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Tecta

Brand Name: Tecta
Common Name: pantoprazole magnesium

How does this medication work? What will it do for me?

Pantoprazole magnesium belongs to the family of medications called proton pump inhibitors (PPIs). Proton pump inhibitors are used to treat conditions where a reduction in stomach acid is needed, such as stomach ulcers, duodenal (intestinal) ulcers, reflux esophagitis (a severe form of heartburn), and symptoms of gastroesophageal reflux disease (GERD; e.g., heartburn and acid regurgitation). Pantoprazole is also sometimes used along with antibiotics to treat duodenal ulcers that are caused by bacteria known as H. pylori.

Pantoprazole works to reduce the amount of acid the stomach produces by blocking the action of an enzyme (proton pump) that produces acid in the stomach.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.


How should I use this medication?

The recommended adult dose to treat reflux esophagitis is 40 mg once daily in the morning for 4 to 8 weeks.

To treat symptoms of GERD, including heartburn and acid regurgitation, the recommended dose is 40 mg once daily for up to 4 weeks. Contact your doctor if the symptoms have not improved after 4 weeks. Other, more serious, causes of heartburn and acid regurgitation may need to be ruled out.

To treat duodenal (intestinal) ulcers, the recommended adult dose is 40 mg once daily in the morning for 2 to 4 weeks.

The recommended dose of pantoprazole magnesium to treat gastric (stomach) ulcers, is 40 mg once daily in the morning for 4 to 8 weeks.

To treat duodenal (intestinal) ulcers caused by H. pylori in adults, the dose of pantoprazole magnesium is 40 mg twice daily taken with amoxicillin 1,000 mg twice daily and clarithromycin 500 mg twice daily, or pantoprazole magnesium 40 mg twice daily taken with metronidazole 500 mg twice daily and clarithromycin 500 mg twice daily. The usual duration of this treatment is 7 days.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Pantoprazole magnesium tablets must be swallowed whole. Do not chew or crush the tablets. Take this medication with a glass of water in the morning before, during, or after breakfast.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.


What form(s) does this medication come in?

Each yellow, round, biconvex, enteric-coated tablet marked "40" on one side contains pantoprazole 40 mg as pantoprazole magnesium. Nonmedicinal ingredients: anhydrous sodium carbonate, mannitol, crospovidone, povidone, calcium stearate, hypromellose, titanium dioxide, ferric oxide, propylene glycol, and poly (ethylacrylate, methacrylic acid) and triethyl citrate.


Who should NOT take this medication?

Do not take pantoprazole magnesium if you:

  • are allergic to pantoprazole magnesium or any ingredients of the medication
  • are also taking the medication atazanavir


What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • diarrhea
  • dizziness
  • flu-like symptoms (headache, chills, muscle or joint pain, tiredness)
  • gas
  • headache
  • itching
  • nausea
  • tiredness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • signs of liver damage (such as yellow skin or eyes, abdominal pain, dark urine, pale or clay-coloured stools, loss of appetite)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
  • signs of a serious allergic reaction (e.g., abdominal cramps; swelling of the face, throat, or tongue; hives; or difficulty breathing)
  • signs of muscle damage (unexplained muscle pain, tenderness or weakness, or brown or discoloured urine - especially if you also have a fever or a general feeling of being unwell)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.


Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

April 4, 2013

Health Canada has issued new information concerning the use of Tecta® (pantoprazole magnesium). To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.

Previous advisories on Tecta® were issued on February 16, 2012 and on October 19, 2012.

To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Cancer: There is some evidence to suggest that people who take pantoprazole magnesium are at slightly increased risk of developing certain types of cancer, such as liver, thyroid, or stomach cancers. Talk to your doctor if you have concerns.

Infections: Pantoprazole magnesium changes the acidity of the digestive system, particularly the stomach. This increases the risk of certain types of infections in the digestive system. If you experience diarrhea with fever, chills, nausea or severe abdominal cramps, contact your doctor as soon as possible.

Kidney function: The kidneys are responsible for removing pantoprazole magnesium from the body. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: If you have severe liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Severe stomach problems: If you experience recurrent vomiting, difficulty swallowing, blood in the stool (dark stools), significant unintentional weight loss, fatigue, or are coughing up blood, contact your doctor right away. These may be symptoms of other medical problems that should be checked out by your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication may pass into breast milk. If you are a breast-feeding mother and are taking pantoprazole magnesium, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.


What other drugs could interact with this medication?

There may be an interaction between pantoprazole magnesium and any of the following:

  • amoxicillin
  • atazanavir
  • "azole"-type antifungals (e.g., itraconazole, ketoconazole, posaconazole)
  • clarithromycin
  • clopidogrel
  • dasatanib
  • delavirdine
  • mesalamine
  • methotrexate
  • nelfinavir
  • rifampin
  • rilpivirine
  • tetracycline
  • tetrahydrocannabinol (THC)
  • topotecan
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.





All material copyright MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

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