2. What should I know before I take ZOTON FasTabs?
Do not take if you have ever had an allergic reaction to ZOTON FasTabs, other proton
pump inhibitors (PPIs) or any of the ingredients listed at the end of the CMI; have
severe liver disease or are taking atazanavir.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with ZOTON FasTabs and affect how it works.
4. How do I take ZOTON FasTabs?
Your doctor or pharmacist will tell you how much to take and for how long to take
ZOTON FasTabs . It needs to be taken in the morning before food, dissolved on the
tongue or swallowed whole with a glass of water. More instructions can be found in
Section
4. How do I take ZOTON FasTabs? in the full CMI.
5. What should I know while taking ZOTON FasTabs?
|
Things you should do
|
Tell all doctors, dentists, pharmacists and nurses who are treating you, that you
are taking ZOTON FasTabs.
Tell your doctor if you become pregnant while you are taking ZOTON FasTabs; or experience
stomach pain, fever and diarrhoea which may contain blood/mucus, or red, itchy, blistering
spots, or skin rash including peeling, with fever, weakness/fatigue or muscle pain.
|
|
Things you should not do
|
Do not breastfeed while taking ZOTON FasTabs.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not take ZOTON FasTabs to treat any other complaints unless your doctor tells you
to.
|
|
Alcohol & Driving/using machines
|
Be careful before you drink alcohol, or drive or use any machines or tools until you
know how ZOTON FasTabs affects you as ZOTON FasTabs may cause dizziness in some people.
|
|
Looking after your medicine
|
Keep it in a cool dry place where the temperature stays below 25 °C.
|
6. Are there any side effects?
ZOTON FasTabs is well tolerated, and side effects are generally mild and transient.
Side effects may include headache, dizziness, tiredness, feeling unwell, nausea, vomiting,
diarrhoea, constipation, stomach pain, indigestion, flatulence, taste disturbances,
muscle/joint pain, hair thinning, increased sensitivity to sunlight. Serious side
effects include severe allergic reaction (shortness of breath; wheezing/difficulty
breathing; swelling of the face, lips, tongue; rash, itching or hives on the skin);
signs of infection (fever, sore throat); skin rash that can include blisters and peeling;
severe persistent diarrhoea and increased risk of bone fracture. 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(s):
lansoprazole
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking ZOTON FasTabs. 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 ZOTON FasTabs.
Where to find information in this leaflet:
1. Why am I taking ZOTON FasTabs?
ZOTON FasTabs contains the active ingredient lansoprazole.
ZOTON FasTabs is a type of medicine called a proton pump inhibitor (PPI). It works
by reducing 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.
ZOTON FasTabs is taken for:
Peptic Ulcers
ZOTON FasTabs is used to treat peptic ulcers (also called gastric or duodenal ulcers)
in adults.
Too much acid being made in the stomach can cause these ulcers. ZOTON FasTabs is also
used to help stop duodenal ulcers from coming back.
Reflux Oesophagitis
ZOTON FasTabs is used to treat 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/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.
ZOTON FasTabs is 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 a bacteria called Helicobacter pylori
in their stomach. ZOTON FasTabs 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.
2. What should I know before I take ZOTON FasTabs?
Warnings
Do not take ZOTON FasTabs if:
you are allergic to lansoprazole, other proton pump inhibitors (PPIs) or any of the
ingredients listed at the end of this leaflet. Always check the ingredients to make
sure you can take this medicine.
you have severe liver disease
you are already taking atazanavir, a medicine used to treat HIV infection. If atazanavir
is taken at the same time as ZOTON FasTabs, atazanavir will not be absorbed properly
and will be less effective in treating HIV infection
Check with your doctor if you:
had or have any other medical conditions including:
kidney or liver problems
inflammation of the bowel
a tumour in the stomach area
osteoporosis
low magnesium levels
glucose-galactose malabsorption
a rash or skin reaction after treatment with a proton pump inhibitor medicine like
ZOTON FasTabs that reduces stomach acid.
have problems with digestion, or have an intolerance to:
fructose, glucose, galactose, sucrose or maltose
lactose
aspartame.
During treatment, you may be at risk of developing certain side effects, including
fractures if treatment is long-term. 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 will discuss the possible risks and benefits of taking Zoton FasTabs during
pregnancy. Talk to your doctor if you are breastfeeding or intend to breastfeed. Taking
Zoton FasTabs during breastfeeding should be avoided as it is not known if this medicine
passes into your breast milk.
