Teva Teva-Loperamide Loperamide Hydrochloride Tablets USP 2 mg 100 Tablets

Uses - Relieves diarrhea How to Use Directions Adults and children 12 years and older: - Drink plenty of clear fluids to help prevent dehydration caused by diarrhea - Take 2 tablets initially followed by 1 tablet after each loose bowel movement - Do not take more than 8 tablets in 24 hours. Warnings WARNINGS DOSAGE WARNING Taking more than directed can cause serious heart problems or death. DO NOT USE - if you have bloody or black stool, fever, constipation, abdominal pain, swollen abdomen, ulcer, bacterial infection in your bowel, a rash or allergic reaction to loperamide hydrochloride or any other ingredient in this product - in children under 12 years of age, except on the advice of a doctor. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU - have liver disease, meningitis, mucus in the stool, history of abnormal heart rhythm - take any prescription drug including antibiotics - are pregnant or breastfeeding. WHEN USING THIS PRODUCT - tiredness, dizziness, or drowsiness may occur - do not drive or operate machinery. STOP USE AND ASK A DOCTOR IF - diarrhea gets worse or lasts longer than 2 days - unusual symptoms appear - you get abdominal pain, swelling or bulging. These may be signs of a serious condition. KEEP OUT OF REACH OF CHILDREN. In case of overdose, call a poison control centre or get medical help right away. IMPORTANT: PLEASE READ CONSUMER INFORMATION Teva-Loperamide Loperamide Hydrochloride Tablets This leaflet is part Ill of a three-part "Product Monograph" published when TEVA-LOPERAMIDE Tablets was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about TEVA-LOPERAMIDE Tablets. Contact your doctor or pharmacist if you have any questions about the drug. ABOUT THIS MEDICATION What the medication is used for: TEVA-LOPERAMIDE is used for the rapid relief of diarrhea symptoms. What it does; TEVA-LOPERAMIDE makes the stools more solid and less frequent. When it should not be used: You should not use TEVA-LOPERAMIDE if you have any of the following conditions: - If there is blood in the stools or you have a fever; - If you are constipated or your abdomen is swollen or have abdominal pain; - if you have a bacterial infection in your digestive system, or suspect food poisoning due to bacterial contamination; - if you have an inflammation of the lower bowel - if you are taking prescription drugs that may cause constipation such as anti-psychotic and anti-depressant medications; - if you are taking antibiotics or have ulcerative colitis; - if you know you are sensitive to one of the ingredients or to any other component of this formulation (see What the Important non-medicinal ingredients are); - if in doubt, ask your pharmacist or doctor for advi What the medicinal ingredient is: Loperamide hydrochloride What the important non-medicinal ingredients are: Non-medicinal ingredients in alphabetical order include D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, magnesium stearate, lactose monohydrate, pregelatinized starch and sodium starch glycolate. What dosage forms it comes in: 2 mg tablet WARNINGS AND PRECAUTIONS KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. BEFORE you use TEVA-LOPERAMIDE talk to your doctor or pharmacist if you: - have mucus in the stool; - are pregnant or nursing a baby. TEVA-LOPERAMIDE is not recommended for nursing mothers because small amounts of loperamide can end up in your milk; - have meningitis or liver disease, as you may need medical supervision while taking TEVA-LOPERAMIDE; - have a history of abnormal heart rhythm (e.g ., Brugada syndrome). Dosage warning: Taking more than directed can cause serious heart problems or death. STOP USE and see your doctor or pharmacist if: - Diarrhea gets worse, lasts longer than 48 hours or you get any Unusual symptoms; - You are infected with HIV and you have any signs of abdominal swelling or bulging. Although TEVA-LOPERAMIDE stops diarrhea, it will not treat the cause of it. Whenever possible, the cause of diarrhea should also be treated. Tiredness, dizziness, or drowsiness may occur in the setting of diarrheal symptoms treated with loperamide. Therefore, it Is advisable to use caution when driving a car or operating machinery. INTERACTIONS WITH THIS MEDICATION Always tell your doctor or pharmacist: - if you are using other drugs including herbal medicines because some drugs should not be taken together; - if you are taking drugs that slow down the action of the stomach and intestines (for example, some antidepressants and cold and allergy medication), because these can make the effect of TEVA-LOPERAMIDE too strong; -if you are taking sedating medications. In particular, tell your doctor or pharmacist if you are taking any of the following: - ritonavir (used to treat HIV) - quinidine (used to treat abnormal heart rhythms) - oral desmopressin (used to treat excessive urination) - itraconazole or ketoconazole (used to treat fungal infections) - gemfibrozil (used to lower cholesterol) PROPER USE OF THIS MEDICATION TEVA LOPERAMIDE tablets should be taken by the mouth. You can take TEVA-LOPERAMIDE at any time of day. The tablets should be taken with liquid. 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 and spicy or fatty foods. These items tend to aggravate diarrhea. Usual Dose; Adults (12 years and older): Take 2 tablets (4 mg) initially and 1 tablet every time you have a loose bowel movement, to a Maximum of 8 tablets (16 mg) per day. 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 TEVA-LOPERAMIDE is usually well tolerated and few undesired effects are likely when it is taken as directed. Constipation may occur. If so, stop TEVA-LOPERAMIDE and if these effects are severe, consult your doctor. Over sensitivity to TEVA-LOPERAMIDE is rare. It can be recognized, for instance, by skin rash or itching, If any of these signs occur, see your doctor. The following complaints sometimes occur, but they may be due to the diarrhea itself: nausea and vomiting, tiredness, dizziness or drowsiness, dry mouth and flatulence SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM Symptom / effect Talk with your doctor or pharmacist Only if severe, In all cases Stop taking drug and seek immediate emergency medical attention Uncommon Abdominal pain, Difficulty urinating, Bloating, Shortness of breath, Swollen face, Abnormal coordination, Muscular tension, Pupil constriction, Abdominal pain upper This is not a complete list of side effects. For any unexpected effects while taking TEVA-LOPERAMIDE, contact your doctor or pharmacist. HOW TO STORE IT Store TEVA-LOPERAMIDE tablets between 15º℃-30℃. Boxes of unit dose strips should be stored between 15"℃-25 ℃ and protected from high humidity. Protect from light. Keep out of reach and sight of children. Reporting Side Effects You can report any suspected side effects associated with the use of health products to Health Canada by: - Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.ge.ca/dhp-mps/medeff/report-declaration /index-eng. php) for information on how to report online, by mail or by fax; or - Calling toll-free at 1-866-234-2345. NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. MORE INFORMATION This document plus the full product monograph. prepared for health professionals can be found by contacting Teva Canada Limited by: Phone: 1-800-268-4127 ext. 3; Email: [email protected]; or Fax: 1-416-335-4472 This leaflet was prepared by Teva Canada Limited. Last revised: November 23, 2020