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.
1. Why am I taking ZOPRAL & ZOPRAL ODT?
ZOPRAL & ZOPRAL ODT contains the active ingredient lansoprazole. ZOPRAL & ZOPRAL ODT
are used to treat peptic ulcers, reflux oesophagitis, heartburn and stomach pain associated
with reflux, or peptic ulcer and peptic ulcers associated with helicobacter pylori
infection. For more information, see Section
1. Why am I taking ZOPRAL & ZOPRAL ODT? in the full CMI.
2. What should I know before I take ZOPRAL & ZOPRAL ODT?
Do not take if you have ever had an allergic reaction to lansoprazole or any of the
ingredients listed at the end of the CMI.
3. What if I am taking other medicines?
4. How do I take ZOPRAL & ZOPRAL ODT?
Take ZOPRAL & ZOPRAL ODT in the morning before food.
Swallow whole with a glass of water. Do not crush or chew the capsules.
5. What should I know while taking ZOPRAL & ZOPRAL ODT?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking ZOPRAL & ZOPRAL
ODT.
If you become pregnant while taking this medicine, tell your doctor immediately.
Tell your doctor if any of your symptoms return after stopping treatment.
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Things you should not do
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Do not stop taking this medicine or change the dosage without checking with your doctor.
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Driving or taking machines
|
Be careful driving or operating machinery until you know how the medicine affects
you. ZOPRAL or ZOPRAL ODT may cause dizziness, blurred vision or headache.
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Drinking alcohol
|
Be careful when drinking alcohol while you are taking this medicine. If you drink
alcohol, dizziness may be worse.
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Looking after your medicine
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Keep your medicine in a cool dry place where the temperature stays below 25°C.
Store in original container.
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6. Are there any side effects?
Less serious side effects: stomach or bowel problems, headache, dizziness, tiredness, muscle aches, confused,
depressed, hallucinations, skin rashes, upper respiratory tract infection, urinary
tract infection, tingling or numbness of hands and feet, blurred vision, sensitivity
to sunlight, taste disturbances.
Serious side effects: red, itchy blistering spots, joint pain, watery & severe diarrhoea, swelling which
may cause difficulty breathing, yellowing of the skin or eyes, fever, fatigue, loss
of appetite, dark coloured urine, light coloured bowel movements, pain in the kidney
region, swelling of the hands, ankles or feet, bruising, severe blisters, bleeding,
sudden or severe hives or itchy skin accompanied by fever, infections, cramping of
the muscles in your hands or feet, irregular heartbeat, fits or seizures.
Tell your doctor immediately if you notice pain or indigestion occurring during treatment,
vomiting blood or food, passing of black (blood-stained) bowel motions as these are
likely to arise from the ulcer itself rather than the treatment. This is not a complete
list of all possible side effects.
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.
Active ingredient:
lansoprazole
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking ZOPRAL & ZOPRAL ODT. 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 ZOPRAL & ZOPRAL ODT.
Where to find information in this leaflet:
1. Why am I taking ZOPRAL & ZOPRAL ODT?
ZOPRAL & ZOPRAL ODT contains the active ingredient lansoprazole. ZOPRAL & ZOPRAL ODT is a type of medicine called a proton pump inhibitor (PPI). It
works by decreasing the amount of acid the stomach makes, to give relief from the
symptoms of excessive acid and allow healing to take place. This does not stop food
being digested in the normal way.
ZOPRAL & ZOPRAL ODT are used for the following conditions:
Peptic Ulcers
ZOPRAL & ZOPRAL ODT are used to treat peptic ulcers in adults. Depending on the position
of the ulcer, it is either 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
of the stomach.
Too much acid being made in the stomach can cause these ulcers.
ZOPRAL and ZOPRAL ODT are also used to help stop duodenal ulcers from coming back.
Reflux Oesophagitis
ZOPRAL and ZOPRAL ODT are used to treat the symptoms of reflux oesophagitis or reflux
disease in adults and in children from 6 to 17 years of age.
This can be caused by backflow (reflux) of food and acid from the stomach into the
food pipe or gullet, also known as the oesophagus.
Reflux can cause a burning sensation in the chest rising up to the throat, also known
as heartburn.
Heartburn and Stomach Pain Associated with Reflux or Peptic Ulcer
ZOPRAL and ZOPRAL ODT are used for the short-term treatment of heartburn and peptic
ulcer symptoms in adults.
