Consumer Information for: PANTOPRAZOLE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


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), 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 sesquihydrate

What the non-medicinal ingredients are

Calcium stearate, cellulose microcrystalline, crospovidone, ferric oxide black, ferric oxide red, ferric oxide yellow, hydroxypropylcellulose, hypromellose, macrogol, methacrylic acid – ethyl acrylate copolymer, polysorbate 80, ponceau 4R aluminium lake, povidone, quinoline yellow aluminium lake, shellac, silica-colloidal anhydrous, sodium carbonate anhydrous, sodium laurilsulfate, titanium dioxide, triethyl citrate.

What dosage form it comes in

Delayed-Release tablets of 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 non-medicinal 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).

Overdose

In case of drug overdose, contact a healthcare practitioner (e.g. doctor), hospital emergency department or regional Poison Control Centre 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.

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*
Isolated Cases
Liver damage (symptoms include yellowing of the skin and eyes)
Severe skin reactions such as, Stevens-Johnson-Syndrome, erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis, photosensitivity
Muscle wasting

*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

Store in a dry place at room temperature (between 15°C and 30°C) and keep out of reach of children.

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:

  • 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 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 obtained by contacting the sponsor, Dominion Pharmacal , at: 1-888-550-6060.

This leaflet was prepared by:

Dominion Pharmacal
Montreal, Quebec
H4P 2T4

Last revised: March 27, 2015