What Nexium is used for and how to use it
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Nexium - Consumer Medicine Information

Manufacture: AstraZeneca
Country: Canada
Condition: Barrett's Esophagus, Duodenal Ulcer Prophylaxis, Erosive Esophagitis, GERD, Helicobacter Pylori Infection, NSAID-Induced Gastric Ulcer, Pathological Hypersecretory Conditions, Zollinger-Ellison Syndrome
Class: Proton pump inhibitors
Form: Tablets, Powder
Ingredients: esomeprazole magnesium trihydrate, cellulose microcrystalline, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid ethylacrylate copolymer, polyethylene glycol, polysorbate, synthetic paraffin, sodium stearyl fumarate, sugar spheres, talc, titanium dioxide, triethyl citrate, citric acid, crospovidone, dextrose, glycerol monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid copolymer type C, polysorbate, sugar spheres, talc, triethyl citrate, xanthan gum

NEXIUM

esomeprazole

About Nexium

What the medication is used for

In adults, NEXIUM is used for the treatment of acid-related disorders such as:

  • reflux esophagitis (tissue damage caused by stomach content flowing back up the food pipe) and symptoms of gastroesophageal reflux disease (GERD) in patients with reflux esophagitis;
  • duodenal ulcers caused by infection with a bacterium called Helicobacter pylori in combination with other antibiotics, and to help reduce the risk of these ulcers from coming back;
  • the symptoms of nonerosive reflux disease (NERD), which are not related to tissue damage within the food pipe, such as: a burning feeling rising from the chest towards the neck (heartburn) and the flow of bitter/sour juice into the mouth (regurgitation);
  • rare pathological hypersecretory conditions, including ❝Zollinger-Ellison syndrome❞, which cause the stomach to produce large amounts of acid.

NEXIUM is also used to heal and/or reduce the risk of ulcers that can be caused by medication you may be taking for pain or joint problems such as NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) or acetylsalicylic acid (i.e. Aspirin).

In children (1- 17 years of age), NEXIUM is used for the treatment of acid-related disorders such as:

  • reflux esophagitis (tissue damage caused by stomach content flowing back up the food pipe) and symptoms of gastroesophageal reflux disease (GERD) in patients with reflux esophagitis;
  • the symptoms of nonerosive reflux disease (NERD), which are not related to tissue damage within the food.

pipe, such as: a burning feeling rising from the chest towards the neck (heartburn) and the flow of bitter/sour juice into the mouth (regurgitation).

What it does

NEXIUM works by causing less acid to be made in your stomach.

When it should not be used

If you are allergic to the active ingredient esomeprazole or any of the other ingredients of NEXIUM (see What the important nonmedicinal ingredients are). If you think you may be allergic, ask your doctor for advice.

What the medicinal ingredient is

NEXIUM contains esomeprazole magnesium trihydrate as the active ingredient.

What the important nonmedicinal ingredients are

Each NEXIUM tablet contains the following non-medicinal ingredients (listed in alphabetical order): cellulose microcrystalline, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid ethylacrylate copolymer, polyethylene glycol, polysorbate, synthetic paraffin, sodium stearyl fumarate, sugar spheres, talc, titanium dioxide, triethyl citrate.

NEXIUM granules for oral suspension contain the following non-medicinal ingredients (listed in alphabetical order): citric acid, crospovidone, dextrose, glycerol monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid copolymer type C, polysorbate, sugar spheres, talc, triethyl citrate, xanthan gum.

Check with your doctor or pharmacist if you think you may be allergic to any of the above ingredients.

What dosage forms it comes in

NEXIUM 20 mg tablets come in blister packages that contain 28 or 30 tablets. NEXIUM 40 mg tablets come in blister packages that contain 28, 30 or 60 tablets, or bottles that contain 100 tablets.

NEXIUM 10 mg granules for oral suspension come in unit dose sachets in cartons of 30.

Warnings and Precautions

BEFORE or DURING your use of NEXIUM talk to your doctor or pharmacist about:

  • symptoms that may be a sign of a more serious problem in your stomach or intestine such as: trouble swallowing, unplanned weight loss, vomiting blood or food, or black (blood-stained) stools;
  • if you are pregnant or trying to become pregnant;
  • if you are allergic to esomeprazole or any other ingredients or components of the container;
  • if you have health problems now or have had any in the past;
  • other medications you take, including ones you can buy without a prescription.

