Patient Medication Information: uses, side effects, how to take - Q-Pantoprazole
ABOUT THIS MEDICATION
What the medication is used for:
Q-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).
What it does:
Q-PANTOPRAZOLE works by reducing the amount of acid made in your stomach.
When it should not be used:
You should not take Q-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
What the non-medicinal ingredients are: betacyclodextrin, calcium stearate, crospovidone, ferric oxide, hydroxy propyl cellulose, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, povidone, propylene glycol, sodium carbonate anhydrous, titanium dioxide, and triethyl citrate.
What dosage forms it comes in:
enteric-coated tablet, 40 mg pantoprazole
WARNINGS AND PRECAUTIONS
BEFORE you use Q-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 HIV protease inhibitors such as atazanavir sulphate (Reyataz) or nelfinavir mesylate (Viracept) advise your doctor as they may interact with Q-PANTOPRAZOLE
- if you are allergic to pantoprazole or to the non-medicinal ingredients which are present in Q-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)
Under rare circumstances, supervised by your doctor, proton pump inhibitors might be used for long periods. You should take Q-PANTOPRAZOLE exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed.
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. Talk to your doctor about your risk of bone fracture if you take Q-PANTOPRAZOLE.
Long term use of proton pump inhibitors may prevent normal absorption of Vitamin B12 from the diet and could lead to Vitamin B12 deficiency. Talk to your doctor.
INTERACTIONS WITH THIS MEDICATION
Talk to your doctor or pharmacist if you are taking warfarin. Warfarin may interact with Q-
PANTOPRAZOLE.
Q-PANTOPRAZOLE may interact with atazanavir sulphate (Reyataz), nelfinavir mesylate (Viracept) and methotrexate.
| IMPORTANT: PLEASE READ |
PROPER USE OF THIS MEDICATION
Usual adult dose:
Your doctor will have explained why you need to be treated with Q-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.
Q-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 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 Q-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, Q-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 Q-
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 Q-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 see or reach them.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect. NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document can be found at:
www.qdpharmaceuticals.ca.
The full product monograph prepared for health professionals can be obtained by contacting the sponsor, QD Pharmaceuticals ULC, at: 1-800-661-3429
Revised on: July 24, 2015