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ZOTON FASTAB 15MG

Active substance(s): LANSOPRAZOLE / LANSOPRAZOLE / LANSOPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zoton FasTab* 15 mg oro-dispersible tablets
Zoton FasTab* 30 mg oro-dispersible tablets
lansoprazole
Read all of this leaflet carefully before you start taking this medicine.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
– If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor.
In this leaflet:
1. What Zoton is and what it is used for
2. Before you take Zoton
3. How to take Zoton
4. Possible side effects
5. How to store Zoton
6. Further information
1. What Zoton is and what it is used for
The active ingredient in Zoton is lansoprazole,
which is a proton pump inhibitor. Proton
pump inhibitors reduce the amount of acid
that your stomach makes.
Your doctor may prescribe Zoton for the
following indications:
– Treatment of duodenal and stomach ulcer
– Treatment of inflammation in your
oesophagus (reflux oesophagitis)
– Prevention of reflux oesophagitis
– Treatment of heartburn and acid
regurgitation
– Treatment of infections caused by the
bacteria Helicobacter pylori when given
in combination with antibiotic therapy
– Treatment or prevention of duodenal or
stomach ulcer in patients requiring
continued NSAID treatment (NSAID
treatment is used against pain or
inflammation)
– Treatment of Zollinger-Ellison syndrome.
Your doctor may have prescribed Zoton for
another indication or with a dose different
from that which is written in this information
leaflet. Please follow your doctor’s
instructions for taking your medicine.

experience side effects like these you should
take caution as your ability to react may be
decreased.
You alone are responsible to decide if you are
in a fit condition to drive a motor vehicle or
perform other tasks that demand increased
concentration. Because of their effects or
undesirable effects, one of the factors that
can reduce your ability to do these things
safely is your use of medicines.
Descriptions of these effects can be found in
other sections.
Read all the information in this leaflet for
guidance.
Discuss with your doctor, nurse or pharmacist
if you are unsure about anything.
Important information about some of the
ingredients of Zoton
Zoton contains lactose. If you have been told
by your doctor that you have an intolerance
to some sugars, contact your doctor before
taking this medicine.
Zoton contains aspartame. Aspartame is a
source of phenylalanine, which may be
harmful for people with phenylketonuria.
3. How to take Zoton

