Patient Medication Information: uses, side effects, how to take - RBX-Pantoprazole
ABOUT THIS MEDICATION
What the medication is used for:
RBX-PANTOPRAZOLE is used to treat acid-related stomach problems such as stomach ulcers (also known as gastric ulcers), duodenal ulcers (including ulcers that are associated with a bacterium called Helicobacter pylori), reflux esophagitis (a severe form of heartburn), symptoms of gastro-esophageal reflux disease (heartburn and acid regurgitation), and the prevention of gastrointestinal damage (such as erosions and/or ulcers in the stomach /duodenum) and symptoms caused by non-steroidal anti-inflammatory drugs [(NSAIDs) medicines commonly used to treat arthritis and certain muscle conditions] when individuals must continue to take NSAIDs and where these individuals are considered to have an increased risk of developing gastrointestinal damage.
What it does:
RBX-PANTOPRAZOLE works by reducing the amount of acid made in your stomach.
When it should not be used:
You should not take RBX-PANTOPRAZOLE if you think you might be allergic to any of the ingredients (see “What the non-medicinal ingredients are”). You should not use RBX-PANTOPRAZOLE at the same time as atazanavir sulphate (Reyataz).
What the medicinal ingredient is:
pantoprazole sodium
What the non-medicinal ingredients are:
calcium stearate, crospovidone, ferric oxide, mannitol, methylhydroxypropyl cellulose, poly (ethylacrylate, methacrylic acid), polysorbate 80, polyvidone, propylene glycol, anhydrous sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate.
What dosage forms it comes in:
- enteric-coated tablet, 20 mg and 40 mg pantaprazole
WARNINGS AND PRECAUTIONS
BEFORE you use RBX-PANTOPRAZOLE talk to your doctor or pharmacist:
- about all health problems you have now or have had in the past, including liver problems;
- about all other medicines you take, including ones you can get without a prescription;
- if you are allergic to pantoprazole or to the “non-medicinal” ingredients which are present in RBX-PANTOPRAZOLE;
if you are pregnant, plan to become pregnant or are breastfeeding. In one study, a single case of pantoprazole excretion in human breastmilk was detected. The clinical relevance of this finding is not known. Discuss this with your doctor.
- if you suffer unexplained weight loss, recurrent vomiting or vomiting blood, dark stools, fatigue (anemia) or difficulty in swallowing.
INTERACTIONS WITH THIS MEDICATION
Talk to your doctor or pharmacist if you are taking warfarin. Warfarin may interact with RBX-PANTOPRAZOLE.
RBX-PANTOPRAZOLE may interact with atazanavir sulphate (Reyataz).
PROPER USE OF THIS MEDICATION
Usual adult dose:
Your doctor will have explained why you need to be treated with RBX-PANTOPRAZOLE and will have told you what dose to take. Follow your doctor’s directions carefully as they may be different from the information provided in this leaflet.
RBX-PANTOPRAZOLE should be taken in the morning, with or without food. Swallow the tablet(s) whole, with water. Do not crush or chew the tablet(s).
RBX-PANTOPRAZOLE may be used in combination with two antibiotics to treat ulcers associated with Helicobacter pylori. Doses of RBX-PANTOPRAZOLE and each of the antibiotics should be taken twice a day, or as prescribed by your doctor.
Overdose:
If you or someone you know takes a lot more than the recommended dose (an overdose) you should contact a doctor or pharmacist immediately.
Missed Dose:
If you forget to take one dose of RBX-PANTOPRAZOLE, 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.
IMPORTANT: PLEASE READ
RBX-PANTOPRAZOLE (pantoprazole sodium) Page 36 of 36
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like any medication, RBX-PANTOPRAZOLE may cause side effects in some people. When side effects have been reported, they have been generally mild and did not last a long time. Headache, diarrhea and nausea are the most common side effects; less often rash, itchiness and dizziness can occur. If any of these become troublesome, consult your doctor. If you experience any unusual or unexpected symptoms while using RBX-PANTOPRAZOLE, consult your doctor.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptom / effect | Stop taking drug and call your doctor or pharmacist | |
| Uncommon | Disturbances in vision* | √ |
| Very Rare | Liver damage (symptoms include yellowing of the skin and eyes) | √ |
| Isolated Cases | Severe skin reactions such as, Stevens-Johnson-Syndrome, Erythema multiforme, Exfoliative dermatitis, Toxic epidermal necrolysis, Photosensitivity | √ |
| Isolated Cases | Muscle wasting | √ |
*Most cases reported are not serious
This is not a complete list of side effects. For any unexpected effects while taking RBX-PANTOPRAZOLE, contact your doctor or pharmacist.
HOW TO STORE IT
Keep your tablets at room temperature (15°C to 30°C) and in a safe place, where children cannot reach them.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and: -Fax toll-free to 1-866-678-6789, or
-Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701C Ottawa, ON K1A 0K9
Postage Paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full Product Monograph, prepared for health professionals, can be found by contacting the sponsor:
Ranbaxy Pharmaceuticals Canada Inc., at: 1-866-840-1340.
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200
Mississauga, Ontario L4W 0A5