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Details for: PMS-RABEPRAZOLE EC

Company: PHARMASCIENCE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02310805PMS-RABEPRAZOLE ECRABEPRAZOLE SODIUM10 MGTABLET (ENTERIC-COATED)ORAL
02310813PMS-RABEPRAZOLE ECRABEPRAZOLE SODIUM20 MGTABLET (ENTERIC-COATED)ORAL
Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Safety Review - Proton Pump Inhibitors - Assessing the Potential Risk of Clostridium difficile Infection
Summary Safety Review - Proton Pump Inhibitors (PPIs) - Assessing the risk of a type of skin reaction [Subacute Cutaneous Lupus Erythematosus (SCLE)]

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

pms-RABEPRAZOLE EC 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 pms-RABEPRAZOLE EC with antibiotics such as amoxicillin and clarithromycin, as directed by your doctor.
    • following the information on the antibiotics provided to you by the pharmacist.
What it does

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

When it should not be used
  • rabeprazole or other medications in this class.
  • the "nonmedicinal" ingredients in pms-RABEPRAZOLE EC tablets (see What are the ingredients in pms-RABEPRAZOLE EC).
  • the antibiotics amoxicillin or clarithromycin if these are used with pms-RABEPRAZOLE EC to treat ulcers caused by H. pylori.

Do not use pms-RABEPRAZOLE EC if you are:

  • taking rilpivirine
What the medicinal ingredient is

rabeprazole sodium

What the non-medicinal ingredients are

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, 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, Zein.

What dosage form it comes in

Enteric-coated tablets of 10 mg and 20 mg

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-RABEPRAZOLE EC. 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 pms-RABEPRAZOLE EC may prevent normal absorption of vitamin B12 from the diet and could lead to vitamin B12 deficiency. Talk to your doctor.

Using pms-RABEPRAZOLE EC 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 pms RABEPRAZOLE E 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 pms RABEPRAZOLE EC.

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

Interactions with this medication
  • ketoconazole
  • digoxin
  • warfarin
  • antiretroviral drugs such as atazanavir, nelfinavir, saquinavir
  • methotrexate

Proper use of this medication
  • Take pms-RABEPRAZOLE EC 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 pms-RABEPRAZOLE EC even when you start to feel better. If you stop taking pms-RABEPRAZOLE EC tablets too soon, your symptoms may return.
  • Take pms-RABEPRAZOLE EC 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 infectionǂ 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 pms-RABEPRAZOLE EC 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 pms-RABEPRAZOLE EC, contact your health care 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 pms-RABEPRAZOLE EC 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.

Side effects and what to do about them

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

Headache and diarrhea are the most common side effects experienced with pms-RABEPRAZOLE EC. 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 pms-RABEPRAZOLE EC and contact your healthcare professional immediately.

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

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).
  • 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.

How to store

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.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

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.

More information
  • Talk to your healthcare professional.
  • For questions or concerns contact the manufacturer, Pharmascience Inc. (www.pharmascience.com)
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (hc-sc.gc.ca/index-eng.php); the manufacturer’s website www.pharmascience.com, or by calling 1-888-550-6060.

This leaflet was prepared by
              Pharmascience Inc.
              Montréal, Québec
              H4P 2T4

Last revised: February 5, 2019

Date modified: