Patient Medication Information: uses, side effects, how to take - Van-Pantoprazole
ABOUT THIS MEDICATION
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
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PART III: CONSUMER INFORMATION
PrVAN-Pantoprazole pantoprazole sodium
This leaflet is part III of a three-part “Product Monograph” published when VAN-Pantoprazole was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about VAN-Pantoprazole. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for:
VAN-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:
VAN-Pantoprazole works by reducing the amount of acid made in your stomach.
When it should not be used:
You should not take VAN-Pantoprazole if you think you might be allergic to any of the ingredients (see “What the non-medicinal ingredients are”).
What the medicinal ingredient is:
pantoprazole sodium
What the non-medicinal ingredients are:
Calcium stearate, colloidal silicon dioxide, crospovidone, mannitol, hydroxypropylmethyl cellulose, polyethylene glycol, sodium carbonate anhydrous, sodium starch glycollate, sodium hydroxide, Eudragit (contains: methacrylic acid-ethyl acrylate copolymer, Sodium lauryl sulfate and polysorbate) and opadry yellow contains: lecithin (soy), titanium dioxide, yellow iron oxide, polyvinyl alcohol, talc and xanthan gum).
What dosage forms it comes in:
Delayed-Release Tablet, 40 mg pantoprazole
BEFORE you use VAN-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 taking atazanavir sulphate (Reyataz)
advise your doctor as this may interact with VAN-Pantoprazole.
- if you are allergic to pantoprazole or to the non-medicinal ingredients which are present in VAN-Pantoprazole
if you are pregnant, plan to become pregnant or are breastfeeding. Excretion into human milk has been reported, discuss this with your doctor.
- if you suffer unexplained weight loss, recurrent vomiting or vomiting blood, dark stools, fatigue (anemia) or difficulty in swallowing
- If you have severe and/or persistent diarrhea, because products which reduce stomach acid have been associated with a small increase in infectious diarrhea
- if you experience any cardiovascular (e.g. heart) or neurological (e.g. brain) symptoms including palpitations (rapid heartbeat), dizziness, seizures, and tetany (muscle condition with symptoms such as twitching, spasms, cramps and convulsions) as these may be signs of hypomagnesaemia (low magnesium levels in the body)
People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take VAN-Pantoprazole exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take VAN-Pantoprazole.
Talk to your doctor or pharmacist if you are taking warfarin. Warfarin may interact with VAN-Pantoprazole.
VAN-Pantoprazole may interact with atazanavir sulphate (Reyataz).
Usual adult dose:
Your doctor will have explained why you need to be treated with VAN-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.
WARNINGS AND PRECAUTIONS
HOW TO STORE IT
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VAN-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).
VAN-Pantoprazole may be used in combination with two antibiotics to treat ulcers associated with
Helicobacter pylori. Doses of VAN-Pantoprazole and each of the antibiotics should be taken twice a day, or as prescribed by your doctor.
Overdose:
In case of drug overdose, contact a healthcare professional (e.g. doctor), hospital emergency department or regional Poision Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you forget to take one dose of VAN-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.
SIDE EFFECTS AND WHAT TO DO ABOUT
Like any medication, VAN-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 VAN-Pantoprazole, consult your doctor.
After stopping your medication, your symptoms may get worse and your stomach may increase the acid production.
Treatment in combination with antibiotics:
If you experience symptoms such as severe (watery or bloody) diarrhea, fever, abdominal pain or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this happens, stop taking these drugs and call your healthcare professional immediately.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptom / effect | Stop taking drug and call your doctor or pharmacist | |
| Rare | Disturbances in vision* | √ |
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptom / effect | Stop taking drug and call your doctor or pharmacist | |
| Isolated cases | 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 | √ |
This is not a complete list of side effects. For any unexpected effects while taking VAN-Pantoprazole, contact your doctor or pharmacist.
Keep your tablets at room temperature (15°C to 30°C) in the recommended packaging and in a safe place, where children cannot reach them.
GS AND PRECATIONS
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:
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- 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
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect 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.
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Vanc Pharmaceuticals Inc. Building 152, 11782 River Road
Richmond, BC V6X 1Z7 www.Vancpharm.com
Email: safety@Vancpharm.com
Helpline: 1-877-929-0699
Date of Revision: September 23, 2014