Purg-Odan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

PURG-ODAN is a white powder. It is a very strong purgative

(i.e. to empty bowels). PURG-ODAN 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.

When it should not be used:

1. 1. If you are allergic to any of the ingredients in this formulation (see below).
2. 2. If you have any of the following; gastric retention (reduced ability of the stomach to empty), gastric or intestinal ulcers, appendicitis, gastrointestinal blockage or perforation.
3. 3.

   If 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.

4. 4. If you have congestive cardiac failure (the heart is unable to pump blood efficiently around the body).
5. 5. If you have severely reduced kidney function.

What it does:

Magnesium oxide and citric acid combine together (chemical reaction) in water to form magnesium citrate, which works as an osmotic laxative 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.

What the medicinal ingredient is:

Each sachet contains 16.1 g of powder which has three active ingredients: sodium picosulfate 10 mg, magnesium oxide 3.5 g and citric acid 12 g;, the later two form magnesium citrate in solution.

What the important nonmedicinal ingredients are:

Natural orange flavour, potassium bicarbonate and saccharin sodium

What dosage forms it comes in:

Powder

WARNINGS AND PRECAUTIONS

Please consult your doctor before taking PURG-ODAN^® if you:

• Have recently had gastrointestinal surgery,
• Have a medical condition affecting the heart or kidneys,
• Have inflammatory bowel disease such as ulcerative colitis or Crohn’s disease,
• Are using bulk forming laxatives e.g. bran.

• Have heart problems such as a recent heart attack, irregular or fast heartbeat ( arrhythmia), lengthened

  heart beat (QT prolongation) or angina

• Have a history of seizures
• Have an impaired gag reflex

Pregnancy or Breast-Feeding: If you are pregnant, planning to become pregnant, breast-feeding, or planning to breastfeed, ask your doctor or pharmacist for advice before taking PURG-ODAN.

INTERACTIONS WITH THIS MEDICATION

Taking Other Medicines:

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.
• If you are taking anti-epileptics, contraceptives, antibiotics, diabetes medications and cardiac glycosides as they may be affected during treatment with PURG-ODAN.
• If you are taking diuretics, corticosteroids and lithium as these drugs may affect electrolyte balance.
• If you are taking nonsteroidal anti-inflammatory drugs (NSAIDS), tricyclic antidepressants, antipsychotic drugs or carbamazapine as these drugs may add to the electrolyte imbalance.
• If you are taking oral iron preparations for a week before colonoscopy.
• If you are taking constipating drugs (e.g. cholinergics, opioids); they should be temporarily discontinued for a few days before the procedure.
• If you are taking Tetracycline and fluoroquinolone antibiotics, digoxin, chlorpromazine and penicillamine they should be taken 2 hours before or not less than 6 hours after taking PURG-ODAN, 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.

IMPORTANT: PLEASE READ

IMPORTANT: PLEASE READ

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

ADULT DOSING INSTRUCTIONS:

Fill a mug with 150 ml (5 oz) of cold water. Empty contents of one sachet in the mug (rarely, mixture may heat up - allow to cool before drinking). Stir for 2-3 minutes until completely dissolved before you drink. Following each sachet, drink 1.5 to 2 Litres of a variety of clear fluids over 4 hours.

DO NOT DRINK JUST WATER ALONE. 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 (e.g. Gastrolyte^†, Pedialyte^†) 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^†), Gastrolyte^†, Pedialyte^†, Kool-Aid^†, clear broth (chicken, vegetable or beef stock with no noodles, meat or vegetables), fruit juices (e.g. apple, white (not red) cranberry, white (not purple) grape), tea or coffee (black, sweetened to taste, no milk, cream or soy), clear sodas (e.g. ginger ale), plain Jell-O^† (not red or purple), Popsicles^† (not red or purple) and water.

Diabetics can use a fibre-free supplement/meal replacement.

One day before your procedure you should have clear fluids ONLY and no solid food. See list above.

Morning colonoscopy - before 12:00 pm (noon);

One day before your procedure: Take 1 sachet (first dose) at

5:00 pm followed by 1.5 to 2 Litres of a variety of clear fluids.

One day before your procedure: Take 1 sachet (second dose) at 10:00 pm followed by 1.5 to 2 Litres of a variety of clear fluids.

No fluid should be taken at least 2 hours prior to your procedure.

Afternoon colonoscopy - 12:00 pm (noon) or later:

One day before your procedure: Take 1 sachet (first dose) at

7:00 pm followed by 1.5 to 2 Litres of a variety of clear fluids.

On the same day as your procedure: Take 1 sachet (second dose) at 6:00 am, followed by 1.5 to 2 Litres of a variety of clear fluids.

In order to replace fluid lost from the body, it is important to drink plenty of clear fluids throughout the treatment with

PURG-ODAN until bowel movements have ceased.

No fluid should be taken at least 2 hours prior to your procedure.

PEDIATRIC DOSING INSTRUCTIONS:

Fill a mug with 150 ml (5 oz) of cold water. Empty contents of one sachet in the mug (rarely, mixture may heat up - allow to cool before drinking). Stir for 2-3 minutes until completely dissolved before you drink.

If possible, it is recommended that PURG-ODAN should be given at least 5-6 hours before bedtime to avoid interference with sleep. Therefore splitting the dose over two days is recommended for children as follows:

(1 to 6 years old):

One day before your procedure: Take ¼ of the prepared solution as per DOSING INSTRUCTIONS (first dose) at 6:00 pm followed by one cup of clear liquid (250 mL, 8 oz) every hour while the child is awake. No solid food should be taken after 6:00 PM.

On the same day as your procedure: Take ¼ of the prepared solution as per DOSING INSTRUCTIONS (second dose) at 8:00 am, followed by one cup of clear liquid (250 mL, 8 oz) every hour up to 2 hours prior to your child’s procedure.

(6-12 years old):

One day before your procedure: Take ½ of the prepared solution as per DOSING INSTRUCTIONS (first dose) at 6:00 pm followed by one cup of clear liquid (250 mL, 8 oz) every hour while the child is awake. No solid food should be taken after 6:00 PM.

On the same day as your procedure: Take ½ of the prepared solution as per DOSING INSTRUCTIONS (second dose) at 8:00 am, followed by one cup of clear liquid (250 mL, 8 oz) every hour up to 2 hours prior to your child’s procedure.

In order to replace fluid lost from the body, it is important to drink plenty of clear fluids throughout the treatment with PURG-ODAN until bowel movements have ceased. In general, patients should drink about 250 mL of water or clear fluid and/or a balanced electrolyte solution (e.g.: Gastrolyte^†, Pedialyte^†) as recommended by a health care professional, every hour while they feel the effects of PURG-ODAN.

No fluid should be taken at least 2 hours prior to your procedure

IMPORTANT: PLEASE READ

IMPORTANT: PLEASE READ

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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, PURG-ODAN can cause side effects, although not everybody gets them. Adverse reactions to PURG-ODAN 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.

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:

--------------------------------------------------------------------------

• 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 0701D

    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 product monograph, prepared for health professionals, can be provided by contacting the manufacturer, Odan Laboratories Limited, at: 1-800-387-9342.

Odan Laboratories Limited.

Pointe-Claire, Québec

H9R 2Y6

Canada

Last revised: February 22, 2016

This is not a complete list of side effects. For any unexpected effects while taking PURG-ODAN, contact your doctor or pharmacist.

® Registered Trademark of Odan Laboratories Limited

† All other trademarks are the property of their respective owners

HOW TO STORE IT

Store at room temperature (15°C to 25°C). Keep out of reach and sight of children.