Abbott-Pantoprazole - Consumer Medicine Information
|Condition:||Barrett's Esophagus, Duodenal Ulcer, Erosive Esophagitis, Gastritis (Gastritis/Duodenitis), GERD, Helicobacter Pylori Infection, Peptic Ulcer, Stress Ulcer Prophylaxis, Stomach Ulcer (Gastric Ulcer), Zollinger-Ellison Syndrome|
|Class:||Proton pump inhibitors|
About This Medication
What the Medication is Used For
Abbott- Pantoprazole 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
Abbott- Pantoprazole works by reducing the amount of acid made in your stomach.
When it Should not be Used
You should not take Abbott-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
What the Nonmedicinal Ingredients Are
Calcium stearate, crospovidone, ferric oxide yellow, hydroxy propyl cellulose, hypromellose, mannitol, methacrylicacid-ethylacrylate copolymer (1:1) dispersion 30%, propylene glycol, purified water, sodium carbonate anhydrous, talc, titanium dioxide, and triethyl citrate.
Composition of the brown ink: Shellac Glaze ~45% (20% Esterified) in Ethanol, N- Butyl Alcohol, Isopropyl Alcohol, Iron Oxide Black, Iron Oxide Red, Propylene Glycol, Iron Oxide Yellow and Ammonium Hydroxide 28%.
What Dosage Forms it Comes In
enteric-coated tablet, 20 mg and 40 mg of pantoprazole.
Warnings and Precautions
BEFORE you use Abbott-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 (Reyataz) advise your doctor as this may interact with Abbott-Pantoprazole;
- if you are allergic to pantoprazole or to the “non-medicinal” ingredients which are present in Abbott-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 Abbott-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 Abbott-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 Abbott-Pantoprazole.
Abbott-Pantoprazole 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 Abbott-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.
Abbott-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).
Abbott-Pantoprazole may be used in combination with two antibiotics to treat ulcers associated with Helicobacter pylori. Doses of Abbott-Pantoprazole and each of the antibiotics should be taken twice a day, or as prescribed by your doctor.
|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.|
If you forget to take one dose of Abbott-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, Abbott-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 Abbott-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 Abbott-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
- 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
Postal Locator 0701D
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.
The most recent version of this document plus the full Product Monograph, prepared for health professionals, can be found at: www.abbott.ca or by contacting the sponsor, Abbott Laboratories, Limited, Saint-Laurent, QC, H4S 1Z1 at: 1-800-699-9948.
This leaflet was prepared by Abbott Laboratories, Limited.
Last revised: June 3, 2015
Reyataz is a trademark of its respective owner and is not a trademark of Abbott Laboratories, Limited.