NOXICID® CAPS HEARTBURN RELIEF
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
NOXICID CAPS HEARTBURN RELIEF contains the active ingredient esomeprazole (as magnesium).
It is used for the relief of frequent heartburn and stomach acid complaints due to
gastro-oesophageal reflux disease (GORD).
For more information, see Section 1. Why am I taking NOXICID CAPS HEARTBURN RELIEF? in the full CMI.
Do not take if you have ever had an allergic reaction to NOXICID CAPS HEARTBURN RELIEF
or any of the ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take NOXICID CAPS HEARTBURN RELIEF? in the full CMI.
Some medicines may interfere with NOXICID CAPS HEARTBURN RELIEF and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
NOXICID CAPS HEARTBURN RELIEF is available as enteric capsules. The dose is usually
20 mg per day, once daily, for 7 - 14 days, depending on the severity of your symptoms.
Follow all directions given to you by your doctor and/or pharmacist.
More instructions can be found in Section 4. How do I take NOXICID CAPS HEARTBURN RELIEF? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking NOXICID CAPS
HEARTBURN RELIEF.
Tell your doctor if you become pregnant.
Tell your doctor if your symptoms return.
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Things you should not do
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Do not take NOXICID CAPS HEARTBURN RELIEF 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.
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Driving or taking machines
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Be careful before you drive or take any machines or tools until you know how NOXICID
HEARTBURN RELIEF CAPS affects you.
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Looking after your medicine
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Keep your medication in the blister pack until it is time to take it.
Keep it in a cool, dry place where the temperature stays below 25°C
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For more information, see Section 5. What should I know while taking NOXICID CAPS HEARTBURN RELIEF? in the full CMI.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. These include nausea or vomiting, constipation, diarrhoea,
headache, wind, stomach pain, skin rash, itchy skin, dizziness or dry mouth. However,
some serious side effects may need urgent medical attention. These include 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,
blood in the urine and increased or decreased urine output.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
NOXICID® CAPS HEARTBURN RELIEF
Active ingredient(s):
Esomeprazole (as magnesium)
Consumer Medicine Information (CMI)
This leaflet provides important information about taking NOXICID CAPS HEARTBURN RELIEF.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking NOXICID CAPS HEARTBURN RELIEF.
Where to find information in this leaflet:
NOXICID CAPS HEARTBURN RELIEF contains the active ingredient esomeprazole. NOXICID CAPS HEARTBURN RELIEF 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.
NOXICID CAPS HEARTBURN RELIEF is used for the relief of frequent heartburn and stomach
acid complaints due to gastro-oesophageal reflux disease (GORD). 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. Frequent heartburn is when you have heartburn
for two or more times a week. Heartburn that occurs frequently is a typical symptom
of GORD.
Your doctor may have prescribed NOXICID CAPS HEARTBURN RELIEF for another reason.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
NOXICID CAPS HEARTBURN RELIEF is not addictive.
Do not take NOXICID CAPS HEARTBURN RELIEF if:
you are allergic to esomeprazole, or any of the ingredients listed at the end of this
leaflet.
you are allergic to any medicines containing proton-pump inhibitors (omeprazole, rabeprazole,
lansoprazole, pantoprazole).
Symptoms of an allergic reaction may include:
Symptoms of an allergic reaction may include:
Shortness of breath, wheezing or difficulty breathing
Swelling of the face, lips or other parts of the body
Rash, itching or hives on the skin
Always check the ingredients to make sure you can take this medicine.
you are also taking atazanavir or cilostazol.
Please check with your pharmacist or doctor if you are taking these medicines. These
medicines will be affected by NOXICID CAPS HEARTBURN RELIEF.
the expiry date printed on the pack has passed, 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.
Check with your doctor or pharmacist if you have:
allergies to any other medicines, foods, dyes or preservatives
any problems with your liver
severe kidney problems
difficulty swallowing, persistent vomiting or vomiting of blood, blood in stools,
unexplained weight loss or some other significant medical conditions
previously taken heartburn/indigestion medications continuously for 4 or more weeks
to control your heartburn
recently finished a course of NOXICID CAPS HEARTBURN RELIEF or a similar medicine
in the last two weeks
any other medical conditions
been diagnosed with osteoporosis
ever had a skin reaction after the treatment with a medicine similar to NOXICID CAPS
HEARTBURN RELIEF that reduces stomach acid
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant or may become pregnant except on the
advice of a doctor or pharmacist.
