Patient Medication Information: uses, side effects, how to take - AG-Pantoprazole Sodium
What is AG-PANTOPRAZOLE SODIUM used for?
AG-PANTOPRAZOLE SODIUM 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 SODIUM 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.
How does AG-PANTOPRAZOLE SODIUM work?
AG-PANTOPRAZOLE SODIUM is a proton pump inhibitor. It reduces the amount of acid your stomach makes.
What are the ingredients in AG-PANTOPRAZOLE SODIUM?
Medicinal ingredients: pantoprazole sodium sesquihydrate.
Non-medicinal ingredients: Calcium stearate, colloidal silicon dioxide, crospovidone, mannitol, hydroxypropyl methylcellulose, polyethylene glycol, sodium carbonate anhydrous, sodium starch glycolate, sodium hydroxide, Eudragit (contains: methacrylic acid and 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.
AG-PANTOPRAZOLE SODIUM comes in the following dosage forms:
- Delayed-Release Tablets, 20 mg and 40 mg.
Do not use AG-PANTOPRAZOLE SODIUM if:
- You are allergic to any of its ingredients. (See What are the ingredients in AG-PANTOPRAZOLE SODIUM?);
- You are taking rilpivirine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG-PANTOPRAZOLE SODIUM. 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 SODIUM).
are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. Pantoprazole has been found in human breast milk. Talk with your doctor.
- 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:
Tell your doctor if you experience the following symptoms before taking AG-PANTOPRAZOLE SODIUM:
- unexplained weight loss.
- severe or persistent diarrhea.
- repeated vomiting.
- vomiting blood.
- dark stools.
- tiredness (anemia).
- difficulty in swallowing.
You should take AG-PANTOPRAZOLE SODIUM 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.
Using AG-PANTOPRAZOLE SODIUM for a long period of time may cause a growth in your stomach (polyp), especially after one year.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with AG-PANTOPRAZOLE SODIUM:
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How to take AG-PANTOPRAZOLE SODIUM:
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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 SODIUM may be used in combination with two antibiotics to treat ulcers caused by H. pylori. AG-PANTOPRAZOLE SODIUM 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.
What are possible side effects from using AG-PANTOPRAZOLE SODIUM?
If you think you, or a person you are caring for, have taken too much AG-PANTOPRAZOLE SODIUM, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Like all medicines, AG-PANTOPRAZOLE SODIUM 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 have when taking AG-PANTOPRAZOLE SODIUM. If you experience any side effects not listed here, tell your healthcare professional.
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 and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
Disturbances in vision. Most cases reported are not serious. | ✓ | ||
| UNKNOWN | |||
| Liver damage. Symptoms include a yellow tinge to the skin and eyes. | ✓ | ||
| Severe Cutaneous Adverse Reactions (SCAR) (Severe Skin Reactions): Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet). You may also experience fever, chills, body aches, shortness of breath, or enlarged lymph nodes. | ✓ | ||
| Muscle wasting. | ✓ | ||
| Clostridium difficile colitis (bowel inflammation). Symptoms include severe (watery or bloody) diarrhea, fever, and abdominal pain or tenderness. | ✓ | ||
| Microscopic colitis (inflammation of the gut). Symptoms include chronic | |||
Serious side effects and what to do about them
| Symptom / effect | |
|---|---|
| Talk to your healthcare professional | Stop taking drug and get immediate medical help |
| Only if severe | In all cases |
watery diarrhea, abdominal pain, cramps or bloating, weight loss, nausea, uncontrollable bowel movement, signs of dehydration such as extreme thirst, less frequent urination, dark-coloured urine, fatigue, dizziness, confusion. The symptoms of microscopic colitis can come and go frequently. If you have watery diarrhea that lasts more than a few days, contact your doctor. | ✓ |
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.
Storage:
Store AG-PANTOPRAZOLE SODIUM at room temperature, 15-30°C.
Keep out of reach and sight of children.
If you want more information about AG-PANTOPRAZOLE SODIUM:
- Talk to your healthcare professional
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 (https://www.canada.ca/en/health-canada/services/drugs-health-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.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 450-449-9272.
Angita Pharma Inc.
1310, rue Nobel
Boucherville, Quebec
J4B 5H3, Canada