Patient Medication Information: uses, side effects, how to take - Pro-Rabeprazole

What is PRO-RABEPRAZOLE used for?

PRO-RABEPRAZOLE is used in adults to:

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 PRO-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 PRO-RABEPRAZOLE work?

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

What are the ingredients in PRO-RABEPRAZOLE?

Medicinal ingredient: rabeprazole sodium

Non-medicinal ingredients:

10 mg Tablets: Antifoam, Hydroxypropyl Cellulose, Hypromellose, Iron Oxide Black, Iron Oxide Red, Lecithin, Magnesium Oxide, Magnesium Stearate, Mannitol, Methacrylic Acid Copolymer, Polyethylene Glycol, Shellac Glaze, Sodium Lauryl Sulfate, Talc, Titanium Dioxide, Triethyl Citrate and Zein.

20 mg Tablets: Ammonium Hydroxide, FD&C Red No. 40 Aluminum Lake, Hydroxypropyl Cellulose, Hypromellose, Magnesium Oxide, Magnesium Stearate, Mannitol, Methacrylic Acid Copolymer, Polyethylene Glycol, Propylene Glycol, Shellac Glaze, Sodium Lauryl Sulfate, Talc, Titanium Dioxide, Triethyl Citrate, Yellow Iron Oxide and Zein.

PRO-RABEPRAZOLE comes in the following dosage forms:

Enteric-coated tablets of 10 mg and 20 mg

Do not use PRO-RABEPRAZOLE if you are allergic to:

rabeprazole or other medications in this class.
the "non-medicinal" ingredients in PRO-RABEPRAZOLE tablets (see What are the ingredients in PRO-RABEPRAZOLE).
the antibiotics amoxicillin or clarithromycin if these are used with PRO-RABEPRAZOLE to treat ulcers caused by H. pylori.

Do not use PRO-RABEPRAZOLE if you are:

taking rilpivirine

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

all health problems you have now or have had in the past.
any liver problems.
if you 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.
if you are taking methotrexate.
if you are pregnant or planning to become pregnant.
if you are breast-feeding or planning to breast-feed.
if you are due to have a specific blood test (Chromogranin A).

Other warnings you should know about:

Long-term use of PRO-RABEPRAZOLE may prevent normal absorption of vitamin B₁₂from the diet and could lead to vitamin B₁₂deficiency. Talk to your doctor.

Using PRO-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 PRO-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 PRO-RABEPRAZOLE.

Tell your healthcare professional about all the medicines you take, including any drugs (prescription and non-prescription), vitamins, minerals, natural supplements or alternative medicines.

The following may interact with PRO-RABEPRAZOLE:

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

How to take PRO-RABEPRAZOLE:

Take PRO-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 PRO-RABEPRAZOLE even when you start to feel better. If you stop taking PRO-RABEPRAZOLE tablets too soon, your symptoms may return. • Take PRO-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:

Condition	Adult Dose	How Often	How Long
reflux symptoms with esophagitis	20 mg	once daily	four weeks
reflux symptoms without esophagitis, such as heartburn and regurgitation	10 mg to a maximum of 20 mg	once daily	four weeks
duodenal ulcer	20 mg	once daily	up to four weeks
stomach ulcer	20 mg	once daily	up to six weeks
ulcer caused by H. pylori infection^ǂ	20 mg	twice daily in combination with antibiotic drugs (clarithromycin and amoxicillin), preferably with the morning and evening meals	one week

^ǂIf you are given PRO-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:

If you think you have taken too much PRO-RABEPRAZOLE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to take one dose of PRO-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 PRO-RABEPRAZOLE?

Like all medicines, PRO-RABEPRAZOLE tablets can cause side effects.

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

Treatment in combination with antibiotics: If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking PRO-RABEPRAZOLE and contact your healthcare professional immediately.

If you experience symptoms of low magnesium levels in your body, your doctor may stop PRO-RABEPRAZOLE.

Tell your doctor right away if you have any of these symptoms:

seizures.
dizziness.
abnormal or fast heartbeat.
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).
new or worsening joint pain.
rash on your cheeks or arms that gets worse in the sun.
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.

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
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:

Keep your tablets stored at room temperature (15°C to 30°C) and protected from moisture.

Keep out of the sight and reach of children.

If you want more information about PRO-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); or by contacting Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca.

Pro Doc Ltée

Laval, Québec

H7L 3W9

Pro-Rabeprazole: Uses, Side Effects and Dosage