Nexium (Esomeprazole) 40mg Tablets Pack of 30

NEXIUM(R)

Esomeprazole magnesium trihydrate
Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions people ask about Nexium. It does not contain all the information that is known about Nexium.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Nexium against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Nexium is used for

Reflux Oesophagitis

Nexium is taken to treat reflux oesophagitis. This can be caused by “washing back” (reflux) of food and acid from the stomach into the food pipe (oesophagus).

Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.

Nexium is also taken to help stop reflux oesophagitis coming back or relapsing.

Upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drugs (NSAIDs) therapy

Nexium is taken to treat the symptoms of pain or discomfort, in the stomach caused by NSAIDs, a type of medicine for pain or inflammation.

Nexium is also taken to help heal and prevent ulcers caused by NSAIDs.

Peptic Ulcers Associated with Helicobacter pylori Infection

Most people who have a peptic (gastric and duodenal) ulcer also have a bacterium called Helicobacter pylori in their stomach.

Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out from the stomach.

If you have a peptic ulcer, your doctor will prescribe Nexium with antibiotics. When Nexium and antibiotics are taken together, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics.

Zollinger-Ellison Syndrome

Nexium is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces large amounts of acid, much more than in ulcers or reflux disease.

How Nexium works

Nexium is a type of medicine called a proton-pump inhibitor. It works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. This does not stop food being digested in the normal way.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Ask your doctor if you want more information.

Your doctor may have prescribed Nexium for another reason.

There is no evidence that Nexium is addictive.

Before you take Nexium

When you must not take it

Do not take Nexium if you have allergies to:

  • esomeprazole or any ingredient listed at the end of this leaflet.
  • any medicines containing a proton-pump inhibitor.
  • Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

    Nexium is not approved for use in children younger than 12 years of age.

    There is no specific information about use in children younger than 12 years of age, so Nexium is not recommended in these patients.

    Do not take Nexium after the use by (expiry) date printed on the pack.

    It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.

    Do not take Nexium if the packaging is torn or shows signs of tampering.

    Before you start to take it

    You must tell your doctor if you have:

  • allergies to any other medicines, foods, dyes or preservatives.
  • any problems with your liver
  • any other medical conditions
  • Do not take Nexium if you are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved.

    It is not known if it is safe for you to take Nexium while you are pregnant. It may affect your baby.

    It is not known if your baby can take in Nexium from breast milk if you are breastfeeding.

    Taking other medicines

    Tell your doctor if you are taking any other medicines, including any that you buy without a prescription at the pharmacy, supermarket or health food shop.

    Some medicines may interfere with Nexium. These include:

  • ketoconazole, itraconazole, voriconazole, medicines used to treat fungal infections
  • cisapride
  • diazepam, a medicine used to treat anxiety and some other conditions
  • phenytoin, a medicine used to treat epilepsy
  • citalopram, clomipramine or imipramine, medicines used to treat depression
  • clarithromycin, a medicine used to treat bacterial infections
  • warfarin, a medicine used to prevent blood clots
  • medicines for HIV treatment (atazanavir)
  • These medicines may be affected by Nexium or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines. Your doctor can tell you what to do if you are taking any other medicines.

    Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Nexium.

    If you have not told your doctor about any of these things, tell them before you take Nexium.

  • How to take Nexium

    Follow all directions given to you by your doctor and pharmacist carefully.

    These instructions may differ from the information contained in this leaflet

    If you do not understand the directions on the label, ask your doctor or pharmacist for help.

    How to take it

    Take one Nexium each day, unless your doctor has told you otherwise.

    The dose of Nexium is usually 20 mg or 40 mg a day depending on what condition you are being treated for and how severe it is.

    Swallow Nexium whole with a glass of water. Do not crush or chew the tablets.

    If the tablets are chewed or crushed they will not work properly.

    If you have difficulty swallowing the tablets:

  • 1.Place the tablet in half a glass of non-carbonated water. Mineral water or other liquids are not suitable
  • 2.Gently mix the tablet and water by stirring, taking care not to crush the tablet
  • 3.Stir until the tablet dissolves into little pellets
  • 4.Drink the liquid with the pellets immediately, or within 30 minutes. Do not chew the pellets
  • 5.Rinse the glass with half a glass of water and drink.
  • If you cannot swallow at all, follow steps 1-3 above to disperse the tablets and administer the liquid and pellets through a gastric tube.

    Take Nexium at about the same time each day.

    Keeping a regular time for taking Nexium will help to remind you to take it.

    In most patients, Nexium relieves symptoms rapidly and healing is usually complete within 4 weeks. Continue taking Nexium for as long as your doctor tells you.

