingested after 6:00 pm.
2- On the SAME DAY as the procedure: Give the child ¼ of the prepared solution (second dose) as per DOSING INSTRUCTIONS in the morning (around 8:00 am), followed by 1 cup (250 mL or 8 oz) of a variety of clear fluids as described above, every hour, up to 2 hours prior to the child’s procedure.
No fluids should be ingested at least 2 hours prior to the procedure.
Children (6-12 years old):
1- One day BEFORE the procedure: Give the child ½ of the prepared solution (first dose) as per DOSING
INSTRUCTIONS in the evening (around 6:00 pm), followed by 1 cup (250 mL or 8 oz) of a variety of clear fluids as described above, every hour while the child is awake. No solid food should be ingested after 6:00 pm.
2- On the SAME DAY as the procedure: Give the child ½ of the prepared solution (second dose) as per DOSING INSTRUCTIONS in the morning (around 8:00 am), followed by 1 cup (250 mL or 8 oz) of a variety of clear fluids as described above, every hour, up to 2 hours prior to the child’s procedure.
No fluids should be ingested at least 2 hours prior to the procedure.
In order to replace fluids lost from the body, it is important to drink plenty of clear fluids throughout the treatment with PicoFLO until the bowel movements have ceased. In general, patients should drink about 250 mL (8 oz) of clear fluids and/or a balanced electrolytes solution (e.g., Electrolyte Gastro*, Pediatric Electrolyte*, Gastrolyte*, Pedialyte*) as recommended by a health professional, every hour while they feel the effects of PicoFLO.
You should expect loose bowel movements to start at any time after taking a dose of PicoFLO. Please ensure that you have access to a toilet at all times following each dose, until the effects wear off.
The success of the procedure that you will undergo depends on the bowel being as clear as possible. The procedure may need to be repeated if you do not achieve a clear bowel. Your doctor or clinic may issue a preparation sheet with more detailed instructions, including meals or food/fluid intake, which you will be asked to follow. Please follow your doctor's instructions.
The period of bowel cleansing should not exceed 24 hours because longer preparations may increase the risk of water and electrolyte imbalance. That is, you should not take more
than two sachets of PicoFLO and these are to be taken at the indicated times on the day before you are to go to the hospital for your diagnostic procedure or for surgery.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you forget to take PicoFLO, tell your doctor.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, PicoFLO can cause side effects, although not everybody gets them. Adverse reactions to PicoFLO are very rare (< 1 in 10, 000). Some examples include: hyponatraemia, epilepsy, grand mal convulsions, nausea, rash, headache, anaphylactoid reaction, hypersensitivity.
If any side effects become serious or persist, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Hyponatraemia is a metabolic condition in which there is not enough sodium (salt) in the body fluids outside the cells. Symptoms can include vomiting, confusion, fatigue and irritability | √ | √ | ||
| Convulsion, epilepsy, confusional state, headache. | √ | √ | ||
| Vomiting, diarrhea, abdominal pain, nausea. | √ | |||
This is not a complete list of side effects. For any unexpected effects while taking PicoFLO contact your doctor or pharmacist.
HOW TO STORE IT
Keep PicoFLO out of reach of children. Store the package between 15ºC-30ºC.
REPORTING SUSPECTED SIDE EFFECTS You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
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- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full Prescribing Information, prepared for health professionals, can be obtained by contacting the sponsor, Pharmascience Inc. at 1-888-550-6060.
Last revised: May 7, 2013.
PicoFLOTM is a trademark of Pharmascience Inc. * All other trademarks are the property of their respective owners.