Apo-Rabeprazole: Uses, Side Effects and Dosage

What is APO-RABEPRAZOLE used for?

APO-RABEPRAZOLE is used in adults to treat conditions where reducing stomach acid production is needed, such as:

• relieve symptoms and heal duodenal ulcers.
• relieve symptoms and heal stomach ulcers.

• heal gastroesophageal reflux disease (GERD) and relieve its symptoms such as:

  • the burning feeling that rises from the chest to the throat (heartburn).
  • the flow of bitter/sour juice into the mouth (regurgitation).
• treat symptoms of non-erosive reflux disease (NERD) such as heartburn and regurgitation.
• maintain longer term healing of gastroesophageal reflux disease (GERD).
• treat rare conditions where excess acid is produced in the stomach (e.g., Zollinger-Ellison syndrome).

• treat ulcers caused by infection with the bacterium, Helicobacter pylori (H. pylori), and prevent these ulcers from coming back by:

  • taking APO-RABEPRAZOLE with antibiotics such as amoxicillin and clarithromycin, as directed by your doctor.
  • following the information on the antibiotics provided to you by the pharmacist.

How does APO-RABEPRAZOLE work?

APO-RABEPRAZOLE is a medicine called a proton pump inhibitor (PPI). APO-RABEPRAZOLE works by reducing the amount of acid made in your stomach.

What are the ingredients in APO-RABEPRAZOLE?

Medicinal ingredients: Rabeprazole sodium

Non-medicinal ingredients: Anhydrous lactose, colloidal silicon dioxide, ferric oxide red (10 mg), ferric oxide yellow (20 mg), magnesium stearate, methacrylic acid copolymer dispersion (polysorbate 80, sodium lauryl sulfate), talc, titanium dioxide and triethyl citrate.

APO-RABEPRAZOLE comes in the following dosage forms:

Tablets of 10 mg and 20 mg

Do not use APO-RABEPRAZOLE if:

• you are allergic to:

  • rabeprazole or other medications in this class
  • the “non-medicinal” ingredients in APO-RABEPRAZOLE tablets (see What are the ingredients in APO-RABEPRAZOLE?)
• you are taking rilpivirine
• you are unable to take amoxicillin or clarithromycin if you are using APO-RABEPRAZOLE to treat ulcers caused by an infection (H. pylori)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-RABEPRAZOLE. Talk about any health conditions or problems you may have, including if you:

• have any liver problems
• experience symptoms including palpitations (rapid heartbeat), dizziness, seizures, twitching, spasms, muscle weakness, cramps and convulsions. These may be signs of low magnesium levels in your blood
• are taking methotrexate

• are pregnant or planning to become pregnant

• are breast-feeding or planning to breast-feed
• are due to have a specific blood test (Chromogranin A)

Other warnings you should know about:

Long-term use of APO-RABEPRAZOLE may prevent normal absorption of vitamin B₁₂ from the diet and could lead to vitamin B₁₂ deficiency. Talk to your doctor.

Using APO-RABEPRAZOLE for a long period of time (a year or longer) may increase the risk of fractures of the hip, wrist or spine. Talk to your doctor about your risk.

Using medicines like APO-RABEPRAZOLE for a long period of time may cause a growth in your stomach (polyp). This can lead to intestinal blockage or bleeding. Talk to your doctor if you experience nausea or stomach pain while you are taking APO-RABEPRAZOLE.

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 APO-RABEPRAZOLE:

• ketoconazole
• digoxin
• warfarin
• antiretroviral drugs such as atazanavir, nelfinavir, saquinavir
• methotrexate

How to take APO-RABEPRAZOLE:

• Take APO-RABEPRAZOLE exactly as prescribed by your doctor, usually for a specific number of weeks.
• Use the lowest dose and shortest time as determined by your doctor.
• Do not stop taking APO-RABEPRAZOLE even when you start to feel better. If you stop taking APO-RABEPRAZOLE too soon, your symptoms may return.
• Take APO-RABEPRAZOLE with or without meals.
• Swallow tablets whole with a liquid. Do not chew or crush the tablets.
• Talk to your doctor if you have any concerns.

Usual dose:

1. 1. If you are given APO-RABEPRAZOLE in combination with antibiotic drugs, it is important that you take all medications at the correct time of day and for the entire treatment period to ensure they will work properly. Studies have shown that patients who take their medications as prescribed have better ulcer healing rates and greater success in getting rid of their H. pylori infection.

Overdose:

Missed dose:

If you forget to take one dose of APO-RABEPRAZOLE medication, take a tablet as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed tablet at all. Never double-up on a dose to make up for the one you have missed; just go back to your regular schedule.

What are possible side effects from using APO-RABEPRAZOLE?

Like all medicines, APO-RABEPRAZOLE can cause side effects.

Headache and diarrhea are the most common side effects experienced with APO-RABEPRAZOLE. Less common side effects are rash, itchiness and dizziness. If any of these become troublesome, consult your doctor.

If you experience symptoms of low magnesium levels in your body, your doctor may stop APO-RABEPRAZOLE. Tell your doctor right away if you have any of these symptoms:

• seizures.
• dizziness.
• abnormal or fast heart beat.
• jitteriness.
• jerking movements or shaking (tremors).
• muscle weakness.
• spasms of the hands and feet.
• cramps or muscle aches.
• spasm of the voice box.
• fracture (broken bone).
• blood in stool.

Stopping your PPI therapy after taking it for a long time, may cause your symptoms to get worse and your stomach may increase acid production. Carefully follow your doctor’s instructions when discontinuing your PPI therapy.

Serious side effects and what to do about them

Serious side effects and what to do about them

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

Storage:

Keep your tablets stored at controlled room temperature (15°C to 25°C) and protected from heat and humidity.

Keep out of reach and sight of children.

If you want more information about APO-RABEPRAZOLE:

• 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 (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: MAR 26, 2024