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Esomeprazole Viatris (esomeprazole) Drug / Medicine Information


esomeprazole (as magnesium dihydrate)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about ESOMEPRAZOLE VIATRIS. It does not
contain all the available information. It does not take the place of talking to your
doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking
ESOMEPRAZOLE VIATRIS 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 Esomeprazole VIATRIS is used for

Reflux Oesophagitis

ESOMEPRAZOLE VIATRIS 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.

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

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

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

ESOMEPRAZOLE VIATRIS 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 ESOMEPRAZOLE VIATRIS with antibiotics.
When ESOMEPRAZOLE VIATRIS 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

ESOMEPRAZOLE VIATRIS 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.

Bleeding Peptic Ulcers

When peptic ulcers become severe enough, they start to bleed. You may receive treatment
injected into your veins initially. This treatment may be followed with ESOMEPRAZOLE
VIATRIS tablets or granules prescribed by your doctor for a longer period of time.
This is to help your ulcer/s to heal.

How Esomeprazole VIATRIS works

ESOMEPRAZOLE VIATRIS 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 ESOMEPRAZOLE VIATRIS for another reason.

There is no evidence that ESOMEPRAZOLE VIATRIS is addictive.

Before you take Esomeprazole VIATRIS

When you must not take it

Do not take ESOMEPRAZOLE VIATRIS if you have allergies to:

esomeprazole or any ingredients 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

Do not take ESOMEPRAZOLE VIATRIS if you are also taking atazanavir or cilostazol.

Please check with your doctor or pharmacist if you are taking these medicines. These
medicines will be affected by ESOMEPRAZOLE VIATRIS.

ESOMEPRAZOLE VIATRIS is not approved for use in children younger than 1 year of age.

There is no specific information about use in children younger than 1 year of age,
so ESOMEPRAZOLE VIATRIS is not recommended in these patients.

Do not take ESOMEPRAZOLE VIATRIS after the use by (expiry) date printed on the pack
or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

any problems with your liver

severe kidney problems

any other medical conditions

been diagnosed with osteoporosis

if you have ever had a skin reaction after treatment with a medicine similar to ESOMEPRAZOLE
VIATRIS that reduces stomach acid

Do not take ESOMEPRAZOLE VIATRIS 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 ESOMEPRAZOLE VIATRIS while you are pregnant.

It may affect your baby.

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

Taking other medicines

Do not take ESOMEPRAZOLE VIATRIS if you are taking the following medicines:

atazanavir and nelfinavir, a medicine used to treat Human Immunodeficiency Virus (HIV)

cilostazol, a medicine used to treat intermittent claudication.

Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
shop.

Some medicines may interfere with ESOMEPRAZOLE VIATRIS These include:

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

diazepam, a medicine used to treat anxiety and some other conditions

phenytoin, a medicine used to treat epilepsy or fits

medicines used to treat depression such as citalopram, clomipramine and imipramine

St John’s wort, a herbal remedy used to treat mood disorders

medicines used to treat bacterial infections such as clarithromycin and rifampicin

warfarin and clopigodrel, medicines used to prevent blood clots

digoxin, a medicine used to treat heart conditions

methotrexate, a medicine used to treat arthritis and some types of cancer

tacrolimus and mycophenolate mofetil– a medicine used to assist in organ transplants

erlotinib or related medicines used to treat cancer.

These medicines may be affected by ESOMEPRAZOLE VIATRIS or may affect how well it
works. You may need different amounts of your medicines, 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 ESOMEPRAZOLE VIATRIS.

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

How to take Esomeprazole VIATRIS

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

They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help.

Children 1-11 years

Alternative preparations (oral suspensions) will be required for children in this
age range.

How much to take

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

Swallow ESOMEPRAZOLE VIATRIS tablets 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.

How to take it

ESOMEPRAZOLE VIATRIS is available as tablets.

Take one ESOMEPRAZOLE VIATRIS tablet each day, unless your doctor has told you otherwise.

When to take it

Take ESOMEPRAZOLE VIATRIS at about the same time each day.