Peptic Ulcers Associated with Helicobacter Pylori Infection
Most people who have a peptic ulcer also have bacteria called Helicobacter pylori
in their stomach. ZOPRAL and ZOPRAL ODT can be taken in conjunction with certain antibiotics
to help eradicate Helicobacter pylori and let your peptic ulcer heal. However, it
is possible that the antibiotics may not always get rid of Helicobacter pylori.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
There is no evidence that ZOPRAL and ZOPRAL ODT are habit-forming.
2. What should I know before I take ZOPRAL & ZOPRAL ODT?
Warnings
Do not take ZOPRAL & ZOPRAL ODT if:
you are allergic to lansoprazole, any medicines containing a proton-pump inhibitor
or any of the ingredients listed at the end of this leaflet.
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
Always check the ingredients to make sure you can take this medicine.
you have severe liver disease
you are already taking the medicine atazanavir
Atazanavir is used to treat HIV infection. If it is taken at the same time as ZOPRAL
or ZOPRAL ODT, it won't be absorbed properly and will be less effective in treating
HIV infection.
Do not take this medicine after the 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.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes.
have any other medical conditions:
liver or kidney problems
inflammation of the bowel
a tumour in the stomach region
have problems with digestion, or have an intolerance to:
fructose
glucose
galactose
lactose
sucrose
take any medicines for any other condition.
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
Check with your doctor if you are pregnant or intend to become pregnant.
Your doctor can discuss with you the risks and benefits of taking ZOPRAL or ZOPRAL
ODT during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Taking ZOPRAL or ZOPRAL ODT during breastfeeding should be avoided as it is not known
if this medicine passes into your breast milk.
If you have not told your doctor about any of the above, tell them before you start
taking ZOPRAL or ZOPRAL ODT.
3. What if I am taking other medicines?
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.
Some medicines may interfere with ZOPRAL & ZOPRAL ODT and affect how it works. These
include:
theophylline, used to treat asthma
oral contraceptives
warfarin, used to prevent blood clots
carbamazepine and phenytoin, used to treat seizures
ketoconazole, used to treat fungal infections
digoxin, used to treat heart complaints
sucralfate (used to treat gastric ulcers) and antacids (used to treat heartburn and
indigestion). ZOPRAL and ZOPRAL ODT should be taken at least one hour before taking sucralfate or
an antacid.
iron preparations
ampicillin esters, used in some antibiotics
tacrolimus, used in transplant patients to reduce organ rejection
atazanavir or other medicines used to treat HIV infection
methotrexate used to treat some cancers.
These medicines may be affected by ZOPRAL or ZOPRAL ODT 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 and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ZOPRAL & ZOPRAL ODT.
4. How do I take ZOPRAL & ZOPRAL ODT?
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
How much to take
Take one tablet each day, unless your doctor has told you otherwise.
Adults
The dose is usually 30 mg a day. The dose may vary from 15 mg to 30 mg a day depending
on your condition.
Children (6 years or older)
For children between 6 to 11 years, the recommended dose depends on the weight of
the child.
For children weighing 30 kg or less, the usual dose is 15 mg daily.
For children weighing over 30 kg, the usual dose is one 30 mg tablet daily.
For children between 12 to 17 years, the dose may vary from 15 mg to 30 mg a day depending
on the condition.
When to take ZOPRAL & ZOPRAL ODT
ZOPRAL & ZOPRAL ODT should be taken in the morning before food.
This medicine works best when taken on an empty stomach.
How to take ZOPRAL & ZOPRAL ODT
ZOPRAL (capsules)
Swallow the capsules whole with a glass of water.
Do not crush or chew the capsules.
If the granules in the capsules are crushed or chewed they will not work properly.
If you have difficulty swallowing the capsules whole, empty the capsule contents onto
some food or drink as follows:
The capsules may be emptied onto a small amount of either apple sauce, strained pears,
cottage cheese or yoghurt. Alternatively, the capsules may be emptied into a small
amount of apple, orange or tomato juice.
open the capsule
do not crush the granules
sprinkle the granules onto one tablespoon of apple sauce, strained pears, cottage
cheese or yoghurt or into a small amount of apple, orange or tomato juice
swallow immediately. If drinking, rinse the glass two or three times with more juice
and swallow immediately each time.
Do not take ZOPRAL with any other food or drink.
