Patient Medication Information: uses, side effects, how to take - Famotidine (Acid Controller) Tablets
ABOUT THIS MEDICATION
What the medication is used for:
Each FAMOTIDINE (ACID CONTROLLER) TABLETS is clinically proven to give fast and effective relief from heartburn, acid indigestion and sour or upset stomach due to excess stomach acid.
FAMOTIDINE (ACID CONTROLLER) TABLETS when taken 10 – 15 minutes before a meal, prevents these symptoms brought on by eating or drinking food and beverages.
What it does:
It is normal for the stomach to produce acid, especially after eating food and/or drinking beverages. However, too much acid, can cause, heartburn, acid indigestion and discomfort that interfere with everyday activities. FAMOTIDINE (ACID CONTROLLER) TABLETS contains a medicine that actually reduces the production of excess stomach acid that causes these symptoms. FAMOTIDINE (ACID CONTROLLER) TABLETS is different from antacids that only neutralize existing stomach acid, but do not stop stomach acid from being produced. FAMOTIDINE (ACID CONTROLLER) TABLETS actually stops tough heartburn before it starts. Just one FAMOTIDINE (ACID CONTROLLER) TABLETS tablet provides long lasting acid control, for up to 12 hours day or night. Acid control may not directly correlate to symptom relief.
When it should not be used:
- If you are allergic to famotidine or to any component in the medication (see non-medicinal ingredients);
If you are allergic to other acid reducers;
- With another acid reducer.
What the medicinal ingredient is:
The medicinal ingredient is famotidine.
What the important nonmedicinal ingredients are: FAMOTIDINE (ACID CONTROLLER) TABLETS also contains: colloidal silicon dioxide, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, titanium dioxide.
What dosage forms it comes in:
FAMOTIDINE (ACID CONTROLLER) TABLETS is available as a 20 mg, film-coated tablet and thus easy-to-swallow.
This medicine may not be suitable for some people.
BEFORE you use FAMOTIDINE (ACID CONTROLLER) TABLETS talk
to your doctor or pharmacist if:
You are pregnant or breast-feeding;
- You have trouble swallowing, pain on swallowing, severe vomiting, passage of red/black blood in the stools, wheezing, choking, or your stomach pains continue;
- You have kidney disease, as you may need a dose 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 NSAIDs may be causing your symptoms);
- You have a previous history of erosive esophagitis, irritable bowel syndrome or ulcer disease complications;
- You are experiencing unintended weight loss in association with your symptoms of acid indigestion or heartburn;
- You are taking a proton pump inhibitor;
- Your heartburn is frequent (>3 times per
- and or severe;
- You have heartburn with light headedness, sweating and dizziness;
- You have chest or shoulder pain with shortness of breath, sweating, pain spreading to arms or neck, or light headedness.
HEARTBURN WARNINGS
Heartburn and acid indigestion are common, however heartburn can be a sign of a more serious medical condition, which requires medical intervention. Stop use of this product and any other nonprescription products you are taking for heartburn and see your doctor or pharmacist if:
- you have had heartburn for over 3 months and haven’t seen a doctor about it
your heartburn continues, worsens or returns after using heartburn medication every day for
- days
- you often need to use heartburn medication for 14 consecutive days (for example every 6 weeks or more frequently)
- your heartburn continues after using this or any other nonprescription heartburn product
Before you use FAMOTIDINE (ACID CONTROLLER) TABLETS talk to your doctor or pharmacist if:
- You are taking Itraconazole (for fungal infections).
- You are using calcium carbonate.
INTERACTIONS WITH THIS MEDICATION
IMPORTANT: PLEASE READ
Usual dose:
Adults and children 12 years of age or older: For relief of symptoms, swallow one (1) tablet with full glass of water. For prevention of acid-related symptoms brought on by consuming food and/or beverage swallow one (1) tablet with full glass of water 10 to 15 minutes before eating. If symptoms return, you may take another tablet. Do not take more than two tablets during a 24-hour period. If symptoms get worse or persist for more than two consecutive weeks, or if new symptoms develop, stop use and consult your physician.
TIPS TO HELP AVOID ACID-RELATED SYMPTOMS
Overdose:
This is not a complete list of side effects. For any unexpected effects while taking FAMOTIDINE (ACID CONTROLLER) TABLETS, contact your doctor or pharmacist.
- Store at room temperature (15°C - 30°C) in well-closed, light-resistant containers. Keep this and all medicines out of the reach of children.
FAMOTIDINE (ACID CONTROLLER) TABLETS is generally well tolerated. Side effects such as headache, diarrhea, lung infections, and vomiting were reported in studies where people took either the drug or a placebo (tablet with no medication). Each group had about the same number of side effects.
HOW TO STORE IT
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptoms / effects | Talk with your healthcare professional | Stop taking drug and get immediate medical help | ||||
| Only if severe | In all cases | |||||
| Very Rare | Dizziness and sleepiness | √ | ||||
| Very Rare | Stomach pain, diarrhea, dry mouth, nausea, and vomiting | √ | ||||
| Very Rare | Allergic reactions such as hives, rash, itching, swelling and difficulty to breathe | √ | ||||
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.
Reporting Suspected 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.
IMPORTANT: PLEASE READ
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by 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 http://www.tevacanada.com or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com