Details for: NRA-PANTOPRAZOLE
Company: NORA PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02471825 | NRA-PANTOPRAZOLE | PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) | 40 MG | TABLET (DELAYED-RELEASE) | ORAL |
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 medicinal ingredient is
Medicinal ingredients: Pantoprazole Sodium
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-ethyl
acrylate 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-PANTOPRAZOLE Talk 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 your
condition. 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 of
Vitamin B12 in your body. Talk to your doctor.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or 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 be
different 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
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 your regular 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.
| 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 the skin and eyes. | ✔ | ||
| Severe skin reactions Symptoms include Widespread rash, itching, or hives. Peeling of the skin, blisters on the skin, mouth, nose, eyes and genitals are other symptoms. | ✔ | ||
| 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 to your 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:
- Visiting the Web page on Adverse Reaction Reporting www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada/adverse-reaction-reporting.html for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
Read this carefully before you start taking NRA-PANTOPRAZOLE and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug Talk to your healthcare professional about your medical condition and treatment and ask if there is any new 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 Medication Information by visiting the Health Canada website www.canada.ca/en/health-canada.html; by contacting Nora Pharma 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