nexium-consumer-information-leaflet-en

NEXIUM

PATIENT MEDICATION INFORMATION

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

NEXIUM

esomeprazole delayed release tablets

esomeprazole delayed release granules for suspension

Read this carefully before you start taking NEXIUM 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 NEXIUM.

What is NEXIUM used for?

NEXIUM is used in adults to treat problems caused by too much acid in the stomach such as:

• reflux esophagitis (tissue damage caused by the stomach acid and juices moving up the

foodpipe).

• symptoms of reflux disease (e.g. heartburn, backup of stomach contents to the throat).

• duodenal ulcers (sores on the first part of the intestine) caused by a bacterium, Helicobacter

pylori.

• symptoms of nonerosive reflux disease (NERD), not related to tissue damage of the food pipe

such as:

o a burning feeling that moves up the food pipe (heartburn).

o a sour or bitter taste moving up to the mouth.

• a rare condition where the stomach produces too much acid (Zollinger-Ellison syndrome).

• ulcers caused by nonsteroidal anti-inflammatory drugs (drugs for pain and sore joints).

NEXIUM is used in children 1-17 years old to treat:

• reflux esophagitis (tissue damage caused by the stomach acid and juices moving up the

foodpipe).

• symptoms of reflux disease (e.g. heartburn, backup of stomach contents to the throat).

• symptoms of nonerosive reflux disease (NERD), not related to tissue damage of the food pipe

such as:

o a burning feeling that moves up the food pipe (heartburn).

o a sour or bitter taste moving up to the mouth.

How does NEXIUM work?

NEXIUM is a medicine called a proton pump inhibitor (PPI). NEXIUM works by causing less acid to

be made in your stomach.

What are the ingredients in NEXIUM?

Medicinal ingredients: esomeprazole magnesium trihydrate

Non-medicinal ingredients:

NEXIUM tablet (delayed release): 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 suspension (delayed release): 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 comes in the following dosage forms:

NEXIUM

Tablets (delayed release): 20 mg and 40 mg

Granules for suspension (delayed release): 10 mg per sachet

Do not use NEXIUM if you:

• are allergic to esomeprazole, substituted benzimidazoles or any of the other ingredients of

NEXIUM or component of the container (see What are the ingredients in NEXIUM?).

• are taking rilpivirine, a medicine used to treat HIV infection.

To help avoid side effects and ensure proper use, talk to your healthcare professional before

you take NEXIUM. Talk about any health conditions or problems you may have, including if

you:

• have had any health problems in the past.

• are breastfeeding or planning to breastfeed.

• are due to have a specific blood test (Chromogranin A).

Other warnings you should know about:

NEXIUM is not recommended for use in patients under 1 year of age.

This medicine should be used at the lowest dose and for the shortest time suitable for your

condition. Talk to your healthcare professional if you have any concerns about your treatment.

Serious Side Effects: NEXIUM can cause serious side effects, including:

• Serious Skin Reactions: In very rare cases, serious or life-threatening skin reactions have

been reported with PPIs, such as NEXIUM.

o Drug reaction with eosinophilia and systemic symptoms (DRESS),

o Stevens-Johnson Syndrome (SJS),

o toxic epidermal necrosis (TEN)

o erythema multiforme

o acute generalized exanthematous pustulosis (AGEP)

• Serious Stomach and Intestine Problems: NEXIUM can cause serious stomach and intestine

problems. Tell your healthcare professional about symptoms that may be a sign of a more

serious problem in your stomach or intestine such as:

o trouble swallowing.

o unplanned weight loss.

o vomiting blood or food.

o black (blood-stained) stools.

See the Serious side effects and what to do about them table, below, for more information on

these and other serious side effects.

Antibiotics: If you take antibiotics while taking NEXIUM you may:

• experience symptoms such as severe (bloody or repeated watery) diarrhea, with or without

fever, abdominal pain or tenderness. These are symptoms of bowel inflammation caused by a

bacterial infection (Clostridium difficile).

If this happens, stop taking the drug combination and tell your healthcare professional immediately.

