NTP-Pantoprazole: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NTP-PANTOPRAZOLE (pantoprazole sodium sesquihydrate) is used to treat the following 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:

NTP-PANTOPRAZOLE works by reducing the amount of acid made in your stomach.

When it should not be used:

You should not take NTP-PANTOPRAZOLE delayed-release tablets if you think you might be allergic to any of the ingredients (see “What the non-medicinal ingredients are”). You should not use NTP-PANTOPRAZOLE at the same time as atazanavir sulphate (Reyataz).

What the medicinal ingredient is:

pantoprazole sodium sesquihydrate

What the nonmedicinal ingredients are:

Black iron oxide, Calcium Carbonate, Calcium Stearate, D&C Yellow #10 Aluminium Lake, FD&C Yellow #6 Aluminium Lake, Hypromellose, Iron Oxide Yellow, Lactose Monohydrate, Low-Substituted Hydroxypropyl Cellulose, Methacrylic Acid Copolymer, Microcrystalline Cellulose, Polyethylene glycol, Propylene Glycol, Shellac Glaze, Sodium Carbonate Anhydrous, Stearic Acid, Talc, Titanium Dioxide, Triethyl Citrate.

What dosage forms it comes in:

Delayed-Release Tablets; 20 mg & 40 mg

WARNINGS AND PRECAUTIONS

BEFORE you use NTP-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 “nonmedicinal” ingredients which are present in NTP-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.
• If you have severe and/or persistent diarrhea, because products which reduce stomach acid have been associated with a small increase in infectious diarrhea.

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 dose:

Your doctor will have explained why you need to be treated with NTP-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.

NTP-PANTOPRAZOLE may 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 accidental overdose, consult a physician immediately or contact your regional Poison Control Centre.

In case of drug overdose, contact a healthcare professional (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 NTP-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.

IMPORTANT: PLEASE READ

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like any medication, NTP-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 NTP-PANTOPRAZOLE, consult your doctor.

* Most cases reported are not serious

This is not a complete list of side effects. For any unexpected effects while taking NTP-PANTOPRAZOLE, contact your doctor or pharmacist.

HOW TO STORE IT

Keep your tablets at room temperature (15 to 30ºC) and in a safe place, where children cannot reach them. Protect from light.

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 found by contacting NT Pharma Canada Ltd. at: 1-800-268-4127 ext. 5005 (English Canada) or druginfo@tevacanada.com

or 1-877-777-9117 (French Canada)

NT Pharma Canada Limited

5691 Main Street

Stouffville, Ontario

LA4 1H5

Last revised: November 25, 2011