Patient Medication Information: uses, side effects, how to take - PHL-Pantoprazole
ABOUT THIS MEDICATION
What the medication is used for:
phl-PANTOPRAZOLE is used (short-term, up to 7 days) to treat acid-related stomach problems such as reflux esophagitis (a severe form of heartburn), and pathological hypersecretory conditions (conditions in which the stomach produces large amounts of acid) including Zollinger-Ellison syndrome (ZES). phl-PANTOPRAZOLE is used mainly in hospitals in patients who cannot take oral medication.
What it does:
phl-PANTOPRAZOLE works by reducing the amount of acid made in your stomach.
When it should not be used:
You should not take phl-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 sesquihydrate.
What the non medicinal ingredients are:
Sodium hydroxide and water.
What dosage forms it comes in:
Powder for injection : 40 mg pantoprazole/vial
Your doctor might switch you to pantoprazole tablets as soon as you can start taking oral medications again.
WARNINGS AND PRECAUTIONS
Your doctor will decide if you should receive phl-PANTOPRAZOLE. BEFORE you use phl-PANTOPRAZOLE talk to your doctor or pharmacist:
about all health problems you have now or have had in the
past;
about all other medications you take, including ones you
can get without a prescription;
- if you are taking atazanavir sulphate advise your doctor as this may interact with phl-PANTOPRAZOLE;
- if you are allergic to pantoprazole;
if you are pregnant, plan to become pregnant or are breastfeeding. Excretion into human milk has been reported, discuss this with your doctor;
- about any past problems with the amount of zinc in your blood;
- 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 phl-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 phl-PANTOPRAZOLE.
INTERACTIONS WITH THIS MEDICATION
Talk to your doctor or pharmacist if you are taking warfarin. Warfarin may interact with phl-PANTOPRAZOLE. phl-PANTOPRAZOLE may interact with atazanavir sulphate and methotrexate.
Laboratory test interactions with phl-PANTOPRAZOLE: Talk to your doctor if you are to take a tetrahydrocannabinol (THC / Cannabis) urine screening test, as phl-PANTOPRAZOLE can provide a false positive result.
PROPER USE OF THIS MEDICATION
Your doctor will decide what an appropriate dosage of phl-PANTOPRAZOLE is for you.
Usual adult dose:
For reflux esophagitis the recommended dosage is 40 mg once daily.
For hypersecretory conditions including Zollinger-Ellison syndrome (ZES) the recommended dosage is 80 mg every 12 hours.
IMPORTANT: PLEASE READ
phl-PANTOPRAZOLE Product Monograph Page 29 of 29 Overdose:
In case of drug overdose, contact a healthcare professional (e.g. doctor), hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.
Missed Dose:
Contact your doctor or pharmacist immediately.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like any medication, phl-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, nausea/vomiting, and general abdominal discomfort are the most common side effects; less often inflammation or bruises from the injection, itchiness, and rash can occur. If any of these become troublesome, consult your doctor. If you experience any unusual or unexpected symptoms while using phl-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 phl-PANTOPRAZOLE, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15ºC and 30ºC and protect from light.
REPORTING 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:
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, Pharmel Inc. at, 1-888-550-6060.
Pharmel Inc.
Montréal, Québec, H4P 2T4