2. What you need to know before you take
Zoton
Do not take Zoton:
– if you are allergic (hypersensitive) to
lansoprazole or any of the other ingredients
of Zoton
– if you are taking a medicine containing the
active substance atazanavir (used in the
treatment of HIV).
Warnings and precautions
Please tell your doctor if you have serious
liver disease. The doctor may have to adjust
your dosage.
Your doctor may perform or have performed
an additional investigation called an
endoscopy in order to diagnose your
condition and/or exclude malignant disease.
If diarrhoea occurs during the treatment with
Zoton contact your doctor immediately, as
Zoton has been associated with a small
increase in infectious diarrhoea.
If your doctor has given you Zoton in addition
to other medicines intended for the treatment
of Helicobacter pylori infection (antibiotics) or
together with anti-inflammatory medicines to
treat your pain or rheumatic disease: please
also read the package leaflets of these
medicines carefully.
Taking a proton pump inhibitor like Zoton,
especially over a period of more than one
year, may slightly increase your risk of
fracture in the hip, wrist or spine. Tell your
doctor if you have osteoporosis or if you are
taking corticosteroids (which can increase the
risk of osteoporosis).
If you take Zoton on a long-term basis (longer
than 1 year) your doctor will probably keep
you under regular surveillance. You should
report any new and exceptional symptoms
and circumstances whenever you see your
doctor.
Talk to your doctor before taking Zoton:
• if you are due to have a specific blood
test (Chromogranin A).
• if you have ever had a skin reaction after
treatment with a medicine similar to
Zoton that reduces stomach acid.
If you get a rash on your skin, especially in
areas exposed to the sun tell your doctor as
soon as you can, as you may need to stop
your treatment with Zoton. Remember to also
mention any other ill-effects like pain in your
joints.
Taking other medicines
Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
In particular tell your doctor if you are taking
medicines containing any of the following
active substances as Zoton may affect the
way these drugs work:
– ketoconazole, itraconazole, rifampicin
(used to treat infections)
– digoxin (used to treat heart problems)
– theophylline (used to treat asthma)
– tacrolimus (used to prevent transplant
rejection)
– fluvoxamine (used to treat depression and
other psychiatric diseases)
– antacids (used to treat heartburn or acid
regurgitation)
– sucralfate (used for healing ulcers)
– St John’s wort (Hypericum perforatum)
(used to treat mild depression)
Taking Zoton with food and drink
For the best results from your medicines you
should take Zoton at least 30 minutes before
food.
Pregnancy and breast-feeding
If you are pregnant, breast-feeding or if there
is a chance you might be pregnant ask your
doctor for advice before taking this medicine.
Driving and using machines
Side effects such as dizziness, vertigo,
tiredness and visual disturbances sometimes
occur in patients taking Zoton. If you
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Place the tablet on your tongue and suck
gently. The tablet rapidly dissolves in the
mouth, releasing microgranules which you
should swallow without chewing. You can
also swallow the tablet whole with a glass of
water.
Your doctor might instruct you to take the
tablet with a syringe, in case you have serious
difficulties with swallowing.
The following instructions should be followed
if administered via syringe:
It is important that the appropriateness of the
selected syringe is carefully tested.
– Remove the plunger of the syringe (at
least 5 ml syringe for the 15 mg tablet
and 10 ml syringe for the 30 mg tablet)
– Put the tablet into the barrel
– Put the plunger back onto the syringe
– For the 15 mg tablet: Draw 4 ml tap
water into the syringe
– For the 30 mg tablet: Draw 10 ml tap
water into the syringe
– Invert the syringe and draw an additional
1 ml of air into it
– Shake the syringe gently for
10–20 seconds until the tablet is
dispersed
– The contents can be emptied directly
into the mouth
– Refill the syringe with 2–5 ml of tap water
to flush the remnants out of the syringe
into the mouth
If you are taking Zoton once a day, try to take
it at the same time each day. You may get
best results if you take Zoton first thing in the
morning.
If you are taking Zoton twice a day, you
should have the first dose in the morning and
the second dose in the evening.
The packaging has been printed with the
days of the week to help you keep track of
the medicines you have already taken.
The dose of Zoton depends on your
condition. The usual doses of Zoton for adults
are given below. Your doctor will sometimes
prescribe you a different dose and will tell you
how long your treatment will last.
Treatment of heartburn and acid
regurgitation: one 15 mg or 30 mg
oro-dispersible tablet every day for 4 weeks.
If symptoms persist you should report to your
doctor. If your symptoms are not relieved
within 4 weeks, please contact your doctor.
Treatment of duodenal ulcer: one 30 mg
oro-dispersible tablet every day for 2 weeks
Treatment of stomach ulcer: one 30 mg
oro-dispersible tablet every day for 4 weeks
Treatment of inflammation in your
oesophagus (reflux oesophagitis): one
30 mg oro-dispersible tablet every day for
4 weeks
Long-term prevention of reflux oesophagitis:
one 15 mg oro-dispersible tablet every day,
your doctor may adjust your dose to one 30
mg oro-dispersible tablet every day.
Treatment of infection of Helicobacter
pylori: The usual dose is one 30 mg
oro-dispersible tablet in combination with
two different antibiotics in the morning and
one 30 mg oro-dispersible tablet in
combination with two different antibiotics in
the evening. Treatment will usually be every
day for 7 days.
The recommended combinations of
antibiotics are:
– 30 mg Zoton together with 250–500 mg
clarithromycin and 1000 mg amoxicillin
– 30 mg Zoton together with 250 mg
clarithromycin and 400–500 mg
metronidazole
If you are being treated for infection because
you have an ulcer, it is unlikely that your ulcer
will return if the infection is successfully
treated. To give your medicine the best
chance of working, take it at the right time
and do not miss a dose.
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Treatment of duodenal or stomach ulcer in
patients requiring continued NSAID
treatment: one 30 mg oro-dispersible tablet
every day for 4 weeks.
Prevention of duodenal or stomach ulcer in
patients requiring continued NSAID
treatment: one 15 mg oro-dispersible tablet
every day, your doctor may adjust your
dose to one 30 mg oro-dispersible tablet
every day.
Zollinger-Ellison syndrome: The usual dose
is two 30 mg oro-dispersible tablets every
day to start with, then depending on how you
respond to Zoton the dose that your doctor
decides is best for you.
Use in children:
Zoton should not be given to children.
Take your medicine exactly as your doctor has
told you. You should check with your doctor if
you are not sure how to take your medicine.
If you take more Zoton than prescribed
If you take more Zoton than you have been
told to, seek medical advice quickly.
If you forget to take Zoton
If you forget to take a dose, take it as soon as
you remember unless it is nearly time for your
next dose. If this happens skip the missed
dose and take the remaining oro-dispersible
tablets as normal. Do not take a double dose
to make up for a forgotten oro-dispersible
tablet.
If you stop taking Zoton
Do not stop treatment early because your
symptoms have got better. Your condition
may not have been fully healed and may
reoccur if you do not finish your course of
treatment.
If you have any further questions on the use
of this product, ask your doctor.
4. Possible side effects
Like all medicines, Zoton can cause side
effects, although not everybody gets them.
The following side effects are common
(occur in more than 1 in 100 patients):
– headache, dizziness
– diarrhoea, constipation, stomach pains,
feeling or being sick, wind, dry or sore
mouth or throat
– skin rash, itching
– changes in liver function test values
– tiredness
– benign polyps in the stomach
The following side effects are uncommon
(occur in less than 1 in 100 patients):
– depression
– joint or muscle pain
– fluid retention or swelling
– changes in blood cell counts.
The following side effects are rare (occur in
less than 1 in 1000 patients):
– fever
– restlessness, drowsiness, confusion,
hallucinations, insomnia, visual
disturbances, vertigo
– a change in the way things taste, loss of
appetite, inflammation of your tongue
(glossitis)
– skin reactions such as burning or pricking
feeling under the skin, bruising, reddening
and excessive sweating
– sensitivity to light
– hair loss
– feelings of ants creeping over the skin
(paresthesiae), trembling
– anaemia (paleness)
– kidney problems
– pancreatitis
– inflammation of the liver (may be seen as
yellow skin or eyes)
– breast swelling in males, impotence
– candidiasis (fungal infection, may affect
skin or the mucosa)
– angioedema; You should see your doctor
immediately if you experience symptoms of
angioedema, such as swollen face, tongue
or pharynx, difficulty to swallow, hives and
difficulties to breath.
The following side effects are very rare (occur
in less than 1 in 10000 patients):
– severe hypersensitivity reactions including
shock. Symptoms of a hypersensitivity
reaction may include fever, rash, swelling
and sometimes a fall in blood pressure
– inflammation of your mouth (stomatitis)
– colitis (bowel inflammation)
– changes in test values such as sodium,
cholesterol and triglyceride levels
– very severe skin reactions with reddening,
blistering, severe inflammation and skin loss
– very rarely Zoton FasTab may cause a
reduction in the number of white blood
cells and your resistance to infection may
be decreased. If you experience an
infection with symptoms such as fever and
serious deterioration of your general
condition, or fever with local infection
symptoms such as sore throat/pharynx/
mouth or urinary problems you should see
your doctor immediately. A blood test will
be taken to check possible reduction of
white blood cells (agranulocytosis).
Frequency not known
if you are on Zoton for more than three
months it is possible that the levels of
magnesium in your blood may fall. Low
levels of magnesium can be seen as
fatigue, involuntary muscle contractions,
disorientation, convulsions, dizziness,
increased heart rate. If you get any of these
symptoms, please tell your doctor
promptly. Low levels of magnesium can
also lead to a reduction in potassium or
calcium levels in the blood. Your doctor
may decide to perform regular blood tests
to monitor your levels of magnesium.
– skin-related forms of lupus or a lupus rash
– rash, possibly with pain in the joints
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide
more information on the safety of this medicine.

