Patient Medication Information: uses, side effects, how to take - Pantoprazole (Cobalt Pharmaceuticals)
ABOUT THIS MEDICATION
What the medication is used for:
PANTOPRAZOLE is used to treat acid-related stomach problems such as stomach ulcers (also known as gastric ulcers), duodenal ulcers, reflux esophagitis (a severe form of heartburn), symptoms of gastro-esophageal reflux disease (heartburn and acid regurgitation).
What it does:
PANTOPRAZOLE works by reducing the amount of acid made in your stomach.
When it should not be used:
You should not take PANTOPRAZOLE if you think you might be allergic to any of the ingredients (see “What the non-medicinal ingredients are”). You should not use PANTOPRAZOLE at the same time as atazanavir sulphate (Reyataz).
What the medicinal ingredient is:
pantoprazole sodium
What the important non-medicinal ingredients are:
Colloidal anhydrous silica, crospovidone,
hydroxypropylmethylcellulose, magnesium stearate, mannitol, sodium lauryl sulphate, talc. The tablet coatings contain: glycerol monostearate, iron oxide yellow, lecithin (soya), methacrylic acid – ethyl acrylate copolymer, polysorbate 80, polyvinyl alcohol – partially hydrolysed, titanium dioxide, talc, triethyl citrate, quinoline yellow aluminum lake, xanthan gum
What dosage forms it comes in:
PANTOPRAZOLE are available as 40 mg enteric-coated tablets.
WARNINGS AND PRECAUTIONS
BEFORE you use 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 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 PANTOPRAZOLE.
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 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.
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).
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.
| In the event of overdosage, contact your | ||
| doctor, hospital emergency department or regional Poison Control | ||
| Centre. | ||
Missed Dose:
If you forget to take one dose of 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 THEM
Like any medication, 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 PANTOPRAZOLE, consult your doctor.
IMPORTANT: PLEASE READ
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||
| Only if severe | In all cases | ||||
| Uncommon | Disturbances in vision* | T | |||
| Very Rare | Liver damage (symptoms include yellowing of the skin and eyes) | T | |||
| Isolated Cases | Severe skin reactions such as, Stevens- Johnson- Syndrome, Erythema multiforme, Exfoliative dermatitis, Toxic epidermal necrolysis, Photosensitivity | T | |||
| Isolated Cases | Muscle wasting | T | |||
* Most cases reported are not serious.
This is not a complete list of side effects. For any unexpected effects while taking 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 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. | |||
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Cobalt Pharmaceuticals Inc. at: 1-866-254-6111