Microsoft word - 1.3.1 imodium lg product monograph (feb 17-12)

IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
glycol, purified water, simethicone, sodium benzoate, sorbic acid, sucralose, titanium dioxide, xanthan gum. IMODIUM® Caplets, Quick-Dissolve Tablets, Calming Liquid &
LIQUI-GELS®: Each blue-coloured, liquid filled capsule contains Loperamide Hydrochloride the following nonmedicinal ingredients (alphabetical): FD&C blue No. 1, gelatin, glycerol, propylene glycol, propylene glycol This leaflet is part III of a three-part "Product Monograph" monocaprylate, soya lecithin, triglycerides and water. published when IMODIUM® was approved for sale in Canada and
is designed specifically for Consumers. This leaflet is a summary What dosage forms it comes in: and will not tell you everything about IMODIUM®. Contact your
2 mg caplet, 2 mg Quick-Dissolve tablet, 2 mg/15 mL Calming doctor or pharmacist if you have any questions about the drug. Liquid (oral solution) and 2 mg LIQUI-GELS ,. ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
What the medication is used for: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF IMODIUM® is used for the rapid relief of diarrhea symptoms.
BEFORE you use IMODIUM® talk to your doctor or pharmacist
IMODIUM® makes the stools more solid and less frequent.
 are pregnant or nursing a baby. IMODIUM® is not
When it should not be used: recommended for nursing mothers because small amounts of You should not use IMODIUM® if you have any of the following
loperamide can end up in your milk; have meningitis or liver disease, as you may need medical if there is blood in the stools or you have a fever; supervision while taking IMODIUM®.
if you are constipated or your abdomen is swollen or have STOP USE and see your doctor or pharmacist if:  if you have a bacterial infection in your digestive system, or  Diarrhea gets worse, lasts longer than 48 hours or you get any suspect food-poisoning due to bacterial contamination; unusual symptoms;  if you have an inflammation of the lower bowel;  You are infected with HIV and you have any signs of  if you are taking prescription drugs that may cause abdominal swelling or bulging. constipation such as anti-psychotic and anti-depressant Although IMODIUM® stops diarrhea, it will not treat the cause of
 if you are taking antibiotics or have ulcerative colitis; it. Whenever possible, the cause of diarrhea should also be  if you know you are sensitive to one of the ingredients or to any other component of this formulation (see What the important nonmedicinal ingredients are); Tiredness, dizziness, or drowsiness may occur in the setting of  if in doubt, ask your pharmacist or doctor for advice. diarrheal symptoms treated with loperamide. Therefore, it is advisable to use caution when driving a car or operating What the medicinal ingredient is: Loperamide hydrochloride What the important nonmedicinal ingredients are: INTERACTIONS WITH THIS MEDICATION
Caplets: Each light green, capsule-shape tablet, embossed "IMODIUM A-D" on one side, and "2 mg" on the other side, Always tell your doctor or pharmacist contains the following nonmedicinal ingredients (alphabetical):  if you are using other drugs including herbal medicines cellulose, colloidal silicon dioxide, D&C yellow No. 10, dibasic because some drugs should not be taken together calcium phosphate, FD&C blue No. 1, and magnesium stearate.  if you are taking drugs that slow down the action of the stomach and intestines (for example, some antidepressants Quick-Dissolve tablets: Each white, circular tablet contains the and cold and allergy medication), because these can make the following nonmedicinal ingredients (alphabetical): aspartame, effect of IMODIUM® too strong.
flavour, gelatin, mannitol and sodium bicarbonate.  if you are taking sedating medications. Calming Liquid: The Calming Liquid is an opaque, green liquid In particular, tell your doctor or pharmacist if you are taking any with a mint odour, packaged in plastic bottles. Nonmedicinal of the following: ingredients (alphabetical): carboxymethylcellulose sodium,  ritonavir (used to treat HIV) cellulose, citric acid, D&C yellow no.10, dimethyl siloxane,  quinidine (used to treat abnormal heart rhythms) FD&C blue no.1, flavour, glycerin, methylcellulose, propylene  oral desmopressin (used to treat excessive urination) IMODIUM® McNeil Consumer Healthcare Loperamide Hydrochloride Page 31 of 33  itraconazole or ketoconazole (used to treat fungal infections) The following complaints sometimes occur, but they may be due  gemfibrozil (used to lower cholesterol) to the diarrhea itself: nausea and vomiting, tiredness, dizziness or drowsiness, dry mouth and flatulence. PROPER USE OF THIS MEDICATION
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
IMODIUM® should be taken by the mouth. You can take
HAPPEN AND WHAT TO DO ABOUT THEM
IMODIUM® at any time of day. The caplets and LIQUI-GELS
capsules should be taken with liquid. The Quick-Dissolve tablet is
Symptom / effect
Talk with your
Stop taking
doctor or
a fast-dissolving tablet which can be taken without fluid. The pharmacist
call your
tablet disintegrates within seconds on the surface of the tongue and doctor or
is then swallowed with the saliva. The Quick-Dissolve tablets pharmacist
should not be pushed through the blister, as this would damage them. To take the tablets out of the blister, pull up the edge of the Uncommon Abdominal foil, tear the foil completely off, press out and then remove the tablet. The dose for the Calming Liquid should be administered with the attached measuring cup only. When you have diarrhea, you will lose a lot of fluids. Therefore, drink plenty of clear fluids, water, unsweetened juices or clear soups.  do not drink alcohol or milk and avoid fruit, green vegetables This is not a complete list of side effects. For any unexpected and spicy or fatty foods. These items tend to aggravate effects while taking IMODIUM®, contact your doctor or
pharmacist. HOW TO STORE IT
Adults (12 years and older): Take 2 caplets or 2 tablets or 2 capsules or 30 mL oral solution (4 mg) initially and 1 caplet or 1 Store IMODIUM® LIQUI-GELS®, caplets and oral solution at tablet or 1 capsule or 15 mL oral solution every time you have a room temperature (15-30°C). Protect from light. loose bowel movement, to a maximum of 8 caplets or 8 tablets or 8 Store IMODIUM® Quick-Dissolve tablets at room temperature capsules or 120 mL oral solution (16 mg) per day. (15-30°C) and protect from moisture. Keep out of reach of Stop use if you have a solid or hard stool or if you go for 24 hours without a bowel movement. 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

IMODIUM® is usually well tolerated and few undesired effects are
likely when it is taken as directed.
Constipation may occur. If so, stop IMODIUM® and if these
effects are severe, consult your doctor.
Over sensitivity to IMODIUM® is rare. It can be recognized, for
instance, by skin rash or itching. If any of these signs occur, see
your doctor.
IMODIUM® McNeil Healthcare Loperamide Hydrochloride Page 32 of 33 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, ON 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 obtained by contacting the sponsor,
McNeil Consumer Healthcare at:
1-877-IMODIUM (1-877-466-3486)
This leaflet was prepared by McNeil Consumer Healthcare,
division of Johnson & Johnson Inc.
®LIQUI-GELS is a registered trademark of Catalent Pharma Solutions, Inc. used
under licence
Last revised: February 17, 2012
IMODIUM® McNeil Healthcare Loperamide Hydrochloride Page 33 of 33

Source: http://www.imodium.ca/sites/www_imodium_ca/files/documents/Imodium%20Consumer%20Information%20Eng.pdf