NEXIUM should not be used in combination with the antibiotic clarithromycin during pregnancy or

when breastfeeding, unless your healthcare professional tells you. Clarithromycin may harm your

unborn baby or newborn.

Pregnancy: Tell your healthcare professional if you are pregnant or planning to become pregnant.

There are specific risks you must discuss with your healthcare professional.

Long term use of NEXIUM: Long-term use of NEXIUM may:

NEXIUM

• interfere with the absorption of Vitamin B12 from the diet. This may cause a shortage of

Vitamin B12 in your body. Talk to your healthcare professional about this risk.

• lead to low blood magnesium in some people. When blood magnesium is lower than normal, it

may also lead to low blood calcium and low blood potassium.

• increase risks of broken bones of the hip, wrist or spine. This is more likely to happen if you use

NEXIUM every day for a year or longer. Talk to your healthcare professional about this risk.

• 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 NEXIUM:

• Medications that prevent blood clots such as warfarin, acetylsalicylic acid and clopidogrel. Use

of NEXIUM with clopidogrel should be avoided as it may decrease the effectiveness of

clopidogrel.

• Medicines used to treat HIV such as atazanavir, nelfinavir and saquinavir. NEXIUM may

decrease the effectiveness or increase side effects of some medicines used to treat HIV.

NEXIUM should not be used with atazanavir, nelfinavir or saquinavir.

• Methotrexate, used in high doses to treat cancer. Your healthcare professional may tell you to

stop taking NEXIUM temporarily while you are taking methotrexate.

• Medicines used to treat fungal infections such as itraconazole, ketoconazole, and voriconazole

• Diazepam, used to treat anxiety

• Phenytoin, used to treat epilepsy

• Cisapride (not available in Canada), used to help empty the stomach

• Tacrolimus, used to lower the risk of organ rejection

• Cilostazol (not available in Canada), used to treat poor circulation in the legs

• Digoxin, used to treat heart disorders

• Medicines used to treat tuberculosis such as rifampin

• Herbal medicines such as St John’s Wort

• Medicines used in cancer therapy such as erlotinib

Drug interactions can be different if you take NEXIUM for short periods of time than if you take it

every day.

How to take NEXIUM:

Follow your healthcare professional’s directions carefully. They may be different from the

information contained in this leaflet.

• Take all doses of NEXIUM that your healthcare professional prescribes even when you or your

child feel well. In some cases, doses every day are needed to control pain and symptoms, to

correct acid problems and to help damaged areas heal.

• If you take NEXIUM with antibiotic drugs, it is important that you take all medications twice each

day. Take them at the right time each day for one week. Studies have shown that patients who

take their medications as prescribed have better ulcer healing rates and greater success

getting rid of their Helicobacter pylori infection.

• Take NEXIUM until your healthcare professional tells you to stop. Even if you start to feel

better in a few days, your symptoms may return if NEXIUM is stopped too soon. NEXIUM

needs to be taken for the full treatment duration to help correct acid problems.

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

Tablets (delayed release):

• 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.

NEXIUM

Granules for Suspension (delayed release):

• 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

Your healthcare professional may tell you to take NEXIUM:

• 20 to 40 mg once a day for 2 to 8 weeks.

• Continue taking NEXIUM 20 mg each day. This is to keep your symptoms from coming back.

• In combination 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.

o If your prescription says NEXIUM 1-2-3 A

, you will take NEXIUM with the antibiotics

clarithromycin and amoxicillin.

o Your pharmacist should also give you information on the two antibiotics.

Maintenance Treatment of NERD (on-demand) Dose

After first treatment of NERD, your healthcare professional may suggest that you take NEXIUM 20

mg once daily, as needed, if symptoms of heartburn and regurgitation return once in a while.

Contact your healthcare professional if your symptoms get worse, won’t go away, or if new

symptoms arise.

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 mg once a day for 2 to 8 weeks.

Overdose:

If you think you, or a person you are caring for, have taken too much NEXIUM, contact a healthcare

professional, 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.

What are possible side effects from using NEXIUM?

