Drug Details - Drug and Health Product Register (2024)

Company: NORA PHARMA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02471825NRA-PANTOPRAZOLEPANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)40 MGTABLET (DELAYED-RELEASE)ORAL
Search Reported Side Effects Report a Side Effect

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

NRA-PANTOPRAZOLE is used to treat stomach acid related problems. This includes:

  • Stomach ulcer.
    A stomach ulcer is a sore on the lining of the stomach. This is also known as a gastric ulcer.
  • Duodenal ulcer.
    A sore on the lining of the duodenum. The duodenum is the first part of the small intestine.
  • Duodenal ulcer caused by the bacteria Helicobacter pylori (H. pylori).NRA-PANTOPRAZOLE, is used in combination with two antibiotics.
  • Reflux esophagitis.
    This is a severe form of heartburn.
  • Symptoms of gastro-esophageal reflux disease (GERD).
    The symptoms include heartburn and acid regurgitation. GERD is a condition in which stomach acid backs up into your esophagus.
  • When taking Non-steroidal anti-inflammatory drugs (NSAIDs).
    Stops stomach and duodenal ulcers from forming.

What it does

NRA-PANTOPRAZOLE is a proton pump inhibitor. It reduces the amount of acid your stomach makes.

When it should not be used
What the non-medicinal ingredients are

Non-medicinal ingredients: Calcium stearate, colloidal silicon dioxide, crospovidone, mannitol, hydroxypropylmethyl cellulose,polyethylene glycol, sodium carbonate anhydrous, sodium starch glycollate, sodium hydroxide, Eudragit (contains: methacrylic acid-ethylacrylate copolymer, Sodium lauryl sulfate and polysorbate), opadry yellow contains: lecithin (soy), titanium dioxide, yellow iron oxide,polyvinyl alcohol, talc and xanthan gum).
Composition of printing ink: Shellac, isopropyl alcohol, black iron oxide, n-butyl alcohol, propylene glycol and ammonium hydroxide.

What dosage form it comes in

Delayed-Release Tablet, 40 mg

Warnings and precautions

Serious Warnings and Precautions

Do not use NRA-PANTOPRAZOLE if:

  • You are allergic to any of its ingredients. (See What are the ingredients in NRA-PANTOPRAZOLE?);
  • You are taking rilpivirine

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NRA-PANTOPRAZOLETalk about any health conditions or problems you may have, including if you:

  • are taking other medications (see The following may interact with NRA-PANTOPRAZOLE).
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breast feed. Pantoprazole has been found in human breast milk. Talk with your doctor.
  • suffer these effects:
    • unexplained weight loss
    • severe or persistent diarrhea
    • repeated vomiting
    • vomiting blood
    • dark stools
    • tiredness (anemia)
    • difficulty in swallowing
    • have a history of liver problems
  • have low magnesium in the body, which may cause symptoms such as:
    • - rapid heartbeat
    • dizziness, seizures
    • muscle cramping, twitches or spasms
  • are due to have a specific blood test (Chromogranin A)

Other warnings you should know about:
You should take NRA-PANTOPRAZOLE, exactly as prescribed. You will use the lowest dose and shortest time suitable for yourcondition. Talk to your doctor if you have any concerns about your treatment.
Depending on your condition, your doctor may tell you to use this type of medicine (proton pump inhibitors) for a longer period.
Using proton pump inhibitors for a long time (every day for a year or longer) may increase risks of broken bones of the hip, wrist or spine.Talk to your doctor about this risk.
Long term use of proton pump inhibitors may interfere with the absorption of Vitamin B12 from the diet. This may cause a shortage ofVitamin B12 in your body. Talk to your doctor.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplementsor alternative medicines.

Interactions with this medication

Warfarin, atazanavir, nelfinavir, saquinavir/ritonavir, methotrexate.

Proper use of this medication

How to take NRA-PANTOPRAZOLE:

  • Take NRA-PANTOPRAZOLE in the morning.
    • with or without food
  • Swallow the tablet(s) whole, with water.
  • Do not crush or chew the tablet(s).

Usual Dose

Usual adult dose:
Your doctor will have told you what dose to take for your condition. Follow your doctor’s directions carefully as they may bedifferent from the information provided in this leaflet.
NRA-PANTOPRAZOLE may be used in combination with two antibiotics to treat ulcers caused by H.pylori. NRAPANTOPRAZOLE and both antibiotics are to be taken twice a day, or as prescribed by your doctor.

Overdose

If you think you have taken too much NRA-PANTOPRAZOLE, contact your healthcare professional, hospital emergency department or regionalPoison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose. Take the next dose at yourregular time. Do not double doses.

Side effects and what to do about them

Like all medicines, NRA-PANTOPRAZOLE, may cause side effects. Side effects have generally been mild and did not last a long time.These are not all the possible side effects you may feel when taking NRA-PANTOPRAZOLE,

The most common side effects are:

  • headache
  • diarrhea
  • nausea

Tell your doctor right away if you have any of these symptoms:

  • new or worsening joint pain
  • rash on your cheeks or arms that gets worse in the sun

Your symptoms may get worse after stopping your medication. This may occur as your stomach may increase the production of acid.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk to your healthcare professional only if severe Talk to your healthcare professional in all cases Stop taking drug and get immediate help
RARE
Disturbances in vision*Most cases reported are not serious
ISOLATED CASES
Liver damage. Symptoms include yellow tinge to theskin and eyes.
Severe skin reactions Symptoms include Widespreadrash, itching, or hives. Peeling of the skin, blisterson the skin, mouth, nose, eyes and genitals are othersymptoms.
Muscle wasting
Clostridium difficile colitis (bowel inflammation).Symptoms include severe (watery or bloody)diarrhea, fever, and abdominal pain or tenderness.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk toyour healthcare professional.

How to store

Store NRA-PANTOPRAZOLE, at room temperature, 15°- 30°C.
Keep out of reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The CanadaVigilance Program does not provide medical advice.

More information

Read this carefully before you start taking NRA-PANTOPRAZOLE and each time you get a refill. This leaflet is a summary and will nottell you everything about this drug Talk to your healthcare professional about your medical condition and treatment and ask if there is anynew information about NRA-PANTOPRAZOLE

If you want more information about NRA-PANTOPRAZOLE:

  • Talk to your healthcare professional.
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient MedicationInformation by visiting the Health Canada website www.canada.ca/en/health-canada.html; by contacting NoraPharma Inc.; or by calling toll free number +1-855-627-2261.

This leaflet was prepared by
Nora Pharma Inc,
205-2900 Boul Cote-Vertu,
Saint-Laurent, Quebec
H4R 3E8

Date of Revision: March 20, 2019

Date modified:
Drug Details - Drug and Health Product Register (2024)
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