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

ESOMEPRAZOLE VIATRIS can be taken with food or on an empty stomach.

How long to take it

Keep taking ESOMEPRAZOLE VIATRIS for as long as your doctor recommends.

In most patients, ESOMEPRAZOLE VIATRIS relieves symptoms rapidly and healing is usually
complete within 4 weeks.

Continue taking ESOMEPRAZOLE VIATRIS for as long as your doctor tells you to.

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 to take your medicine, ask your pharmacist for some
hints.

If you take too much (overdose)

Telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice,
or go to Accident and Emergency at the nearest hospital, if you think that you or
anyone else may have taken too much ESOMEPRAZOLE VIATRIS. Do this even if there are
no signs of discomfort or poisoning.

While you are taking Esomeprazole VIATRIS

Things you must do

Take ESOMEPRAZOLE VIATRIS 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 ESOMEPRAZOLE VIATRIS.

Tell all doctors, dentists and pharmacists who are treating you that you are taking
ESOMEPRAZOLE VIATRIS.

Tell your doctor if you become pregnant while you are taking ESOMEPRAZOLE VIATRIS.

Tell your doctor if your symptoms return.

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

If you need to have any medical tests while you are taking ESOMEPRAZOLE VIATRIS, tell
your doctor.

It may affect the results of some tests.

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 ESOMEPRAZOLE VIATRIS.

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

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist 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 side effects are usually mild.

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

blurred vision

mood changes, confusion or depression

muscle pain or weakness, joint pain

increase in breast size (males)

increased sweating

changes in sleep patterns

fever

increased bruising

“pins and needles”

hair loss

tremor

blood in the urine

skin reaction, especially in sun-exposed areas, with joint pain

These side effects may require medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your 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

signs of liver inflammation including yellowing of the skin or eyes, feeling generally
unwell, nausea, vomiting, loss of appetite.

These are very serious side effects.

You may need urgent medical treatment or hospitalisation.

Occasionally, ESOMEPRAZOLE VIATRIS may be associated with changes in your liver or
blood, which may require your doctor to do certain blood tests

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 ESOMEPRAZOLE VIATRIS.

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 ESOMEPRAZOLE VIATRIS

you begin to vomit blood or food

you pass black (blood- stained) motions.

Tell your doctor if your reflux symptoms return after you stop taking ESOMEPRAZOLE
VIATRIS.

After taking Esomeprazole VIATRIS

Storage

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

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

Keep it in a cool, dry place where the temperature stays below 25°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 ESOMEPRAZOLE VIATRIS or the expiry date has
passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

ESOMEPRAZOLE VIATRIS 20 mg tablet: elliptically shaped, biconvex, light pink enteric
coated tablet.

ESOMEPRAZOLE VIATRIS 40 mg tablet: elliptically shaped, biconvex, pink, enteric-coated
tablet.

Ingredients

ESOMEPRAZOLE VIATRIS contains 20 mg or 40 mg base of esomeprazole (as magnesium dihydrate)
as the active ingredient.

The tablets also contain the following inactive ingredients:

methacrylic acid polymer

purified talc

triethyl citrate

hypromellose

sucrose

maize starch

magnesium stearate

hydroxypropyl cellulose

glyceryl monostearate

polysorbate 80

microcrystalline cellulose

povidone

macrogol 6000

crospovidone

sodium stearylfumarate

titanium dioxide

macrogol 400

iron oxide red

iron oxide yellow

ESOMEPRAZOLE VIATRIS tablets are available in blister packs of 30 tablets.

Sponsor

ESOMEPRAZOLE VIATRIS is distributed in Australia by:

Alphapharm Pty Ltd trading as Viatris

Level 1, 30 The Bond

30-34 Hickson Rd

Millers Point NSW 2000

Phone: 1800 274 276

This leaflet was prepared in January 2023.

Australian registration numbers:

AUST R 210854

AUST R 210844

ESOMEPRAZOLE VIATRIS_cmi\Jan23/00



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