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Sandoz Rabeprazole

(rabeprazole)



How does this medication work? What will it do for me?

Rabeprazole belongs to the class of medications known as proton pump inhibitors (PPIs). It works by slowing or preventing the production of acid in the stomach. Rabeprazole is used to treat and maintain healing of gastroesophageal reflux disease (GERD). It is also used to treat symptoms, such as heartburn and regurgitation, of non-erosive reflux disease (NERD).

It is also used for short-term treatment in the healing and relief of symptoms associated with duodenal and gastric ulcers. Rabeprazole is used in combination with antibiotics to treat ulcers caused by the bacterium Helicobacter pylori. Finally, rabeprazole is used for long-term treatment of conditions associated with constant production of excess acid in the stomach, including Zollinger-Ellison syndrome.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The dose of rabeprazole used depends on the condition being treated.

To treat non-erosive reflux disease (NERD), the recommended adult dose of rabeprazole is 10 mg to 20 mg, taken once daily for up to 4 weeks.

To treat gastroesophageal reflux disease (GERD), the recommended adult dose of rabeprazole is 20 mg, taken once daily. The recommended adult dose for maintaining long-term healing of GERD is 10 mg to 20 mg, taken once daily. The usual length of treatment for GERD is 4 to 8 weeks.

To treat duodenal ulcer, the recommended adult dose of rabeprazole is 20 mg, taken once daily for a period of up to 4 weeks.

To treat gastric ulcer, the recommended adult dose of rabeprazole is 20 mg, taken once daily for a period of up to 6 weeks.

To treat ulcer caused by Helicobacter pylori infection, the recommended adult dose is 20 mg, taken twice daily for 7 days in combination with 2 antibiotics, usually amoxicillin and clarithromycin.

To treat Zollinger-Ellison syndrome, the recommended adult starting dose of rabeprazole is 60 mg, taken once daily. Some people may require higher doses. Your doctor will adjust the dose of this medication as needed.

Rabeprazole delayed release tablet has been designed to work throughout the day, and therefore needs to be taken only once daily. This medication may be taken with or without food. Swallow the tablets whole with a beverage. Do not chew, crush, or split the tablets.

Most people will experience some improvements in symptoms 1 to 2 weeks after starting rabeprazole. It may take up to 4 weeks for people to experience maximum benefit from this medication.

If the symptoms that were causing you problems have not gone away by the time you finish your medication or as discussed with your doctor, call your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

10 mg
Each pink, round, biconvex, enteric-coated tablet with "R10" printed on one side contains rabeprazole sodium 10 mg. Nonmedicinal ingredients: calcium hydroxide, dibutyl sebacate, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose phthalate, low-substituted hydroxypropyl cellulose, mannitol, sodium stearyl fumarate, talc, and titanium dioxide.

20 mg
Each yellow, round, biconvex enteric-coated tablet "R20" printed on one side contains rabeprazole sodium 20 mg. Nonmedicinal ingredients: calcium hydroxide, dibutyl sebacate, ferric oxide yellow, hypromellose, hypromellose phthalate, low-substituted hydroxypropyl cellulose, mannitol, sodium stearyl fumarate, talc, and titanium dioxide.

Who should NOT take this medication?

Rabeprazole should not be taken by anyone who:

  • is allergic to rabeprazole or to any of the ingredients of the medication
  • is allergic to other proton pump inhibitors

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • diarrhea
  • headache
  • mouth sores
  • nausea
  • rash
  • runny nose
  • vomiting
  • weight changes

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abdominal pain
  • joint pain
  • mouth sores that are getting worse
  • shortness of breath
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • sore muscles
  • swelling of legs or hands
  • unusual tiredness or weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • convulsions (seizures)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of a severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

HEALTH CANADA ADVISORY

April 4, 2013

Health Canada has issued new information concerning the use of rabeprazole. To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.

Previous advisories on rabeprazole were issued on February 16, 2012 and on October 19, 2012.

To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Liver disease: People with reduced liver function or liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if rabeprazole passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children and adolescents: The safety and effectiveness of using this medication have not been established for children and adolescents under 18 years of age.

What other drugs could interact with this medication?

There may be an interaction between rabeprazole and any of the following:

  • atazanavir
  • "azole" antifungal medications (e.g., itraconazole, ketoconazole, posaconazole)
  • clopidogrel
  • dasatinib
  • delavirdine
  • erlotinib
  • mesalamine
  • methotrexate
  • nelfinavir
  • tacrolimus

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material © 1996-2014 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

Mackenzie Health / 10 Trench St. Richmond Hill, On. L4C 4Z3 / Main Hospital Site: (905) 883-1212 / TTY Service: (905) 883-2123