Panto-Byk: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

PANTO-BYK 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:

PANTO-BYK works by reducing the amount of acid made in your stomach.

When it should not be used:

You should not take PANTO-BYK 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 non-medicinal ingredients are:

calcium stearate, crospovidone, ferric oxide, mannitol, methylhydroxypropyl cellulose, poly (ethylacrylate, methacrylic acid), polysorbate 80, polyvidone, propylene glycol, anhydrous sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate.

What dosage forms it comes in:

enteric-coated tablet, 20 mg and 40 mg pantoprazole

WARNINGS AND PRECAUTIONS

BEFORE you use PANTO-BYK 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

  (Reyataz) advise your doctor as this may interact with PANTO-BYK

• if you are allergic to pantoprazole or to the non-medicinal ingredients which are present in PANTO- BYK.

• 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 PANTO-BYK 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 PANTO-BYK.

INTERACTIONS WITH THIS MEDICATION

Talk to your doctor or pharmacist if you are taking warfarin. Warfarin may interact with PANTO-BYK.

PANTO-BYK may interact with atazanavir sulphate (Reyataz) and methotrexate.

PROPER USE OF THIS MEDICATION

Usual adult dose:

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

PANTO-BYK 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).

IMPORTANT: PLEASE READ

PANTO-BYK (pantoprazole sodium) Page 37 of 37

PANTO-BYK may be used in combination with two antibiotics to treat ulcers associated with Helicobacter pylori. Doses of PANTO-BYK and each of the antibiotics should be taken twice a day, or as prescribed by your doctor.

Overdose:

In case of drug overdose, contact a health care 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 PANTO-BYK, 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, PANTO-BYK 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 PANTO-BYK, 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.

* most cases reported are not serious

This is not a complete list of side effects. For any unexpected effects while taking PANTO-BYK, 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
• 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 0701D 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 at:

http://www.nycomed.ca or by contacting the sponsor, Nycomed Canada Inc., at: 1-866-295-4636

Last revised: February 21, 2013.