Nexium (Esomeprazole)

Follow your doctor’s directions carefully. They may be different from the information contained in this leaflet.

• Take all doses of NEXIUM that your doctor 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 doctor tells you to stop. Even if you start to feel better in a few days, your symptoms may return ifNEXIUM 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:

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:

Your doctor 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.
  • If your prescription says NEXIUM 1-2-3 A, you will take NEXIUM with the antibiotics clarithromycin and amoxicillin.
  • Your pharmacist should also give you information on the two antibiotics.

After first treatment of NERD, your doctor 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 doctor 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.

How to use a compliance pack:

There are 14 days of labelled tablets, with one extra to make 15. All 15 tablets are exactly the same (including the one labelled "Take this tablet last"). When you have finished the 14 labelled tablets in the blister pack, take the one marked "Take this tablet last". Then start 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:

If you think you have taken too much NEXIUM, contact your 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.

Like all medicines, NEXIUM may cause side effects in some people. Side effects are usually mild. They usually go away a short time after starting NEXIUM.

These are not all the possible side effects you may feel when taking NEXIUM. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions. These side effects may not be caused by NEXIUM in your case, but only a doctor can assess this.

If these side effects become bothersome (or last longer than 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.
• Feeling like you or your surroundings are moving (vertigo).

Rare:

• 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 doctor’s instructions when stopping NEXIUM.

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 doctor if you have any concerns about your treatment.

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, stop taking the drug combination and call your healthcare professional immediately.

Long-term use of PPIs 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 about this risk.

Long-term use of PPIs may 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.

Using PPIs 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.

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 NEXAVAR:

• drugs used to prevent blood clotting (warfarin or coumarin derivatives, clopidogrel). Speak to your doctor or pharmacist if you are taking any of these drugs. Use of NEXIUM with clopidogrel should be avoided.
• medication for HIV: NEXIUM may decrease the effectiveness of some drugs used for HIV treatment; atazanavir and nelfinavir should not be used with NEXIUM.
• a high dose of methotrexate (a drug used in high doses to treat cancer): NEXIUM may need to be temporarily withdrawn.
• 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.

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