Pepcid Complete Berry Flavour 25 Chewable Tablets

Uses - Relieves and prevents, heartburn, acid indigestion, upset and sour stomach How to Use Directions - Adults and children 12 years and over: For relief of symptoms, chew 1 tablet at onset of symptoms, If symptoms return, you may chew another tablet, For prevention of symptoms, chew 1 tablet 1 hour before eating, Do not chew more than 2 tablets in 24 hours. Other information - Do not use if inner foil seal is broken - Store at 15 to 30℃ - Protect from moisture. IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION PEPCID® COMPLETE Famotidine, Calcium Carbonate and Magnesium Hydroxide Tablets (Chewable) This leaflet is part III of a three-part "Product Monograph" published when PEPCID® COMPLETE was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about PEPCID® COMPLETE. Contact your doctor or pharmacist if you have any questions about the drug. ABOUT THIS MEDICATION What the medication is used for: PEPCID® COMPLETE begins to work on contact to provide fast, long lasting and effective relief from heartburn, acid indigestion and upset or sour stomach due to excess stomach acid. PEPCID® COMPLETE also prevents these symptoms brought on by consuming food and/or beverage. What it does: PEPCID® COMPLETE contains the medicinal ingredient famotidine (an acid reducer) along with the antacids, calcium carbonate and magnesium hydroxide. This advanced formula combines the benefits of both an antacid and acid reducer in one tablet. PEPCID® COMPLETE combines these two types of ingredients because they relieve heartburn in two different ways. The antacid begins by neutralizing acid on contact. The acid reducer keeps working, day or night, to reduce the production of excess stomach acid. When it should not be used: Do not use PEPCID® COMPLETE - if you are allergic to Famotidine or any non-medicinal ingredients in the product. - if you have had an allergic reaction to another product that contains an acid reducer (e.g. ranitidine). - with other acid reducers. What the medicinal ingredients are: Each tablet of PEPCID® COMPLETE contains 10 mg of famotidine, 800 mg of calcium carbonate and 165 mg of magnesium hydroxide. Each tablet provides 320 mg of elemental calcium and 70 mg of elemental magnesium. What the important non-medicinal ingredients are: PEPCID® COMPLETE chewable tablets also contain the following non-medicinal ingredients: Cellulose acetate, crospovidone, dextrose monohydrate, flavours, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, Prosweet® Powder (contains corn starch), sucralose. PEPCID® COMPLETE chewable tablets - berry flavour also contain D&C Red #7, FD&C Red #40 and FD&C Blue #1. What dosage forms it comes in: PEPCID® COMPLETE is available as a chewable tablet. SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM Symptoms / effects: Very Rare: Dizziness, headache, sleepiness, weakness: Talk with your healthcare professional: Only if severe: ✔, In all cases: ; Stop taking drug and get immediate medical help Symptoms / effects: Very Rare, Stomach pain, diarrhea, dry mouth, nausea, vomiting; Talk with your healthcare professional, Only if severe: , In all cases: ✔; Stop taking drug and get immediate medical help Symptoms / effects: Very Rare, Allergic reactions such as hives, rash, swelling, itching and difficulty to breathe; Talk with your healthcare professional, Only if severe: , In all cases: ✔; Stop taking drug and get immediate medical help For any unexpected effects while taking PEPCID® COMPLETE contact your doctor or pharmacist. 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 (https://www.canada.ca/en/ health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction -reporting.html) 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. Warnings WARNINGS DO NOT USE - with other acid reducers. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU - have, had heartburn over 3 months. This may be a sign of a more serious condition, heartburn with light headedness, sweating and dizziness, chest or shoulder pain with shortness of breath, sweating, pain spreading to arms or neck, or light headedness, kidney disease, history of ulcer disease or any other severe illness, difficulty swallowing or continuous stomach pain, unexplained weight loss, severe vomiting, black stool, choking - take, any prescription drug, calcium carbonate, iron or zinc sulfate, non-steroidal anti-inflammatory drugs (NSAIDs) - are, pregnant or breastfeeding, over 40 years old and have had new or changed symptoms of acid indigestion or heartburn. STOP USE AND ASK A DOCTOR IF - your heartburn continues or worsens - new symptoms develop - you need to take this product more than 14 days. KEEP OUT OF REACH OF CHILDREN. In case of overdose, call a Poison Control Centre or get medical help right away. WARNINGS AND PRECAUTIONS THIS MEDICINE MAY NOT BE SUITABLE FOR SOME PEOPLE. BEFORE YOU USE PEPCID® COMPLETE TALK TO YOUR DOCTOR OR PHARMACIST IF: - You are pregnant or breast-feeding. - You have difficulty or pain on swallowing, severe vomiting, black stool, choking, chest pain, or persistent stomach pains/discomfort. - You have kidney disease as you may need a dosage adjustment. - You have any other severe illnesses. - You are over 40 years of age and you are experiencing new or recently changed symptoms of acid indigestion or heartburn. - You are taking any prescription or over-the-counter medications, such as nonsteroidal anti-inflammatory drugs [NSAIDs] (because these medicines may be causing your symptoms). - You have a previous history of ulcer disease complications. - You are experiencing unintended weight loss in association with your symptoms of acid indigestion or heartburn. - You have heartburn over 3 months. This may be a sign of a more serious condition. - You have heartburn with light headedness, sweating and dizziness. - You have chest or shoulder pain with shortness of breath, sweating, pain spreading to arms, neck or shoulders; or light headedness. STOP USE AND ASK A DOCTOR IF: - Your heartburn continues or worsens - You need to take this product for more than 14 days INTERACTIONS WITH THIS MEDICATION BEFORE YOU USE PEPCID® COMPLETE TALK TO YOUR DOCTOR OR PHARMACIST IF: - You are taking a prescription drug, iron, calcium carbonate or zinc sulfate as some drug interactions could occur. - You are using Itraconazole (for fungal infections). - You are using antibiotics or drugs for HIV. Most interactions can be avoided by taking PEPCID® COMPLETE 2 hours before or after ingestion of other drugs. PROPER USE OF THIS MEDICATION USUAL DOSE: FOR HEARTBURN OR ACID INDIGESTION: Adults and children 12 years and over: For fast, long lasting and effective relief of symptoms, chew one (1) tablet. If symptoms return, you may chew another tablet. For prevention of acid-related symptoms brought on by consuming food and/or beverage, chew one (1) tablet 1 hour before eating. Maximum 2 tablets in 24 hours. WHAT ELSE CAN BE DONE TO AVOID SYMPTOMS - Do not lie down soon after eating. - If you are overweight, lose weight. - If you smoke, stop or cut down. - Avoid or limit foods such as caffeine, chocolate, fatty foods, spicy foods and alcohol. - Do not eat just before bedtime. Do not take within two hours of another medicine because the effectiveness of the other medicine may be altered. If symptoms get worse or persist for more than two consecutive weeks, or if new symptoms develop, stop use and consult your doctor. 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 PEPCID® COMPLETE is generally well tolerated.