Patient Medication Information: uses, side effects, how to take - Pantoprazole (Sorres Pharma)
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, (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:
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”).
What the medicinal ingredient is:
Pantoprazole sodium
What the nonmedicinal ingredients are:
Calcium Stearate, Crospovidone, Hydroxypropyl Cellulose, Hydroxypropyl Methylcellulose, Mannitol, Methacrylic Acid Copolymer, Pharmaceutical ink, Polyethylene Glycol, Sodium Carbonate Anhydrous, Talc, Titanium Dioxide, Triethyl Citrate, Yellow Iron Oxide, Zein F4000.
What dosage forms it comes in:
Enteric-coated tablet: 20 mg and 40 mg pantoprazole
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 taking atazanavir sulphate advise your doctor as this may interact with PANTOPRAZOLE
- if you are allergic to pantoprazole or to the nonmedicinal ingredients which are present in 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 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 PANTOPRAZOLE.
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 and methotrexate.
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).
PANTOPRAZOLE may be used in combination with two antibiotics to treat ulcers associated with Helicobacter pylori. Doses of PANTOPRAZOLE and each of the antibiotics should be taken twice a day, or as prescribed by your doctor.
Overdose:
IMPORTANT: PLEASE READ
PANTOPRAZOLE Product Monograph Page 39 of 39
In case of drug overdose, contact a healthcare practioner (e.g. doctor), hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.
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.
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 seek immediate emergency medical attention | |||
| Rare | Disturbances in vision* | √ | ||
| 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 | √ | ||
*most cases reported are not serious
This is not a complete list of side effects. For any unexpected effects while taking PANTROPRAZOLE, contact your doctor or pharmacist.
HOW TO STORE IT
Keep your tablets between 15˚C and 30˚C, in tight containers 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:
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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, or
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.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Sorres Pharma Inc., at 1-888-550-6060.
Sorres Pharma Inc.
Montréal, Québec H4P 2T4