Talk to your health care provider about your risk of bone fracture if you are taking NEXIUM for a long time. People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take NEXIUM exactly as prescribed by your doctor.

Long term use of proton pump inhibitors may prevent normal absorption of Vitamin B12 from the diet and could lead to Vitamin B12 deficiency. You should take NEXIUM exactly as prescribed by your doctor.

Interactions with Nexium

Blood levels of some drugs may be influenced if NEXIUM is taken at the same time as drugs used to prevent fungal infections (itraconazole, ketoconazole, voriconazole), anxiety (diazepam), epilepsy (phenytoin), drugs to speed up stomach emptying (cisapride*), transplant rejection (tacrolimus), poor circulation in the legs (cilostazol*), heart problems (digoxin), treatment for tuberculosis (rifampin), St John's Wort (Hypericum perforatum) or a certain type of anticancer drug (erlotinib or any other anticancer drug from the same class). However, none of these interactions have been shown to change the effectiveness of NEXIUM or the other drug.

* not marketed in Canada

Drugs used for blood clotting (warfarin or coumarin derivatives, clopidogrel) have been reported to interact with NEXIUM. Speak to your doctor or pharmacist if you are taking any of these drugs. Use of NEXIUM with clopidogrel should be avoided.

NEXIUM may decrease the effectiveness of some drugs used for HIV treatment; atazanavir and nelfinavir should not be used with NEXIUM.

If you are taking a high dose of methotrexate (a drug used in high doses to treat cancer), NEXIUM may need to be temporarily withdrawn.

During episodic dosing of NEXIUM when needed, your response to potential drug interactions may change as compared to daily dosing during the entire, initial treatment period.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines.

Proper use of Nexium

Administration

NEXIUM may be taken with food or on an empty stomach.

Tablets

The tablet may be swallowed whole with water. It may also be put in half a glass of water where it will break apart. This will make it easier to swallow. Be sure to swallow all the tiny pellets that come out of the tablet without chewing them. Don't let the pellets sit in water for more than 30 minutes before drinking them. After drinking, rinse the glass with water and drink this as well.

Granules for Oral suspension

Empty the contents of each sachet into a container containing 1 tablespoon (15 mL) of water. Stir. Leave for a few minutes to thicken. The mixture will appear as a thick yellow suspension with small white and/or brownish granules. Stir again and drink within 30 minutes. If any material remains after drinking, add more water, stir, and drink right away.

Usual dose

Adults

Take all doses of NEXIUM as directed by your doctor. Do so even when you feel well. In some cases, daily doses are needed to control your pain and symptoms and to help damaged areas heal. The suggested dose for treating acute disease is 20 to 40 mg once a day for 2 to 8 weeks. Your doctor may suggest that you continue taking NEXIUM 20 mg each day. This is to keep your symptoms from coming back.

Follow the directions given to you by your doctor. They may differ from the information contained in this leaflet.

NEXIUM may be used together with antibiotic drugs for one week to treat ulcers caused by Helicobacter pylori. This also helps to reduce the risk of these ulcers from coming back. Your prescription may say NEXIUM 1-2-3A. This tells the pharmacist to give you three different drugs (NEXIUM and two antibiotics). The pharmacist should also give you information on the two antibiotics that will be used in combination with NEXIUM.

If you receive NEXIUM plus antibiotic drugs, take all three drugs twice each day. Do so at the correct time each day for one week. This will ensure they work properly. Studies have shown that patients who take their drugs as prescribed, have better ulcer healing rates and greater success getting rid of their Helicobacter pylori infection.

It is important to take NEXIUM until your doctor tells you to stop. This is true even if you start to feel better in a few days. NEXIUM needs to be taken for the full treatment duration to help correct acid problems.

Maintenance Treatment of NERD (on-demand) dose

After initial treatment of NERD, your doctor may suggest that you take NEXIUM 20 mg once daily, as needed, if symptoms of heartburn and regurgitation return periodically. Contact your doctor if your symptoms get worse, persist or if new symptoms arise.

Children (1 – 17 years of age)

Take all doses of NEXIUM as directed by your doctor. Do so even when you/your child feels well. NEXIUM needs to be taken for the full treatment duration to help correct acid problems.
Follow the directions given to you by your doctor. They may differ from the information contained in this leaflet.

Children (1 – 11 years of age)

The suggested dose for treating acute disease is 10 mg (1 sachet) or 20 mg (2 sachets) once daily for 8 weeks.