ZOPRAL ODT (tablets)
Swallow the tablet whole with a glass of water, or gently suck the tablet, then swallow
the granules with your saliva.
If the tablet is chewed or crushed, it will not work properly.
How long to take ZOPRAL or ZOPRAL ODT
Continue taking your medicine for as long as your doctor tells you.
In most patients, ZOPRAL or ZOPRAL ODT relieves symptoms rapidly and healing is usually
complete within 4 weeks. In some patients a further 4 weeks of treatment may be needed
for complete healing.
In some cases, your doctor may decide that long-term treatment is needed.
Tell your doctor if any of your symptoms return after stopping long-term treatment.
ZOPRAL and ZOPRAL ODT are recommended only for short-term use (8 to 12 weeks) in children.
For children aged 6-11 years, do not exceed 12 weeks of treatment with ZOPRAL or ZOPRAL
ODT.
For children aged 12-17 years, do not exceed 8 weeks of treatment with ZOPRAL or ZOPRAL
ODT.
Tell your doctor if your symptoms return. You may need further treatment.
If you forget to take ZOPRAL & ZOPRAL ODT
ZOPRAL & ZOPRAL ODT should be taken regularly at the same time each day.
If you miss your dose at the usual time, and it is almost time for your next dose,
skip the dose you missed and take your next dose when you are meant to. Otherwise,
take it as soon as you remember, and then go back to taking your medicine as you would
normally.
Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much ZOPRAL & ZOPRAL ODT
If you think that you or anyone else may have taken too much ZOPRAL & ZOPRAL ODT,
urgent medical attention may be needed.
You should immediately:
phone the Poisons Information Centre
(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.
5. What should I know while taking ZOPRAL & ZOPRAL ODT?
Things you must do
Take ZOPRAL or ZOPRAL ODT exactly as your doctor has prescribed.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking ZOPRAL or ZOPRAL ODT.
Call your doctor straight away if you:
become pregnant while taking this medicine
Remind any doctor, dentist or pharmacist you visit that you are taking ZOPRAL & ZOPRAL
ODT.
Things you must not do
Do not take ZOPRAL or ZOPRAL ODT to treat any other complaints unless your doctor
tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or change the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen or you may have unwanted
side effects.
Things that may help your condition
Some self-help measures suggested below may help your condition. Talk to your doctor
or pharmacist about these measures and for more information.
aspirin and many other medicines used to treat arthritis, period pain or headaches
These medicines may irritate the stomach and may make your condition worse. Your doctor
or pharmacist may suggest other medicines you can take.
caffeine
Your doctor may advise you to limit the number of drinks that contain caffeine, such
as coffee, tea, cocoa and cola drinks because they contain ingredients that may irritate
the stomach.
eating habits
Eat smaller, more frequent meals. Eat slowly and chew your food carefully. Try not
to rush at meal times. Eat your meals well before bedtime.
smoking
Your doctor may advise you to stop smoking or at least cut down.
weight
Your doctor may suggest losing some weight to help your condition.
Driving or taking machines
Be careful before you drive or take any machines or tools until you know how ZOPRAL
& ZOPRAL ODT affects you.
This medicine generally does not cause any problems with your ability to drive a car
or operate machinery. However, as with many other medicines, ZOPRAL or ZOPRAL ODT
may cause dizziness, blurred vision or headache in some people.
Make sure you know how you react to ZOPRAL or ZOPRAL ODT before you drive a car, operate
machinery, or do anything else that could be dangerous if you are dizzy.
Drinking alcohol
Tell your doctor if you drink alcohol.
Your doctor may advise you to limit your alcohol intake.
Be careful when drinking alcohol while you are taking this medicine. If you drink
alcohol, dizziness may be worse.
Looking after your medicine
Keep your medicine it in a cool dry place where the temperature stays below 25°C.
Keep your medicine in the pack until it is time to take them. If you take the capsules
or tablets out of the pack they may not keep well.
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.
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.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking ZOPRAL or ZOPRAL ODT.
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.