It is not known if it is safe for you to take NOXICID CAPS HEARTBURN RELIEF while
you are pregnant. It may affect your baby.
Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.
Do not take this medicine if you are breastfeeding or wish to start breastfeeding.
It is not known if your baby can take in NOXICID CAPS HEARTBURN RELIEF from breast
milk if you are breastfeeding.
Tell your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
Children younger than 1 year
NOXICID CAPS HEARTBURN RELIEF is not approved for use in children younger than 18
years of age.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Do not take NOXICID CAPS HEARTBURN RELIEF if you are taking the following medicines:
atazanavir and nelfinavir, medicines used to treat Human Immunodeficiency Virus (HIV)
cilostazol, a medicine used to treat pain and/or cramping in the lower legs (or arms)
due to inadequate blood flow to the muscles
warfarin or clopidogrel-medicines used to prevent blood clots
methotrexate, a medicine used to treat arthritis and some types of cancer
Some medicines may interfere with NOXICID CAPS HEARTBURN RELIEF and affect how it
works. These include:
medicines used to treat fungal infections such as ketoconazole, itraconazole and voriconazole
cisapride
diazepam, a medicine used to treat anxiety and some other conditions
phenytoin, a medicine used to treat epilepsy
medicines used to treat depression such as citalopram, clomipramine or 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, a medicine used to prevent blood clots
medicines for HIV treatment such as atazanavir and nelfinavir
digoxin, a medicine used to treat heart conditions
tacrolimus and mycophenolate mofetil, medicines used to assist organ transplants
erlotinib or related medicines used to treat cancer
These medicines may be affected by NOXICID CAPS HEARTBURN RELIEF or may affect how
well it works. You may need different amounts of your medicine.
Your pharmacist or doctor can tell you what to do if you are taking any other medicines.
If you have not told your pharmacist or doctor about any of these things, tell them
before you take NOXICID CAPS HEARTBURN RELIEF.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect NOXICID CAPS HEARTBURN RELIEF.
How much to take
NOXICID CAPS HEARTBURN RELIEF is available as enteric capsules.
Take one NOXICID CAPS HEARTBURN RELIEF capsule each day.
NOXICID CAPS HEARTBURN RELIEF should be taken for at least 7 days and up to 14 days.
You should not take it for more than 14 days unless directed by a doctor.
When to take NOXICID CAPS HEARTBURN RELIEF
NOXICID CAPS HEARTBURN RELIEF should be taken at about the same time each day.
Keeping a regular time for taking NOXICID CAPS HEARTBURN RELIEF will help to remind
you to take it.
NOXICID CAPS HEARTBURN RELIEF is not intended for immediate relief. It may take several
days to achieve maximum results.
How to take NOXICID CAPS HEARTBURN RELIEF
Follow all directions given to you by your pharmacist and doctor carefully.
Swallow NOXICID CAPS HEARTBURN RELIEF enteric capsules whole with a glass of water.
NOXICID CAPS HEARTBURN RELIEF can be taken with food or on an empty stomach.
Do not crush or chew the capsules.
If the capsules are chewed or crushed, they will not work properly.
If you do not understand the instructions on the label, ask your pharmacist or doctor
for help.
If you forget to take NOXICID CAPS HEARTBURN RELIEF
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.
If you take too much NOXICID CAPS HEARTBURN RELIEF
If you think that you or anyone else has taken too much NOXICID CAPS HEARTBURN RELIEF,
urgent medical attention maybe needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Things you should do
Take NOXICID CAPS HEARTBURN RELIEF exactly as pharmacist or doctor has prescribed.
If you are about to be started on any new medicine, tell your pharmacist, doctor or
dentist that you are taking NOXICID CAPS HEARTBURN RELIEF.