    Nexium can be taken with food or on an empty stomach.

    If you forget to take it

    If you forget to take a dose, take it as soon as you remember, and then go back to taking it as you would normally.

    If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

    Do not take a double dose to make up for the dose that you missed.

    If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

    Taking too much (overdose)

    Telephone your doctor or the Poisons Information Centre (13 11 26) or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too many Nexium even if there are no signs of discomfort or poisoning.

    While you are taking NEXIUM

    Things you must do

    Take Nexium exactly as your doctor has prescribed.

    If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking Nexium.
    Tell all doctors, dentists and pharmacists who are treating you that you are taking Nexium.

    Tell your doctor if you become pregnant while you are taking Nexium.

    Tell your doctor if your symptoms return.

    Although Nexium can heal ulcers successfully, it may not prevent them recurring at a later date.

    Things you must not do

    Do not take it to treat any other complaints unless your doctor tells you to.

    Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

    Side effects

    Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Nexium.

    Nexium helps most people with peptic ulcers or reflux disease, but it may have unwanted side effects in a few people.

    All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

    Ask your doctor or pharmacist to answer any questions you may have.
    Tell your doctor if you notice any of the following and they worry you:

  • nausea or vomiting
  • constipation
  • diarrhoea
  • headache
  • wind
  • stomach pain
  • skin rash
  • itchy skin
  • dizziness
  • dry mouth.
  • These are side effects are usually mild.

    Tell you doctor immediately if you notice any of the following:

  • blurred vision
  • sad mood (feeling depressed)
  • muscle pain
  • hair loss
  • signs of liver inflammation including yellowing of the skin or eyes, feeling generally unwell, nausea, vomiting, loss of appetite.
  • These are all rare or very rare side effects. These side effects may require medical attention.

    If you notice any of the following, tell your doctor immediately or go to Accident and Emergency at the nearest hospital:

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • severe skin reaction which may include rash, itching, redness, blistering or peeling of the skin
  • These are very serious side effects. You may need urgent medical treatment or hospitalisation. These side effects are rare.

    Tell your doctor if you think you have any of these effects or notice anything else that is making you feel unwell.

    Some people may get other side effects while taking Nexium.

    Other problems are more likely to arise from the condition itself rather than the treatment.

    For this reason, contact your doctor immediately if you notice any of the following:

  • pain or indigestion during treatment with Nexium
  • you begin to vomit blood or food
  • you pass black (blood-stained) motions.
  • After taking it

    Storage

    Keep your Nexium in the blister pack until it is time to take them.

    If you take Nexium out of the blister pack it will not keep well.

    Keep it in a cool, dry place where the temperature stays below 25 degrees C.

    Do not store it or any other medicine in the bathroom or near a sink.

    Do not leave it in the car or on a window sill.

    Heat and dampness can destroy some medicines.

    Keep it where young children cannot reach it.

    A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

    Disposal

    If your doctor tells you to stop taking Nexium or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets you have left over.

    Product description

    What Nexium looks like

    Nexium 20 mg are a light pink, oblong shaped tablets engraved 20 mg on one side and A / EH on the other.

    Nexium 40 mg are a pink, oblong shaped tablets engraved 40 mg on one side and A / EI on the other.

    Ingredients

    Each Nexium tablet contains esomeprazole magnesium trihydrate as the active ingredient equivalent to esomeprazole 20mg or 40mg;

    plus,

  • Glyceryl monostearate (E 471)
  • Hydroxypropyl cellulose
  • Hypromellose
  • Magnesium stearate (E 572)
  • Methylacrylic acid copolymer
  • Microcrystalline cellulose (E 460)
  • Paraffin hard
  • Macrogol 6000
  • Polysorbate 80 (E 433)
  • Crospovidone
  • Sodium stearyl fumarate
  • Purified talc (E 553(b))
  • Titanium dioxide (E 171)
  • Triethyl citrate
  • Sugar spheres
  • The tablets are coloured with iron oxide red CI77491 and/or iron oxide yellow CI77492

    Nexium tablets are available in blister packs of 7 or 30 tablets.

    Nexium tablets do not contain gluten.

  • Sponsor

  • AstraZeneca Pty Ltd
  • ABN 54 009 682 311
  • Alma Road
  • NORTH RYDE NSW 2113
  • This leaflet was prepared in October 2006.
  • Australian Registration Number
  • Nexium 20 mg (blister) – 74133
  • Nexium 40 mg (blister) – 74134
  • Non-marketed presentations
  • Nexium 20 mg (bottle) – 75726
  • Nexium 40 mg (bottle) – 75727
  • Trade Marks herein are the property of the AstraZeneca group
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