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 ZOTON FasTabs and affect how it works.
theophylline, used to treat asthma.
carbamazepine and phenytoin, used to treat seizures (fits).
warfarin, used to prevent blood clots.
tacrolimus or mycophenolate, immune suppressants used in transplant patients to reduce
organ rejection.
fluvoxamine, used to treat depression and other mental health conditions.
oral contraceptives (birth control pills).
ampicillin esters, used in some antibiotics.
ketoconazole, used to treat fungal infections.
iron preparations.
digoxin, used to treat heart conditions.
methotrexate, used in rheumatoid arthritis, psoriasis and certain cancers.
atazanavir, nelfinavir and other HIV medicines.
sucralfate (used to treat stomach ulcers) and antacids (used to treat heartburn).
ZOTON FasTabs should be taken at least an hour before taking sucralfate or antacids.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ZOTON FasTabs.
4. How do I take ZOTON FasTabs?
How much to take
Your doctor or pharmacist will tell you how much to take and for how long to take
ZOTON FasTabs as it depends on the condition you are taking it for.
Adults
The usual dose for adults is 30 mg once daily. The dose may vary from 15 mg daily
to 30 mg twice daily depending on the condition being treated.
Children
6 to 11 years old
The recommended dose for this age group depends on the weight of the child.
For children weighing 30 kg or less, the usual dose is 15 mg once daily.
For children weighing over 30 kg, the usual dose is 30 mg once daily.
12 to 17 years old
The usual dose may vary from 15 mg to 30 mg once daily depending on the condition
being treated.
When to take ZOTON FasTabs
ZOTON FasTabs should be taken in the morning before food.
ZOTON FasTabs works best when taken on an empty stomach.
How to take ZOTON FasTabs
There are two ways you can take:
Place the tablet on the tongue and gently suck the tablet, then swallow the granules
with your saliva.
Swallow the tablet whole with a glass of water.
Do not chew or crush the tablet as this affects how well ZOTON FasTabs works.
How long to take ZOTON FasTabs
Keep taking ZOTON FasTabs as directed, unless your doctor gives you other instructions.
In most patients, ZOTON FasTabs 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.
ZOTON FasTabs is recommended only for short term use (8 to 12 weeks) in children.
For children aged 6 to 11 years, do not exceed 12 weeks of treatment with ZOTON FasTabs.
For children aged 12 to 17 years, do not exceed 8 weeks of treatment with ZOTON FasTabs.
Tell your doctor if your symptoms return.
You may need further treatment.
If you forget to take ZOTON FasTabs
ZOTON FasTabs should be taken regularly at the same time each day. If you miss your
dose at the usual time, take it as soon as you remember, and then go back to your
normal routine.
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 you missed.
If you take too much ZOTON FasTabs
If you think that you have taken too much ZOTON FasTabs, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), 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 ZOTON FasTabs?
Things you should do
Take ZOTON FasTabs exactly as your doctor has prescribed.
If you are about to start any new medicine, remind your doctor and pharmacist that
you are taking ZOTON FasTabs.
Tell all doctors, dentists, pharmacists and nurses who are treating you, that you
are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
Tell your doctor if you become pregnant while you are taking ZOTON FasTabs.
Discuss the need for any additional supplements (e.g. vitamin D, magnesium, calcium,
vitamin B12), with your doctor, especially if taking ZOTON FasTabs long-term.
Immediately alert your doctor if you experience:
stomach pain and fever with diarrhoea which may contain blood or mucus
red, itchy, blistering spots on skin, or a rash that may include peeling, and may
be accompanied by fever, weakness, fatigue or muscle pain.
Things you should not do
Do not breastfeed while taking ZOTON FasTabs.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not take ZOTON FasTabs to treat any other complaints unless your doctor tells you
to.
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.
Driving or taking machines
Be careful before you drive or take any machines or tools until you know how ZOTON
FasTabs affects you.
ZOTON FasTabs generally does not cause any problems with your ability to drive a car
or operate machinery. However, as with many other medicines, ZOTON FasTabs may cause
dizziness in some people. Make sure you know how you react to ZOTON FasTabs before
you drive a car, operate machinery, or do anything else that could be dangerous if
you are dizzy.
