Details for: SANDOZ RABEPRAZOLE
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02314177 | SANDOZ RABEPRAZOLE | RABEPRAZOLE SODIUM | 10 MG | TABLET (ENTERIC-COATED) | ORAL |
| 02314185 | SANDOZ RABEPRAZOLE | RABEPRAZOLE SODIUM | 20 MG | TABLET (ENTERIC-COATED) | ORAL |
Summary Reports
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
Sandoz Rabeprazole is used in adults to:
- symptomatic relief and healing of duodenal ulcers;
- symptomatic relief and healing of 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 Sandoz 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.
What it does
Sandoz Rabeprazole is a medicine called a proton pump inhibitor (PPI). Sandoz Rabeprazole works by reducing the amount of acid made in your stomach.
When it should not be used
Do not use Sandoz Rabeprazole if you are allergic to:
- rabeprazole or other medications in this class
- the “nonmedicinal” ingredients in Sandoz Rabeprazole tablets. (See What are the ingredients in Sandoz Rabeprazole)
- the antibiotics amoxicillin or clarithromycin if these are used with Sandoz Rabeprazole to treat ulcers caused by H. pylori
Do not use Sandoz Rabeprazole if you are:
- taking rilpivirine
What the medicinal ingredient is
rabeprazole sodium
What the non-medicinal ingredients are
calcium hydroxide, dibutyl sebacate, hypromellose, hypromellose phthalate, low-substituted hydroxypropyl cellulose, mannitol, sodium stearyl fumarate, talc, titanium dioxide.
The 10 mg tablet also contains ferric oxide red and ferric oxide yellow as colouring agents. The 20 mg tablet contains ferric oxide yellow as a colouring agent.
What dosage form it comes in
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 Sandoz 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 Sandoz Rabeprazole may prevent normal absorption of vitamin B12 from the diet and could lead to vitamin B12 deficiency. Talk to your doctor
Using Sandoz Rabeprazole for a long period of time (a year or longer) increase the risk of fractures of the hip, wrist or spine. Talk to your doctor about your risk.
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
The following may interact with Sandoz Rabeprazole:
- ketoconazole
- digoxin
- warfarin
- atazanavir,
- methotrexate
Proper use of this medication
- Take Sandoz 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 Sandoz Rabeprazole even when you start to feel better. If you stop taking Sandoz Rabeprazole too soon, your symptoms may return.
- Take Sandoz 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† | 20 mg | twice daily in combination with antibiotic drugs (clarithromycin and amoxicillin) preferably with the morning and evening meals | one week |
Overdose
Missed Dose
If you forget to take one dose of Sandoz 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.
Side effects and what to do about them
Like all medicines, Sandoz Rabeprazole can cause side effects.
Headache and diarrhea are the most common side effects experienced with Sandoz Rabeprazole. Less common side effects are rash, itchiness and dizziness. If any of these become troublesome, consult your doctor.
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 Sandoz Rabeprazole and contact your healthcare professional immediately.
If you experience symptoms of low magnesium levels in your body, your doctor may stop Sandoz 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
- a 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
Store in original container between 15°C and 25°C, protected from moisture and heat.
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:
- Visiting the Web page on Adverse Reaction Reporting ((https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffectcanada/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..
More information
If you want more information about Sandoz 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 (health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.
This leaflet was prepared by Sandoz Canada Inc.
Last revised: 01 October 2019.