Acid Control (Apotex, 20 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Each ACID CONTROL tablet is clinically proven to give fast and effective relief from heartburn, acid indigestion and sour or upset stomach due to excess stomach acid. ACID CONTROL when taken 10 to 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. ACID CONTROL contains a medicine that actually reduces the production of excess stomach acid that causes these symptoms. ACID CONTROL is different from antacids that only neutralize existing stomach acid, but do not stop stomach acid from being produced. ACID CONTROL actually stops tough heartburn before it starts. Just one ACID CONTROL 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 nonmedicinal ingredients are:

ACID CONTROL also contains: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red and ferric oxide yellow, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid and titanium dioxide.

What dosage forms it comes in:

ACID CONTROL (famotidine tablets 20 mg), are film coated and thus easy-to-swallow. Each beige coloured tablet contains 20 mg of famotidine and has APO over 20 embossed on one side.

WARNINGS AND PRECAUTIONS

This medicine may not be suitable for some people.

Before taking ACID CONTROL (FAMOTIDINE TABLETS 20 mg), 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 week) 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 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 you use ACID CONTROL talk to your doctor or pharmacist if:

• you are taking 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.

TIPS TO HELP AVOID ACID-RELATED SYMPTOMS

• Do not lie down or bend over soon after eating.
• If you are overweight, lose weight.
• If you smoke, stop or cut down.
• Certain foods are more likely to cause acid-related symptoms, so you should consider reducing or avoiding 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

ACID CONTROL 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.

This is not a complete list of side effects. For any unexpected effects while taking ACID CONTROL, contact your doctor or pharmacist.

HOW TO STORE IT

STORAGE CONDITIONS

Store at room temperature (15˚C to 30˚C). Protect from light and moisture.

Keep this and all medicines out of the 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 (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

MORE INFORMATION

If you want more information about ACID CONTROL:

• 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: September 17, 2019