Consumer Information for: AG-PANTOPRAZOLE
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
AG-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).
AG-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 stomachacid backs up into your esophagus. - When taking Non-steroidal anti-inflammatory drugs (NSAIDs).
Stops stomach and duodenal ulcers from forming.
What it does
AG-Pantoprazole is a proton pump inhibitor. It reduces the amount of acid your stomach makes.
When it should not be used
- You are allergic to any of its ingredients. (See What are the ingredients in AG-Pantoprazole?);
- You are taking rilpivirine.
What the medicinal ingredient is
pantoprazole sodium.
What the non-medicinal 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 form it comes in
- Tablet, 20 mg and 40 mg.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG-Pantoprazole. Talk about any health conditions or problems you may have, including if you:
- are taking other medications (see The following may interact with AG-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.
Other warnings you should know about:
You should take AG-Pantoprazole exactly as prescribed. You will use the lowest dose and shortest time suitable for your condition. Talk to you 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
- Take AG-Pantoprazole in the morning.
- with or without food.
- Swallow the tablet(s) whole with water.
- Do not crush or chew the tablet(s).
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.
AG-Pantoprazole may be used in combination with two antibiotics to treat ulcers caused by H. pylori. AG-Pantoprazole 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, AG-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 AG-Pantoprazole.
The most common side effects are:
- headache.
- diarrhea.
- nausea.
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 call your doctor or pharmacist |
|---|---|---|---|
| RARE. | |||
| Disturbances in vision. Most cases reported are not serious. |
✔ | ||
| ISOLATED CASES. | |||
| Liver damage. Symptoms include a yellow tinge to the skin and eyes. | ✔ | ||
| Serious 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 AG-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/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, bymail 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
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals andincludes this Patient Medication Information by visiting the Health Canada website
This leaflet was prepared by Angita Pharma Inc.
Last revised: July 13, 2018
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| JAMP DUTASTERIDE | 02484870 | JAMP PHARMA CORPORATION | DUTASTERIDE 0.5 MG |