Ratio-Pantoprazole: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ratio-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:

ratio-PANTOPRAZOLE works by reducing the amount of acid made in

your stomach.

When it should not be used:

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

What the medicinal ingredient is:

pantoprazole sodium

What the non-medicinal ingredients are: crospovidone, glyceryl behenate, hydroxypropyl methylcellulose, lactose monohydrate, colloidal anhydrous silica, iron oxide black, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, polyvinyl alcohol, propylene glycol, sodium bicarbonate, sodium lauryl sulphate, talc, titanium dioxide and triacetin.

What dosage forms it comes in:

enteric-coated tablet, 20 mg and 40 mg pantaprazole

WARNINGS AND PRECAUTIONS

BEFORE you use ratio-PANTOPRAZOLE talk to your doctor or pharmacist:

x about all health problems you have now or have had in the past,

including liver problems;

x about all other medicines you take, including ones you can get

without a prescription;

x if you are allergic to pantoprazole or to the "non-medicinal"

ingredients which are present in ratio-PANTOPRAZOLE; x 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; x 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 ratio-PANTOPRAZOLE.

ratio-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 ratio-

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.

ratio-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 take too much ratio-PANTOPRAZOLE tablets at once, contact your doctor, pharmacist or your regional Poison Control Centre immediately.

Missed Dose:

If you forget to take one dose of ratio-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

IMPORTANT: PLEASE READ ratio-PANTOPRAZOLE (pantoprazole sodium extended release tablets) Page 29 of 29

This is not a complete list of side effects. For any unexpected effects while taking ratio-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 ③ Call toll-free at 1-866-234-2345 ③ 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 obtained by contacting the sponsor, ratiopharm inc., at: 1-800-337-2584

Last revised: November 24, 2009