These are not all the possible side effects you may have when taking NEXIUM. If you experience

any side effects not listed here, tell your healthcare professional.

If these side effects become bothersome (or last longer than 1-2 days), discuss with your

healthcare professional:

Common side effects include:

• Nausea

• Stomach upset

• Diarrhea

• Headache

NEXIUM

Uncommon side effects include:

• Dry mouth

• Dizziness

• Insomnia

• Feeling of burning/prickliness/numbing

• Swelling of extremities

• Feeling sleepy

• Feeling like you or your surroundings are moving (vertigo)

Rare side effects include:

• Taste disorders

• Nervousness

• Hair loss

• Increased sweating

Stopping your PPI therapy after taking it for a long time may cause your symptoms to get worse

and your stomach may increase acid production. Carefully follow your healthcare professional’s

instructions when stopping NEXIUM.

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

Blood disorders (low white and/or red

blood cell count): feeling tired or weak,

pale skin, bruising or bleeding for

longer than usual if you hurt yourself,

fever, chills



Blurred vision



Confusion



Depression



Feeling ill



Gastrointestinal fungal infection:

diarrhea, vomiting, melena,

hemorrhage, abdominal pain, and fever



Hepatitis (inflammation of liver): skin

and eyes appear yellow



Myalgia (muscle pain): aching

muscles, tenderness or weakness



Photosensitivity (sensitivity to

sunlight): itchy, red skin when exposed

to sunlight



Severe allergic reaction: shortness of

breath, chest pain or discomfort, feeling

thirsty, urinating less often, less urine

or dark urine, swelling or anaphylactic

reaction/shock



Shortness of breath



Skin reactions: rash, dermatitis,

itching and/or hives



Sore joints



Stomatitis (mouth sores, redness and

swelling of the lining of the mouth):

inflammation in the mouth



VERY RARE

Aggressive behaviour



Clostridium difficile colitis

(bowel inflammation): severe or



NEXIUM

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

persistent diarrhea, abdominal

pain, nausea and vomiting, fever

Decreased consciousness



Gynecomastia: breast enlargement in

men (and /or women)



Hallucinations: seeing or hearing

things that are not there



Hypomagnesemia (low level of

magnesium in the blood): abnormal eye

movements, fatigue, muscle spasms or

cramps, muscle weakness, numbness



Liver failure (serious disturbance of

liver function, hepatic failure): yellow

colour to skin, whites of the eyes

(jaundice), bleeding easily, swollen

abdomen, mental disorientation or

confusion, sleepiness, coma



Muscular weakness



Nephritis (inflammation of the kidney):

decreased appetite, difficulty breathing,

fatigue, frequent urination, itchiness,

nausea, vomiting



Serious skin reactions:

• Skin peeling, scaling, or blistering

(with or without pus) which may

also affect your eyes, mouth, nose

or genitals, itching, severe rash,

bumps under the skin, skin pain,

skin color changes (redness,

yellowing, purplish)

• Swelling and redness of eyes or

face

• Flu-like feeling, fever, chills, body

aches, swollen glands, cough



UNKNOWN

Subacute cutaneous lupus

erythematosus: new or worsening

joint pain, rash on your cheeks or arms

that gets worse in the sun



If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to

interfere with your daily activities, tell your healthcare professional.

NEXIUM

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.

Storage:

Keep all tablets sealed in the blister strips and the granules for 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 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.

Keep out of reach and sight of children.

If you want more information about NEXIUM:

• 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:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-

product-database.html; the manufacturer’s website www.astrazeneca.ca, or by calling 1-800-

668-6000.

• This Patient Medication Information is current at the time of printing. The most up-to-date

version can be found at www.astrazeneca.ca

This leaflet was prepared by AstraZeneca Canada Inc., Mississauga, Ontario L4Y 1M4.

NEXIUM

, NEXIUM 1-2-3 A

and the AstraZeneca logo are registered trademarks of AstraZeneca

AB, used under license by AstraZeneca Canada Inc.

Last Revised: SEP 16, 2021