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5. How to store Zoton
Keep out of the reach and sight of children.
Do not use Zoton after the expiry date which
is stated on the blister and carton. The expiry
date refers to the last day of that month.
Do not store above 25°C. Keep your medicine
in the packaging that it came in to help
protect it from moisture.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. Further information
What Zoton contains
– The active substance is lansoprazole
– The other ingredients are lactose
monohydrate, microcrystalline cellulose,
magnesium carbonate, low-substituted
hyprolose, hyprolose, hypromellose,
titanium dioxide, talc, mannitol, methacrylic
acid – ethyl acrylate copolymer,
polyacrylate dispersion, macrogol 8000,
glycerol monostearate, polysorbate 80,
triethyl citrate, citric acid anhydrous,
crospovidone, magnesium stearate,
aspartame (E951), strawberry flavour and
iron oxide red and yellow (E172).
What Zoton looks like and contents of the
pack
Zoton FasTab 15 mg and 30 mg are white to
yellowish white oro-dispersible tablets
speckled with orange to dark brown gastroresistant microgranules. Zoton FasTab 15 mg
have “15” imprinted on one side of the tablets
and Zoton FasTab 30 mg have “30” imprinted
on one side of the tablets. Each Zoton FasTab
oro-dispersible tablet is strawberry flavoured.
Zoton FasTab 15 mg and 30 mg are available
in packs of 28 tablets.
Marketing Authorisation Holder and
Manufacturer
The marketing authorisation holder is:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
The manufacturer is:
Pfizer Ireland Pharmaceuticals
Little Connell
Newbridge
County Kildare
Ireland
Or
Pfizer Manufacturing Deutschland GmbH,
Betriebsstätte, Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
This leaflet was last revised in 03/2017.
* Trademark of, and under
licence agreement with,
Takeda Pharmaceutical
Company Limited, Japan.

This leaflet can be made
available in large print, audio
or Braille on request. Contact
0800 198 5000 to request
this, quoting the following
numbers: 00057/1296 or
00057/1297.
Ref: ZT 15_0

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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