Apo-Famotidine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-FAMOTIDINE provides fast effective relief from heartburn, acid indigestion and upset or sour stomach due to excess stomach acid. In addition, when taken 10 to 15 minutes before a meal, APO-FAMOTIDINE can actually prevent heartburn before it starts.

Day or night, APO-FAMOTIDINE relieves and prevents these symptoms brought on by consuming food and/or beverage. One tablet, taken before your evening meal can prevent night-time heartburn symptoms so you can sleep through the night.

What it does:

Unlike antacids which neutralize existing stomach acid, but allow stomach acid to continue to be produced, APO-FAMOTIDINE reduces the production of excess stomach acid which can lead to heartburn and upset stomach. This enables APO-FAMOTIDINE to provide long lasting acid control, day or night.

When it should not be used:

• If you are allergic to Famotidine or any nonmedicinal ingredients (see complete list) in this product;
• If you have had an allergic reaction to another product that contains an acid reducer (e.g. ranitidine);
• With another acid reducer.

What the medicinal ingredient is:

Each film-coated tablet of APO-FAMOTIDINE contains 10 mg of famotidine.

What the nonmedicinal ingredients are:

Film-coated tablets contain the following non-medicinal ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

What dosage forms it comes in:

APO-FAMOTIDINE is available as a film-coated tablet to ease swallowing.

WARNINGS AND PRECAUTIONS

This medicine may not be suitable for some people. BEFORE you use APO-FAMOTIDINE talk to your doctor or pharmacist if:

• You are pregnant or breast-feeding;

• You have difficulty or pain on swallowing, severe vomiting, black stools, choking, or persistent stomach pains/ discomfort);
• 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 ulcer disease complications;
• You are experiencing unintended weight loss in association with your symptoms of acid indigestion or heartburn;
• 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 14 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.

INTERACTIONS WITH THIS MEDICATION

Before taking APO-FAMOTIDINE talk to your doctor or pharmacist if:

• You are using Itraconazole (for fungal infections).
• You are using calcium carbonate

PROPER USE OF THIS MEDICATION

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.

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 foods known to cause symptoms, and avoid or limit foods such as caffeine, chocolate, fatty foods, spicy foods and alcohol.
• Do not eat just before bedtime.
• Raise the head of your bed.
• Wear loose fitting clothing around your stomach.

Overdose:

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

APO-FAMOTIDINE is generally well tolerated.

Serious side effects and what to do about them

This is not a complete list of side effects. If you have any unexpected effects after taking APO-FAMOTIDINE contact your doctor or pharmacist.

Reporting Side Effects

HOW TO STORE IT

• Store these tablets at room temperature (15°C to 30°C) and protect from light and moisture.
• It is advisable to keep blisters in carton until all tablets are used.
• Keep this and all medicines out of the reach and sight of children.

MORE INFORMATION

If you want more information about APO-FAMOTIDINE:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last revised: January 27, 2020