Patient Medication Information: uses, side effects, how to take - Pepcid Complete
What is PEPCID® COMPLETE® used for?
- 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.
- Prevents these symptoms brought on by consuming food and/or beverage.
How does PEPCID® COMPLETE® work?
PEPCID® COMPLETE® contains the active 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.
What are the ingredients in PEPCID® COMPLETE®?
Medicinal ingredients: famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg
Non-medicinal ingredients: cellulose acetate, corn starch, crospovidone, dextrose monohydrate, flavours, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, Prosweet® Powder, sucralose
PEPCID® COMPLETE® chewable tablets – mint flavour also contains FD&C Blue #1 and yellow iron oxide.
PEPCID® COMPLETE® chewable tablets – berry flavour also contains D&C Red #7, FD&C Red #40, FD&C Blue #1 and corn starch modified.
PEPCID® COMPLETE® comes in the following dosage forms:
Chewable tablet
Do not use PEPCID® COMPLETE® if:
- you are allergic to famotidine, calcium carbonate, magnesium hydroxide or any nonmedicinal ingredients (see What are the ingredients in PEPCID® COMPLETE®?) 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
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PEPCID® COMPLETE®. Talk about any health conditions or problems you may have, including if you:
are pregnant or breast-feeding
- have difficulty or pain on swallowing, severe vomiting, black stool, choking, or persistent stomach pains/discomfort
- have kidney disease as you may need a dosage adjustment
- have any other severe illnesses
- are over 40 years of age and are experiencing new or recently changed symptoms of acid indigestion or heartburn
- are taking any prescription or over-the-counter medications, such as nonsteroidal anti-inflammatory drugs [NSAIDs] (because these medicines may be causing your symptoms)
- have a previous history of ulcer disease complications
- are experiencing unintended weight loss in association with your symptoms of acid indigestion or heartburn
- have heartburn over 3 months as this may be a sign of a more serious condition
- have heartburn with light headedness, sweating and dizziness
- have chest or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or light headedness
Other warnings you should know about:
Stop use and ask a doctor if:
- your heartburn continues or worsens
- new symptoms develop
- you need to take this product for more than 14 days
Pepcid® Complete® is not expected to affect your ability to drive or operate machinery. However, if tiredness or dizziness occur, you should not drive or use machines.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with PEPCID® COMPLETE®:
- prescription drugs
- iron, calcium carbonate or zinc sulfate
- posaconazole oral suspension and itraconazole (for fungal infection)
- penicillamine
- tetracycline hydrochloride, doxycycline, fluoroquinolones (antibiotics) or drugs for HIV
- minerals
- thiazide diuretics (water pills)
- most of the tyrosine kinase inhibitors: dasatinib, erlotinib, gefitinib, pazopanib (to treat cancers)”
Most interactions can be avoided by taking PEPCID® COMPLETE® 2 hours before or after ingestion of other drugs.
How to take PEPCID® COMPLETE®:
- Do not swallow tablet whole: chew completely
- 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
Usual dose:
For Heartburn or Acid Indigestion: Adults and children 12 years and older: 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
Overdose:
If you think you, or a person you are caring for, have taken too much PEPCID® COMPLETE®, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
What are possible side effects from using PEPCID® COMPLETE®?
PEPCID® COMPLETE® is generally well tolerated.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY RARE | |||
| Dizziness, headache, sleepiness, weakness | ✓ | ||
| Stomach pain, diarrhea, dry mouth, nausea, vomiting | ✓ | ||
| Allergic reactions such as hives, rash, swelling, itching and difficulty breathing | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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.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.
Storage:
Store tablets at 15°C - 30°C. Protect from moisture.
Keep out of reach and sight of children.
If you want more information about PEPCID® COMPLETE®:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.pepcid.ca, or by calling 1-800-4PEPCID.