Drinking alcohol
As you may experience dizziness when taking ZOTON FasTabs, drinking alcohol may make
the dizziness worse.
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.
Alcohol
Your doctor may advise you to limit your alcohol intake.
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 mealtimes. 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.
Looking after your medicine
Keep your tablets in their blister pack until it is time to take them.
If you take the tablets out of the blister pack, they may not keep well.
Keep it in a cool dry place where the 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 windowsills.
Keep it where young children cannot reach it.
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?
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 about side effects.
Side effects
|
Side effects
|
What to do
|
|
headache
dizziness, vertigo
tiredness and generally feeling unwell
nausea, vomiting
diarrhoea, constipation, stomach pain
indigestion, flatulence
joint/muscle aches or pain
feeling confused, depressed or hallucinating
skin rash, hives or itchy skin
hair thinning
breast enlargement and impotence in men
coughs, colds, sore throats or sinuses indicating an upper respiratory tract infection
frequent and painful passing of urine/wee indicating a urinary tract infection
dry or sore mouth or throat
tingling or numbness of hands and feet
blurred vision
increased sensitivity to sunlight
taste disturbances
swelling of the hands, ankles or feet
|
Speak to your doctor if you have any of these side effects and they worry you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Allergy and immune related
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 (severe allergic
reaction)
Liver related
yellowing of the skin or eyes, especially if accompanied by fever, fatigue, loss
of appetite, dark coloured urine/wee or light-coloured bowel movements
Bowel related
diarrhoea, usually with blood and mucus, stomach pain, fever
Kidney related
pain in the lower back or side, painful urination, fever, fatigue, swelling of hands,
ankles or feet
Blood related
frequent infections such as fever, severe chills, sore throat or mouth ulcers
bruising or bleeding more easily than normal, bleeding under the skin or red or purple
flat pinhead spots under the skin
muscle cramp or weakness of the muscles in your hands or feet, abnormal heart rhythms,
difficulty breathing, tingling and numbness, fits or seizures
Skin related
red, itchy blistering spots, especially if it appears in areas of the skin that are
exposed to the sun and is accompanied by joint pain
skin rash that can include blisters, peeling and may be accompanied by fever, weakness
and fatigue
Bone related
pain, swelling, bruising or discolouration, unusual shape of the limb, weakness and
difficulty moving the limb indicating a fracture
|
Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
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.
As natural acid in the stomach helps to kill bacteria, the lowering of acid by acid-reducing
medicines such as ZOTON FasTabs may cause some people to get certain stomach infections.
Other problems are more likely to arise from the ulcer itself rather than the treatment.
For this reason, contact your doctor immediately if you notice any of the following:
Pain or indigestion occurring during treatment with ZOTON FasTabs.
You begin to vomit blood or food.
You pass black (blood-stained) 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 ZOTON FasTabs contains
|
Active ingredient
(main ingredient)
|
lansoprazole
|
|
Other ingredients
(inactive ingredients)
|
lactose monohydrate
microcrystalline cellulose
magnesium carbonate hydrate
low-substituted hyprolose
hyprolose
hypromellose
titanium dioxide
purified talc
mannitol
methacrylic acid - ethyl acrylate copolymer (1:1) 30 per cent
polyacrylate dispersion 30 per cent
macrogol 8000
citric acid
glyceryl monostearate
polysorbate 80
triethyl citrate
iron oxide yellow (E172)
iron oxide red (E172)
crospovidone
magnesium stearate
strawberry flavour
aspartame
|
|
Potential allergens
|
lactose monohydrate
aspartame
|
Do not take this medicine if you are allergic to any of these ingredients.
ZOTON FasTabs does not contain gluten, tartrazine or any other azo dyes.
What ZOTON FasTabs looks like
ZOTON FasTabs 15 mg tablets: AUST R 153575.
ZOTON FasTabs 15 mg tablets are white to yellowish white uncoated tablets with orange
to dark brown speckles, with "15" marked on one side.
ZOTON FasTabs 15 mg is available in a blister pack of 28 tablets.
ZOTON FasTabs 30 mg tablets: AUST R 153701.
ZOTON FasTabs 30 mg tablets are white to yellowish white uncoated tablets with orange
to dark brown speckles, with "30" marked on one side.
ZOTON FasTabs 30 mg is available in a blister pack of 7 or 28 tablets.
Who distributes ZOTON FasTabs
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in November 2024.