Consumer Patient Information

LAX-A-DAY^®
Polyethylene Glycol 3350 Powder for Oral Solution

This information is part III of a three-part Prescribing Information published when LAX-A-DAY^® was approved for sale in Canada and is designed specifically for Consumers. This information is a summary and will not tell you everything about LAX-A-DAY^®. Contact your doctor or pharmacist if you have any questions about the drug.

Please read this information carefully before you start to take your medicine, even if you have taken this drug before. Do not throw away this leaflet until you have finished your medicine as you may need to read it again. For further information or advice, please see your doctor or pharmacist.

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ABOUT THIS MEDICATION

What the medication is used for:
LAX-A-DAY^® is a laxative used to treat occasional constipation.

What it does:
LAX-A-DAY^® softens the stool and increases the frequency of bowel movements by retaining water in the stool.
Your first bowel movement will usually happen in two to four days, although results may vary for individual patients.

When it should not be used:

• If you are allergic to polyethylene glycol, do not use this drug product. Stop taking the drug and contact your doctor immediately if you experience an allergic reaction or any severe or unusual side effects.
• Do not use LAX-A-DAY^® if you have a known or suspected bowel obstruction.
• LAX-A-DAY^® should not be used by children under 18 years of age unless recommended by a physician.
• Although there is no evidence for special considerations when LAX-A-DAY^® is administered to elderly patients, if diarrhea occurs, LAX-A-DAY^® should be discontinued.
• If pregnant or breast-feeding, ask a health care professional before use.

What the medicinal ingredient is:
Polyethylene Glycol 3350

What the non-medicinal ingredients are:
There are no non-medicinal ingredients in LAX-A-DAY^®.

What dosage forms it comes in:
LAX-A-DAY^® is available in powdered form, for oral administration after dissolution in water, juice, soda, coffee, or tea.

LAX-A-DAY^® is available in the following formats: bottles (119 g, 238 g, or 510 g) and single-dose sachets of 17 g (available in packs of 10 sachets). The bottle formats include a dosing cap marked with a measuring line which should be used to measure a single LAX-A-DAY^® dose of 17 g (about 1 heaping tablespoon).

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WARNINGS AND PRECAUTIONS

• Patients with symptoms suggestive of bowel obstruction, appendicitis, or inflamed bowel (fever, nausea, vomiting, abdominal pain or bloating) should consult a doctor to rule out these conditions before initiating LAX-A-DAY^® therapy.
• Taking more than the recommended dose of LAX-A-DAY^® may cause loss of fluid or dehydration due to severe diarrhea.
• Should unusual cramps, bloating, or diarrhea occur, consult your physician.
• This product should be used for one (1) week or less or as directed by a physician. Prolonged, frequent or excessive use of LAX-A-DAY^® may result in electrolyte imbalance and dependence on laxatives.

Before taking LAX-A-DAY^®, tell your doctor or pharmacist:

• if you have ever had any allergic reaction to medications, food, etc;
• about your medical conditions and medications;
• if you are pregnant or thinking about becoming pregnant, or if you are breast feeding;

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INTERACTIONS WITH THIS MEDICATION

No specific drug interactions have been demonstrated. However, the desired effect of other medications may be reduced if taken with laxatives. Avoid taking LAX-A-DAY^® within two (2) hours of taking another medication.

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PROPER USE OF THIS MEDICATION

Usual dose:
A single dose is 17 grams and should be taken once a day or as directed by your physician or a health care professional.

Directions:
Note (bottles): The bottle formats are supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line.

1. Bottles: Pour 17 grams (about 1 heaping tablespoon) of powder into the dosing cap provided. Sachets: Open one sachet (17 g).
2. Stir the powder in a cup (250 mL) of water, juice, soda, coffee, or tea until completely dissolved.
3. Drink the solution.
4. Treatment for 2 to 4 days may be required to produce a bowel movement.

LAX-A-DAY^® should be used for one week or less or as directed by a physician. Treatment for two to four days (48 to 96 hours) may be required to produce a bowel movement.

You may discontinue taking the drug after you have had several satisfactory bowel movements. Should unusual cramps, bloating, or diarrhea occur, consult your physician.

LAX-A-DAY^® is intended for up to a one week course of therapy. You should not use for a longer time unless directed by your physician.
Patients presenting with complaints of constipation should have a thorough medical history and physical examination to detect associated metabolic, endocrine and neurogenic conditions, and medications. A diagnostic evaluation should include a structural examination of the colon.

Patients should be educated about good defecatory and eating habits (such as high fiber diets) and lifestyle changes (adequate dietary fiber and fluid intake, regular exercise) which may produce more regular bowel movements.

Overdose:
There have been no reports of accidental overdosage. In the event of an overdosage, dehydration due to diarrhea may result. Stop taking LAX-A-DAY^® and drink plenty of water.

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SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, LAX-A-DAY^® can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary.

If you experience an allergic reaction (including red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, blisters of the skin, sores or pain in the mouth or eyes) or any severe or unusual side effects, stop taking the drug and contact your doctor immediately.

Some side effects of LAX-A-DAY^® are:

• Nausea, abdominal bloating, cramping and flatulence
• Diarrhea and excessive stool frequency, particularly in elderly
  nursing home patients
• Urticaria suggestive of an allergic reaction

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom/ effect		Talk with your doctor or pharmacist right away		Seek urgent medical attention
		Only if severe	In all cases
Common	Nausea, abdominal bloating, cramping and flatulence
Uncommon	Diarrhea
Rare	Allergic reactions[ red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, blisters of the skin, sores or pain in the mouth or eyes]

This is not a complete list of side effects. For any unexpected effects while taking LAX-A-DAY®, contact your doctor or pharmacist.

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HOW TO STORE IT

• Store LAX-A-DAY^® at room temperature (15°C -30°C), in a dry place.
• Keep container tightly closed.
• Keep all medicines out of the reach of children.

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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 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.

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MORE INFORMATION

This document plus the full prescribing information, prepared for health professionals can be obtained by contacting the sponsor, Pendopharm, division of Pharmascience Inc., at: 1-888-550-6060

This leaflet was prepared by Pendopharm, division of Pharmascience Inc.

Last revised: July 20th, 2011

LAX-A-DAY^® is a registered trademark of Pharmascience Inc.