Children (12 – 17 years of age)

The suggested dose for treating acute disease is 20 or 40 mgonce a day for 2 to 8 weeks.

How to use a compliance pack

There are 14 days of labeled tablets, with one extra to make 15. All 15 tablets, including the one labeled "Take this tablet last", are exactly the same. Once you have finished the 14 labeled tablets in the blister pack, take the one marked "Take this tablet last" before starting your next blister pack.

To treat ulcers caused by Helicobacter pylori in adults, take one 20 mg tablet from each of the two blisters (2 tablets per day) that match the day you start the pack.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you/your child miss a dose of NEXIUM, and remember within 12 hours, take the tablet/sachet as soon as possible. Then go back to the regular schedule. If more than 12 hours have passed, do not take the missed dose. Do not double the dose. Just take the next dose on time.

Side Effects of Nexium and what to do about them

Like any drug, NEXIUM may cause side effects in some people. Side effects that may occur are usually mild. They usually go away a short time after starting NEXIUM. These side effects may not be caused by NEXIUM in your case, but only a doctor can assess this. If these become bothersome (or exceed 1-2 days), discuss with your doctor:

Common: nausea, stomach upset, diarrhea, headache

Uncommon: dry mouth, dizziness, insomnia, feeling of burning/prickliness/numbing, swelling of extremities, feeling sleepy, vertigo

Rare: taste disorders, nervousness, hair loss, increased sweating

Treatment in combination with antibiotics: If you experience symptoms such as severe (bloody or repeated watery) diarrhea, with or without fever, abdominal pain or tenderness, you may have bowel inflammation caused by a bacterial infection (Clostridium difficile). If this happens call your doctor or pharmacist immediately and stop taking the drug combination.

Long-term use of proton pump inhibitors may lead to low blood magnesium in some people; and when blood magnesium is lower than normal it has been reported in the literature that this may also lead to low blood calcium and low blood potassium.

As with other proton pump inhibitors, stopping NEXIUM therapy after taking it for a long time, may cause an increase in secretion of stomach acid and associated acid-related symptoms. Carefully follow your doctor's instructions when discontinuing your NEXIUM therapy.

If you experience any bothersome or unusual effects while using NEXIUM, check with your doctor or pharmacist.

Serious side effects of nexium, how often they happen and what to do about them

Symptom / effectTalk with
your doctor or
pharmacist in
all cases
Stop taking
drug and call
your doctor or
pharmacist
Rare (frequency of greater than or equal to 1 in 10 000 patients but less than 1 in 1000 patients)
skin reactions (such as rash,
dermatitis, itching and/or hives)
X
blurred visionX
depressionX
confusionX
shortness of breathX
inflammation in the mouthX
severe allergic reaction (such
as swelling or anaphylactic
reaction/shock)
X
muscle painX
blood disorders (reduced
number of cells in the blood,
low blood sodiumθ)
X
inflammation of liver (skin
and eyes appear yellow)
X
gastrointestinal fungal infectionX
photosensitivityX
sore jointsX
feeling illX
Very Rare (frequency of less than 1 in 10 000 patients)
severe skin disorders (blisters,
ulcers and/or lesions)
X
aggressionX
hallucinationsX
severely impaired liver functionX
decreased consciousnessX
inflammation of the kidneyX
muscular weaknessX
development of breasts in
males
X
low blood magnesiumθ
(which may result in low
blood calcium and/or low
blood potassium)
X
Inflammation in the gut
(leading to diarrhea)
X

θ These would only be seen if a blood test was taken.

How to Store Nexium

  • Keep all tablets sealed in the blister strips and the granules for oral suspension sealed in the sachet until it is time for a dose. If you do not, moisture from the air may damage the drug.
  • Keep NEXIUM well out of reach of children.
  • Keep NEXIUM at room temperature (15-30°C).
  • Do not keep NEXIUM in the bathroom medicine cabinet or other warm, moist places.
  • Do not use NEXIUM after the expiry date marked on the pack.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information about Nexium

NOTE: This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing.

For the most current information, the Consumer Information Leaflets plus the full Product Monograph, prepared for health professionals, can be found at:

www.astrazeneca.ca,

or by contacting the sponsor, AstraZeneca Canada Inc. at:

Customer Inquiries – 1 (800) 668-6000,

Renseignements – 1 (800) 461-3787.