Tell all pharmacists, doctors and dentists who are treating you that you are taking
NOXICID CAPS HEARTBURN RELIEF.
Tell your pharmacist or doctor if you become pregnant while you are taking NOXICID
CAPS HEARTBURN RELIEF.
Tell your doctor if you are not feeling better or your symptoms worsen.
Tell your doctor if your symptoms persist or return within two weeks of completing
the course.
If you have suffered from frequent heartburn /indigestion symptoms for some time you
should see your doctor.
If you need to have any medical tests while you are taking NOXICID CAPS HEARTBURN
RELIEF, tell your doctor. It may affect the results of some tests.
Things you should not do
Do not use it to treat any other conditions unless your pharmacist or doctor tells
you to.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Driving or taking machines
Be careful before you drive or take any machines or tools until you know how NOXICID
CAPS HEARTBURN RELIEF affects you.
There is no evidence that esomeprazole impairs the ability to drive a vehicle or operate
machinery.
Looking after your medicine
Keep your NOXICID CAPS HEARTBURN RELIEF in the blister pack until it is time to take
them.
If you take NOXICID CAPS HEARTBURN RELIEF out of the blister it may not keep well.
Keep it in a cool, dry place where temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
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.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions.
Less serious side effects
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Less serious side effects
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What to do
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Mouth related:
dry mouth
Head related:
headache
dizziness
Stomach related:
stomach pain
nausea or vomiting
constipation
diarrhoea
wind
Skin related:
skin rash
itchy skin
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Speak to your doctor or pharmacist if you have any of these less serious side effects
and they worry you.
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Less serious side effects
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What to do
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General:
fever
hair loss
Sight related:
blurred vision
Hormone related:
mood changes, confusion or depression
increase in breast size (males)
increased sweating
Skin and muscle related:
tremor
pins and needles
skin reaction, especially in sun exposed areas, with joint pain
muscle twitching or jerking movements
muscle pain or weakness, joint pain
increased bruising
Heart related:
irregular (fast or slow) heartbeat
Alertness and sleep related:
loss of consciousness or awareness
changes in sleep patterns
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Tell your pharmacist or doctor immediately if you notice any of these symptoms. These
are rare or very rare side effects and may require medical attention.
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Serious side effects
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Serious side effects
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What to do
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Breathing related:
shortness of breath, wheezing or difficulty breathing
Swelling related:
swelling of the face, lips, tongue or other parts of the body
Skin related:
severe skin reaction which may include rash, itching, redness, blistering or peeling
of the skin. This may be associated with a high fever and joint pains.
Liver related:
signs of liver inflammation including yellowing of the skin or eyes, feeling generally
unwell, nausea, vomiting, loss of appetite
Kidney related:
Blood in the urine
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these very serious side effects.
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pain or indigestion during treatment with NOXICID CAPS HEARTBURN RELIEF
you begin to vomit blood or food
you pass black (blood-stained) motions
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Contact your doctor immediately if you notice any of these side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Other problems are more likely to arise from the condition itself rather than the
treatment.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
This medicine is available over-the-counter without a doctor's prescription.
What NOXICID CAPS HEARTBURN RELIEF contains
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Active ingredient
(main ingredient)
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esomeprazole (as magnesium)
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Other ingredients
(inactive ingredients)
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Sugar spheres (ID 2535)
Sucrose
Crospovidone
Hyprolose
Mannitol
Methacrylic acid - ethyl acrylate copolymer (1:1)
Triethyl citrate
Glyceryl monostearate
Polysorbate 80
Purified talc
Empty Hard Gelatin Capsule
Shells Cap & Body – Pink & Pink Size 3 (ID 109606)
TekPrint SW-9008 Black Ink (ID 2328)
Sodium hydroxide
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Potential allergens
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Traces of Sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What NOXICID CAPS HEARTBURN RELIEF looks like
NOXICID CAPS HEARTBURN RELIEF 20 mg (as magnesium)
capsules are white to cream-coloured pellets filled in hard gelatin capsule with pink cap
and pink body, imprinted with 'Mylan' over 'EM 20' in black ink on cap and body (AUST
R 336014).
Each blister pack contains 14 enteric capsules.