Do not be alarmed by the following list of side effects. You may not experience any
of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Stomach or bowel problems such as:
diarrhoea or constipation
stomach pain
indigestion
vomiting or nausea
flatulence or wind
If you suffer severe persistent diarrhoea and/or vomiting when taking ZOPRAL or ZOPRAL
ODT, tell you doctor. As natural acid in the stomach helps to kill bacteria, the lowering of this stomach
acid by acid-reducing medicines such as ZOPRAL and ZOPRAL ODT may cause some people
to get certain stomach infections.
difficulty in thinking or working because of:
headache
dizziness
tiredness
generally feeling unwell
joint or muscle aches or pains
feeling confused, depressed or having hallucinations
experience changes to your appearance such as:
skin rashes
hives or itchy skin
hair thinning
breast enlargement and impotence in men with long term use
experience any signs of infection such as:
coughs, colds, sore throats or sinuses indicating an upper respiratory tract infection
frequent and painful passing of urine indicating a urinary tract infection
dry or sore mouth/throat
changes in your sight, hearing, taste or touch such as:
tingling or numbness of hands and feet
blurred vision
increased sensitivity to sunlight
taste disturbances
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
The below list includes serious to very serious side effects. You may need urgent
medical attention or hospitalisation. These side effects are rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell,
when taking, or soon after finishing taking ZOPRAL or ZOPRAL ODT.
Other side effects not listed here may occur in some people.
Low levels of magnesium in blood level may occur if you take this medicine for more
than three months. Your doctor may want to take some blood tests from time to time
to check your progress.
Other problems are more likely to arise from the ulcer itself rather than the treatment.
For this reason, tell your doctor immediately if you notice any of the following:
pain or indigestion occurring during treatment with ZOPRAL or ZOPRAL ODT
vomiting blood or food
passing of black (blood-stained) bowel motions
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.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ZOPRAL contains
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Active ingredient
(main ingredient)
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lansoprazole 15 mg or 30 mg per capsule
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Other ingredients
(inactive ingredients)
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Sugar spheres
magnesium carbonate hydrate
sucrose
maize starch
hyprolose
methacrylic acid copolymer
purified talc
macrogol 6000
titanium dioxide
polysorbate 80
colloidal anhydrous silica
Empty Hard Gelatin Capsule Size 2 Green Op/Green Op G2HCSA00735 [15 mg capsule only]
(ARTG PI No.: 107737)
Empty Hard Gelatin Capsule Size 0 Pink Op/Pink Op G0HCSA01082 [30 mg capsule only]
(ARTG PI No.: 107738)
Tek Print SW-9009 Black Ink (ARTG PI No.: 2343)
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Potential allergens
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galactose, phenylalanine, sugars and sulfites
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What ZOPRAL ODT contains
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Active ingredient
(main ingredient)
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lansoprazole 15 mg or 30 mg per orally disintegrating tablet
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Other ingredients
(inactive ingredients)
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magnesium carbonate hydrate
sugar spheres (sucrose & maize starch)
crospovidone
hyprolose
methacrylic acid - ethyl acrylate copolymer (1:1)
triethyl citrate
sodium hydroxide
purified talc
polysorbate 80
macrogol 6000
iron oxide red
iron oxide yellow
mannitol
microcrystalline cellulose
sodium starch glycollate type A
aspartame
sodium lauryl sulphate
sodium bicarbonate
citric acid monohydrate
magnesium stearate
Strawberry 052311 AP0551(flavour) (ARTG PI No.: 105990).
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Potential allergens
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aspartame, phenylalanine and sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What ZOPRAL & ZOPRAL ODT looks like
ZOPRAL 15 mg is white to off-white coloured pellets filled in a hard gelatin capsule
with green opaque cap and green opaque body imprinted with 'MYLAN' over '8015' on
both cap and body with black ink (AUST R 166764).
ZOPRAL 30 mg is white to off-white coloured pellets filled in a hard gelatin capsule
with pink opaque cap and pink opaque body imprinted with 'MYLAN' over '8030' on both
cap and body with black ink (AUST R 166765).
ZOPRAL ODT 15 mg is white to yellowish white round, flat-faced beveled edged tablet
engraved with "LP1" on one side and "M" on other side with orange to dark brown speckles
(AUST R 187430).
ZOPRAL ODT 30 mg is white to yellowish white round, flat-faced beveled edged tablet
engraved with "LP2" on one side and "M" on other side with orange to dark brown speckles
(AUST R 187431).
Available in blister packs of 28 capsules.
Who distributes ZOPRAL & ZOPRAL ODT
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in May 2024.
ZOPRAL® is a Viatris company trade mark
ZOPRAL & ZOPRAL ODT_cmi\May24/01